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2. MESSAGE FROM ISO: 9000
Message in 5 lines
 Say what you do
 Do what you say
 Record what you do
 Check the difference
 Act on the difference
Message in 1 line (1994)
Do right thing, first time, every time
to achieve consistent quality
Message in 1 line (2000)
Continual improvement is the way of life
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3. HOW ARE ISO STANDARDS DEVELOPED?
ISO standards are developed according to the following
principles
1. Consensus
The views of all interests are taken into account:
manufacturers, vendors and users, consumer groups,
testing laboratories, governments, engineering
professions and research organizations.
2. Industry wide
Global solutions to satisfy industries and customers
worldwide.
3. Voluntary
International standardization is market driven and
therefore based on voluntary involvement of all
interests in the market-place.
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4. PLANNED CHANGES TO ISO 9001:2008
1. Forward: All reference to „Quality Assurance‟ have now
been removed
2. Introduction: Mention now made to „Business Environment‟
and the „risks associated with that environment‟.
3. Various: „Statutory and regulatory‟ requirements now
mentioned.
4. Out source process – controls are to be identified through
Cl 7.4.
Various new notes have been added.
5. Documentation: Clarification that a „Record‟ is
documentation.
6 Management representative: Must be a member of the
organization‟s management team.
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5. APPLICATION OF PDCA TO DEPARTMENT /
SECTION HEADS
CHECK
 How is my department doing?
 Are processes under control?
 What are my employees telling me?
 Are we meeting customer requirements?
 Am i meeting my objectives?
 What are the key problems in my area?
 How can we improve?
ACT
 Systematic problem-solving (based on importance, risks involved
etc)
 Develop action plans
 Concentrate on improvement (incremental or “breakthrough”
improvements)
 Review existing procedures, and need for new procedure
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6. 4 TIER DOCUMENTATION STRUCTURE
Quality
manual
Procedures
Work instruction/SOP/process flow
charts/other documents
Quality records
Marketing Purchasing Stores Production Q.A. Dispatch Servicing
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7. RECORDS REQUIRED BY REVISED ISO 9001
List of records
 Document updating records
 Control of quality records and master list of records
 Management reviews
 Record of training and skill and competency of personnel
 Maintenance record
 Process monitoring data and corrective action taken for process control
 Record of product non conformities and products accepted on concession.
 Data analysis and activities for continual improvement.
 Result of internal audits and follow up action.
 Data on customer feedback/satisfaction measurement and action taken on customer
complaints.
 Vendor evaluation and purchase orders and actions arising from the evaluations
 Customer property that is lost, damaged or otherwise found to be unsuitable for use
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8. WORKSHOP 2
ISO 9001: 2008 QUESTIONNAIRE
 Analyze the statement provided and indicate in the box on the paper
whether you consider the statements to be “True” or “False”.
 If you consider the statements to be “True”, please indicate in the box the
clause number from ISO 9001: 2008 which supports your decision
No Question True/False
1. Training and competence records of personnel whose
work affect quality must be maintained.
2. Work environment, temperature and humidity needs
to be taken care as applicable related to the product.
3. The organization must appoint a person from the
organization as M.R.
4. The data for process trend and product inspection
reports is not required to analyzed.
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9. FOR EXISTING CERTIFIED CLIENTS
STEPS FOR UPDATION OF EXISTING ISO:9001-2000 SYSTEM TO REVISED ISO: 9001-
2008 QUALITY MANAGEMENT SYSTEM( EXISTING CERTIFIED CLIENTS )
 Conduct awareness program for revision to ISO:9001-2008
 Review all documents to revised ISO:9001-2008 requirements and Identify changes.
 Review quality policy and establish quality objectives
 Revise quality manual and documents as per ISO:9001-2008.
 Train internal auditors for requirements of revised ISO:9001 standard
 Assess the system through internal audit as per revised ISO standard.
 Take corrective actions for non-conformities.
 Apply to revised existing certificate to ISO:9001-2008 to your existing certifying body.
 Final audit( Either in surveillance audit or special audit by certifying body after release of
ISO:9001-2008.
Note: It can be seen from the list of changes, there are very few of any
consequence and most organizations will have little problem adapting their
system to satisfy these changes. Also all certified company needs to update the
system within 1 year of release of standard.
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