Anda di halaman 1dari 46

ISO/IEC 17011: 2004

Social Accountability Accreditation Services,


June 2010

Social Accountability
Accreditation Services

Mission:
SAAS supports social responsibility by ensuring
the implementation of credible social standards
designed to protect people and their communities.
SAAS evaluates and accredits auditing
organizations to assure they are qualified to hold
their clients accountable to such social standards.

Accreditation
 Accreditation is the process by which formal recognition of
competence is given to qualified organizations, known as
Certification Bodies (CBs).
 CBs are then granted the ability to perform certifications.
 Certification of compliance to SA8000 and other verification
codes within the SAAS scope of accreditation is available
only through qualified CBs granted accreditation by SAAS.
 Accreditation is necessary to assure stakeholders that the
CBs are able to consistently, reliably and effectively perform
certification audits and that these audits are carried out in a
professional manner.
 The accreditation process by SAAS includes documentation
review, site audits and observation of auditors in the field.
3

ISO/IEC 17011:2004

Conformity assessment General


requirements for accreditation
bodies accrediting conformity
assessment bodies.

ISO/IEC 17011
A system to accredit CB conformity
assessment services should provide
confidence in the CBs competency and ability
to perform their tasks. Accreditation bodies
provide impartial verification of that
competence such verification is done by
accreditation bodies that are impartial in
relation to both the CBs and their clients.

SAAS Normative Requirements


SAAS maintains a set of Procedures and Policies,
revised between 2007 and 2008, that it follows in
conducting accreditation work:
 SAAS Procedure 200 sets out the certification process
requirements for Certification Bodies (CBs) undertaking
the assessments of organizations against the SA8000
standard.
 SAAS Procedure 201 sets out the internal policies SAAS
must follow in granting and maintaining accreditation of a
CB by SAAS.
 SAAS Procedure 203 contains the qualifications and
training requirements for accreditation auditors and SAAS
staff.
 SAAS has also developed a set of Work Instructions that
accreditation auditors must follow in undertaking document
reviews, on-site office and witness audits, and review of
corrective actions.
 These policies are all written and maintained within the
requirements of ISO 17011:2004.
6

SAAS Normative Requirements


In addition, SAAS requires implementation
of several ISO documents:
 SAAS maintains procedures and policies in
compliance with ISO/IEC 17011:2004, the
international standard for accreditation bodies
accrediting certification bodies.
 SAAS requires implementation of ISO/IEC
17021:2006 by all accredited CBs. 17021 is the
international standard setting out requirements
for bodies providing audit and certification of
management systems.

ISO/IEC 17011
ISO 17011 specifies the general requirements
for accreditation bodies. Audit and evaluation
mechanisms against ISO 17011 provides
assurance that accreditation bodies are
operating in accordance with the standard.
SAAS conducts internal audits and
management review sessions, as well as
undertaking external verification audits to
ensure continued compliance with ISO 17011
requirements.
8

Accreditation and Certification


Process

What is ISO/IEC?
What ISO's name means
Because "International Organization for
Standardization" would have different
abbreviations in different languages ("IOS" in
English, "OIN" in French for Organisation
internationale de normalisation), it was decided at
the outset to use a word derived from the Greek
isos, meaning "equal". Therefore, whatever the
country, whatever the language, the short form of
the organization's name is always ISO.

What is ISO/IEC?

What IEC means


IEC = International Electrotechnical Commission
The International Electrotechnical Commission
(IEC) is the leading global organization that
prepares and publishes international standards for
all electrical, electronic and related technologies.

How is an ISO standard


developed?
ISO Standards are developed by international
technical committees.
DIS = technical committee meets to discuss,
debate and argue until they reach consensus on a
draft agreement, it is circulated and ISO Members
vote
FDIS = If the voting is in favor, the document, with
modifications, is circulated to the ISO members
vote again
Standard = If that vote is positive, the document is
then published as an International Standard

Accreditation Hierarchy
Requirement Documents

SAAS

ISO/IEC 17011 and


SAAS Procedure 201

Certification Body

ISO/IEC 17021 and


SAAS Procedure 200

Client

Standard

13

ISO/IEC 17011 Structure

Eight Sections:
1 Scope
2 Normative references
3 Terms and definitions

14

ISO/IEC 17011 Structure

Eight Sections 5 Normative:


4 Accreditation Body
5 Management
6 Human Resources
7 Accreditation Process
8 Responsibilities of the AB and CB

15

ISO/IEC 17011 Content

Section 1 Scope:
Specifies general requirements for ABs accrediting CBs.
CBs may be accredited for:
Testing
Inspection services
Management system certification
Personnel certification
Product certification
Calibration.

16

ISO/IEC 17011 Content

Section 2 - Normative references:


ISO 9000:2000, Quality management systems
Fundamentals and vocabulary
ISO/IEC 17000:2004, Conformity assessment
Vocabulary and general principles

17

ISO/IEC 17011 Content


Section 3 - Terms and definitions : For the purposes of
this document, the terms and definitions given in ISO/IEC
17000 and the following apply.
3.1: accreditation third party attestation related
to a CB conveying formal demonstration of
competence.
3.2: accreditation body body that performs
accreditation.
3.3: logo logo used by AB.
3.4: accred certificates document stating
accreditation has been granted, within a scope.
3.5: accred symbol symbol used to indicate
accred status.
3.6: appeal request for reconsideration of
18
adverse decision.

ISO/IEC 17011 Content


Section 3 - Terms and definitions : For the purposes of
this document, the terms and definitions given in ISO/IEC
17000 and the following apply.
3.7: assessment process undertaken to assess
the competence of a CB based on a normative
document.
3.8: assessor person assigned by the AB as part
of the assessment team.
3.9: complaint expression of dissatisfaction,
other than an appeal, to an AB relating to the
activities of the AB or accredited CB.
3.10: conformity assessment body body that
performs conformity assessment services, can be
object of accreditation.
19

ISO/IEC 17011 Content


Section 3 - Terms and definitions : For the purposes of
this document, the terms and definitions given in ISO/IEC
17000 and the following apply.
3.11: consultancy participation in activities of a
CB subject to accreditation.
3.12: expert person assigned by AB to provide
specific knowledge.
3.13: extending accreditation enlarging the
scope of accreditation.
3.14: interested parties parties with direct or
indirect interest in accreditation.
3.15: lead assessor overall responsibility for
assessment activities.
3.16: reducing accreditation cancelling partial
20
scope of accreditation.

ISO/IEC 17011 Content


Section 3 - Terms and definitions : For the purposes of
this document, the terms and definitions given in ISO/IEC
17000 and the following apply.
3.17: scope of accreditation specific conformity
assessment services for which accreditation is
sought.
3.18: surveillance set of activities to monitor
continued fulfillment of requirements.
3.19: suspending accreditation temporarily
making accreditation invalid.
3.20: withdrawing accreditation cancelling
accreditation in full.
3.21: witnessing observing CB carrying out
assessment services.
21

ISO/IEC 17011 Content

Section 4 Accreditation Body:


Clause 4 describes the principles on which credible
accreditation is based. These principles include the
structure, legal responsibility, confidentiality and liability
for accreditation activity.

22

ISO/IEC 17011 Content

Section 4 General:
Principles for inspiring confidence include
4.1
legal responsibility,
4.2
structure,
4.3
impartiality
4.4
confidentiality,
4.5
liability and financing, and
4.6
accreditation activity.

23

4.1 Legal Responsibility

The accreditation body must be a registered legal


entity.

24

4.2 Structure

The structure of the AB must give confidence in


its accreditations.
The AB retains authority and responsibility for
accreditation decisions.
The AB has to have a description of its legal
status, names of owners, etc.
The AB must have documentation of duties,
structure, responsibilities, authorities of
personnel and management.
The AB shall have access to technical experts.
25

4.3 Impartiality
The AB shall safeguard objectivity and
impartiality of its activities.
AB policies must be non-discriminatory and be
administered in a non-discriminatory way.
The AB services shall be accessible to all
applicants.
All personnel and committees shall act
objectively and free from undue pressures.
Decisions on accreditation shall be taken by
competent persons or committees different from
the assessment team.
The AB shall not provide consultancy or auditing
services that might affect impartiality.
26

4.4 Confidentiality

The AB must have adequate arrangements to


ensure confidentiality of the information obtained
through accreditation activities.
This includes committees, external bodies,
individuals acting on behalf of the AB, etc.
Confidential information shall not be disclosed
without written consent of the CB.

27

4.5 Liability and Financing

The AB shall have arrangements to cover


liabilities arising from its activities.
The AB shall have resources for operation of
activities and descriptions of sources of income.

28

4.6 Accreditation activity

The AB shall describe its activities.


The AB may adopt guidance documents and
such documents must be formulated by
competent committees/persons.
The AB shall have procedures for extending
activities and to meet the demands of interested
parties.

29

ISO/IEC 17011 Content

Section 5 Management:
Principles for inspiring confidence include
5.1
General,
5.2
Management System,
5.3
Document Control,
5.4
Records,
5.5
Nonconformities,
5.6
Preventive Actions,
5.7
Internal Audits,
5.8
Management Reviews, and
5.9
Complaints.
30

5.0 Management of the AB


The AB shall establish and maintain an effective
management system. Such procedures include
systems for:
Policies and objectives, including a quality policy.
Document control for approval, review, updating.
Records maintenance including IDing, collecting, storing
records.
Identification of nonconformities and corrective actions,
including rot cause analysis, action plans and review.
Identification of opportunities for improvement.
Conduct of annual internal audits.
Establishment of management reviews for review of audits,
activities, feedback, trends and CAs.
Complaints management and response.

31

ISO/IEC 17011 Content

Section 6 Human Resources:


6.1
6.2
6.3
6.4

Personnel Associated with AB,


Personnel involved in accreditation,
Monitoring,
Personnel Records

32

6.0 Human Resources


The AB shall have a sufficient number of competent
personnel to perform necessary work.
These personnel must have appropriate education,
training, technical knowledge, skills and experience.
The AB must have access to sufficient assessors to
cover activities.
Personnel shall commit themselves by signature to
comply with the rules defined by AB.
The AB shall set out required qualifications,
experience, and training required.

33

6.0 Human Resources


The AB shall ensure that assessors and experts:
Are familiar with procedures, criteria and other
requirements.
Have undergone training.
Have knowledge of assessment methods.
Are able to communicate effectively.

The AB shall ensure satisfactory performance of the


accreditation process through procedures and
monitoring of personnel performance.
The AB shall maintain records of qualifications,
training and experience of personnel.
34

ISO/IEC 17011 Content

Section 7 Accreditation Process:


This section provides general information on the
process of accreditation including the
application, audit, findings, and decision making.

35

7.0 Accreditation Process

The AB shall use normative documents and


references throughout it process.
The AB will make information publicly available
describing its accreditation process, fees, complaints
process, rights and obligations of CBs, rights and
duties and information about its financial support.

36

7.2 Application Process


The CB must submit a formal application to the AB.
The application must include:
General features of the CB.
General information about the CB.
Requested scope of accreditation.
Agreement to fulfill the requirements.
Description of services the CB undertakes.
A copy of the CB quality manual.

37

7.0 Resources and Subcontracting


The AB shall review its ability to carry out the
assessment of the applicant re: competence and
availability of assessors.
The AB may subcontract assessment activities but
must take full responsibility for all assessment and
decision-making.

38

7.5 Preparation
The AB shall formally appoint the assessment team.
The team shall have appropriate knowledge to
conduct the audit.
The AB shall ensure the team is impartial.
The AB will notify the CB of the audit team and
provide sufficient time in case there is an objection.
The initial assessment will include a visit to the CB
head office and others where key activities are
performed.
The audit team will have access to the appropriate
criteria and documents.
39

7.0 Document and On-Site


Assessment
The assessment team shall review all relevant
documents and records.
The AB may decide not to proceed with the on-site
assessment if NCs are identified.
The on-site assessment will have an opening
meeting where criteria are clearly defined.
The assessment will be conducted at the premises
of the CB where key activities are performed, to
gather objective evidence that the CB is competent.
The assessment team will witness the performance
of CB staff to provide assurance of the competence
of the CB.
40

7.8 Analysis and Report


The assessment team shall analyze all relevant
information and evidence from the document and
record review and on-site assessment.
The reporting procedures shall ensure that:
A closing meeting occurs.
A written report is promptly given to the CB.
The CB be invited to respond to the report.
The AB shall remain responsible for the report and
content.
The AB shall ensure the CBs NC responses are
sufficient and effective.
41

7.8 Analysis and Report


Information provided to the decision makers shall
include:
ID of the CB
Dates of the assessment
Names of the assessors
Proposed scope
Assessment report
Statement on the adequacy of the organization
Information on resolution of NCs

42

7.9 Decision Making


The AB shall, without undue delay, make the
decision on accreditation on the basis of the
evaluation information.
The accreditation certificate to the CB shall identify:
The ID and logo of the AB
Unique ID of the CB
Location of the key activities of the CB
Effective and expiration date of the
accreditation
Scope of accreditation
Reference to normative document.
43

7.0 Appeals, Reassessment and


Surveillance
The AB shall have procedures to address appeals.
The AB shall have procedures for carrying out
surveillances and reassessments.
Between surveillances and reassessments shall
include representative samples of the scope of
accreditation.
The AB shall have strict time limits for NCs identified
during surveillances or reassessments.
The AB shall develop procedures for suspension,
withdrawal and reduction of scope
The AB shall maintain records on CBs and ensure
their confidentiality.
44

ISO/IEC 17011 Content

Section 8 Responsibilities and


Obligations of the AB and CB

45

8.0 Responsibilities and Obligations


The CB shall commit to fulfill the requirements set
out.
The CB shall afford accommodation and cooperation
to enable fulfillment and monitoring by the AB.
The CB shall notify the AB of significant changes
within its organization.
The AB shall make information publicly available
about the status of its accreditations.
The AB shall have a policy governing the use of its
accreditation symbol and monitor its use.

46