ISO 9000 SERIES

ISO 9000: is a series of three International Standards for Quality Management Systems.
They specify requirements and recommendations for the design and assessment of
management systems. ISO 9000 is not a product standard. None of the standards in the family
contain requirements with which a product or service can comply. There are no product
acceptance criteria in ISO 9000 so you can't inspect a product against the standard.

Standards and guidelines:

The ISO 9000 standards and guidelines listed below are available separately, or as collections
The ISO 9000 Compendium presents the lSO 9000 family in hard copy form The documents
are also available on CD ROM for users who prefer the flexibility of an electronic format.

Standards and guidelines : Purposes:

ISO 8402, quality management and quality Defines the fundamental term used in the iso
assurance Vocabulary 9000 family, which you need to know to be
sure of avoiding misunderstanding both
internally and externally.
ISO 9000-1.Quality management and quality Establishes a starting point for understanding
assurance standards Part 1 :guidelines for and selecting the standards appropriate to
selection and use your needs.

ISO 9000-2. Quality management and quality Assists you In Interpreting and applying ISO
assurance standards Part2: Generic guidelines 9001, ISO 9002 and ISO 9003.
for the application of lSO 9007, ISO 9002
and ISO 9003
ISO 9000-3, Quality management and quality Provides you With specific Interpretation of
assurance standards Pan 3. Guidelines for the the requirements of ISO 9001 for computer
application of ISO 9001 7994 to the software development applications.
development, supply, Installation and
maintenanceof computer software

ISO 9000-4, Quality management and quality Gives you guidance on how to plan, organize
assurance standards Part 4: guide to and control resources to produce reliable and
dependability programme management maintainable products.

ISO 9001. Quality systems Model for quality This is the requirement standard you use
assurance in design, development, when you wish to demonstrate capability for
production, installation and servicing. design/development of your product or
service. as well as for production, Installation
and servicing.
ISO 9002, Quality systems Model for quality This is the requirement standard you use
assurance in production, Installation and when you are not responsible for the
servicing. design/development of your product
orservice, but wish to demonstrate capability
for production, installation and servicing.

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ISO 9003,Quality system- model for quality This is the requirements standards you use
assurance in final inspection and test. when you only need to demonstrate capability
to control your product by final inspection
and test
ISO 9004-1, Quality management and quality This is not a requirement standard. but
system elements Part 1: Guidelines provides you with guidelines to Implement a
quality system to satisfy your customers’ and
your own organization’s needs.

ISO 9004-2. Quality management and quality Thus standard is made up in asimilar way as
system elements Part2: Guidelines for ISO 9004-1, but the guidelines are designed
services with special regard to the conditions
Pertinent to the service sector.

ISO 9004-3, Quality management and quality This standard provides you With quality
system elements Part 3: Guidelines for management guidelines applicable If you are
processed materials a producer of processed materials, which are
Typically provided In bulk.

Provides you With guidelines for

ISO 9004-4, Quality management and quality implementing continuous quality
system elements Part 4: Guidelines for Improvement within your organization using
quality improvement tools and techniques based on data collection
and analyses.

ISO 10005. Quality management Guidelines This standard gives you guidance on how to
for quality plans prepare quality plans for the control of
specific products. projects or contracts.

ISO 10006, Guidelines to quality in project Guidelines to help you ensure the quality of
management both the project processes and the project
product

ISO 10007, Quality management -Guidelines Gives you guidelines to ensure that a complex
for configuration management product continues to function when
components are changed individually.

ISO 10011-1, Guidelines for auditing quality Provides you with guidelines for auditing a
systems -Part 1 : Auditing quality system, and for verifying the system's
ability to achieve defined quality objectives.
You can use thus standard Internally or for
auditing your suppliers

ISO 10011-2, Guidelines for auditing quality Provides guidance on the education, training.
systems Pan 2: Qualification criteria for experience personal attributes and
quality systems auditors management capability as needed to carry out
an audit.

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ISO 10011-3, Guidelines for auditing quality Providesbasicguidelines for managing
systems Part 3: Management of audit quality system audit programmes.
programmes.

ISO 10012-1, Quality assurance requirements Gives you guidelines on the main features of
for measuring equipment Part 1: Metrological a calibration system to ensure that
confirmation system for measuring measurements are made With the Intended
equipment accuracy.

ISO 10012-2, Quality assurance for Provides supplementary guidance on the

measuring equipment Part 2: Guide/Ines for application of statistical process control when
control of measurement processes this is appropriate for achieving the
objectives of Part 1
ISO 10013, Guideline for developingquality Provides guidelines for the development.
manuals preparation and control of quality manuals
tailored to your specific needs.

Selection:
There are many different ways to apply and combine the standards of the ISO 9000 family.

There are a few examples:

Example 1: A small computer software development company used the handbook ISO 9000
for Small Businesses plus ISO 9000-3 as a basis for developing its quality system. When it
undertook a contract for a more substantial software development project, it used ISO 10005
to guide the development of the contract quality plan and also consulted ISO 10007 for
advice on configuration management.

Example 2: A welfare agency decided to establish a quality improvement strategy. It adopted

ISO 9004-2 and ISO 9004-4 as a basis for planning and implementing its system. The agency
found that ISO 9002 and ISO 9000-2 provided very useful additional guidance, particularly
since it expected that future certification to ISO 9002 would give it more credibility.

Example 3: A washing machine manufacturer had a well-established company culture of

continuous improvement and effective production control. It decided to improve its product
development processes and tohere are many different ways to apply and combine the
standards of the ISO 9000 family. implement ISO 9001 as an internal improvement strategy.
The company used ISO 9000-4 to guide its dependability management programme. Over a
period of time, it developed a full quality management system in compliance with ISO 9001.
It used ISO 10011 Parts 1, 2 and 3 to help its internal audit programme and as a basis for
supplier audits.

Example 4: A large chemical processing company was required by its major customers to
gain certification to ISO 9002. In order to obtain additional benefits, it planned a
comprehensive management strategy based on ISO 9004-1 and ISO 9002. The company used
ISO 10013 to guide the development of quality documentation in its various production
divisions and ISO 9004-3 for advice on quality assurance for processed materials. When it

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decided to commence a structured approach to quality improvement, it selected ISO 9004-4
as a guide.

Requirements:
This is a summary of principle requirements of ISO 9000. Use it to explain to managers and
others what ISO requires and why. The requirements for written documentation under ISO
9000 are often exaggerated. The standard unconditionally requires documentation for only a
few items. However, common sense, experience, and the Auditors may demand
documentation beyond the minimum requirements.

1. Management responsibilities:
 The quality policy shall be defined, documented, understood, implemented
and maintained.
 Responsibilities and authorities for all personnel specifying, achieving and
monitoring quality shall be defined.
 In-house verification resources shall be defined, trained and funded.
 A designated management person sees that the Q91 program is implemented
and maintained.
2. Quality system:
 Procedures shall be prepared.
 Procedures shall be implemented
3. Contract review:
 Incoming contracts (and purchase orders) shall be reviewed to see whether the
requirements are adequately defined, agree with the bid and can be supplied

4. Design control:
 The design project shall be planned.
 Design input parameters shall be defined.
 Design output, including crucial product characteristics shall be documented.
 Design output shall be verified to meet input requirements.
 Design changes shall be controlled.
5. Document control:
 Generation of documents shall be controlled.
 Distribution of documents shall be controlled.
 Changes to documents shall be controlled.

6. Purchasing:
 Potential subcontractors and sub-suppliers shall be evaluated for their ability
to provide stated requirements.
 Requirements shall be clearly defined in contracting data.

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  Effectiveness of the subcontractor's quality assurance system shall be
assessed.

7. Customer- supplied material:

 Any customer-supplied material shall be protected against loss or damage
8. Product identification and tracability:
 The products shall be identified and traceable by item, batch or lot during all
stages of production, delivery and installation.
9. Process control:
 Production (and installation) processes shall be defined and planned.
 Production shall be carried out under controlled conditions: documented
instructions, in-process controls, approval of processes and equipment, and
criteria for workmanship
10. Inspection and testing:
 Incoming materials shall be inspected or verified before use.
 In-process inspection and testing shall be performed.
 Final inspection and testing shall be performed prior to release of finished
product.
11.Inspection/ measuring/ test equipment :
 Equipment used to demonstrate conformance shall be controlled, calibrated
and maintained.
 Identify measurements to be made.
 Identify affected instruments.
 Calibrate instruments (procedures and status indicators).
 Periodically check calibration.
 Assess measurement validity if found out of calibration.
 Control environmental conditions in metrology lab.
 Measurement uncertainty and equipment capability shall be known.
 Where test hardware or software is used, it shall be checked before use and
rechecked during use.

12. Inspection and test status:

 Status of inspections and tests shall be maintained for items as they progress
through various processing steps.
 Records shall show who released conforming product.
13.Control of nonconfirming product:

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  Nonconforming product shall be controlled to prevent inadvertent use or
installation.
 Review and disposition of nonconforming product shall be formalized.
14.Corrective action:
 Problem causes shall be identified.
 Specific problems and their causes shall be corrected.
 Effectiveness of corrective actions shall be assessed.
15.Handling , storage, packaging and delivery:
 Procedures for handling, storage, packaging and delivery shall be developed &
maintained.
 Handling controls shall prevent damage and deterioration.
 Secure storage shall be provided. Product in stock shall be checked for
deterioration.
16.Quality records:
 Quality records shall be identified, collected, indexed, filed, stored, maintained
and dispositioned.
17.Internal quality audit:
 Audits shall be planned and performed.
 Results of audits shall be communicated to management.
 Any deficiencies found shall be corrected.
18.Training:
 Training needs shall be identified.
 Training shall be provided.
 Records of training shall be maintained.
19.Servicing:
 Servicing activities shall be performed to written procedures.
 Servicing activities shall meet requirements
20. Statistical techniques:
 Statistical techniques shall be identified.
 Statistical techniques shall be used to verify acceptability of process
capability and product characteristics.
REFERANCES:-
www.strategos.m.com-(requirements)
www.simplyquality.org>selusee.pdf.com-(Standards,guidelines and selection)

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