This introduction is specific to this committee draft (CD) and it is not intended for incorporation to the final version of the standard. The introduction to ISO 9001:2008 has not been included in this committee draft. It will be revised as part of the response to the CD comments and ballots and incorporated into the draft international standard (DIS).
Annex SL
ISO/IEC Directives, Part 1, Consolidated ISO Supplement, 2013, Annex SL, Appendix 2 sets out the high level structure, identical core text and common terms and core definitions that are to form, when possible, the nucleus of future and revised management system standards such as ISO 9001.
‗All MSS (whether they are Type A or Type B MSS) shall, in principle, use consistent structure, common text and terminology so that they are easy to use and compatible with each other. The guidance and structure given in Appendix 2 to this Annex SL shall, in principle, also be followed (based on ISO/TMB Resolution 18/2012)‘.
Accordingly, ISO/CD 9001 has adopted the structure, common text and terminology provided in Annex SL, Appendix 2 as the nucleus of this revision and highlighted this in the document by the use of a red italic font.
Annex SL, Appendix 2 allows discipline specific additions to the core text and this has been utilised for the following:
specific quality management system requirements considered essential to meet the scope of the standard;
requirements that may appear to be generic but are considered essential to reflect use of the Quality Management Principles that form the basis for the quality management system standards within the ISO 9000 family;
requirements and notes that enhance or clarify the core text.
Significant Changes a) Redrafting to make the standard more generic and more easily applicable by service industries.
Continued omission of specific reference to „services‟ was considered to be unsustainable if relevance to the service sector was to be enhanced. On that basis „product‟ has been replaced by „goods and services‟ when specifically referring to the deliverables for the customer. This proposed change will be subject to a specific briefing note and a request for ballot input from ISO/TC 176/SC 2 member bodies.
Where possible, clauses of the standard have been revised to reduce the prescriptive nature of some requirements which were originally derived from practices for the hardware sector, in particular clauses 7.1.4 Monitoring and measuring devices and 8.5 Development of goods and services.
b) Context of the organisation
Annex SL, Appendix 2 High Level Structure and core text has introduced two new clauses relating to the context of the organisation, 4.1 Understanding the organization and its context and 4.2 Understanding the needs and expectations of interested parties. Together these clauses require the organisation to determine the issues and requirements that can impact on the planning of the quality management system and can be used as an input into the development of the quality management system.
Although there is now reference to determining the requirements of relevant interested parties there is no new requirement to ensure goods and services meet the needs and expectations of external parties other than those already identified in ISO 9001:2008, i.e. customers, regulators, etc. Such a change would require a change to the scope of the standard which is not permitted by the design specification for the revision.
c) Process approach
ISO 9001:2008 promoted the adoption of a process approach when developing, implementing and improving the effectiveness of a quality management system. This proposed revision to the standard makes this more explicit by including clause 4.4.2 Process approach – specifying requirements considered essential to the adoption of a process approach.
d) Risk and Preventive Action
Annex SL, Appendix 2 High Level Structure and core text does not include a clause giving specific requirements for „preventive action‟. This is because one of the key purposes of a formal management system is to act as a preventive tool. Consequently, the High Level Structure and Identical text require an assessment of the organization‟s „external and internal issues that are relevant to its purpose and that affect its ability to achieve the intended outcome(s)‟ in clause 4.1, and to „determine the risks and opportunities that need to be addressed to: assure the quality management system can achieve its intended outcome(s); prevent, or reduce, undesired effects; achieve continual improvement.‟ in clause 6.1. These two sets of requirements are considered to cover the concept of „preventive action‟, and also to take a wider view that looks at risks and opportunities. This approach is continued in the discipline specific text added to the Annex SL core text to require risk based thinking and a risk driven approach to preventive action throughout the development and implementation of the quality management system. This has also facilitated some reduction in prescriptive requirements and their replacement by performance based requirements. Although risks have to identified and acted upon there is no requirement for formal risk management.
e) Documented information
The Annex SL Appendix 2 clause on Documented Information has been adopted without significant change or addition. Where appropriate, text elsewhere in the standard has been aligned with its requirements. Consequently the terms „document‟ and „record‟ have both been replaced throughout the requirements text by „documented information‟.
f) Control of external provision of goods and services
Clause 8.6 Control of external provision of goods and services – addresses all forms of external provision, whether it is by purchasing from a supplier, through an arrangement with an associate company, through the outsourcing of processes and functions of the organisation or by any other means. The organisation is required to take a risk based approach to determine the type and extent of controls appropriate to each external provider and all external provision of goods and services.
{Drafting Note The sources of text in this revision can be identified by the font colour as follows:
Red italics - Annex SL text
Black – Text taken from existing ISO 9001: 2008 and text developed by WG24}
