MALAYSIAN STANDARD QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009)

Transcription

1 MALAYSIAN STANDARD MS ISO 9001:2008 QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS (FIRST REVISION) (ISO 9001:2008, IDT) (PUBLISHED BY STANDARDS MALAYSIA IN 2009) ICS: Descriptors: quality management, documentation, quality policy, management commitment, customer-related process, requirements Copyright 2009 DEPARTMENT OF STANDARDS MALAYSIA

2 DEVELOPMENT OF MALAYSIAN STANDARDS The Department of Standards Malaysia (STANDARDS MALAYSIA) is the national standardisation and accreditation body. The main function of the Department is to foster and promote standards, standardisation and accreditation as a means of advancing the national economy, promoting industrial efficiency and development, benefiting the health and safety of the public, protecting the consumers, facilitating domestic and international trade and furthering international cooperation in relation to standards and standardisation. Malaysian Standards are developed through consensus by committees which comprise of balanced representation of producers, users, consumers and others with relevant interests, as may be appropriate to the subject in hand. To the greatest extent possible, Malaysian Standards are aligned to or are adoption of international standards. Approval of a standard as a Malaysian Standard is governed by the Standards of Malaysia Act 1996 (Act 549). Malaysian Standards are reviewed periodically. The use of Malaysian Standards is voluntary except in so far as they are made mandatory by regulatory authorities by means of regulations, local by-laws or any other similar ways. The Department of Standards appoints SIRIM Berhad as the agent to develop Malaysian Standards. The Department also appoints SIRIM Berhad as the agent for distribution and sale of Malaysian Standards. For further information on Malaysian Standards, please contact: Department of Standards Malaysia OR SIRIM Berhad Century Square, Level 1 & 2 (Company No V) Block 2300, Jalan Usahawan 1, Persiaran Dato Menteri Cyberjaya P.O. Box 7035, Section 2 Selangor D.E Shah Alam MALAYSIA Selangor D.E. Tel: Tel: Fax: Fax: central@standardsmalaysia.gov.my STANDARDS MALAYSIA All rights reserved

3 CONTENTS Page Committee representation... National foreword... iii iv 1 Scope General Application Normative references Terms and definitions Quality management system General requirements Documentation requirements Management responsibility Management commitment Customer focus Quality policy Planning Responsibility, authority and communication Management review Resource management Provision of resources Human resources Infrastructure Work environment Product realization... 7 STANDARDS MALAYSIA All rights reserved i

4 CONTENTS (continued) Page 7.1 Planning of product realization Customer-related processes Design and development Purchasing Production and service provision Control of monitoring and measuring equipment Measurement, analysis and improvement General Monitoring and measurement Control of nonconforming product Analysis of data Improvement Annex A (informative) Correspondence between ISO 9001:2008 and ISO 14001: Annex B (informative) Changes between ISO 9001:2000 and ISO 9001: Bibliography ii STANDARDS MALAYSIA All rights reserved

5 Committee representation The Industry Standards Committee on Quality Management and Quality Assurance (ISC Y) under whose authority this Malaysian Standard was adopted, comprises representatives from the following organisations: Department of Standards Malaysia Federation of Malaysian Manufacturers Institute of Quality Malaysia Lembaga Pembangunan Industri Pembinaan Malaysia Malaysian Administrative, Modernisation and Management Planning Unit Malaysian Agricultural Research and Development Institute Malaysian Automotive Association Malaysian Institute of Management Malaysian International Chamber of Commerce and Industry Ministry of International Trade and Industry Malaysia National Pharmaceutical Control Bureau PERODUA Manufacturing Sdn Bhd Perusahaan Otomobil Nasional Berhad Science and Technology Research Institute for Defence SIRIM Berhad SIRIM QAS International Sdn Bhd The Institution of Engineers, Malaysia Universiti Malaya Universiti Utara Malaysia The Technical Committee on Quality Management and Quality Assurance - TC2 on Quality Systems which recommended the adoption of the ISO Standard consists of representatives from the following organisations: Department of Standards Malaysia Federation of Malaysian Manufacturers Institute of Quality Malaysia Lembaga Pembangunan Industri Pembinaan Malaysia Malaysian Administrative, Modernisation and Management Planning Unit Malaysian International Chamber of Commerce and Industry Science and Technology Research Institute for Defence SIRIM QAS International Sdn Bhd Universiti Utara Malaysia STANDARDS MALAYSIA All rights reserved iii

6 NATIONAL FOREWORD The adoption of the ISO Standard as a Malaysian Standard was recommended by the Technical Committee on Quality Management and Quality Assurance - TC2 on Quality Systems under the authority of the Industry Standards Committee on Quality Management and Quality Assurance. This Malaysian Standard is the first revision of MS ISO 9001, Quality management systems - Requirements. This Malaysian Standard is identical with ISO 9001:2008, Quality management systems - Requirements, published by the International Organization for Standardization (ISO). However, for the purposes of this Malaysian Standard, the following apply: a) in the source text, "this International Standard" should read "this Malaysian Standard"; b) the comma which is used as a decimal sign (if any), to read as a point; and c) reference to International Standards should be replaced by equivalent Malaysian Standards as follows: Referenced International Standards ISO 9000:2005, Quality management systems - Fundamentals and vocabulary Corresponding Malaysian Standards MS ISO 9000:2005, Quality management systems - Fundamentals and vocabulary This Malaysian Standard cancels and replaces MS ISO 9001:2000. Compliance with a Malaysian Standard does not of itself confer immunity from legal obligations. NOTE. IDT on the front cover indicates an identical standard i.e. a standard where the technical content, structure, wording (or is an identical translation) of a Malaysian Standard is exactly the same as in an International Standard or is identical in technical content and structure although it may contain the minimal editorial changes specified in clause 4.2 of ISO/IEC Guide iv STANDARDS MALAYSIA All rights reserved