Why ISO 9001:2015
This is an important question which both auditors hear and most top management want to further understand. Before a revision or amendment is made with regard to the management system standard, review and study of that standard and its user’s needs are undertaken. The ISO Technical Committee TC176 has done some excellent work for all users of management system standards. Their work indicates the need for an ISO 9001:2015 revision that encompasses::
- Adapting to a changing world
- Enhancing an organization’s ability to satisfy the customer
- Providing a consistent foundation for the future
- Enabling more QMS flexibility for different business types and further ISO 9001:2015 usage
- Harmonizing ISO 9001:2015 to further address relevant interested parties and supporting additional quality management systems currently in use
Annex SL Provides a Framework
Annex SL is the High Level Structure (HLS) and framework for a generic management system standard. Going forwards all quality management systems will use this framework to define the outline of specific auditable requirements. Some of the important elements that the creation of Annex SL provides include:
Annex SL contains 8 clauses and 4 appendices; the Appendix 3 also defines the format for all management system standards inclusive of three components, high-level- structure, common terms and core definitions and identical core text.
Annex SL provides for industry specific requirements to be contained within any standard’s Clause 8 (Operations) for multiple standard coverage and implementation e.g., such as ISO 9001 or ISO 14000. Annex SL sets the foundation for consistent and harmonious understanding of management system requirements globally.
All new standards will contain 45 shall statements that generate a baseline of 84 requirements. Depending upon the industry sector and specific standard used with it, additional requirements for implementation are added to the baseline especially regarding Clause 8 (Operations).
Annex SL supports the prior understanding that quality management systems which are effective shall follow the Plan Do Check Act approach to establish intended outcomes and process results. See section 0.3 in ISO 9001:2015.
The ISO 9001:2015 was released in September of 2015 and the new ISO 9001:2015 standard follows the Annex SL format and is constructed in inline with Annex SL Appendix 3 as:
- Scope
- Normative references
- Terms and definitions
- Context of the organization
- Leadership
- Planning
- Support
- Operation
- Performance evaluation
- Improvement
Understanding some of the history of ISO 9000 in brief allows your organization to see how the ISO 9001 standard has changed over the years and how these new requirements are still part of the goal of harmonizing the standard’s requirements and intent.