ISO Introductory Awareness Training

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ISO awareness
Introduction

Every organization would like to improve the way it operates, whether
that means increasing market share, driving down costs, managing risk
more effectively or improving customer satisfaction.
A quality management system gives your organisation the framework
they need to monitor and improve performance in any areas you
choose.
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What is ISO

The ISO series of standards are the international standard for Quality
Management , environmental & other management Systems

ISO is the International Standards Organisation based in Geneva,
Switzerland with over 100 member countries. Their Technical
Committees define internationally recognised standards for goods and
services.
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ISO 9001 is by far the worlds most established quality framework,
currently being used by around 897,000 organizations in 170 countries
worldwide, and sets the standard not only for quality management
systems, but management systems in general.
It helps all kinds of organizations to succeed through improved
customer satisfaction, staff motivation and continual improvement.
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Discover ISO

In 1946, delegates from 25 countries met in London and decided to create a
new international organization, of which the object would be "to facilitate the
international coordination and unification of industrial standards".


The new organization, ISO, officially began operations on 23 February 1947,
in Geneva, Switzerland.
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ISO

"ISO" is a word, derived from the Greek isos, meaning "equal.
ISO an acronym -International Organization for Standardization
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Global market

With the increasing globalization of markets, International Standards (as
opposed to regional or national standards) have become critical to the
trading process, ensuring a level playing field for exports, and ensuring
imports meet internationally recognized levels of performance and safety.
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Purpose

ISO's purpose is to facilitate international trade by providing a single set
of standards that people everywhere would recognize and respect.
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Categorization

Standards can be broadly sub-divided into three categories, namely product,
process and management system standards.
The first refers to characteristics related to quality and safety for example.
Process standards refer to the conditions under which products and
services are to be produced, packaged or refined.
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Categorization - Continue

Management system standards assist organizations to manage their
operations.

They are often used to help create a framework that then allows the
organization to consistently achieve the requirements that are set out in
product and process standards.
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ISO 9000 Series of Standards

ISO 9000 Fundamentals and Vocabulary: this introduces the user to the
concepts behind the management systems and specifies the terminology
used.
ISO 9001 Requirements: this sets out the criteria you will need to meet if
you wish to operate in accordance with the standard and gain certification.
ISO 9004 Guidelines for performance improvement
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The benefits of implementing an ISO management system
Standards make an enormous and positive contribution to most
aspects of our lives.
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The benefits of implementing ISO 9001
When products and services meet our expectations, we tend to take
this for granted and be unaware of the role of standards. However,
when standards are absent, we soon notice. We soon care when
products turn out to be of poor quality, do not fit, are incompatible
with equipment that we already have, are unreliable or dangerous.
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The benefits of implementing ISO 9001
Continue
Cost savings can be made through improved efficiency and
productivity, as product or service deficiencies will be highlighted.
From this, improvements can be developed, resulting in less waste,
inappropriate or rejected work and fewer complaints. Customers
will notice that orders are met consistently, on time and to the
correct specification. This can open up the market place to
increased opportunities.
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Why seek certification to ISO 9001?
Registration to ISO 9001 by certification body shows committed to
quality, customers, and a willingness to work towards improving
efficiency.
It demonstrates the existence of an effective quality management
system that satisfies the rigours of an independent, external audit.
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An ISO 9001 certificate enhances company image in the eyes of
customers, employees and shareholders alike.
It also gives a competitive edge to an organisation's marketing.
Why seek certification to ISO 9001?
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How do you start to implement ISO 9001? What is involved?


Planning & designing

Describing

Implementing

Improving
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How do you start to implement ISO 9001? What is involved?

Establish quality objectives and how they fit in to the operation of
the business.

Identify the requirements of ISO 9001 and how they apply to the
business involved.

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Produce a documented quality policy indicating how these
requirements are satisfied.

Communicate them throughout the organisation.

How do you start to implement ISO 9001? What is involved? Continue

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Evaluate the quality policy, its stated objectives and then prioritise
requirements to ensure they are met.

Identify the boundaries of the management system and produce
documented procedures as required.


How do you start to implement ISO 9001? What is involved? Continue

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Ensure these procedures are suitable and adhered to.


Once developed, internal audits are needed to ensure the system
carries on working.

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How do you start to implement ISO 9001? What is involved? Continue

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STANDARD - ISO 9001 OR SIMILAR
QUALITY MANUAL
Policy, objectives, organisation,
outline of quality system
PROCESS DOCUMENTS
AND PROCEDURES
INSTRUCTIONS
FORMS
Processes,practices,
responsibilities,
interfaces
Detailed instructions
on how to carry out
specific tasks
Quality
records
Design IT Support Installation Training
TYPICAL QMS STRUCTURE
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REQUIREMENTS OF ISO 9001



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REQUIREMENTS OF ISO 9001


4.1 The organisation shall establish, document, implement maintain
and continually improve a Quality Management System

4.2.2 A Quality Manual shall be established containing details of the
Quality Management System

4.2.3 Documents shall be controlled

4.2.4 Records shall be controlled
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REQUIREMENTS OF ISO 9001 (cont).


5.1 Management shall demonstrate commitment to the Quality
Management System

5.2 The organisation shall focus on the needs of the Customer

5.3 A formal Quality Policy shall be established by Top
Management and communicated to all staff

5.4.1 Quality Objectives shall be set


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REQUIREMENTS OF ISO 9001 (cont).


5.5.2 A Quality Representative of sufficient seniority must be
appointed from within the organisation to administer the
Quality Management System

5.5.3 Quality objectives shall be communicated to all staff

5.6 A periodic review shall held of the Quality Management System
and decisions actioned

6 Sufficient resources shall be provided



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REQUIREMENTS OF ISO 9001 (cont).


6.2 Personnel shall be trained and competent

6.3, 6.4 Facilities and the work environment shall be appropriate
and properly maintained

7.1 The product realisation process shall be planned

7.2 Customer requirements shall be determined

7.2.3 Communication with Customers shall be maintained

7.3 The design and development process shall be controlled


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REQUIREMENTS OF ISO 9001(cont).

7.4 Purchasing and the receipt of purchased goods and services shall be
controlled

7.5 Operations and their verification shall be planned and controlled

7.5.3 All work must be traceable (if required) and its status shall be
identifiable at all stages

7.5.4 Customer property shall be properly cared for

7.6 Measuring and monitoring devices shall be calibrated and maintained

8.1 Quality performance data shall be identified

8.2.1 Customer satisfaction shall be determined


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REQUIREMENTS OF ISO 9001 (cont).

8.2.2 Internal audits of the Quality Management System shall be carried out

8.2.3 Operations processes and the product/service shall be monitored for
effectiveness

8.3 Non-conformance shall be controlled and corrected

8.4 Quality performance data shall be collected and analysed

8.5 Corrective and Preventive actions shall be determined and
implemented in order to continually improve the Quality Management
System.


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ROLE OF QUALITY REPRESENTATIVE

Ensuring that the processes needed for the Quality Management System are
implemented and maintained;

Reporting to Top Management on the effectiveness of the Quality Management
System and the need for improvement;

Ensuring that the importance of meeting Customer requirements is
communicated throughout the organisation

It follows, therefore that the Quality Representative must be a member of
the senior management team in whom the Chief Executive has confidence.


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SIGNIFICANCE OF MANAGEMENT REVIEW

The Management Review meeting is the core of the whole process.

It must be held regularly and must review:

Quality policy and objectives
Improvement
Non-conformance and customer complaints
Corrective and preventive action
Internal and external audits.
Planning and future resource requirements
Training
Supplier performance
Customer satisfaction


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Chairing a meeting


Agenda List of things to be discussed.

Minutes Record of decisions taken and actions delegated.

Circulate agenda and other papers to all attendees in plenty of time for
the meeting.

Get items of Any Other Business notified to yourself before the
meeting.



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Chairing a meeting - Continue

Ensure all items on agenda discussed and decisions minuted

Try to make sure everyone has their say

Try to make sure no one (including yourself) dominates the discussion

Manage time so as not to overrun (it is a review meeting)

Ensure one person is responsible for each action agreed and that
they report progress back to the next meeting


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Setting (SMART) objectives and measuring performance

Identify Key Performance Indicators (KPIs)

Set measurable targets

Collect information and compare with target

Initiate action if targets not met

Review targets (suitability, practicality)


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SMART Objectives


Specific

Measurable

Agreed

Realistic

Time Oriented


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CONTINUAL IMPROVEMENT OF THE QUALITY
MANAGEMENT SYSTEM
Clause 5
Clause 6
Clause 8
Clause 7
Service/Product
realization
Output
Customers

Satisfaction

Service
Product
Resource
Management
Measurement,
analysis and
improvement

Management
responsibility
Customers
Input
Requirements

Value adding activities
Information flow
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Continual Improvement

It is a requirement that the Quality Management System be
continually improved

Improvements can be made to any of the Companys activities:



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Continual Improvement - Continue

Customer requirements
Design
Planning
Procurement
Process control
Storage, shipping, handling
Internal and external communications, customer relations
Documentation and records
Software
Facilities and equipment
Recruitment, retention, training, personal development
Etc. etc. etc.

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Continual Improvement - Continue

Initiatives for improvement can come from:

Feedback from Customers
Feedback from staff
Evaluation of the competition
Questionnaires or surveys
Review of equipment in use, including down time
Review of processes/procedures
Costs (direct, indirect, rework, warranty, purchasing)
Non-conformance/complaint levels
On-time performance
Internal and external audit reports
Etc. etc. etc.


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SIGNIFICANCE OF INTERNAL QUALITY AUDITS

Internal Quality Audits must be held regularly to ensure that:

The organisation remains compliant with the ISO 9001 standard
The procedures are being followed
The written procedures are correct and meeting the requirements of
the Organisation
Areas for improvement are identified
Management receives accurate and unbiased information for
decision making


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WHAT IS AN AUDIT?

An audit is the planned and systematic examination of the written
procedures and comparison of these with the actual procedures in
use.

An audit is the search for objective evidence to prove that the
requirements or procedures are being complied with.

Objective evidence is obtained by the examination of records and
other documents, interviews, physical observation.


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CHARACTERISTICS OF AN AUDIT

Audits should be :-

Formalised and official

Regular

Systematic

Objective


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SELECTION OF AUDITORS

Auditors should be :-

Prepared, Open minded,
Analytical, Patient ,
Industrious,
Human,
Unbiased,
Trained

Auditors must not audit their own area of responsibility

Auditors must have the authority and the time to carry out
audits


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STRUCTURE OF AN AUDIT

Planning

Preparation

Carrying it out

Agreeing action

Reporting

Follow up (close out)


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PLANNING

Responsibility of the Quality Representative to:

Plan to allow for each element of the Quality Management System to
be audited at least annually.

Plan to spread auditing evenly throughout the year.

Published and circulate the plan.


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PREPARATION FOR AUDIT

Always use a checklist based on the area to be audited.

Obtain copies of any previous internal or external audit reports.

Give the personnel involved prior warning of the audit (but always
remember, you are auditing the procedure, not the person).


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PREPARATION OF CHECKLIST

Study the procedure to see:

Who is involved.
What documents are involved and where are they kept.
What are the essentials of the procedure and what is mere
comment.

Make a list of:

The people you want to see.
The size and nature of the evidence you want to seek.



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CARRYING OUT AN AUDIT

Check that all personnel are familiar with the procedure.

Observe what actually occurs.

Ask questions and verify the answers (Show me please).

Verify corrective action resulting from previous audits.

Be prepared to depart from the checklist (Do not be afraid
to look over the fence at other activities).

Take detailed notes on your checklist (objective evidence).


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CARRYING OUT AN AUDIT (cont.)

Determine the significance of any non-conformances.

Do not go out of your way to find non-conformances

Try to assess the effectiveness of the procedure (does it
meet Company requirements).

Be alert to any procedure/process improvements that can
be made.


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BEING AUDITED

Cooperate with the Auditor, be open and honest. It is the Procedure
that is being audited (not you).

Accompany the Auditor at all times and ensure his or her safety.

Have the necessary documents to hand (you should always receive
warning of the audit).



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BEING AUDITED - Continue


Do not take offence at silly questions or if any non-conformances
are detected.

Be prepared to discuss and challenge the findings but do not get
involved in an argument (escalate to the Quality Representative if
necessary).

Correct any non-conformances promptly.


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CATEGORIES OF NON CONFORMANCE


Category 1 - Major non conformances

Category 2 - Minor non conformances

Category 3 - Observations


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AGREE ACTION

Agree with the person responsible that a non-conformance exists.

Specify what quality requirement has been breached.

Agree on the corrective action (by whom and by when).

Try and agree preventive action.

In case of disagreement, refer problem to the Quality
Representative.


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PREVENTIVE ACTION

May not be possible to agree during the audit

Always has longer term implications.

May require additional resources or management approval.

May involve other departments/functions.

May require additional research.

Quality Representative may need to take to Management Review.


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REPORTING

Complete the Internal Audit Report (for each audit).

Submit to the Quality Representative for comment and further action
if necessary.

Have available for reporting to the Management Review Meeting.


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FOLLOW-UP (CLOSE-OUT)

After the agreed time for the implementation of corrective action:

Re-visit the area where the non-conformance was detected.

Ensure that the corrective action has been completed within the
agreed timescale.

Ensure that the preventive action is effective (or is on the agenda of
the next Management Review Meeting).

Report close-out to the Quality Representative.


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UNSCHEDULED AUDITS

Audits may be carried out at times other than those scheduled
in the audit plan

If preventive action needs to be verified.

If a problem with a procedure is suspected.

To confirm that a newly introduced procedure is working
satisfactorily.

If a problem is suspected with a Supplier.