1. INTRODUCTION This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period of ISO 9001:2008 and ISO 9001:2015. A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2015 matrix showing the correlation between the clauses of these international standards can be found on the website. The revision of ISO 9001:2015 introduces a new 10 clause structure, many new requirements and many terms. Users will need to take into consideration that changes may be necessary to their Quality Management System (QMS). 2. BACKGROUND TO THE ISO 9001:2015 REVISION PROCESS In order to assist organizations to have a full understanding of the new ISO 9001:2015, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development. Prior to the commencement of a revision to a management system standard, a Study” is “Justification prepared to present a case for the proposed project which outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2015 user needs were identified from the following: ISO Annex SL provides a common structure, text, terms and definitions for management system standards The results of a formal Review” on ISO 9001:2008 was performed by the members of “Systematic ISO/TC 176/SC2 Feedback from the ISO/TC 176/SC2 Working Group on Interpretations An extensive worldwide Feedback Survey” on ISO 9001 was performed by ISO/TC 176/SC 2 “User The Justification Study identified the need for a revision to: adapt to a changing world enhance an organization's ability to satisfy its customers provide a consistent foundation for the future reflect the increasingly complex environments in which organizations operate ensure the new standard reflects the needs of all relevant interested parties with other management systems The key focus of the ISO 9001:2015 revision was to enhance clarity and compatibility with other management system standards. The benefits identified for the ISO 9001:2015 edition: Provides clarity Enhanced leadership involvement in the management system Risk-based thinking Simplified language, common structure and terms Aligning QMS policy and objectives with the strategy of the organization
1. INTRODUCTION This Implementation Guidance has been developed to assist users in understanding the issues that need to be considered during the co-existence period of ISO 9001:2008 and ISO 9001:2015. A wide diffusion of this implementation guidance is recommended, in particular the comparison table between ISO 9001:2008 and ISO 9001:2015 matrix showing the correlation between the clauses of these international standards can be found on the website. The revision of ISO 9001:2015 introduces a new 10 clause structure, many new requirements and many terms. Users will need to take into consideration that changes may be necessary to their Quality Management System (QMS). 2. BACKGROUND TO THE ISO 9001:2015 REVISION PROCESS In order to assist organizations to have a full understanding of the new ISO 9001:2015, it may be useful to have an insight on the revision process, how this revision reflects the inputs received from users of the standard, and the consideration given to benefits and impacts during its development. Prior to the commencement of a revision to a management system standard, a “Justification Study” is prepared to present a case for the proposed project which outlines details of the data and inputs used to support its arguments. In relation to the development of ISO 9001:2015 user needs were identified from the following: ISO Annex SL provides a common structure, text, terms and definitions for management system standards The results of a formal “Systematic Review” on ISO 9001:2008 was performed by the members of ISO/TC 176/SC2 Feedback from the ISO/TC 176/SC2 Working Group on Interpretations An extensive worldwide “User Feedback Survey” on ISO 9001 was performed by ISO/TC 176/SC 2 The Justification Study identified the need for a revision to: adapt to a changing world enhance an organization's ability to satisfy its customers provide a consistent foundation for the future reflect the increasingly complex environments in which organizations operate ensure the new standard reflects the needs of all relevant interested parties with other management systems The key focus of the ISO 9001:2015 revision was to enhance clarity and compatibility with other management system standards. The benefits identified for the ISO 9001:2015 edition: Provides clarity Enhanced leadership involvement in the management system Risk-based thinking Simplified language, common structure and terms Aligning QMS policy and objectives with the strategy of the organization
ISO9001_2015_Implementation_Guidance.docx