ISO 9001 Revision Uses New Structure

According to Ms. Lorri Hunt, the US Expert on Revision to ISO 9001, the biggest change to users is the structure. Both the 1987 and 1994 versions of ISO 9001 used a "20-element" model that had familiarity to manufacturing industries. In the year 2000, ISO 9001 transitioned to a process approach and moved from the "20-element" model to a structure of five clauses. This structure was used for both the 2000 and 2008 versions of the standard.

The ISO Technical Management Board has adopted a standardized format and common core text for use in all new and revised ISO management system standards, to promote greater ease of use for organizations that seek to integrate the requirements of (for example) ISO 9001, ISO 14001, ISO 50001 into a single, coherent system. This standardized format is referred to as Annex SL. Table 1 compares the clause titles of ISO 9001:2008 to the clause titles in the proposed version of ISO 9001.

Table 1

Annex SL

ISO 9001:2008

4 Context of Organization

4 Quality Management System

5 Leadership Planning

5 Management Responsibility

6 Planning

6 Resource Management

7 Support

7 Product Realization

8 Operation

8 Measurement, Analysis, Improvement

9 Performance & Evaluation

10 Improvement

While there is not an ISO 9001 requirement for an organization to develop its quality management system and document architecture using the structure of ISO 9001, many organizations choose to do so because it is easier to understand and maintain compliance as well as demonstrate compliance to external parties. As a result, many organizations structured their quality management systems around the ISO 9001:2008 structure.

Organizations that see the structure change might be overwhelmed. Before making any quality management system structure changes, it is important to consider the opportunities and issues associated with making such a change. Any change should add value. Making a change for the sake of lining up a quality management system to a structure of any kind adds unneeded cost and overhead to the organization.

To avoid making a structure change, organizations can develop a cross reference of procedures and methods of compliance from whatever structure they are using to the requirements in the revised standard. It is anticipated that the revised version of ISO 9001 will include a cross reference of existing requirements in ISO 9001:2008 to ISO 9001:2015 (estimated date).

If an organization chooses to make a structure change, they should focus on creating a structure that is unique from any standard or governing document or that is easy to change. For example, don’t change document numbers, but create a filter in your quality management system that aligns documents with whatever standard you are using. This method can meet the needs of the organization but be more cost effective in managing long term.

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