ISO Revision ISO 9001:2015

For development, a large distance still needs to be covered. For first of all, the international community has the opportunity of commenting work done. The contents might still change significantly before the worldwide users of the Standard have reached a final consensus.

The first meeting of the competent workgroup ISO/TC 176/SC 2/WG 24, Revision of ISO 9001, was held in Bilbao, Spain, in June 2012. One year later and only after two further personal meetings of the group, it was agreed to release the first draft of the Committee.

Before addressing the changes, we would briefly like to state what has remained unchanged so that continuity is guaranteed:

First, this refers to the scope - therefore, such topics as efficiency and TQM (Total Quality Management) continue to stay outside the scope of the Standard. Besides, there will only be one Standard, which applies to all kinds of organizations, even in future. Calls for streamlined or expanded versions of the Standard have not been taken into account.

Nevertheless, the Standard changes to a large extent. One of the main sources of the change is use of the ISO Directive, Annex SL. This document establishes a common definition and structure for all the new ISO Management System Standards and revisions of existing Standards. Furthermore, it guarantees that there will be a common main text in the clauses of all the Management System Standards.

This common framework establishes ten clauses:

1. Scope

2. Normative references

3. Terms and definitions: hinting at the general terms presented in the Annex SL as well as any specific terms in the Standard

4. Kontext der Organisation: understanding the internal and external affairs, the requirements and expectations of relevant interested parties, the management system and its scope

5. Leadership: management responsibility and commitment, policy, organizational functions, responsibility and authority

6. Planning: measures for identifying risks and opportunities, the relevant objectives and targets of the Standard and plans helping to achieve these objectives and targets

7. Support: resources needed for the respective Standard, competence, awareness, communication and documented information

8. Operation: operational planning and control

9. Performance rating: monitoring, measurement, analysis and assessment, internal audit and management review

10. Improvement: nonconformity, corrective action and continual improvement

The current draft ISO/CD 9001:2013 was created according to this new structure. The draft, which can be purchased at BSI (British Standards Institute) in the webshop, also gives the first insights into the aspects where the Standard might change in its most important contents.

We would like to discuss some of these new requirements and concepts:

• Process approach: In the draft, the process approach is intensified. In Clause 4, the most important requirements are summarized as a compact set of sub-clauses with a very useful framework for implementation.
• Risk based approach: This is a decisive new concept in the published draft. Considering risks is integrated on many levels: in the process approach, leadership and very much in the section about planning. In fact, the stipulations of the system relating to the risks must be adequate in relation to conformity and customer satisfaction and also enable the organization to seize the opportunities.
• Documented information: With the intention to give more flexibility to the users, the generic term “documented information” is used instead of definite terms (e.g. “records” or “documents”). However, this is less precise.
• Goods and services: The draft is to be more suitable for service industry. A signal in this direction is the change of the choice of words - instead of product, the term “goods and services” is put up for discussion.
• Design and development: In the section discussing design and development, significant changes have been made. This makes it easier to consider different innovation approaches.As far as the next steps are planned, at the moment, they are to help to consolidate the draft even more. Therefore, a first official Draft International Standard (DIS) might be available in the first half of 2014. The final draft should be presented later in 2014. It is planned that the Standard in a revised form will appear as ISO 9001:2015.