Quality Assurance ISO 9000 Quality Standard Kinnison

Quality Assurance & ISO 9000 Quality Standard Kinnison, Chapter 17 March 18 393 SYS 1

ISO 9001: 2000 Quality Management System March 18 393 SYS 2

Different levels of Standards n Company Standard n n Industry Standard n n GM’s paint standards for automobiles IEEE standards National Standards ANSI/ASQC: American National Standards Institute / American Society for Quality n BSI for British Standard n GB/T for Guojia Biaozhun (國 家 標 準 ) /T for tuījiàn (推荐, recommended). n EN European Norm for the European Union n … n n International Standard n ISO International Organisation for Standards March 18 393 SYS 3

National Standards Equivalent to ISO Standards March 18 393 SYS 4

ISO 9000: 2000 & GB/T 19000 -2000 n n n 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 March 18 n n n 393 SYS 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 5

WHAT IS ISO • ISO (International Organization for Standardization) is a Genevabased 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. March 18 393 SYS 6

Relationship of ISO 9001 & IS 0 14001: 1996 n n n 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 IS 0 14001 Annex B March 18 393 SYS 7

What is BS EN ISO 9001: 2000 n n n This is a British Standard version of EN ISO 9001: 2000. It is identical with ISO 9001: 2000. It supersedes n n all obsolescent: 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. --- ISO 9000 March 18 393 SYS 8

Application of ISO 9001: 2000 -1 n n 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) n n - Production, final inspection and testing (module D), n n supersedes BS EN ISO 9003: 1994 supersedes BS EN ISO 9002: 1994 - Design manufacture and final product inspection and testing (module H). n supersedes BS EN ISO 9001: 1994, March 18 393 SYS 9

Application of ISO 9001: 2000 -2 ISO 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. March 18 393 SYS 10

ISO 9001: 2000 Exclusion ref. 1. 2 & 4. 2. 2 a Module E Permissible exclusions Module D Permissible exclusions Module H Permissible exclusions 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 March 18 393 SYS 11

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? March 18 393 SYS 12

Example of ISO 9001: 2000 Exclusion: 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. March 18 393 SYS 13

Example of ISO 9001: 2000 Exclusion: 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. March 18 393 SYS 14

Why ISO 9000 n n n 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 prerequisition 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. March 18 393 SYS 15

Another reason for ISO 9000 March 18 393 SYS 16

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. ” March 18 393 SYS 17

Functions of QA 1. 2. 3. 4. March 18 Administration and management of QA and CASS activities Conduct QA audit Maintenance of technical records Liaison with the regulatory authority 393 SYS 18