Latest Developments in the ISO 9001 Revision Process
June 27, 2014 – The latest developments in the ISO 9001 revision process arrived with the issue of ISO/DIS 9001. While the formal draft describes the requirements outlined in the revised version of ISO 9001 it is not the final version. However, it does give an indication on what might be included. Caution – further changes are likely before final publication of ISO 9001:2015 which is currently scheduled to be released in Q4 2015.
As previously noted – the main areas of changes proposed in ISO/DIS 9001 are:
- Structure and terminology, including incorporation of Annex SL framework;
- The wider internal and external context of an organization’s Quality Management Systems (QMS) (Clauses 4 and 6);
- Detailed Quality Management System (QMS) requirements’ (broadly clauses 5 & 7 – 10)
1. Structure and Terminology: DIS adopts Annex SL, notable changes in terminology
ISO/DIS 9001 adopts the new clause structure specified in Annex SL which is now the required framework for all new and revised ISO Standards. This is to ensure that the final version of ISO 9001 is aligned and harmonized with other management systems standards. Following Annex SL structure presents QMS requirements in a more consistent, rational manner and not simply a template for elements of an organization’s QMS.
ISO/DIS 9001 contains some notable changes in the terminology used in ISO 9001:2008:
|ISO 9001:2008||ISO 9001:2015 (DIS version)|
|‘Products’||‘Products and services’|
|‘Documentation’ ‘Records’||‘Documented information’|
|‘Work environment’||‘Environment for the operation of processes’|
|‘Purchased product’||‘Externally provided products and services’|
In addition, there would no longer be any requirement to identify any ‘Exclusions’, i.e. QMS requirements that could not be applied due to the nature of the organizations business (clause 1.2 in ISO 9001: 2008).
2. Organizational Context: Quality Management Systems to be more externally oriented
ISO/DIS 9001 requires organizations establishing a QMS to
A. determine relevant internal and external issues,
B. understand the needs and expectations of interested parties,
C. specify the scope of applicability of the Quality System
D. consider these aspects together in order to properly understand the risks and opportunities and they present
The proposed changes in methodology require a move away from a purely inward-focusing approach to QMS development and implementation to one where external or ‘outside’ factors have a greater influence on the way in which the QMS is focused and prioritized; to be as effective as possible in meeting key internal and external objectives. An organization seeking to implement a QMS needs to determine the interested parties relevant to its QMS and their requirements.
Another important change is the adoption of a risk-based approach when developing and implementing its QMS. Organizations must identify the risks and opportunities that need to be addressed to ensure that the QMS can achieve its intended outcome(s) including those relevant to or determined by its organizational context. Organizations must plan actions to address these risks and opportunities, integrate and implement them into its QMS processes and evaluate their effectiveness.
3. Numerous changes to QMS Requirements
In addition to the adoption of a risk-based approach, there are several other new requirements:
A. Organizations implementing a QMS must identify the necessary competence for personnel doing work that affects its quality performance, and ensure that they are competent to do so.
B. A requirement to identify and maintain the knowledge needed to ensure the Organization achieves conformity of products and services.
C. While ‘Preventive action’ is no longer a specific clause in ISO/DIS 9001, it is now the primary objective of a risk based QMS.
ISO/ DIS 9001 fully expects organizations to apply a process approach when planning, implementing and developing their QMS. It specifies requirements identifying the quintessential elements of such an approach, as well as the key aspects of their interaction(s).
How can Quality Resource Center HELP?
Quality Resource Center provides training to assist our clients in understanding the requirements of ISO/ DIS 9001. Quality Resource Center offers ISO 9001 Consultants and ISO Consulting Services. Quality Resource Center offers a broad array of training and certification services, as well as Internal Auditor and Auditing expertise.
A copy of the ISO/DIS 9001 standard can be purchased.
The official ISO 9001:2015 working group (ISO/TC 176/SC 2) responsible for the development and publishing of the ISO 9001:2015 standard will develop a matrix showing a correlation between the clauses of ISO 9001:2008 and ISO/DIS 9001:2015.