July 15 393SYS 1 Quality Assurance & ISO9000 Quality Standard Kinnison, Chapter 17.

Apr 19, 2023 393SYS 1

Quality Assurance & ISO9000 Quality Standard

Kinnison, Chapter 17

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ISO 9001:2000 Quality Management System

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Different levels of Standards

Company Standard GM’s paint standards for automobiles

Industry Standard IEEE standards

National Standards ANSI/ASQC: American National Standards Institute / American Society for Quality BSI for British Standard GB/T for Guojia Biaozhun ( 國家標準 ) /T for tuījiàn ( 推荐 , recommended).

EN European Norm for the European Union …

International Standard ISO International Organisation for Standards

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National Standards Equivalent to ISO Standards

International Organisation for Standards

IS09001:2000

European EN ISO 9001

U. Kingdom BS EN ISO 9001:2000 part 1

China GB/T 19000-2000

USA ANSI/ASQC Q9000

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ISO 9000:2000 & GB/T 19000-2000 ISO 9000:2000 Quality

Management System - Fundamentals and vocabulary

ISO 9001:2000 Quality Management System – Requirements

ISO 9004:2000 Quality Management System - Guidelines for performance improvement

GB/T 19000-2000 質量管理體系基本原理和術語

GB/T 19000-2000 質量管理體系要求

GB/T 19000-2000 質量管理體系業績改善指南

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WHAT IS ISO

•ISO (International Organization for Standardization) is a Geneva-based worldwide federation of national standards bodies.

•The work of preparing International Standards is normally carried out through ISO technical committees.

•ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.

*ISO is a Greek work means the same. ** Standardization means that everyone agrees to do something the same way.

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Relationship of ISO 9001 & IS0 14001:1996

Although ISO 9001 is applied to the process stream of a business (i.e. production) while ISO 14001 is applied to all aspects of an organization’s activities.

ISO 9001:2000 has been aligned (compatible) with ISO 14001:1996 in order to enhance the compatibility of the two standards for the benefit of the user community. (e.g.; 9001 4.4.2 & 14001 6.2.2 on Human resources competence, training and awareness)

More on IS0 14001 Annex B

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What is BS EN ISO 9001:2000 This is a British Standard

version of EN ISO 9001:2000.

It is identical with ISO 9001:2000.

It supersedes BS EN ISO 9001:1994, BS EN ISO 9002:1994

and BS EN ISO 9003:1994

which are all obsolescent.

Compliance with this Standard does not of itself confer immunity from legal obligations. --- ISO9000

all obsolescent:

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Application of ISO 9001:2000 -1

Three of the modules E, D and H, require the manufacturer must operate an approved quality system”. The scope of the quality systems required by these modules addresses:

- Final product inspection and testing (module E) supersedes BS EN ISO 9003:1994

- Production, final inspection and testing (module D), supersedes BS EN ISO 9002:1994

- Design manufacture and final product inspection and testing (module H).

supersedes BS EN ISO 9001:1994,

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Application of ISO 9001:2000 -2ISO 9001:2000 clause 1.2 Application

All requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.

Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable regulatory requirements.

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ISO 9001:2000 Exclusionref. 1.2 & 4.2.2 a

Module E

Permissible exclusions

Module D


Module H


Sub-clause 7.1: planning of product realization

Sub-clause 7.2.3: customer communication

Sub-clause 7.3: design and development

Sub-clause 7.4 purchasing

Sub-clause 7.5.1: control of production and service provision

Sub-clause 7.5.2: validation of processes for production and service provision

Sub-clause 7.5.3: Identification and Traceability

Sub-clause 7.3: design and

development

NO exclusions permitted

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Example of ISO 9001:2000 Exclusion:

Customer property controlled by a bank.

Situation:

A bank provides a variety of services to its customers and chooses to implement a QMS only for its Internet banking services. For this service the bank has claimed conformity to ISO 9001:2000. The bank clearly states in its Quality Manual which services are covered by the QMS. The bank applies all the requirements of ISO 9001:2000 for the realization of its Internet banking services, with the exception of sub-clause 7.5.4 Customer property. The bank does not feel that it has possession of any customer property as part of its Internet banking services and has stated this in the justification for the exclusion of sub-clause 7.5.4 Customer property from its QMS.

Issue(s):

Can the bank exclude sub-clause 7.5.4 Customer property from its QMS and claim conformity to ISO 9001:2000?

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Customer property controlled by a bank. (conti.)

Issue(s):

Can the bank exclude sub-clause 7.5.4 Customer property from its QMS and claim conformity to ISO 9001:2000?

Analysis and Conclusion:

The decision made by the bank to exclude sub-clause 7.5.4 Customer property was not justified because the bank does receive information from its customers such as personal and confidential data. ISO 9001, 7.5.4 Customer property requires an organization to exercise care with customer property while it is under the organizations control or being used by the organization. In this situation, the bank’s customers provide important information in confidence when using the service, which constitutes “Customer property”. Therefore the bank has to address the requirements for customer property in its QMS.

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Exclusion of design and development by a contract manufacturer

Situation:

XYZ Electronics is building a new factory to perform manufacturing of mobile phones, as a subcontractor. It has only one customer and this customer maintains responsibility and authority for product design. XYZ Electronics is responsible for purchasing of all components and for performing the manufacturing activities. The customer provides XYZ with the manufacturing and parts specifications, and is also responsible for notifying XYZ of any design changes and providing the appropriate change information.

XYZ Electronics, in the development of its QMS, has excluded the requirements of ISO 9001:2000 sub-clause 7.3 Design and development. XYZ Electronics considers the customer specifications as a customer supplied product and therefore controls this according to ISO 9001:2000 sub-clause 7.5.4 Customer property.

Issue(s)

Can the XYZ Electronics exclude sub-clause 7.3 Design and development from its QMS and claim conformity to ISO 9001:2000?

Analysis and Conclusion:

XYZ Electronics was justified with its decision to exclude sub-clause 7.3 Design and development from its QMS since it does not have any authority or accountability for design of the mobile phone product. Its customer provides the design.

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Why ISO 9000

There are more than 560,000 certificates of ISO 9000 issued until end 2002 in 161 countries. Most of the certified organizations are located in Europe (about 52%). About 26.5% of the world total are located in Far East. China is the area that recorded the highest growth in recent years and is the country with most of the ISO 9001:2000 certified organizations.

Considering the number of certified organizations, the top five countries are the United Kingdom, China, Italy, USA and Germany.

Many companies now use ISO 9000 certification as a pre-requisition of its supplier evaluation system. For example, many major local organizations such as the HKSAR Government, MTRC, KCRC, New Bus and Kowloon Bus consider ISO 9000 certification as a scoring criteria in their supplier evaluation system.

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Another reason for ISO 9000

Requirement of Quality Assurance (QA)For each type of aircraft flown, airlines must generate the Operations

Specifications (Ops Specs) that establish the maintenance and inspection programs to be used to keep the aircraft in an airworthy condition. It is referred as the Continuous Airworthiness Maintenance Program (CAMP) section in the Ops Specs.

In addition, Federal Aviation Regulation (FAR) 121.373 Continuing Analysis and Surveillance System (CASS) provides an additional requirement as follows: “Each certification holder shall establish and maintain a system for the continuing analysis and surveillance of the performance and effectiveness of its inspection program and the program covering other maintenance, preventive maintenance, and alternations and for the correction of any deficiency in those programs, regardless of whether those programs are carried out by the certificate holder or another person.”

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Functions of QA

1. Administration and management of QA and CASS activities

2. Conduct QA audit3. Maintenance of technical records4. Liaison with the regulatory authority

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July 15 393SYS 1 Quality Assurance & ISO9000 Quality Standard Kinnison, Chapter 17.

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