DRAFT SAINT LUCIA NATIONAL STANDARD DNS/ISO 9001 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS [ISO 9001: 2015, IDT]

Transcription

1 DRAFT SAINT LUCIA NATIONAL STANDARD DNS/ISO 9001 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS [ISO 9001: 2015, IDT] Copyright SLBS Saint Lucia Bureau of Standards, 2015 No part of this standard may be reproduced in any form without the prior written consent of the Saint Lucia Bureau of Standards. This does not preclude quotation(s) from the standard for the purpose of review or comments. SAINT LUCIA BUREAU OF STANDARDS P. O. BOX CP 5412 BISEE INDUSTRIAL ESTATE CASTRIES SAINT LUCIA TEL: FAX: Website: THIS IS AN IDENTICAL ADOPTION OF ISO 9001: 2015

2 GENERAL STATEMENT The Saint Lucia Bureau of Standards was established under the Standards Act (No. 14 of 1990) and started operations on 01 April A broad-based 15-member Standards Council directs the affairs of the Bureau. The Standards Act gives the Bureau the responsibility to develop and promote standards and codes of practice for products and services for the protection of the health and safety of consumers and the environment as well as for industrial development in order to promote the enhancement of the economy of Saint Lucia. The Bureau develops standards through consultations with relevant interest groups. In accordance with the provisions of the Standards Act, public comment is invited on all draft standards before they are declared as Saint Lucia National Standards. The Bureau also administers the Metrology Act No. 17 of This legislation gives the Bureau the responsibility to regulate all weights and measures and to manage and co-ordinate the metrication of Saint Lucia. The Bureau operates a Product Certification Scheme applicable to all products for which national standards exist. If a product satisfies all the requirements for certification, a license to carry the Saint Lucia Standard Mark is issued to the manufacturer of the product. The presence of the mark on a product indicates that the product conforms to all the requirements of a specific national standard and assures consistent quality (of the product) to the consumer. The Bureau is a member body of the International Organisation for Standardisation (ISO), an affiliate member of the International Electrochemical Commission (IEC) and a member of the CARICOM Regional Organisation for Standards and Quality (CROSQ) and the Pan American Standards Commission (COPANT). The Bureau is the local agent for several foreign standards bodies such as the British Standards Institution (BSI) and the ASTM International (formerly known as the American Society for Testing and Materials). The Bureau serves as the enquiry point for the World Trade Organisation (WTO) on matters pertaining to the Technical Barriers to Trade (TBT) Agreement. The Bureau also serves as the National CODEX Alimentarius enquiry point with responsibility for coordinating national positions on CODEX matters. In accordance with good practice for the adoption and application of standards, Saint Lucia National Standards are subject to review every five years. Suggestions for improvements are always welcomed at any time after publication of the standard. ii SLBS 2015

3 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS [ISO 9001: 2015, IDT] AMENDMENTS ISSUED SINCE LAST PUBLICATION Amendment No. Date of Issue Type of Amendment Text(s) Affected SLBS 2015 iii

4 ATTACHMENT PAGE FOR SLBS AMENDMENT SHEET iv SLBS 2015

5 DRAFT SAINT LUCIA NATIONAL STANDARD DNS/ISO 9001 Edition 2.0 QUALITY MANAGEMENT SYSTEMS REQUIREMENTS [ISO 9001: 2015, IDT] TECHNICAL COMMITTEE FOR MANAGEMENT SERVICES The following persons comprised the Technical Committee, which was responsible for the formulation of this standard: Chairperson Representing Yvonne Agard Saint Lucia Coalition of Services Industries (SLCSI) Vice Chairman Betty Combie Moz - Training & Consultancy Organization Members Arlene Devaux Engineering Construction and Management Consulting Ltd Peter Lorde Ministry of Commerce Business Development, Investment and Consumer Affairs Wilton Bleasdile Samara Nicole Aurelien Keith Millar Tzarmallah Haynes (Technical Secretary) Risk Management Consultant Saint Lucia Employers Federation Association of Management Consultant Saint Lucia (AMCS) Inc Saint Lucia Bureau of Standards SLBS 2015 v

6 Contents Pages National foreword Scope Normative references Terms and definition Context of the organization... Error! Bookmark not defined. 5 Leadership... Error! Bookmark not defined. 6 Planning... Error! Bookmark not defined. 7 Support... Error! Bookmark not defined. 8 Operation... Error! Bookmark not defined. 10 Improvement... Error! Bookmark not defined. Annex A (informative)clarification of new structure, terminology and concepts... Error! Bookmark not defined. Annex B (informative) Other International Standards on quality management and quality management systems developed by ISO/TC Error! Bookmark not defined. Bibliography... 2 Tables Table A.1 Major differences in terminology between ISO 9001:2008 and ISO 9001: Error! Bookmark not defined. Table B.1 Relationship between other International Standards on quality management and quality management systems and the clauses of this International Standard Error! Bookmark not defined. vi SLBS 2015

7 National foreword This national standard is an identical adoption of ISO 9001: 2015 Quality management systems Requirements. This standard represents a revision of existing national standard of SLNS/ISO 9001: 2008 Quality management systems Requirements. This second edition was adopted by the Standards Council on... The adoption of a quality management system is a strategic decision for an organization that can help to improve its overall performance and provide a sound basis for sustainable development initiatives. The potential benefits to an organization of implementing a quality management system based on this national standard are: a) the ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements; b) facilitating opportunities to enhance customer satisfaction; c) addressing risks and opportunities associated with its context and objectives; d) the ability to demonstrate conformity to specified quality management system requirements. This national standard can be used by internal and external parties. It is not the intent of this national standard to imply the need for: 1) uniformity in the structure of different quality management systems; 2) alignment of documentation to the clause structure of this national standard; 3) the use of the specific terminology of this national standard within the organization. The quality management system requirements specified in this national standard are complementary to requirements for products and services. Annexes A and B are informative and do not form part of the requirements of this standard but provide further information for users. 1 Scope This national standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b) aims to enhance customer satisfaction through the effective application of the system, SLBS

8 including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements. All the requirements of this national standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides. NOTE 1 In this national standard, the terms product or service only apply to products and services intended for, or required by, a customer. NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 9000:2015, Quality management systems Fundamentals and vocabulary 3 Terms and definition For the purposes of this document, the terms and definitions given in ISO 9000:2015 apply. NOTICE Given Copyright agreement with the International Organisation for Standardisation (ISO) we are unable to circulate the full text of this standard for public voting and perusal. Only informative sections of the standards are publically available online. To access the full text/content of this standard please contact the Saint Lucia Bureau of Standards for more information on how a copy of the full text can be made available to you for comment. Bisee Industrial Estate P.O. Box CP 5412 Castries Saint Lucia Telephone // // // Fax: info@slbs.org; slbs@candw.lc web: 2 SLBS 2015

9 Bibliography [1] ISO 9004, Managing for the sustained success of an organization A quality management approach [2] ISO 10001, Quality management Customer satisfaction Guidelines for codes of conduct for organizations [3] ISO 10002, Quality management Customer satisfaction Guidelines for complaints handling in organizations [4] ISO 10003, Quality management Customer satisfaction Guidelines for dispute resolution external to organizations [5] ISO 10004, Quality management Customer satisfaction Guidelines for monitoring and measuring [6] ISO 10005, Quality management systems Guidelines for quality plans [7] ISO 10006, Quality management systems Guidelines for quality management in projects [8] ISO 10007, Quality management systems Guidelines for configuration management [9] ISO 10008, Quality management Customer satisfaction Guidelines for businessto-consumer electronic commerce transactions [10] ISO 10012, Measurement management systems Requirements for measurement processes and measuring equipment [11] ISO/TR 10013, Guidelines for quality management system documentation [12] ISO 10014, Quality management Guidelines for realizing financial and economic benefits [13] ISO 10015, Quality management Guidelines for training [14] ISO/TR 10017, Guidance on statistical techniques for ISO 9001:2000 [15] ISO 10018, Quality management Guidelines on people involvement and competence [16] ISO 10019, Guidelines for the selection of quality management system consultants and use of their services [17] ISO 14001, Environmental management systems Requirements with guidance for use SLBS

10 [18] ISO 19011, Guidelines for auditing management systems [19] ISO 31000, Risk management Principles and guidelines [20] ISO 37500, Guidance on outsourcing [21] ISO/IEC 90003, Software engineering Guidelines for the application of ISO 9001:2008 to computer software [22] IEC , Dependability management Part 1: Guidance for management and application [23] IEC 61160, Design review [24] Quality management principles, ISO1 [25] Selection and use of the ISO 9000 family of standards, ISO2 [26] ISO 9001 for Small Businesses What to do, ISO3 [27] [28] 1 Available from website: 2 Available from website: 3 Available from website: 4 SLBS 2015