Anda di halaman 1dari 56

Quality and Certification

Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

Revision

Date

Changes follow up

06/11

Para 5.1.2 - food added, para 5.4.1 food safety systems added, 6.5.3
deleted (approval of contractors)

11/11

12.2.1c - resources added, Para 13 - IAF MD 7 added, 3.7 added

10

12/11

12.2.1d and e - resources added,

11

06/12

Quality Manual restructured and updated in accordance with ISO


17021:2011, added para. 1.1 - QMS according to option 1, added para
10.6.7 - Management Representative, para 10.5.2 added for periodical
review of the documentation.

12

07/12

Quality Manual updated - clause 9 added in details

13

09/12

Para 5.2 updated - impartiality analysis, 5.3 updated, 8.3 - website


added, 8.6.3 updated, 9.1.4.6.7 updated, 9.1.5 - multi-site updated, 9.4.1
revised, 9.4.3 updated

Division Directors Signature: Eli Cohen - Kagan

Valid from : 09/12

Edition 13

Page : 1 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual
Quality Manual
Content

Para.
1
2
3
4
5
5.1
5.2
5.3
6
6.1
6.2
7
7.1
7.2
7.3
7.4
7.5
8
8.1
8.2
8.3
8.4
8.5
8.6
9
9.1
9.2
9.3
9.4

Subject
General and Scope of Activities
Normative Reference- Obligatory Standards and other Documentation

Terms and Definitions


Principles
General Requirements - Background of the Standards Institution of
Israel
Legal and Contractual Matters
Management of Impartiality
Liability and Financing
Structural Requirements
Organizational Structure and Top Management of the SII - Quality and
Certification Division
Committee for Safeguarding Impartiality
Resource requirements
Competence of Management and Personnel
Personnel Involved in the Certification Activities
Use of Individual External Auditors and External Technical Experts
Personnel Records
Outsourcing
Information Requirements
Publicly Accessible Information
Certification Documents
Directory of Certified Clients
Reference to Certification and Use of Marks
Confidentiality
Information Exchange between a Certification Body and its Clients
Process requirements
General requirements
Initial Audit and Certification
Surveillance Activities
Recertification

Valid from : 09/12

Edition 13

Page : 2 of 55

Page
4
4
4
5
6
6
6
7
8
9
9
10
10
10
10
10
10
10
11
11
11
11
11
11
11
11
12
25
28

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.5
9.6
9.7
9.8
9.9
10
10.4
10.5.1
10.9

Special Audits
Suspending, Withdrawing or Reducing the Scope of Certification
Appeals
Complaints
Records of Applicants and Clients
Quality Management System requirements - Option 1
Exclusions
Quality Policy
Core Processes

31
32
33
34
35
37
37
37
43

11

Division's Products

50

12

Sanctions according to IMF MD-7


Cross-reference division procedures to ISO 9001 standard

53

13

requirements

Valid from : 09/12

Edition 13

Page : 3 of 55

54

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

1. General and Scope of Activities


1.1

The Quality and Certification Division has chosen to establish and


maintain a Quality Management System based on ISO 9001 and
developed for conformity with the requirements of ISO 17021
following Option 1.

1.2 This Quality Manual was prepared according to ISO 17021:2011requirements.


1.3 The Quality Manual refers to the Quality and Certification Division which is one of the divisions of
the Standards Institution of Israel.
1.4 The manual refers to all the divisions activities, in the field of :
1.4.1

Operating the Management Quality systems certification

1.4.2

Standards mark systems' operation for processes and products.

1.4.3

Training center of the Standards Institution Professional guidance only..

1.4.4

Providing Assessment services such as IQ NET 9004

1.4.5

Operating Green Label and Green Building systems

2. Obligatory guidelines and required rules governing the division:


2.1 Standards Law 1953 ( combined version )
2.2 Standards mark regulations Standards mark and supervision symbol 1982
2.3 ISO IEC 17021 : 2011 Conformity assessment Requirements for bodies providing audit and
certification of management standards.
2.4 ISO IEC GUIDE 65
2.5 ISO IEC GUIDE 67
2.6 IAF MD 1 - Mandatory Document for the Certification of Multiple Sites Based on Sampling
2.7 IAF MD 2 - Mandatory Document for the Transfer of Accredited Certification Management Systems
2.8 IAF MD 3 - Advanced Surveillance and Recertification Procedures (ASRP) - Not eligible for ANAB
accreditation.
2.9 IAF MD 5 - Mandatory Document for Duration of QMS and EMS Audits
2.10 IAF MD 7 - IAF Mandatory document for Harmonization of Sanctions to be applied to CAB
2.11 I.S. ISO 9001:2008
2.12 I.S ISO 14001 : 2004
2.13 AS 9100 rev C
2.14 Ethical Code W.I 0.1
2.15 Form 101.06 - Milestones and meeting minutes for the Committee for safeguarding impartiality

3. Terms and definition


3.1

See ISO 9000

Valid from : 09/12

Edition 13

Page : 4 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

4. Principles
4.1 General Background and Objectives
4.1.1 The QCD provides certification services to quality management, environmental and safety systems
and product certification in order to promote the quality of management, service and human resource
and to improve the competitive ability and quality of life in the country. In addition the division provides
operational management services to the Standards Mark System which certifies products and
processes by permit committees. Certificate holders of the Institute benefit from their management
systems and marketing advantages.
4.1.2 The division employs more than 60 academically qualified auditors with experience in engineering,
finance, environmental affairs, programming and IT, safety, chemistry, food, agriculture, public
management, microbiology, and more. The expertise in these fields provides a broad data source
needed for certification and accreditation processes.
4.1.3 The division is accredited by the RvA for ISO 9001, ISO 14001 and ISO 13485 Management
Standards and is currently in a process to achieve accreditation from ANAB for ISO 9001, AS 9100
and ISO 22000 Management Standards.
4.1.4

The division, as a representative of the institute, is a member of IQNET which is a chain of 39


certification bodies that includes 150 branches in different countries. The members are connected
through mutual agreements, so that the certificates provided by the division are recognized in the
countries in which the organizations members operate. This fact assists the manufacturers in
international trade and reduces the cost of auditing required of them in the countries of destination.

4.1.5

The institute cooperates with various certification bodies worldwide, and is used as the operational
section to conduct audits in the organizations in the country. The meaning of it, is that audits are
conducted by qualified auditors of the division and the certificate is given by the relevant certification
body. In this way the certification spectrum given to manufacturers in the country has increased.
Main cooperation partners are : NQA ( England ) in the field of automotive industry, aerospace and
tele-communication, MDC (Germany )- medical products, LNE/GMED (France) medical products ,
ECAS (Holland) agriculture, ISA (Holland) food and agriculture.

4.2 Vision of the division


The Quality and Certification division shall be a leader on the market in all provided services, by innovation
and advancement, professional authority as well as reputation, providing value to its customers. The
division shall operate as a profit and loss center expanding its activities over the course of time.
4.3 Values of the Quality and Certification division
Client focus
Clear understanding and meeting the customer's needs and expectations.
Professional service
Providing service solely on a professional merit.
Cooperation and mutual responsibility
Team work, Openness, Transparency, Listening, Respect of feelings, understanding of needs:
employee to employee and employee to manager, loyalty to work place, responsibility for results.
Continuous Improvement and Innovation

Valid from : 09/12

Edition 13

Page : 5 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

Personal motivations to enrich knowledge, penetration of new products, improve internal processes and
improve performance (efficiency, effectiveness)
Information confidentiality
Safe guarding the intellectual property of the division / client and preventing leaks to concerns to whom
the division/client did not express his agreement (defined manner) of revealing to them.
Impartiality and Objectivity
Decisions based on objective evidence of conformity, not influenced by other interests.
Competence

Responsiveness to complaints

5. General Requirements - Background of the Standards Institution of Israel


5.1 Legal and contractual matters
5.1.1 Legal Responsibility
a) The Standards Institution of Israel is a non profit organization, operating with authorized powers
according to the" Standards Law" determined in 1953.The rules define the goals of the Institution,
Primarily standards preparation and product quality assurance, by standards preparation, conducting
audits, implementation of tests and research, granting approval to label with the Standards mark etc
b) The Standards Institution operates as an objective body and is a nonprofit organisation. The rules and
regulations of the institution determine the managing bodies the general assembly and the operational
committee and its composition. These bodies consist of representatives from organizations which
have influence on the daily activities of country such as Manufacturers Associations, Consumer
organisations, Government offices, Engineers Society, Contractors, Trade Associations, Local Councils
Science and Research Institutes and more.
c) The institute actively initiates, operates and participates in quality processes in the country such as:
National Quality week, National prize for quality in industry, Prize for quality in service and more.
d) The Standards Institution of Israel (SII) represents Israel in International standardization organizations
such as: ISO and IEC and is a member in institutes that manage these organizations. The Institute
maintains diverse contacts with parallel institutes overseas and is connected with parallel bodies under
bilateral recognition agreements. With these agreements the Institute obtains international recognition
allowing complete response to customer's requirements worldwide and provides Israeli companies the
opportunity to market their products overseas.
5.1.2 Certification Agreement
QCD maintains with all clients a legally enforceable agreement for the provision of certification
activities.
Details are defined in Procedure AC 03.01 and AC 03.02.
5.1.3 Responsibility for Certification
QCD is responsible for all decisions relating to certification, including : granting, maintaining,
renewing, extending, reducing, suspending and withdrawing of certification.
Details regarding those activities are defined in Procedures: AC 03.01, AC 03.02, AC 03.03, AC 03.04.
5.2 Management of Impartiality
5.2.1 We are committed to impartiality in our management system certification activities and ensure the
objectivity of our management system certification activities.

Valid from : 09/12

Edition 13

Page : 6 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

5.2.2 We identify, analyze and document the possibilities for conflict of interests arising from provision
of certification and resulting relationships. Detailed information hereto shall be made available to the
committee for safeguarding impartiality (CSI) for decision (see Form 101.06E - Risk Assessment). In
order to attain effective and consistent our impartiality is based on the following details :
5.2.3 We do not provide certification in cases of unacceptable threat to impartiality. There will be no offering
of certification when relationships that threaten impartiality cannot be eliminated or minimized.
5.2.4 We do not certify another certification body's management systems certification activities
5.2.5 The quality and certification division does not deal with consulting and does not provide internal
audits to its certified clients.
5.2.6 We do not outsource audits and do not offer linked activities with organizations that provides
management system consultancy. There are no joined marketing activities with consultancy
organizations.
5.2.7 We make sure, that personnel who have provided management system consultancy in previous
two years, shall not be used to take part in certification activities, unless more than 3 years passed.
5.2.8 We take actions to respond to any threats to our impartiality arising from external actions.
5.2.9 We make sure that all our personnel act impartially and shall not allow commercial, financial or
other pressures to compromise impartiality.
5.2.10 The personnel of the division is instructed to report any situations that might result in threats to
impartiality.
5.2.11 All the activities of the divisions staff are based on the Ethical Code W.I 0.1.
5.2.12 Periodically the Quality and Certification Division reviews conformance with the impartiality
requirements of ISO 17021. The results shall be recorded on form 101.06 - Risk Assessment and
presented to the CSI for further review and approval.
5.3 Liability and Financing
5.3.1 We evaluate periodically the risks arising from certification activities and posses appropriate insurance
to cover liabilities.
5.3.2 The evaluation is based on FMEA and is documented on Form 101.06.
5.3.3 We demonstrate to the committee for safeguarding impartiality (CSI) our finances and sources
periodically during reviews of impartiality. The demonstration is based on the QCD budget and
monthly and annual records of the QCD performance which are being processed by the Finance
Department.

Valid from : 09/12

Edition 13

Page : 7 of 55

Quality and Certification


Division Procedures
Chapter: Organization

6.

Procedure No.: AC.01.00


Procedure : Quality Manual

Organisational Structure of the Institute


Managing
Director
Comptroller

Spokesman

Quality and
Certification
Division.

Standardization
Division.

Industrial
Division.

Construction
Division.

Finance
Division.

Computer
Division.

Human
Resources
And
Maintenance

6.1 In order to complete the designated assignments the standards institution is organized according
to divisions and operational units as follows:
6.1.1 Responsibilities and authorities of the divisions
a) Standardizations division Responsible for the coordination and preparation of the Israeli
Standards and various specifications.
b) Industrial division Responsible for the operation of the Institutes labs such as: Electricity and
electronics lab, Mechanics Hydraulics and Energy lab, Chemistry Food and Textiles lab,
Calibrations lab and teleprocessing lab. The labs perform the tests in the manufacturer's plants,
Importers warehouse and customs.
c) Construction division Responsible for the operation of centralized labs for soil, roads and
construction material. The labs perform tests at the various construction sites. The division has
various branches and centers in the large cities in order to supervise public and private

Valid from : 09/12

Edition 13

Page : 8 of 55

Quality and Certification


Division Procedures
Chapter: Organization
d)

e)

Procedure No.: AC.01.00


Procedure : Quality Manual

construction countrywide.
Quality and Certification division Coordinates the following subjects:
Licenses granted to manufacturers for the production of products, Process certification,
Management Systems Certification approval, Certification of Food Safety Management
Systems, Information Security etc. The operation of the division is conducted through auditors
who perform the checks in order to provide permits in organizations and companies. The
division provides the professional support to the training center.
Service divisions Finance division, Human resource division and central computer division
who provide service to all the institutes units.

6.1.2 Responsibilities and authorities of the QCD Management - see AC 01.02.


6.1.3 Appointment of committees - See AC 01.01.
6.2 Committee for safeguarding impartiality - see AC 01.01
6.3 Organisational Structure of the QCD

Division Director
Eli Cohen-Kagan
Directors Assistant for
Budget and Control

Administration

Ravit Shahar

Training
Center

Orli Zarfati
Quality & Information
Management

Shai Hanoch

Orit Shirian

Rabinovitz

Orit Shirian
Rabinovitz
Head of
Standard
Mark

Operation Directorate
Joshua Miller

Head of Customer
Service Directorate
A. Weinberg

Head of Systems
Certification Directorate

Head of Green
Label Directorate

Jacob Jarosinski

Training Center Professional coordination only

Valid from : 09/12

Edition 13

Page : 9 of 55

Benny Braun

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

7. Resource requirements
7.1 Competence of management and personnel (AC.02.02)
7.1.1 General considerations
QCD ensures that personal have appropriate knowledge relevant to the types of management
standards we certify.
Required competences for each technical area are defined in W.I 2.0.
7.1.2 QCD reviews and approves conformance with competence criteria are defined in procedure.
7.1.3 Evaluation of the initial competence and ongoing monitoring of competence and performance is
based on clearly defined process.
7.1.4 QCD addresses clearly the competence requirements for personnel performing certification and
has sufficient access to technical expertise for each technical area.
7.2 Personnel Involved in the certification process
The process of evaluation of competence, employment of auditors including audit and team leaders
and technical experts, definition of duties and responsibilities, selection, training, authorization of
auditors, use and assignment of auditors, identification of training needs, requirements for personnel
taking decision on granting, maintaining, renewing, extending, reducing, suspending or withdrawing
certifications, observation and monitoring for auditors is laid down in details in procedure AC 02.03.
7.3 Use of individual external auditors and external experts
7.3.1 QCD maintains a written agreement with all auditors whether fully or partially employed.
7.4 Personnel records
QCD maintains up-to date personnel records, including relevant qualifications, training, experience,
competence and any consultancy services provided by any of the personnel.
7.5 Outsourcing
QCD does not outsource any of it's services.
7.6 Human resources (ISO 9001 clause 6.2)
7.6.1 The QCD employs sufficient number of auditors and other personnel (administration etc) to cover all
of its activities and to handle the volume of audit work performed. This issue is considered during
the preparation of the annual budget and is followed continuously by the QCD management.
7.6.2 The Certification Directorate assigns every existing or new organization / Management System
activities to one of the auditors. Periodical operational reports are issued from the computerized
system and reviewed by the Directorate with the purpose of monitoring of open activities (audits)
and in order to allow an exact overview of the work load of every auditor. Those reports allows to
verify if sufficient auditors are available or new auditors have to be hired in order to cover all
required audits for existing and new customers
7.6.3 SII employees few partial employed freelance auditors with different competences, who can
always backup any shortage of auditors until new auditors are hired and authorized

Valid from : 09/12

Edition 13

Page : 10 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

7.6.4 At the beginning of each year, training needs are being identified and a training plan is being
established in order to ensure competency of personnel.
8 Information Requirements
8.1 Publicly accessible Information
8.1.1 QCD maintains and makes publicly accessible accurate information describing the certification and
auditing process, including information about certification granted, suspended or withdrawn.
8.1.2 The information regarding the certification auditing system is available on the AC 04.xx procedures
depending on the Management System.
8.1.3 Information regarding certified / suspended organizations may be found on the SII Website and may
also be received by phone.
8.2 Certification Documents
Procedure AC 03.02 defines the requirements and the process of issuing of certificates
8.3 Directory of certified clients
QCD maintains a data bank of all certified organizations including all details, such as : name, address,
contact people, phones, e-mails, scope of certifications and history of the audit visits. The data is
confidentially maintained and secured. The data related to certified / suspended / withdrawn
organizations is publicly accessible through the SII Website (www.sii.org.il).
8.4 Rules for use of certification logos by organizations are defined on Form 130.03 and are handed over
to every certified organisation.
8.5 Confidentiality
8.5.1 QCD maintains a policy and arrangements to safeguard the confidentiality of the information
obtained during performance of audits.
8.5.2 All employees and any personnel, including members of the committees sign a confidentiality
agreement on Form 124.01.
8.6 Information exchange between a QCD and the clients
8.6.1 QCD provides and updates the customers on details regarding certification activities, normative
requirements and fees for application and certification and procedures for complaints and appeals see AC 04.xx.
8.6.2 Due notice regarding changes to the requirements is given to the customers.
8.6.3 QCD signs with every customer a legally enforceable agreement - e.g 129.01.
9 Process requirements
9.1 General Requirements
9.1.1. Audit Program
9.1.1.1 An audit is an independent systematic activity in order to determine if the activities and their
results conform to the planned arrangements. In an audit, these arrangements are also
checked to see if they have been effectively implemented and if they are suitable for achieving
the objectives. An audit applies to an entire system or to its elements.

Valid from : 09/12

Edition 13

Page : 11 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.1.2 QCD develops an audit program for the full certification cycle in order to demonstrate
that the client's management system fulfils the requirements for certification to the applicable
standards.
9.1.1.3 The audit program includes a two -stage initial certification audit, surveillance audit in the
first and second year and a recertification in the third year prior to expiration of certification.
The determination of the audit program takes into account the size of the organization,
complexity of the processes and products.
9.1.1.4 W here other audits have already been granted to an organiz ation, a reliable information
shall be collected, justified and recorded and shall be an input to adjust the audit program.
9.1.2 Audit Plan
9.1.2.1 Preparations and Audit Planning
Performance of an effective audit in an organizatio n depends on suitable preparations.
For this reason, the auditor must complete at least the following actions prior to the
performance of the audit:
9.1.2.2 Coordinate the date of the visit with the organization, at least one week in a dvance, and
ensure that an appropriate and authorized representative of the organization is present
during the performance of the audit. The organization representative must be notified of the
names of the audit team so he may appeal the participants.
9.1.2.3 Audit objectives, criteria and an audit plan shall be submitted to the organization representative in
order to prepare suitably. Where necessary, the audit plan may be adjusted and modified to the
organization constraints (as long as these adjustments and modifications do not interfere with audit
objectives and its essence).
9.1.2.4 Review the previous audit reports, with emphasis on nonconformities found and corrective
actions required.
9.1.2.5 Study the technologies and production processes and tests existing in the organiz ation.
As deemed necessary and according to the opinion of the auditor, a professional consultant,
from the SII laboratories (or from some other suitable source) shall be assigned to the audit.
9.1.2.6 Review the requirements of the applied standards, laws and/or requirements concerning
the field of certification that the customer has requested or received.
9.1.2.7 When the organization in within the framework of Standards Mark, the last laboratory
reports should be checked to see whether they have any negative findings, and these should
be clarified with the organization.
9.1.2.8 An audit plan shall be prepared on Form 125.xx Audit Plan, or Form 103.xx
Recertification and Audit Plan (see Appendix A).
9.1.2.9 Stage 1 audits shall be based on Stage 1 Audit plans - Form 125.00 for ISO 9001 /
AS9100, Form 125.22 for FSMS audits or equivalent shall be used.
9.1.2.10 The plan shall include an indication of the elements of the quality system and relevant
organizational units that will be audited. Consideration of all subjects in the various
organizational units shall be ensured.
9.1.3

Audit Team Selection and Assignment

Valid from : 09/12

Edition 13

Page : 12 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.3.1 Audits shall be performed by auditors with demonstrated competence (applies also to
technical experts if used), authorized in accordance with Procedures AC.02.02 and AC.02.06
for the Standards Mark system, in accordance with the results of the contract review. The
appointed Lead Auditor shall be entered into the AS400 system and shall be nominated by
Form 127.00. The organization shall be informed in writing regarding the appointment.
9.1.3.2 All team members shall be authorized for the standard / scheme needed to achieve
objectives of the audit.
9.1.3.3 The audit team shall include at least one auditor certified for the scope in the field of
activity of the organization, who will cover during the audit all activities related directly to the
scope (production / service related issues).
9.1.3.4 The lead auditor shall be responsible for all activities in the specific organization (the
attending auditor), unless set otherwise by the Head of Systems Certification Dir ectorate.
9.1.3.5 The audit team shall include persons capable of reading and writing in the language in
which the audit is performed.
9.1.3.6 When establishing a team of auditors to conduct an environmental management system
audit, the lead auditor shall choose additiona l auditors in accordance with their qualifications
concerning the environmental impact levels to be covered at the organization. In any case, at
least one team member shall cover the maximum impact level of the organization (see
AC.02.02).
9.1.3.7 Auditors in training may be included in the audit provided an auditor is appointed as an
evaluator.
9.1.4 Determining Audit Time
9.1.4.1 Determining of audit time is based on IAF MD 5:2009, those shall be used as guidelines for
preparation of quotations, based on questionnaires filled in by the customers and additional information
received about the customers premises and processes.
9.1.4.2 The tables provide a framework for further planning and adjustments to audit durations for all types
of audits.
9.1.4.3 Determining of audit time shall take into account the following aspects : the requirements of the
relevant management system standard, size and complexity of the organization, technological and
regulatory context, any outsourcing activities, the results of any prior audits, number of sites and multi-site
considerations
9.1.4.4 Time spent by any team member that is not assigned as an auditor (observers, auditors in training,
technical experts) shall not count as a part of the audit.
9.1.4.5 For the purpose of calculating the number of required man-days, the number of employees in an
organization shall include all employees, including administrative staff. see definition Effective
Number of Personnel
9.1.4.6 EMS audit duration

Valid from : 09/12

Edition 13

Page : 13 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.4.6.1 Risks, the nature of the organization and gravity of the environmental aspects shall be
considered. Determination of audit duration shall be based on the following complexity
categories :

9.1.4.6.2

High (Level 1) environmental aspects with significant nature and gravity (typically
manufacturing or processing organizations)

Medium (Level 2) environmental aspects with medium nature and gravity (typically
manufacturing organizations).

Low (Level 3) environmental aspects with low nature and gravity (typically assembly
organizations).

Limited (Level 4) environmental aspects with limited medium nature and gravity (typically
office type environment).

Special (Level X) require unique consideration.

See Table B for the four first complexity categories

Flexibility in consideration of man-days shall be applied, as not always organizations in a


specific sector fall in the same complexity category.

The attending auditor, assigned to the organization shall confirm the appropriate category on
Form 100.01 (Stage1), based on the gathered information concerning possible
environmental influences, the processes, the organization's complexity and legal obligations.
Possible sources of information are (but are not limited to) documents supplied by the
organization, information concerning processes in the relevant industry, visit to the site,
consultation with the engineer of the attending Division, etc. The auditor shall estimate the
time needed on the basis of this information.

Increase of audit duration should be considered n in the following cases :


- Complicated logistics involving many buildings and locations
- Staff speaking in foreign languages and an interpreter is required.
- High degree of regulation (food, drugs, aerospace etc)
- Highly complex system with relatively high number of unique activities
- Activities that require visiting of temporary sites (project management sites, service,
installation sites etc).
- Additional, indirect or unusual environmental aspects for the sector or higher sensitivity
compared to the industry sector

9.1.4.6.3

Reduction may be made for organizations in the following cases :


- Temporary unskilled personnel is available
- Client is not Design Responsible (for QMS only)

Valid from : 09/12

Edition 13

Page : 14 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

- Few of the standard elements are not covered in the scope (e.g no manufacturing
processes or offices only)
- Low risk products or processes.
- Maturity of management system
- Combined audit of an integrated system
- Prior knowledge of the client management system (e.g certified to another standard)
- Low complexity activities (service only)
- Identical activities performed on all shifts (based on previous audits / internal audits)
- Significant proportion of staff carry out similar simple functions in respect to the product
or service provided e.g. assembly workers in a mass production plant
- Staff include a number of people who work Off Location e.g salespersons, drivers,
service personnel, security guards and appropriate records for review are available
9.1.4.6.4

Where organizations operate on shift basis, the extent of auditing of each shift shall be based on
the level of control that is demonstrated by the client. The justification for not auditing each shift shall
be documented

9.1.4.6.5

For the first certification cycle a reduction of audit duration should not exceed 30 % of audit time
as established in tables.

9.1.4.6.6

Time required for audit planning and report writing should not reduce the total audit on-site to less
than 80% of the total audit time.

9.1.4.6.7

Reduction of times established in tables shall be justified on Calculation Forms.

9.1.4.6.8

Combined ISO 9001 / ISO 14001 audits - Man days for organizations with combined QMS / EMS
systems shall be calculated as follows : the number of man-days for QMS, based on the number of employees
shall be added to the required man-days defined for EMS, based on the environmental impact of the
organization

9.1.4.6.9

Modifying and updating the calculation - The planned surveillance audit duration shall be
reviewed from time to time, at least at the time of recertification

9.1.5

Multi-site Sampling

9.1.5.1 Multi-site sampling applies to organizations with similar processes, methods or activities (e.g
manufacturing, service, sales etc.). Where processes in each location are not similar, but clearly linked,
the sampling plan shall include at least one sample of each process conducted by the organization.
9.1.5.2 QCD conducts a contract review in order to ensure the eligibility of the organization for a multi-site
sampling. The contract review shall identify the complexity and scale of the activities covered by the
management system, including any differences between sites, as a basis for determining the level of
sampling and competency requirements.

Valid from : 09/12

Edition 13

Page : 15 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.5.3 If all sites of the organization are not ready to be submitted for certification at the same time, the
organization shall inform the QCD in advance of the ready and those to be excluded.
9.1.5.4 A representative of the QCD shall explain to the candidate the application of multi-sampling prior to
commencement of an audit.
9.1.5.5 A multi-site organization need not be a unique legal entity, but all sites shall have a legal or contractual
link with the central office of the organization.
9.1.5.6 The management system shall be under a centrally controlled QMS which shall include the following
items : System Documentation and changes, Management Review, Handling of Complaints,
Evaluation of Corrective Actions, Internal Audit Planning and evaluation of results, Changes to aspects
and associated aspects of EMS, Legal requirements, Nonconformities.
9.1.5.7 When nonconformities are found at any individual site, either through internal or external auditing,
investigation should take place to determine whether the other sites may be affected.
9.1.5.8 Evidence of resolution shall be required until control is re-established (frequency and/or size of sampling
may be increased as necessary).
9.1.5.9 At the time of the decision making process, if any site has a nonconformity, certification shall be denied
to the whole network of listed sites, pending satisfactory corrective action.
9.1.5.10 Exclusions of nonconformities at a single site can only be agreed in advance.
9.1.5.11

Certification Documents for multi-site organisations

9.1.5.11.1 Certificates shall contain the name and address of the central office and a list of all sites to which
the certification documents relate.
9.1.5.11.2 Certificates may be issued for each site under the condition, that they contain the same scope,
or a sub-scope of that scope.
9.1.5.11.3 The organization shall be requested to inform the SII about the closure of any sites covered by
the organization.
9.1.5.11.4

Addition of new sites additional audits shall be based on update of the audit program.

9.1.5.12 Sampling
9.1.5.12.1

At least 25% of the sample should be random.

9.1.5.12.2

Initial Audits sample size shall be calculated as follows : sample size = number of sites

9.1.5.12.3

Surveillance Audits sample size shall be calculated as follows sample size = 0.6 number of sites

9.1.5.12.4 Re-certification Audits sample size shall be calculated as follows sample size = 0.8 number of
sites.
9.1.5.12.5

Valid from : 09/12

Edition 13

Page : 16 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.5.12.6 Sampling may include the following aspects : results of internal audits, recordes of complaints,
significant variation in size, shifts, modifications since last audit etc.).
9.1.5.12.7 The sampling size may be increased due to the complexity of the activity, associated impacts for
EMS, audit results etc.
9.1.5.13

Adding of additional sites - each new group of sites shall be considered as an independed set for
the determination of the sample size. Following certification of the new group, the new sites shall be
cumulated to the previous one for determining the future sampling size.

9.1.5.14 Audit Time - The number of man-days per site, including main office shall be calculated according
to approved man-days Tables. The audit days shall never be less, than if the work had been
undertaken ar a single site.

9.1.6

Communication of Audit Tasks

9.1.6.1

The tasks given to the audit team include the following objectives: determination of the conformity of
the client's Management System, conformance with the applicable regulatory and contractual
requirements, continual evaluation of the effectiveness of the system.

9.1.6.2

Examination of the quality manual and procedures from the customer.

9.1.6.3

Auditing of the locations, organizational units, activities and processes. Generally, the totality of the
audits shall be consistent with the scope.

9.1.6.4

The audit criteria shall be used as a reference for conformity evaluation and shall provide a basis
for confidence in the client's management system.

9.1.6.5

The audit team leader shall communicate to the client any inconsistencies between the clients
policy, objectives and targets and the results.

9.1.7

Communication concerning audit team members

9.1.7.1

The Head of the Systems Certification Directorate shall appoint an attending auditor (in coordination
with the Customer Directorate).

9.1.7.2

Prior to the appointment, the Systems Certification Directorate shall ensure the suitability of the auditor
for the organization, namely:

9.1.7.2.1 His certification according to Procedure AC.02.02 for required standards and scopes,
technical knowledge and skills appropriate to the needed competencies for the organization
9.1.7.2.2 Impartiality - No connections, such as: family or business relationships, advising of competitors, etc.
that may influence the performance of the audit and the conclusions.
9.1.7.2.3 More than two years have passed since the auditor completed his function as a consultant to the
organization.
9.1.7.2.4 The attending auditor shall be appointed and the client informed accordingly, sufficient time to object.
9.1.8 Communication of the audit plan

Valid from : 09/12

Edition 13

Page : 17 of 55

Quality and Certification


Division Procedures
Chapter: Organization
9.1.8.1

Procedure No.: AC.01.00


Procedure : Quality Manual

The audit plan shall be communicated and the audit days agreed with the organization's
representatives.

9.1.9 Conducting on-site audits


9.1.9.1

QCD defined a process for conduction on-site audits.

9.1.9.2

Conducting the opening Meeting

9.1.9.2.1 The opening meeting shall take place with representatives of the organization. It is
important to assure that these representatives shall be of the appropriate level to able
and are authorized to transmit information on behalf of the organization. It is essential
that the person responsible for quality in the organizat ion should participate and it is
desirable that member(s) of the management also participate.
9.1.9.2.2 Information and clarification of the audit goals, scopes to be assessed and the system
of carrying out the audit shall be delivered, and the audit plan and timeta ble shall be
finalized.
9.1.9.2.3

An opening meting shall cover the following issues :

9.1.9.2.3.1

introduction of the participants, including an outline of their roles;

9.1.9.2.3.2

confirmation of the scope of certification;

9.1.9.2.3.3

confirmation of the audit plan (including type and scope of audit, objectives and criteria),
any changes, and other relevant arrangements with the client, such as the date and time
for the closing meeting, interim meetings between the audit team and the client's
management;

9.1.9.2.3.4

confirmation of formal communication channels between the audit team and the client;

9.1.9.2.3.5

confirmation that the resources and facilities needed by the audit team are available;

9.1.9.2.3.6

confirmation of matters relating to confidentiality;

9.1.9.2.3.7

confirmation of relevant work safety, emergency and security procedures for the audit team

9.1.9.2.3.8

confirmation of the availability, roles and identities of any guides and observers;

9.1.9.2.3.9

the method of reporting, including any grading of audit findings;

9.1.9.2.3.10 information about the conditions under which the audit may be prematurely terminated;
9.1.9.2.3.11

confirmation that the audit team leader and audit team representing the certification body is
responsible for the audit and shall be in control of executing the audit plan including audit
activities and audit trails;

9.1.9.2.3.12

confirmation of the status of findings of the previous review or audit, if applicable;

9.1.9.2.3.13

methods and procedures to be used to conduct the audit based on sampling;

Valid from : 09/12

Edition 13

Page : 18 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.9.2.3.14

confirmation of the language to be used during the audit;

9.1.9.2.3.15

confirmation that, during the audit, the client will be kept informed of audit progress and
any concerns;

9.1.9.2.3.16

opportunity for the client to ask questions.

9.1.9.2.3.17

A short general review of the organization and its quality system, and a very
short tour of acquaintance, if this is the first audit.

9.1.9.2.3.18

Evaluation of safety risks to the audit team during the audit

9.1.9.2.3.19

Information about changes in the processes, the product, the organizational


structure and the functions - if this is not a first audit.

9.1.9.2.3.20

The opening meeting should be kept as short as possible and not longer than 30
minutes.

9.1.9.3

Communication during the audit

9.1.9.3.1 During the audit, the audit team shall periodically assess audit progress and exchange
information.
9.1.9.3.2 The audit team leader shall reassign work as needed between the team members and
communicate the progress of the audit and any concerns to the client.
9.1.9.3.3 Where the audit evidence indicates that the audit objectives are unattainable or there is a risk to
the team members, the client shall be informed accordingly. The Lead Auditor is responsible to
advise any required plan changes, termination of the audit or scope changes to the team and to the
client.
9.1.9.3.4
9.1.9.4

Observers and Guides

9.1.9.4.1

9.1.9.4.2
9.1.9.4.3

9.1.9.5

Head of the System Certification shall be notified regarding the action taken in such cases.

The presence of observers dur ing the audit shall be agreed with the client prior to the
conduct of the audit.
During the audit, each auditor shall be accompanied by a guide
The Lead Auditor shall ensure that observers and guides do not influence or interfere
in the audit process.

Collecting and verifying information

9.1.9.5.1 During the audit information relevant to the audit objectives, scope and criteria,
including interfaces between functions and processes shall be collected to become audit
evidence.

Valid from : 09/12

Edition 13

Page : 19 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.9.5.2 These findings shall be collected by means of checking the documents (procedures,
work instructions, various approvals, etc.), checking the serviceability of equipment and
materials, checking work processes (including their compliance with procedures and work
instructions and interviewing the employees. Information gathered by questioning
employees, should be also verified by other means.
9.1.9.5.3 The audit also includes checking of publications of the organization, catalogues, information
sheets, packages and on the products, and checking that the customer does not publish misleading
information, (according to SII Procedures AC 04.01, AC.04.02, AC.04.03 etc). Every case of
misleading publication shall be reported and dealt with, by the person responsible for misleading
publications. In addition, the audit will include checking of complaints and appeals received in the
organization, or indirect complaints against the organization brought to the attention of the
division.
9.1.9.5.4 During the audit, check if there is conformity with the requirements while gat hering
relevant evidence to reach conclusions concerning the quality system being tested, and to
analyze these findings.
9.1.9.5.5

The audit plan and it's contents shall be followed.

9.1.9.5.6 The criticism should be constructive while preserving the respect of the employees of
the surveyed organization.
9.1.9.5.7 The auditors shall not add requirements beyond those specified in the standards, the
guideline documents or the organization procedures.
9.1.9.6

Identifying and recording audit findings

9.1.9.6.1 Findings shall be recorded against a specific re quirement of the applicable standard.
(following a discussion with the client, to ensure that the evidence is accurate and the
nonconformity is understood).
9.1.9.6.2 Opportunities for improvement may be identified and recorded, however
nonconformities shall not be classified as opportunities for improvement .
9.1.9.6.3 Objective evidence upon which conclusions are reached determining classification of
subjects on the report conclusion page shall be detailed
9.1.9.6.4 During the summary, if a disagreement arises between the auditor a nd the
representative of the organization, the claims of the representative of the organization
shall be heard with sincerity.
The auditor shall reconsider his judgment and determine whether to change his initial
decision and will act accordingly.
Disagreements not settled during the summary meeting, shall be noted in the audit
summary.
9.1.9.7

Preparing Audit conclusion

9.1.9.7.1 Prior to the closing meeting, the audit team shall review the audit findings and any
other information collected during the audit, agree upon t he audit conclusion and identify
any necessary follow-up action.

Valid from : 09/12

Edition 13

Page : 20 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.9.7.2 Appropriateness of the audit program shall be confirmed (e.g scope, audit time,
surveillance frequency, competence).
9.1.9.8

Conducting The Closing Meeting

9.1.9.8.1 A formal closing meeting (attendance shall be recorded) shall be held with customer's
management representatives.
9.1.9.8.2 The purpose is to present audit conclusions including recommendation regarding
certification.
9.1.9.8.3 Any Nonconformities shall be presented and explained during the audit. The audit
report shall include all nonconformities identified.
9.1.9.8.4 The closing meeting shall include also the following elements as applicable :
explanation regarding sampling during the audit, report presentation, grading of
nonconformities, process of handling nonconformities, status of certification, timeframe
for corrective action, information about the appeals process to the SII.
9.1.9.8.5 The audit report shall be submitted to the customer (in accordance with Procedure
AC.03.03). For initial audits (even if an organizations was class ified as conforming), the
pages of comments alone will be transmitted to the organization. The summary page shall
be transmitted to the organization only after all the stages of certification and approval
have been completed. Upon request of the organizat ion, the auditor may hand over a
summary page with the general classification no classification only.
9.1.9.8.6 The QCD process of handling nonconformities including any consequences relating to
the certification shall be explained
9.1.9.8.7

Information about the complaint handling and appeal process.

9.1.9.8.8

The client shall be given opportunity for questions.

9.1.10 Audit Report


9.1.10.1

At the end of the audit and prior to the summary meeting of the audit, a full audit report shall be
prepared, where findings shall be referred to the applicable standard element.

9.1.10.2

Audit findings shall be recorded for each audit on relevant report forms as follows:
Page of the summary of findings signed by the lead auditor, to which is attached a summary of the
audit, to which is attached details of findings.

9.1.10.3

The report must include details of corrective actions performed as a result of nonconformities
raised in previous reports. The remarks shall include details of corrective actions requested in the
past and not completed.

9.1.10.4

At the end of the audit, in accordance wi th new data accumulated, the Lead Auditor
shall check whether there is a need to update the number of man -days for the next audits,
and report his decision to the relevant assistant of the Customer Directorate. Information
regarding this change (if applic able) shall be communicated to representatives of the
organization.

Valid from : 09/12

Edition 13

Page : 21 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.10.5

The Lead Auditor is responsible for the contents of the audit including all relevant
information, such as : name and address of the customer, type of audit, audit criteria,
audit objectives, audit scope, names of the participants, place of audit, audit findings etc.

9.1.10.6

The audit plans and audit reports shall be transferred to the head of the directorate of
system certification for approval.

9.1.11 Cause Analysis on Nonconformities


9.1.11.1

Following the issuance of any nonconformities during the audit (classified as Major or
Minor), it is mandatory to require from the organization a written Correction / Corrective
Action Report which shall include a Root Cause Analysis, affected documentation and CA
effectiveness. CA may be submitted on Form 101.01or Form 101.02 or on a compatible
form of the audited organization which shall include all the information as detailed on the
a.m forms.

9.1.11.2

The auditor shall determine a timetable for receipt and review of the correction
/corrective action within a reasonable time in accordance with the significance of the
nonconformities.

9.1.12 Effectiveness of corrections and corrective actions


9.1.12.1

The Lead Auditor shall review (onsite or based on documentation) and approve the
correction / corrective action reports, including identified root causes and corrective
actions submitted by the client, to determine if all subjects were properly addresses, the
responsible people were identified and time tables for corrections and corrective action
implementation have been properly addresses and these are acceptable. The Lead
auditor shall verify the effectiveness of any correction and corrective action taken.

9.1.12.2

For Initial certification and recertification audits the nonconformities have to be closed
out prior to recommendation of certification or certification continuation

9.1.12.3

For surveillance audits the nonconformities may be reviewed during the next audit, up
to the decision of the Lead Auditor. If it is necessary to change the classification of the
audit as a result of the correction / corrective action submission, the decision shall be
transferred to the Head of the System Certification Directorate for approval.

9.1.12.4

In case no satisfactory correction / corrective action reports have been received,


including sufficient evidences of implementation of the corrective action , it is the
responsibility of the Lead Auditor to set a special audit or to initiate a suspension /
withdrawal of the certification.

9.1.12.5

The clients shall be informed accordingly regarding the statu s of correction /corrective
action verification.

9.1.13 Additional Audits


9.1.13.1

The client shall be informed in case an additional audit should be required.

9.1.14 Certification decision


9.1.14.1

The person who makes the certification decision is always different from those who
carried out the audit.

Valid from : 09/12

Edition 13

Page : 22 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.1.15 Actions prior to making decision


9.1.15.1 The recommendation file shall be transferred to the responsible professional coordinator of the
scheme (or scope) for professional review and once approved, to the Head of the System
Certification Directorate for final review and approval (by a signature). The signature of the Head of
the Directorate on the recommendation form 128.00, constitutes the decision to grant certification.
9.1.15.2 The approval is based on the following issues :
9.1.15.2.1 the information provided by the audit team was sufficient
9.1.15.2.2 The effectiveness of corrections and corrective actions was evaluated and accepted
9.1.15.2.3 Client's plan for corrections / corrective actions was approved
9.2 Initial Audit and Certification
9.2.1 Application
9.2.1.1

Organizations requesting certification for their management systems, may approach the Department
in a number of ways: By telephone, in writing, by email or through the internet.

9.2.1.2

The client shall prepare an application form, according to the requested certification.

9.2.1.3

The submitted information shall include :

9.2.1.3.1

The specific requested Standard (ISO 9001; MOD, ISO14001, IS18001 etc.) is clearly defined
on the application.

9.2.1.3.2

Requested scope of activity.

9.2.1.3.3

Location

9.2.1.3.4

The number of employees.

9.2.1.3.5

The name of the contact person.

9.2.1.3.6

Customer signature. An unsigned application shall be returned to the customer.

9.2.1.3.7

Information concerning employed consultants, shifts, exclusions etc.

9.2.1.3.8

Technologies, processes and products are clearly described, regulatory matters,


outsourcing etc.

9.2.2 Application Review


9.2.2.1 Upon receiving from the customer, the completeness of the application shall be checked by an
Assistant to the Directorate. The following details are to be considered:
9.2.2.1.1 The information about the applicant organization and its management system is sufficient for the
conduct of the audit and includes the following issues at least :

Valid from : 09/12

Edition 13

Page : 23 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.2.2.1.2 The specific requested Standard (ISO 9001; MOD, ISO14001, IS18001 etc.) is clearly defined
on the application.
9.2.2.1.3 Requested scope of activity.
9.2.2.1.4 The number of workers.
9.2.2.1.5 The name of the contact person.
9.2.2.1.6 The QCD has the competence and ability to perform the certification activity
9.2.2.1.7 Records of the decision are maintained
9.2.2.2 The reason for decline of an application shall be documented
9.2.2.3 Based on the review, the competences of the team shall be determi ned
9.2.2.4 The audit team shall be appointed based on the competences of the auditors.
9.2.2.5 The QCD established a list of competent certification decision makers
9.2.3 Initial Certification audit - shall be conducted in two stages
9.2.3.1 Stage 1 Audit
9.2.3.1.1 Stage 1 audit shall be based on Stage 1 audit plan - form 125.00 and shall
include the following issues:
9.2.3.1.1.1 The clients management system documentation
9.2.3.1.1.2 Evaluation of the clients location and assessment of preparedness for stage 2
audit and site-specific conditions and undertake discussions with the client's personnel.
9.2.3.1.1.3 Review of clients understanding of the standard with respect to processes,
objectives and operation of the management system.
9.2.3.1.1.4 Collecting of information regarding the scope of the management system, statutory
and regulatory aspects, legal aspects and risks and processes and locations.
9.2.3.1.1.5 Preparation of an audit plan for stage 2 audit.
9.2.3.1.1.6 Evaluation of internal audits and management review performed by the customer.
9.2.3.1.1.7 All Stage 1 audits under ANAB accreditation shall be co nducted onsite. The
statement is valid for new certifications as well as for transfers of ISO 9001 and ISO
22000 which had not include an onsite Stage 1 audit.
9.2.3.1.1.8 Consideration shall be given to the needs of the client to resolve areas of concern
identified during stage 1 audit.
9.2.3.1.1.9 Review of Quality Manual / Procedures and supporting Documentation

Valid from : 09/12

Edition 13

Page : 24 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.2.3.1.1.9.1 The review shall be performed by a certified auditor onsite or offsite as a


part of stage 1 audit.
9.2.3.1.1.9.2 The attending auditor shall review the suitability of the Quality Manual and related
Documentation, submitted by the customer, to the Standard, within 30 days of their
receipt in the Division.
9.2.3.1.1.9.3 The review of the Quality Manual shall be documented.
9.2.3.1.1.9.4 The report of the Quality Manual review shall be sent to the representative of the
organization prior to conducting the certification audit.
9.2.3.1.1.9.5 An auditor is authorized to approve the execution of an audit even if nonconformities
were found in documentation, or if corrections were not carried out sufficiently prior
to the certification audit. However, the certification of the organization is dependent
upon completion of all requirements
9.2.3.1.2 Stage 1 audit findings shall be documented and communicated to th e client.
9.2.3.1.3 Any areas of concern, which could be classified as nonconformities during stage 2
audit or may lead to postponement or cancellation of the Stage 2 audit.
9.2.3.2 Stage 2 Audits shall include :
9.2.3.2.1 Evaluation of the implementation, including effectiveness of the clients management
system.
9.2.3.2.2 Evidence about conformity to all requirements of the applicable standard or scheme.
9.2.3.2.3 Performance monitoring and reviewing against key performance objectives and
targets.
9.2.3.2.4 Conformance to regulatory and legal aspects relevant to the standard.
9.2.3.2.5 Operational control of the clients processes.
9.2.3.2.6 Internal auditing, management review and management responsibility, competence of
personnel, performance data, audit findings and conclusions.
9.2.3.2.7 Links between the normative requirements, policy, p erformance objectives and targets
9.2.4 Initial Certification audit Conclusion
9.2.4.1 The audit team shall analyze all information and audit evidence gathered during stage 1
and stage 2 audits and agree on conclusions
9.2.5 Information for Granting Initial Certification
9.2.5.1 The attending Lead auditor shall prepare the recommendation file.
9.2.5.1.1 The following documents shall be filed in the recommendation file in the following order:

Valid from : 09/12

Edition 13

Page : 25 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.2.5.1.2 Application form, filled out by the customer, requesting certification (Form 126);
9.2.5.1.3 Results of Stage 1 audit, including summary of procedure review (Form 100.01);
9.2.5.1.4 Report on Stage 2 audits conducted (Form 104) and correspondence regarding required
corrections / corrective actions (approved by the Lead Auditor), including organizations response;
9.2.5.1.5 Surveillance man-days calculation form (Form 120)
9.2.5.1.6 A Draft of the approved certification certificate (Form142);
9.2.5.1.7 Recommendation form (Form 128 ), signed by the attending auditor;
9.2.5.1.8 Surveillance Audit program (Form 103.xx) shall contain a detailed list of main processes,
departments / sites of the organization ;
9.2.5.1.9 Companys registration form.
9.2.5.2 Any existing information, such as public information, comments on the audit report from the client
shall be evaluated.
9.3 Surveillance Activities
9.3.1 General
9.3.1.1 QCD develops the surveillance activities so that representative areas and functions
covered by the scope of the management system are monitored on regular basis and take
into account changes to the client and his management system
9.3.1.2 Surveillance activities include semi-annual or annual on-site audits
9.3.2 Surveillance Audit
9.3.2.1 The objectives of the surveillance procedures are:
9.3.2.1.1 To verify that the management system of the organization continues to perform in compliance
with the requirements of the Standard and the follow-up agreement.
9.3.2.1.2 To check whether any changes occurred in the organization which necessitate a modification of
the management system.
9.3.2.1.3 To verify that corrective actions, which should have been implemented, were indeed carried out
as planned and as promised.
9.3.2.2 Surveillance methods :
9.3.2.2.1 The organizations may choose one of two surveillance methods:
9.3.2.2.1.1 Annual surveillance method - which includes conducting one surveillance audit annually, and
performing a Recertification every third year (conditioned for MOD suppliers upon confirmation
from MOD).

Valid from : 09/12

Edition 13

Page : 26 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.3.2.2.1.2 Semi-annual surveillance method - which includes conducting two audits annually and a
Recertification every third year .
9.3.2.2.1.3 Surveillance audits shall be conducted at least once a year. The date of the first surveillance
audit shall be not more than12 month from the last day of stage 2 audit.
9.3.2.2.1.4 Noncompliance with the requirement to conduct periodical audits in a timely manner (more
than 18 month for annual audits or more than 12 month for semi-annual audits will require to
start the certification process from the beginning, including Stage 1 audit. A waiver to this
procedure can be granted by the Head of the Certification Directorate only.
9.3.2.2.1.5 It is possible to transfer between the methods at the beginning of each surveillance year
only.
9.3.2.2.2 Audit Program and Audit Plan
9.3.2.2.2.1 The Customer Directorate, in combination with the attending auditor shall prepare a program
for conducting surveillance audits in the organization, in advance, according with the
surveillance method that the organization chose.The program shall be updated in the Computer
System, by the directorate workers.
9.3.2.2.2.2 The plan shall include or refer to the following : audit objectives, audit criteria, audit
scope, functional units, processes, dates and sites where the onsite activities are to be
conducted, expected time and duration of onsite audits, roles and responsibilities of the audit
members.
9.3.2.2.2.3 Based upon the program and following certification of the organization, a quotation estimate
shall be prepared for the organization in accordance with Procedure AC.02.04, and an invoice
shall be issued.
9.3.2.2.2.4 In addition, the attending auditor shall prepare an audit plan that includes the system
elements and the relevant organizational units, processes and sites of the assessed
organization. The audit plan shall be prepared on Form 103.xx (Recertification and Audit Plan
Form), Form 125.xx or equivalent. The audit plan shall be sent to the organization prior to the
audit (or left in the organization in advance for the next audit).
9.3.2.2.2.5 The attending auditor shall follow up performance of audits and at the end of each audit shall
mark the elements (sites, procedures, departments and Standard clauses) that were checked
during the audit. (Form 103.xx or equivalent). The follow-up form shall be filed in the customer
file, preferably in the file pocket.
9.3.2.2.3 Audit plans shall be prepared so that the audits meet the following requirements:
9.3.2.2.3.1 The audits shall encompass all the clauses of the Standard and all the sites of the
organization within the 3 years cycle.
9.3.2.2.3.2 The audits shall encompass all the organizational units within a reasonable time limit,
considering the size of the organization.
9.3.2.2.4 The following clauses shall be checked in each surveillance audit cycle:
9.3.2.2.4.1 Implementation or the corrective actions required by the previous audit.

Valid from : 09/12

Edition 13

Page : 27 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.3.2.2.4.2 Review of changes in the organization


9.3.2.2.4.3 At least one of the components of the quality system typical of the core manufacturing
process / service in the organization.
9.3.2.2.4.4 Management reviews.
9.3.2.2.4.5 Internal system audits .
9.3.2.2.4.6 Customer complaints.
9.3.2.2.4.7 Corrective and preventive actions.
9.3.2.2.4.8 Scopes/activities that have changed since the last audit.
9.3.2.2.4.9 Customer complaints & appeals received in the Division concerning the organization.
9.3.2.2.4.10

Use of marks (certification symbols)

9.3.2.2.4.11
Remark : Should the frequency of performing the activities in clauses 4 and 5 be lower
than the surveillance audit frequency, these subjects shall be checked according to their
frequency in the organization.
9.3.2.2.4.12
Also during surveillance and recertification audits, the effectivity of the management
system shall be checked for achievement of organizational goals, and the progress towards the
organizational plans for continuous improvement.
9.3.2.2.4.13
If substantial changes occurred in the organization, the auditor shall update the audit
plan as required.
9.3.2.2.4.14
Coordination of audits and their conducting shall be in accordance with Procedure
AC.02.01.
9.3.3 Maintaining Certification
9.3.3.1 Maintaining of certification is based on demonstration that the client continues to satisfy
the requirements and on positive conclusion by the audit team.
9.3.3.2 In cases of situations that may lead to suspension or withdrawal of certification, a review
by appropriately competent personnel, different from those who carried out the audit may
be required.
9.3.3.3 The Systems Certification Directorate monitors the surveillance activities and the repo rts
by the auditors, to confirm that the certification activity is operating effectively.
9.4 Recertification
9.4.1 Recertification audit planning
9.4.1.1 All organizations due to Recertification shall be identified in the list of organizations by a "RA"

Valid from : 09/12

Edition 13

Page : 28 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.4.1.2 Recertification shall be conducted once in three years for annual and bi-annual audited
organizations.
9.4.1.3 Following significant changes on the system, the need for a stage 1 audit shall be considered.
9.4.1.4 Recertification requirements for annual and bi-annual organizations
9.4.1.4.1 As a preparation for the recertification audit, additionally to the regular annual preparation
the following shall be done :
9.4.1.4.1.1 Review of the QM and relevant procedures - the L.A shall mainly concentrate on
problematic issues resulting from nonconformities from previous audits and shall also
assess the relevance of the procedures to the scope of the organization. If required as
follows from previous performance of the organization, additional documentation may be
reviewed (specs, work instructions etc).
9.4.1.4.1.2 The documentation shall be reviewed on-site as a part of the recertification audit.
9.4.1.4.2 Review of previous audit reports :
9.4.1.4.2.1 Coverage of all main processes and activities and all standard elements shall be checked
9.4.1.4.2.2 All activities which had not been sufficiently covered by previous audits shall be prioritized for
the recertification audit.
9.4.1.4.2.3 Re-occurring nonconformities shall be identified and followed.
9.4.1.4.2.4 Corrective action and corrections shall be reviewed and a close out of those shall be reaffirmed.
9.4.1.4.2.5 The Audit Plan shall confirm with requirements defined in Procedure AC 02.04
9.4.1.4.3

Audit Documentation

9.4.1.4.3.1 Findings resulting from review of the documentation shall be recorded of Form 106.02 (or
equivalent).
9.4.1.4.4

The audit details shall be recorded also on Form 103.xx and shall include :

9.4.1.4.4.1

Name and number of the organization

9.4.1.4.4.2

Recertification period

9.4.1.4.4.3

All audit details done during the certification cycle, including standard elements, sites and
processes.

9.4.1.4.4.4

Classification of findings

9.4.1.4.4.5

Not audited elements / processes for each audit shall be clearly identified ('--" or "NE").

9.4.1.4.4.6

Exclusions shall be clearly identified

Valid from : 09/12

Edition 13

Page : 29 of 55

Quality and Certification


Division Procedures
Chapter: Organization
9.4.1.4.4.7
9.4.2

Procedure No.: AC.01.00


Procedure : Quality Manual

recertification audit report shall include all sites which are part of the organization

Conducting a Recertification Audit

9.4.2.1

A re-assessment audit shall be conducted in the following cases :

9.4.2.1.1

Once in three years in accordance with procedure AC.03.03 surveillance audits.

9.4.2.1.2 When significant changes have occurred in the quality system (following ownership,
equipment or personnel changes).
9.4.2.1.3 When there is a well-founded suspicion that the customer's management system is
no longer in accordance with the requirements (for instance as a result of customer
complaints or other information).
9.4.2.1.4

When the audits were not performed according to planned arrangements.

9.4.2.2

The extent of the audit (man-days) is reflected by orders on the computerized system.

9.4.2.3

The audit shall include at least :

9.4.2.3.1

Implementation of the procedures

9.4.2.3.2 Subject where nonconformities were detected in previous audits including implementation
of correction and corrective actions.
9.4.2.3.3

Activities which had not been covered sufficiently during the certification cycle.

9.4.2.3.4

Conformance of the system with the scope.

9.4.2.3.5

Effectivity of the system and continuous improvement in the processes.

9.4.2.4 The audit shall be summarized on Form 104.xx (the type of the audit shall be recorded in an
appropriate place) in accordance with Procedure AC 02.01.
9.4.2.5 A copy of the audit report shall be handed over to a representative of the organization, the
original shall be filed in the organization's file and shall be submitted to a professional
coordinator of the scheme for review and approval.
9.4.2.6

The re-certification shall be noted also in the cover of the file.

9.4.2.7
Final decision regarding renewal of re-certification shall take into account also previous
performance of the organization.
9.4.2.8 In case of nonconformities, the organization shall be required to submit correction or
corrective action. Should the audit results in a "Requiring Improvement" status - the
organization shall not be recommended for continuation of the certification without detailed
Corrective Action, which shall be verified and confirmed by the Lead Auditor.
9.4.2.9
All orders shall be reported and closed following completion of all activities related to the
recertification audit.

Valid from : 09/12

Edition 13

Page : 30 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.4.2.10 Depending on the result of the recertification audit, additional audit may be set not later than 3
month after the recertification audit. This is at the discretion of the Lead Auditor. There shall not be
any recommendation by the LA without appropriate and approved CA.
9.4.3

Information for granting recertification

9.4.3.1
All the reports (including review of the system over the period of certification and complaints),
including Corrections and Corrective Action shall be submitted in the organization's file for review
and approval of the professional coordinator of the scheme. The approval of the recommended file
and reporting of the audit on the system conclude the activity and allows the issuance a new
certificate to the organization.
9.5

Special Audits

9.5.1

Extension or reduction to Scope

9.5.1.1 A customer interested in expanding his scope of certification shall notify the Division ASAP. The
Division shall attempt to include the additional scope within the regular audits.
9.5.1.2 A request for certification to a new Standard (such as ISO 14001) shall not be considered as an
extension of the existing scope of certification but as a new request.
9.5.1.3
The attending auditor shall check the extent of activity needed for the extension and where
necessary shall notify the organization of additional payments, with a quotation.
9.5.1.4 The auditor shall check the applicability of the procedures and the readiness of the organization
for the extended scope, and in accordance with the results shall present his recommendation as per
Procedure AC.03.02.
9.5.2

Short notice audits


Partial or complementary audit shall be performed in the following instances:

9.5.2.1 When it is necessary to repeat and ensure that a certified system continues to be duly
implemented (within the framework of surveillance audits).
9.5.2.2 When changes have occurred concerning the customer or his products (such as:
additional sites, broadening the fields of activity, extension of scope, investigation
following complaints, etc.) and it is necessary to ensure that th e management system
continues to be properly implemented.
9.5.2.3

When the audits were not performed according to planned arrangements.

9.5.2.4 When it is necessary to ensure the completion of corrective actions required by


previous audits.
9.5.2.5 In case substantial nonconformities are detected in the management system of the organization,
additional audits shall be conducted, in order to verify required corrective actions in accordance with
Procedure AC.03.04. For these audits, the organization shall be sent separate invoices issued by
the Assistant to the Directorate, where required.
9.5.3

Transfer Audits from other Certification Bodies

Valid from : 09/12

Edition 13

Page : 31 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.5.3.1 Organizations transferring to SII from other accredited certification bodies (IAF MLA
signatory) will be required to follow all requirements of this procedure, including a formal application
on Form 126.xx as applicable.
9.5.3.2 The validity of the existing certificate shall be checked, the last audit report and the applicable
Corrective Action is to be reviewed
9.5.3.3 .This is a prerogative of the Heads of the Certification / Customer Directorates to reduce the
required extent of the Quality Manual /Procedures review (may be performed on-site). The extent of
the Transfer / Certification Audit may be reduced up to the extent of a surveillance audit.
9.5.3.4
In case the existing certificate is not valid anymore or the last audit had not been performed
according to the required frequency (6 or 12 month as applicable), the organization shall be
considered a new applicant and not a transferring organization.

9.6 Suspending, withdrawing or reducing the scope of certification


9.6.1 Procedure AC.03.04 defines the requirements related to suspending, withdrawing or reducing
the scope of certification.
9.6.2 The following are the cases for which the Division shall begin certification revocation :
9.6.2.1 Classification of an audit as nonconforming in a surveillance audit.
9.6.2.2 Classification of improvement necessary in two consecutive audits.
9.6.2.3 Classification of improvement necessary in a Recertification audit, not closed within 90 days.
9.6.2.4 Classification of nonconforming in a surveillance audit for a part of the management system.
9.6.2.5 The organization intends to give up a part of the certification.
9.6.2.6 Where there is an excessive complaint or an excessive amount of complaints against the customer.
9.6.2.7 Repeated breach of the surveillance agreement (misleading publication), or any other breach of the
follow-up agreement (such as: preventing surveillance of the management system, etc.) at the
discretion of the Head of the Customer Directorate.
9.6.3

In the cases mentioned above, the attending auditor shall warn the supplier of his intention to
recommend suspension / withdrawal of certification.
The warning shall be given by one or more of the following actions:

9.6.3.1 Sending a warning letter to the customer. The letter shall include a requirement that the client
discontinues its use of the certificate and all other advertising matter that contains any reference to
a certified status.
9.6.3.2 Discussing the subject at the summary meeting of an audit or during a specific meeting with the
customer.
9.6.3.3 A partial revocation may be acceptable in some cases.

Valid from : 09/12

Edition 13

Page : 32 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.6.3.4 In any case, in accordance with the severity of the nonconformities, the auditor may recommend
directly the certification suspension / withdrawal
9.6.3.5 Additional parties authorized to recommend suspension / withdrawal of a management system
certification are the Heads of the Directorates.
9.6.3.6 The warning to the customer shall be documented, including an indication of the corrective action
required of the customer and a date the suspension shall become effective if the nonconformities
shall not be removed.
9.6.3.7 The letter shall detail the meaning of suspension and certification withdrawal, if those become
effective (the organization shall not be able anymore to use certificates or publicize itself as being
certified in any way .
9.6.3.8 The warning shall be approved by a signature of the Head of the Directorate of System
Certification.
9.6.4

If during special audit it was found that the customer did not implement the required corrective action,
or the supplier refused to conduct the special audit within a reasonable period of time, the suspension /
withdrawal process shall be initiated without any further warnings. The name of the organization shall
be removed from the list of certified organizations immediately with start of suspension / withdrawal
activities

9.6.4.1 Returning of the status certified following suspension / withdrawal of system matters, shall be the
responsibility of the System Certification directorate. Suspension and Withdrawal of the
certification shall include all subsidiaries included under the certification process (which are
not performing standalone audits).
9.6.4.2 The time between suspension and withdrawal should not be more than 6 month.
9.6.5 The Directorate of Systems Certification is responsible for conducting the follow-up after the submission
of the recommendation for certification suspension / withdrawal or reduction. In case where the reason
of suspension has not been resolved, a withdrawal shall be started. The withdrawal process shall be
documented.
9.6.6 Conditions for suspension / withdrawal are clearly defined on the surveillance agreement Form 130.01
9.6.7 The decision concerning restoration of the certification, extension of the suspension, or total revocation
shall be transferred to the Customer Directorate and the computerized system shall be updated
accordingly
9.7

Appeals

9.7.1 Procedure AC 01.07 and procedures AC.04.01 - AC.04.05 cover the requirements for handling of
Appeals.
9.7.2 Procedures AC.04.01 - AC.04.05 are accessible to the public
9.7.3 Receiving and handling Appeals

Valid from : 09/12

Edition 13

Page : 33 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.7.3.1 Any received appeals shall be recorded and tracked, including actions undertaken in order to
resolve the appeal. The appeals shall be recorded and followed up on the computerized SII
complaints system.
9.7.3.2 SII shall acknowledge receipt of the appeal and shall provide the appellant with progress
report and the outcome. An immediate response shall be sent to the party making the complaint
within 7 days of its receipt.
9.7.3.3 The appeal shall be validated and investigated and decision shall be taken in response, taking into
account the results of previous similar appeals.
9.7.3.4 Any required Correction / Corrective Action shall be documented
9.7.3.5 Persons engaged in the appeals handling process shall be different from those who carried the
audits and made the certification decisions.
9.7.3.6 Submission, investigation and decision on appeals shall not result in any discriminatory actions
against the appellant.
9.7.3.7 If necessary, the Committee shall summon the appealer's representative to state his arguments
9.7.3.8 Head of System Certification Directorate is responsible for handling and resolving of appeals
9.7.3.9 A final, written response shall be sent to the appellant within 30 days.
9.8 Complaints
9.8.1 Procedures AC.04.01 - AC.04.05 are accessible to the public
9.8.2 Receiving and logging a Complaint
9.8.2.1 Written complaints will similarly be forwarded to the complaints coordinator, who will enter all of the
details into the computerized system. The Division will only handle complaints received in writing.
The complaining party will be asked to point out as many details as possible (including test results,
if there are any).
9.8.2.2 Upon receipt of an indirect complaint the coordinator shall send the complaining party a letter on
Form 110.xx, the organization referred to in the complaint will receive a copy of the complaint,
within 7 working days.
9.8.3 Dealing with a complaint
9.8.3.1 After a review of the compliant, the coordinator will decide, who the most suitable person in the
Division is to handle the complaint. He will then transfer the complaint to this person along with any
accompanying documents.
9.8.3.2 If need, an complaint will be transferred to the Ombudsman. When the topic of the complaint has to
do with the laboratory, the coordinator will send a copy of the complaint to the laboratory, asking
them for their response.
9.8.3.3 The person handling the complaint will investigate all aspects of it, will learn the facts pertaining to it
and will find out if it is justified. If need be, the person handling the complaint will refer to

Valid from : 09/12

Edition 13

Page : 34 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

documents, certificates, standards or any other documentation that may have a bearing on the
complaint and the facts connected with it. The person handling the complaint may decide to meet
with other employees and/or the complaining party and question them as he sees fit.
9.8.3.4 The Complaint Coordinator will enter any complementary information pertaining to the complaint into
the computer. When the Division's part is finished, the person handling the complaint will enter into
the computer his intermediary conclusions
9.8.4 Closure of a complaint
9.8.4.1 Each complaint received a shall be responded in writing by one of the following, according to the
case: complaint coordinator, Head of Directorate, Division Director, Head of a laboratory, Quality
Manager, Ombudsman.
9.8.4.2 The answering letter shall contain a summary of the investigation conducted, the findings and the
conclusions drawn.
9.8.4.3 With the dispatch of the letter, the case will be considered closed and will be so noted on the
database.
9.8.4.4 A final reply to the complaint will be sent within 30 days after receipt of the complaint
9.8.4.5 In cases where it is not possible to complete the inquiry within this period, the complaint coordinator
is responsible to send the complaint an interim response.
9.8.5 Open complaints shall be reviewed after 30 days and the reason shall be documented
9.8.6 QCD shall determine whether and to what extent, the subject of the complaint and its resolution shall
be made public.
9.8.7 Reporting and Corrective Action
9.8.7.1 The complaint coordinator shall report, to the Division's Director, each complaint which, according to
his opinion, is liable to cause damage (defamation, legal action, etc.) to the Division or the
Institution. In this case, a reply will be given to the complainant only after appropriate consideration.
9.8.7.2 When necessary, corrective action to a complaint or a cluster of complaints shall be taken, in
accordance with procedure AC.01.08.
9.8.7.3 A report regarding the complaints and corrective/preventive actions, taken shall be presented during
the management review.
9.8.7.4 The report shall analyze the complaints by category in comparison with findings in previous periods.
This analysis will include, but not be limited to, duration of complaint handling and degree of
justifiability. If need, the coordinator shall add to the report his recommendations regarding
corrective or preventive action to be taken in order to reduce the causes of complaints.

9.8.8 Documentation of Complaints and Appeals


9.8.8.1 The complaint coordinator will maintain an electronic record of all complaints and appeals related to
the activities of the Division, including complaints related to products which had been granted a
Standard Mark.

Valid from : 09/12

Edition 13

Page : 35 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.8.8.2 The records of complaints and appeals, will be retained by the coordinator for a period of three years
9.8.8.3 In addition, the Ombudsman keeps a record of all complaints and appeals and relevant
correspondence handled by him.
9.9 Records of Applicants and Clients
9.9.1 All documents relating to communications between the Institution and the customer shall be filed in a
customer file, apart from audit time determinations which shall be kept in designated files.
9.9.2 Records of Applicants and Clients include the following
9.9.2.1 Customer's Application
9.9.2.2 Customer's Registration
9.9.2.3 Justification for Audit Time (initial, surveillance and recertification) including sampling
9.9.2.4 Stage 1 Audit including a documentation review records
9.9.2.5 Stage 2 Audits
9.9.2.6 Certification agreements
9.9.2.7 Verification of corrections and Corrective Action
9.9.2.8 Scope Recommendation Form
9.9.2.9 Certification Recommendation Form including certification / recertification decisions
9.9.2.10

Surveillance Audits records (including Correction / Corrective Action resolution)

9.9.2.11

Recertification Audit records (including Correction / Corrective Action resolution)

9.9.2.12

Scope extension records

9.9.2.13

Records of appeals and complaints

9.9.2.14

Competence records of administration and auditors

9.9.3 Securing quality records


9.9.3.1 Records shall be kept in dedicated customer files in a cabinet accessible to Division employees
only. The filing cabinet is protected by a fire detecting and extinguishing system which is
periodically checked.
9.9.3.2 Records in the SII computer shall be backed-up and stored in accordance with Computer Unit
Procedure MH 15.01 Central Computer Back-up.
9.9.3.3 Records kept outside the filing cabinet shall be stored in protected locations only.

Valid from : 09/12

Edition 13

Page : 36 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

9.9.3.4 Confidentiality also applies to records taken out of the vicinity of the SII. The files will be kept in a
manner that assures their integrity, prevents their loss and prevents unauthorized access.
9.9.3.5 Under no circumstances will information or reporting pertaining to an organization be transferred to
a third party, without written permission from the organization.
9.9.4 Retaining Customer Documents
9.9.4.1 The period of keeping Customer records is described in procedure AC.01.04.
9.9.4.2 If the customer's file does not have enough space to store all of the documents during the entire
retaining period, some of the documents may be kept in some other manner, provided that such
storage ensures adequate storage and convenient access to the documents.
9.9.5 Discarding Documents
9.9.5.1 Following expiration of the retention period, documents shall be transferred for shredding.
10. Management system requirements
10.1 Scope - the scope of the QMS includes design and development of our certification services.
10.2 The Quality System takes into account the credibility of the certification and the needs of all parties.
10.3 The quality system includes a Quality manual, detailed procedures and Work Instructions.
10.4 Exclusions
10.4.1 Clause 7.6 Control of monitoring and measuring devices The division does not deal with
measuring devices. Within the frame work of the standards mark the labs carry out measurements by
their instruments.
10.5 Requirements of the ISO 9001:2008 Standard
(details include only the issues that are not covered in the division's procedures)
10.5.1 Quality Policy of the division
a) Operating Standards Mark System for processes and products and certifying quality management
systems, certification of environmental management systems and safety and health in the workplace of
organizations in various frameworks, food safety systems and professional guidance of the training
centers activities dealing with the public, providing various services to governmental offices and other
clients, in issues which are the core of the divisions activities, with emphasis on:
- Providing service to all without bias
- High degree of accuracy and reliability
- Courtesy and pleasant manner
- Short reaction time
- Fair price
- Work completed by a professional team selected, trained and qualified for the job.
- The various technological audits carried out by auditors with the appropriate professional
background.
- Ensure maintaining information confidentiality

Valid from : 09/12

Edition 13

Page : 37 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

- Maintain strict professional and personal ethical rules.


b) We guarantee performance of the highest standard in accordance with the appropriate national and
international standards such as ISO Guide 17021:2011, ISO Guide 65 (EN 45011).
c) We operate to provide certification services and mutual recognition worldwide via the international
certification network IQNET, and cooperation with network members with the aim of developing services
and products with added value to its clients. The division's procedures are suited to the IQNET's
procedures.
d) We participate in the advancement of quality in Israel by conducting operations such as:
Initiation of national quality activities, National Quality week, Participation in national quality activities
such as Quality conference for the Israel Association for Quality or the National prize for quality in
industry.
e) We grant the "Gold Mark" to manufacturers and service providers who have quality and excellence
ingrained and who have at least 3 quality standards testifying to the suitability of the management
systems , processes' and products to international and national standards , and "Platinum Mark" for
manufacturers and service providers who have 5 quality standards.
f) We operate to update our clients with innovations/updates/changes in the standards, approval
systems within the scope of the division's activities. In addition we update our clients on general quality
issues that are of interest to the general public
.
g) We encourage all enquiries in order to improve and discuss all suggestions aimed at advancing the
divisions objectives. We initiate continuous improvement of the employee's professional ability through
relevant training and courses.
10.5.2 Quality System Documentation - The conformance of the hierarchy of the QCD documentation
and the continuous compliance of the Quality Manual and procedures with the requirements of
ISO 17021 and the Accreditation Bodies shall be periodically reviewed and reapproved (at least
once in three years). The results of the review shall be documented as a part of the management
review.
10.5.3 Division's Goals - The detailed objectives will be determined within the framework of the annual
management review
10.5.4 Customers Satisfaction Increase customer satisfaction and improve customer loyalty.
10.5.5 Excellence in the process Improve operational efficiency and improve quality of work in particular
service deadlines. Increase clarity, transparency and accuracy of documents dealing with customer
communication
.
10.5.6 Infrastructure Increase employee's satisfaction by improving employee's abilities and
development of knowledge and management information infrastructure.

Valid from : 09/12

Edition 13

Page : 38 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

10.5.7 Financial performance - Maintaining the overall revenues and profitability by providing for product
development and infrastructure.
10.6 Management responsibility (clause 5 in the standard)
10.6.1 Obligation of top management to develop and implement the quality management system and to
improve it's effectiveness, defining measurable quality goals and objectives, conducting management
reviews and initiating activities to advance improvements in processes.
10.6.2 The management assigns resources for the advancement of the quality system as a part of the budget.
10.6.3 Focusing on the client, defined in the manual as a central role in the division's activities. The focus is
expressed by dedicating to each organization a person responsible for customer liaison - the
responsible lead auditor, and a customer manager whose role is to provide back up to the auditor in
connection with customer liaison.
The customers are divided into sectors of activities in order to provide a service suitable for all the
customers' characteristics. Sector managers are responsible for developing services suitable for the
type of customers in the sector.
Focusing includes the needs of all parties that rely upon certification services, such as the public,
legislation and conformance with mandatory standards and our customers customer needs.
10.6.4 The Quality Policy is distributed to the division's employees during the annual training, and is
assessed for its compatibility within the framework of the annual management review.
10.6.5 The Quality goals These goals are detailed in this manual. Measureable goals are defined and
monitored, measured and updated as applicable in the management review.
10.6.6 Planning the Quality system is detailed in this manual. Changes to the system are conducted in a
controlled manner under the supervision of the division's management.
10.6.7 Management representative for quality The Management representative for quality is the Head of
the System Certification directorate. He was appointed due to his long lasting acquaintance with the
QMS of the division and his involvement in the processes.
10.6.8 Internal communication The internal communication of the division is conducted through a
intertwined number of activities : Every auditor has a mail box in which all the internal and customer
correspondence mail may be kept. As the auditor is usually away from the office, most of the
communication is done telephonically/by e-mail. Other communications channels :
a. Communication of auditors with customer managers by telephone and e-mails .
This, in addition to occasional face-to-face meetings in the office.
b. Auditor meetings The division manager and management members conduct periodical
meetings with groups of auditors, to sort out major issues and exchange ideas.

Valid from : 09/12

Edition 13

Page : 39 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

c. Personal meetings- Auditors The division manager organizes personal meetings with the
auditors on his own initiative at least once a year. The head of systems certification directorate
meets the auditors at least twice a year for personal meetings.
d. Personal meetings administration workers The division manager holds periodical meetings
with the administration workers to sort out personal issues and solving professional issues.
e. Training meetings The product managers / professional coordinators conduct training
meetings at least once a year.
f. Open door policy - The division managers keep an " open door policy " for every worker and
every auditor to sort out personal issues and solving professional issues.
g. Electronic mails Messages are passed on to auditors also by way of the e-mail.
h. Northern based auditors have a contact point at the Haifa branch, for information transfer and
data needed on a regular basis.
i. Customer service workers meet for regular meetings to receive information, responsibility of
the customer service manager, at least once a month. The rest of the communication is done
on a one to one basis with the customer service coordinator of the division.
J . Meetings with all the divisions workers periodical meetings are held of all the divisions
workers, including transferring information on a social basis.
10.6.9 Management Review - see AC 01.06
10.6.10 Infrastructure (clause 6.3)a. The working infrastructure of the headquarter includes centralized computing system ,telephon
system for communication with customers and with auditors, and an archive for management of
customers files.
b. Auditors work mainly at the customers sites, and receive communication instruments (cellular
phone),car for mobility and laptops to provide better service to the customer and to ease
communications with headquarters.
10.6.11 Work environmenta. The administrative workers of the division are concentrated on one floor. Auditors, have a specific
area on a separate floor in order to complete office work. The auditors have cubicles, based on
available space, in order to work with the computer system, conducting office work and compiling
information.
The cubicles are used for a number of auditors. In both areas the system is one of "open space". The
coordinators have a separate work areas - coordinators office, to advance their activities.
b. The division has boardrooms to conduct meetings with customers and for work meetings and small
group training.

Valid from : 09/12

Edition 13

Page : 40 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

c. Customer reception The division has a waiting room to receive audience waiting for meetings with
auditors or functionaries in the division.
10.7 Product implementation (clause 7 in the standard)
10.7.1 Communication with the customer - Official communication with the customer includes official
correspondence, especially signature on agreements, certification receipt, detailed in the operational
procedures ( See table in clause 17)
10.7.1 Correlating and dealing with questions and various enquiries the customer managers are available
For the customers needs to clarify various issues by way of fax, telephone, e-mail or face to face
meetings. This, in addition to communication with the auditor, responsible for his service quality. The
details of the customer are updated in the computer system and used by all bodies that have access to
the system. In addition, the customer's details are updated in the customer's files, for the auditor's use.
10.7.2 Design and Development (Clause 7.3. of the standard) The division follows the requirement of
clause 7.3 when developing and implementing new standards and services (see AC.01.09).
10.7.3 Validation of manufacturing processes and service provision (Special processes clause
7.5.2 in the standard) Audits of management system are special processes that can not be
measured on an absolute basis at the end of the audit. Therefore the audits are conducted with
emphasis on the auditors' qualifications, training and supervision of their work process, work by
advanced methods and evaluation over a period of time of the output of their work in relation to the
organization meeting the quality processes demands.
10.7.4 Identification and traceability (clause 7.5.3 in the standard)Customers are identified by a customer number that is output from the computer system. Projects are
identified in accordance with the customer number.
Status of service and certificates of a customer is defined in the computer system.
10.7.5 Customers propertyThe customers purchased information is kept by the auditors in accordance with the confidentiality
agreement and ethical code of the division which obliges each and every worker.
The computer system is backed up according to the procedures of the information systems division and
is its responsibility.
In accordance with customers request, auditors sign a confidentiality agreement ( NDA- non
disclosure agreement).
10.7.6 Measuring ,analysis and improvement ( clause 8 in the standard )
a) Measuring and monitoring (clause 8.2)
Customer satisfaction is measured by customer satisfaction surveys conducted from time to time. The
results of the survey are analyzed and used as a basis for discussions in the division and to improve
the service.
In addition, Sector managers are in direct contact with strategic customers, at least once a year, as a
basis to receive defined feedback from the customer regarding service provided to him. These results

Valid from : 09/12

Edition 13

Page : 41 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

are also analyzed and used for the management review.


Deserting customers are dealt according to a methodical manner by the sector manager and
customer managers, in order to prevent their removal from the system. The feedback from the
customer is recorded , analyzed and documented accordingly.
Measuring and monitoring processes is conducted by measuring the level of service defined in the
framework of the standards mark administration. In addition a measurement of the customer level
service is conducted by means of the Call Center, and by way of additional checking tables enabling
further checks of the service level provided to the customer.
b) Internal Audits (clause 8.2.2) - see AC 01.05
c) Improvement (clause 8.5)
As part of the management review the suitability of the activities is compared to the division's policy
and meeting of defined goals and objectives at least annually. According to results objectives are set
and goals renewed.(If needed)
With regards to the process of internal audits, handling of non conformance, corrective and preventive
actions-see procedures as defined in the following table

Valid from : 09/12

Edition 13

Page : 42 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

10.9 Core Processes


10.9.1 Focusing on the customer
Routine report management
human resources

Initial certification
process
Inspection process

employee
viewpoint survey

Welfare

Continuous information
provision
Human resource
management

Auditors
Headquarter employees

Quality control
implementation

Customer

Training and
certification

Standard
Management
association
system
stamp
approval
administration operation

Payments and collection


Satisfaction survey

Training
center

Administration
services

Development and
professional
advancement

Customer documentation
management

Customer complaints and


handling enquiries

Marketing
Customer
administration

administration

Quality and Certification


Division
Internal processes

Preparation for external audits

Development :
Infrastructure

t if
er
lc
na
er

t
Ex

External accreditation bodies

Development :
New products

t io
ica

w
sta ith In
nd in sti
ar the tut
d
as fra es la
so m bs
cia ew
t io or
n ko
sta f
m
p

Quality management

n
es
di
bo

Valid from : 09/12

Edition 13

Page : 43 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

10.9.2 Flow diagram of work process management system approval

Valid from : 09/12

Edition 13

Page : 44 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

Yes
Documentation approval

Approved ?

Providing price quote

Preliminary ( Initial clarification )


No
Preparation in the organisation
documentation and application

Customer enquiry

Approval of price quote

Yes

Conducting audits and checks


Checking the corrective action

Approved ?

Certification approval

No
Corrective
action
needed ?

Yes

Implementing
corrective action

Signing a
Supervision agreement

No

Supervision

Customer payment
required ( proforma )
Index :

Yes

Yes

Approved ?

Checking the corrective action

Conducting audits and checks

Paid?
No

No
Implementing
corrective action

Yes

Corrective
action
needed ?

Quality and certification


division
Customer

No
Customer reminder

10.9.3. Flow diagram of work process standards mark approval

Valid from : 09/12

Edition 13

Page : 45 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

Informing the
Customer
No
Documentation approval:
Quality procedures
Product file

Conducting quality audits


Conducting process audits
Checking the products

Yes Continuation

Providing price quote


Fields checked :
Quality system
Manufacturing process
Product characteristics

Checking the corrective action

of
process ?

Approval of price quote

Approved ?

Yes

Initial clarification
Standard Association Stamp

Preliminary survey
( if required )

Customer enquiry

Permits committee :
Provision of permit/approval

Approval of
supervision agreement

No
Corrective
action
needed ?

Professional committee :
Recommendation to
grant permit/approval

Implementing
corrective action

Yes

No

Supervision

Conducting audits
and checks
Implementing
corrective action

Yes Approved ? No

Index :
Defect
Discovered ?

Permits committee

Minor defect

No

Yes
Permit cancellation

Checking the corrective action

Permit
revoked ?

Major
defect

Min
or

Yes
defe
ct

No
Yes Minor/Major
defect

No
Quality and certification
division
Lab
Lab/ Quality and
certification division
Customer

Professional committee

10.9.4 Mapping core processes

Valid from : 09/12

Edition 13

Page : 46 of 55

Quality and Certification


Division Procedures
Chapter: Organization
N.o
.

Process

Process
Owner

Procedure No.: AC.01.00


Procedure : Quality Manual

Customer

Input

Output

Procedure

Management systems and processes


1.

Providing
price
quote to
customer

Customer
Service
Directorate
assistant
Auditor

Customer

Customers details

Approved price
quote

AC 02.05
AC 02.04

2.

Conducting
certification
process
especially
checking
and
approving
procedures
, and
practical
audit at
customers
facility

Customer

- Organisations
procedures
- Quality system of
the organisation

Report of
procedure checked
Report of
certification audit
Certification
certificate

AC 02.01

3.

Conductin
g
supervisio
n process

Auditor

Customer
M.O.D
(when relevant )

- Organisations
procedures
- Quality system of
the organisation

AC 03.03
AC 03.04

4.

Changes
in
customers
details

Head of
system
certification
directorate

Customer
Auditor

Details changed at
customer

5.

Quality
control of
auditors

Head of
system
certification
directorate

Customer

6.

Service
(product)
control

Head of
system
certification
directorate

Customer

- Reports of audit
- Accompanying
auditors
- I.S. ISO 19011
- RVA audits
- Accompanying
auditors
- Reports control
- Approval system
- Checking
Customers files

Approval
continuation of
suitability to the
standards
requirements
- Updating
supervision
schedule
- Updating details in
the system
- Updating price
quote
- Updating
certificate
- Progress Reports
Auditors
- Auditor training
- Auditor
accreditation
- Auditor
accompanying
report
- Reports control
report
- Auditor training
- Auditor
assessment

7.

Auditor
training

Auditors

Training schedule
Accompanying
auditors

Product

Management of

- Sector analysis

-Grading auditors
- Customers
satisfaction survey
per auditor
New services and

AC 02.02
AC 02.06

8.

Head of
system
certification
directorate
Head of

Valid from : 09/12

Edition 13

Page : 47 of 55

AC 02.02
AC 02.03

AC 02.03

AC 01.09

Quality and Certification


Division Procedures
Chapter: Organization
N.o
.

Process

Process
Owner

Procedure No.: AC.01.00


Procedure : Quality Manual

Customer

Input

Output

- International
standards

products

- Market reports
- Products reports
- Events and
conferences
- New products
- Products
interpretation
guidelines
- Courses for
consultants

- Expanding the
customer base
- Expanding the
activity of existing
customers
- Consultants
professionalism
- Organisations
better prepared for
audits
- Verification of
attendance report
in order to finalize
orders
- Employees
motivation
Complete and
updated customer
file

Procedure

Management systems and processes

9.

10.

11.

12.

developme
nt and
services
Marketing
activity

customer
service
directorate
Head of
customer
service
directorate

quality and
certification
division
Management of
quality and
certification
division

Relationsh
ip with
consultant
s to
organisatio
ns
Administra
tive
treatment
of auditors

Head of
customer
service
directorate

Management of
quality and
certification
division

Head of
system
certification
directorate

Auditors

- Activity reports
control
- Personal
advancement

Managem
ent of
customers
files (
including
in the
computer
system)

Directorate
assistants

Auditors
Management of
quality and
certification
division

- Customers
documents
- Audit reports
- Correspondence
with the customer

Providing
price quote to
customer
Conducting
initial
clarification

Customer

Customers details

Approved price
quote

WI 03.00

Customer

Standards mark
certificate

WI 03.00

Conducting
supervision
process :

Customer

- Organizations
procedures
- Quality system of
the organization
- Organizations
procedures
- Quality system of
the organization

Signing three
angle"
agreement

Customer
Producer
Customer Marketing

Approval
continuation of
suitability to the
standards mark
requirements/proce
ss documentation
Three way
agreement

WI 03.09
WI 03.01
WI 03.02
WI 03.03
WI 03.40
WI 03.42
WI 03.06

Announcemen
ts of

Customer

Updated testing
schedule for

WI 03.07

AC 01.04

Standards mark system


13.

14.

15.

Valid from : 09/12

Edition 13

- Standards mark
approval for
manufacturer
Manufacturer
enquiry
- Standardizations
committee decision

Page : 48 of 55

Quality and Certification


Division Procedures
Chapter: Organization
N.o
.

Process

Process
Owner

Procedure No.: AC.01.00


Procedure : Quality Manual

Customer

Input

Output

- Announcement to
standards mark
manufacturers
Details changed at
customer

products affected
by change

Procedure

Management systems and processes


revision/chang
e of standards
16.

Changes in
customers
details

Customer
Auditor

17.

Documenting/C
hanging

Manufacturers -Engineering Reports


Institutes labs
International
-standards

monitoring
and
measuring
points
Preparation
for the new
year

19.

- Updating
supervision
schedule
- Updating price
quote
monitoring and
measuring points
updated and
according to control

WI 03.02

WI 03.05

Customer

Work schedule and


pricing per previous
year

Updated work
schedule and
pricing

WI 3.20

Dealing with
misleading
advertising

User-citizen

Divisions auditors

- Canceling
deception in
advertising
- Publics
confidence
Qualified auditors

WI 03.41

Certifying
auditors to
conduct audits
according to
S.I.I 005
Development
of new
certifications

- Information
regarding misleading
advertising
- Standards and
directives
- Auditors
- Certifying and
training schedule

- Certifying new
processes
- Standards mark
for new products
Training Center ( See Quality Manual for
Training Center )

WI 03.10

Valid from : 09/12

User-citizen
-Engineering Reports
Manufacturers
International
-standards

Edition 13

Page : 49 of 55

AC 02.06

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

10.9.5. Diagram of job descriptions of the division

Standard Mark
Operation
Directorate
Management of
existing customers

Sector
manager

Customer liaison

Marketing

Work schedule
control in conjunction
with customers
Cost approval

Management of
existing
customers
Customer
liaison

Marketing with sector


manager

Assist sector
manager

Professional
management

Work schedule
control in
conjunction with
customers

Manage working
relations with labs

Customer Directorate

Customer
managers
Communication
with operational
organizations
Correspondence +
cost preparations
Contract Review *,
Cost approval

Management of
lead auditor in
projects

Auditor assistance

System Certification Directorate

Professional
Coordinator

Routine Control

Preparation
of product
files
Training
material and
interpretation
Auditor
training

Control
performance
percentage
Control sold
hours

Professional
management

Courses

Report
inspection

Control
salary
reporting
Auditor
welfare

Professional
review and
control of
customer files
Future human
resources
planning
Product
development

Marketing
with sector
manager
Costing
consultation
per field
Certification
Decisions
Approval of
certifications

Product
development

Product development

11. Division's Products

Valid from : 09/12

Edition 13

Page : 50 of 55

Auditor
placement

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

11.1 Operational service of the Standards Mark Standard Mark granted by the approval committee
assures that a certain product complies with the set requirements of quality as determined and defined by the
various standards. The quality and certification division operates the Standards Mark System for the institute:
11.1.1 Standards Mark An approval label signifying that a certain product adheres to the standards
requirements. The standards mark system is voluntary.
With that, in accordance with the Minister of Industry and trades decision there are a number of products for
which the labeling of the Standards Mark is obligatory. This obligation deals mainly with products which have a
safety risk. The activity is completed in accordance with the following procedures :
S.I.I procedure 005 Requirements of quality systems operated at the manufacturers producing products
labeled with the Standards Mark.
S.I.I procedure 006 Policy determining the order, the importance and the degree of supervision of
products produced bearing the Standards Mark.
S.I.I procedure 007 Regulations for operating the Standards Mark system.
11.1.2 Safety Mark - An approval label signifying that a certain product adheres to the safety requirements.
The Safety Mark ensures protection from dangers when using the product.
The approval in this field is provided in accordance with the SII procedures as defined by the detailed SII
procedures mentioned in the Standard Mark (clause 5.1.1)
11.1.3 Green Mark An approval label signifying that a product meets the criteria proving that it's
environmental impact is minimal. The label with this Mark prevents deception of the public and ensures
appropriate use of the definition "environmental friendly". The activity is done in accordance with SII procedure
004 regulations governing approval provision for the Green Mark to products with minimal environmental
impact.
11.1.4 Process certification Approval given in the framework of the Standards Mark, ensuring that the
manufacturer maintains relevant means, appropriate organizational system work processes ensuring the
continuation of the process and quality system meeting the demands of the relevant Standards Institute
procedures. Processes such as: Imported cement manufacturing, swaying hydrant maintenance, vehicle
reinforcement, fire detection system maintenance, roof sealing etc.
The approval in this field is provided in accordance with the SII procedures as defined by the detailed SII
procedures mentioned in the Standards Mark (clause 5.1.1)
11.2 Certification of Management systems - All the management systems that the division approves focuses
on the operation of a methodical and controlled process of the management fields in the organization, in
accordance with the requirements of the specific standard. Fulfilling the standards requirements ensures a
clearly defined policy, defined aims and measures of the relevant management processes, process application
control of the company's policy, organizational learning process and continuous lesson building, measurement
of the processes affectivity and efficiency. The division's products in this field are:

Valid from : 09/12

Edition 13

Page : 51 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

I.S. ISO 9001:2008- quality management system certification. Focuses on the quality of the management
process to manufacture products and or services, and to increase their effectivity.
The activity is conducted in accordance with procedure AC 04.01 Approval of quality systems that operate
according to the requirements of Israeli standard I.S. ISO 9001 directives and regulations
I.S. ISO 90003 : 2004 Quality management system approvals in the field of software Approval according
to the requirements of I.S. ISO 9001:2008 and guidelines to this standard serve as a manual for interpreting I.S
ISO 9001:2008 for organizations in the field of software.
I.S. ISO 14001 environmental quality management system Management of the parts of the organization
with impact on the environment, by analyzing the risks to the environment and planning measures for them ,
prevention and/or reduction of environmental impact.
The activity is conducted in accordance with procedure AC 04.02 Approval of environmental management
systems that operate according to the requirements of Israeli standard ISO 14001 regulations.
I.S. 18001 OHSAS Procedure for hygiene and safety in the workplace Controlled management of
operational sections in the organization dealing with workers industrial safety, health and hygiene. The
operation is done in accordance with procedure AC 04.03.
ISO/TSI 16949 Quality management for materials, processes and products supplied to the worldwide
automotive industry approval focusing on the quality of the management processes of manufacturers in the
industry, supplying parts, systems and products to the automotive industry. The process is done and certificates
granted by NQA ( British C.B) . .
I.S. 9301 Safety management of the overland transportation system the standard is based on the
quality management Israeli standard ISO 9001:2008 with emphasis on issues relating to overland transportation
system. The activity is conducted in accordance with procedure AC 04.01.
TL 9000 Quality management in the field of communications industry Approval focusing on the quality
of the management processes of manufacturers developing and providing services in the communication field.
The approval is granted in conjunction with the NQA ( British organization ) . The activity is conducted in
accordance with procedure AC 04.01.
I.S. ISO/IEC 27001 Information security management Approval given to organisations focusing on
providing comprehensive solutions to information security issues throughout all parts of the organization and an
overall organizational view. The standards' requirements include establishing management and maintenance of
the required controls, systematic monitoring and preparation of reaction ways for every possible event.
The activity is conducted in accordance with S.I.I procedure AC 04.01.
AS 9100 - Quality management in the aerospace industry - approval focusing on the quality of the
management processes of manufacturers in the industry, supplying parts, systems and products to the aviation
industry. The approval is granted in conjunction with the NQA (British CB). The activity is conducted in
accordance with procedure AC 04.04.
CE Approval of products in the medical devices Approval of products in the field of medical
equipment given by notified bodies authorized by the EEC. The approval is given in conjunction with MDC

Valid from : 09/12

Edition 13

Page : 52 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

( German organisation ) LNE/GMED ( French organization ). The activity is done according to European
directive EEC 93/42 and appropriate certification bodies procedures'.
I.S. ISO 13485:2003- production and development of medical devices approval given for production of
medical equipment in accordance with European directives and international standards. The activity is
conducted in accordance with procedure AC 04.01. .
I.S. ISO 22000 management system for safety in food. Requirement for every organization in the food
chain Organisational approval especially for production and packaging. The standard includes HACCP
requirements. The activity is conducted in accordance with S.I.I procedure AC 04.05. .
HACCP- safety management for food manufacturers and service providers in the food field the approval
is given by the Standards Institution.
BRC for food manufacturers requirements of British Retailers Consortium for food manufacturers. The
approval is given in cooperation with ISA (Dutch organization) The activity is conducted according to ISA's
guidelines.
BRC IOP for food packaging manufacturers requirements of British Retailers Consortium for food
packaging manufacturers. The approval is given in cooperation with ISA (Dutch organization ) The activity is
conducted according to ISA's guidelines.
BRC for agricultural packing houses requirements of British Retailers Consortium for agricultural
packing houses. The approval is given in cooperation with ECAS (Dutch organization) the activity is conducted
according to ECAS's guidelines.
TNC Approval for agricultural produce and packaging according to standards laid out by TESCO
retail chain. The approval is given in cooperation with ECAS and approved by CMI (British organization).
EUREPGAP - Approval for agricultural produce and packaging according to the EUREPGAP
organization, an international European organization. The approval is given in cooperation with ECAS (Dutch
organization) the activity is conducted according to ECAS's guidelines.
IQNET 9004 standard for checking the organizations excellence The approval is granted for meeting
the requirements of this standard of organizations excellence by the IQNet.
11.3 Conducting audits and additional services according to the customers' requirements:
11.3.1 Second party audits Purchasing administration of the Israeli M.O.D Conducting QMS in
organisations and transferring the audits' findings to M.O.D (Purchasing administration of the ministry of
defense) per customer's request, as a condition of registering as a supplier to the M.O.D.
11.3.2 Production approval for the American M.O.D QPL/QML Qualified
Manufacturers List according to MIL STD 790.

Valid from : 09/12

Edition 13

Product List /Qualified

Page : 53 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

11.4 Appreciation certificates


11.4.1 Gold Mark Certificate granted to organizations who have quality and excellence ingrained and who
have at least 3 quality standards testifying to the suitability of the management systems, processes' and
products to international and national standards.
11.4.2 Platinum Mark - Certificate granted to organizations who have quality and excellence ingrained and
who have 5 or six quality standards testifying to the suitability of the management systems,
processes' and products to international and national standards.
11.4.3 Diamond Mark - Certificate granted to organizations who have quality and excellence ingrained and
who have 7 or more quality standards testifying to the suitability of the management systems,
processes' and products to international and national standards.

12. Sanctions according to IMF MD-7


12.1 Situations that may lead to sanctions by AB's are the following :
12.1.1 Failure to resolve nonconformities in accordance with an AB procedure
12.1.2 Negative outcome of a complaint investigation
12.1.3 Misuse / misinterpretation of an accredited symbol
12.1.4 Non-payment of fees
12.1.5 Proven evidence of fraudulent behavior, provision of false information
12.1.6 Deliberate violation of accreditation rules.
12.1.7 Providing certification to any standard used as a basis for accreditation (e.g ISO
17025)
12.2 Sanctions available may include :
12.2.1 Intensification of surveillance (office, witness or document review)
12.2.2 Reduction of accreditation scope
12.2.3 Suspension or withdrawal
12.2.3 Public notice of scope reduction / suspension / withdrawal / misrepresentation of
accreditation
12.2.4 Legal actions
12.3 SII management is aware of the requirements and acts accordingly in order not to
violate any of them. SII's personnel is trained accordingly.
12.4 SII possesses a liability insurance to cover any possible damage caused to
customers.
12.5 SII is committed to protect the clients and to help any of them to transfer to
another CB following sanctions of Accreditation Bodies.

13. Cross-reference division procedures to ISO 9001 standard requirements:

Valid from : 09/12

Edition 13

Page : 54 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

Standards requirements
Number

Companies procedure
Procedure

Requirement

Procedure Name

Number

(IQNET Doc. Ref.)


4.1

General requirements

AC 01.00

Quality Manual

4.2.1

Quality Manual

AC 01.00

Quality Manual

4.2.3

Document control

AC 01.11

Documentation and information control

4.2.4

Records control

AC 01.04

Records Control / confidentiality

5.1

Managements obligation

AC 01.00

Quality Manual

5.2

Focusing on the customer

AC 01.07

Dealing with appeals and complaints

5.3

Quality Policy

AC 01.00

Quality Manual

5.4

Planning

AC 01.00

Quality Manual

Authority and responsibility

AC 01.01

Areas of responsibility and organizational structure

AC 01.02

Job descriptions

5.5.1

5.5.2

Management representative

AC 01.00

Quality Manual para 10.6.7

5.5.3

Internal communication

AC 01.00

Quality Manual

5.6

Management review

AC 01.06

Management review

6.2

Human Resources

AC 02.02

Certification of auditors

AC 02.05

Certification of supervising auditor according to SII 005

6.3

Infrastructure

AC 01.00

Quality Manual

6.4

Work environment

AC 00.00

Quality Manual

7.1

Product implementation

AC 03.01

Procedures to approve a management system

planning
7.2.1

Setting requirements

AC 02.04

Calculations preparation

concerning the product

AC 02.05

Calculations environmental quality management


system

7.2.2

Survey of requirements

AC 03.01

Procedures to approve a management system

relating to the product


7.2.3

Communication with

AC 01.00

Quality Manual

AC 01.09

Standards mark initial enquiries

customer
7.3

Development and design

7.4

Purchasing

Institutes
procedures

Operation of external auditors according to institutes


procedures.
Agreements with external certification organizations

Valid from : 09/12

Edition 13

Page : 55 of 55

Quality and Certification


Division Procedures
Chapter: Organization

Procedure No.: AC.01.00


Procedure : Quality Manual

Standards requirements
Number

Companies procedure
Procedure

Requirement

Procedure Name

Number

(IQNET Doc. Ref.)


according to institutes purchasing procedures.
7.5.1

Manufacturing and service


provision

7.5.2

Validation of manufacturing

AC 02.01
AC 03.01
AC 03.02
AC 03.03
AC 03.04
AC 01.00

Performing system audit


Processes to approve management system
Approval provision
Annual follow up
Suspension and Withdrawing process and appeals
Quality Manual

processes and service


provision
7.5.3

Identification and traceability

AC 01.00

Quality Manual

7.5.4

Customers property

AC 01.04

Quality records /Information confidentiality

7.5.5

Preserving the product

AC 01.04

Quality records /Information confidentiality

7.6

Control of monitoring and

Excluded

measuring devices
8.2.1

Customer satisfaction

AC 01.00

Quality Manual

8.2.2

Internal audit

AC 01.05

Internal audit

8.2.3

Measuring and monitoring

AC 02.03

Checking and testing

AC 00.00

Quality Manual

processes
8.2.4

Measuring and monitoring


the product

8.3

Non conforming product control

AC 01.08

Non conformances/Corrective actions/Preventative actions

8.4

Data analysis

AC 02.03

Evaluation and monitoring

8.5

Continuous improvement

AC 01.00

Quality Manual

8.5.2

Corrective actions

AC 01.08

Non conformances/Corrective actions/Preventative actions

8.5.3

Preventative actions

AC 01.08

Non conformances/Corrective actions/Preventative actions

Valid from : 09/12

Edition 13

Page : 56 of 55

Anda mungkin juga menyukai