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How Does the Structural Change of ISO 9001:2015 Impact Your Current Documentation ?
(by Choong Ewe Lee)


We wish to share that ISO 9001:2015 has changed the main clauses from 1.0 to 10.0, instead of 1.0 to 8.0 (in the version of 2008). So, what are the key differences?

First, the ISO 9001:2015 does not only focus on Customer Requirements, but also focuses on the “understanding of organization and its context” (Clause 4.1), and the “needs & expectations of relevant interested parties” (Clause 4.2). These key focuses will be the basis for the development & alignment of the Quality Management System (QMS) and its processes (Clause 4.4). These changes are addressed in Clause 4.0.


Second, the ISO 9001:2015 has separated the 5.0 Management Responsibility of old version into 5.0 Leadership and 6.0 Planning. Besides this, we have to further specify the actions to address risks and opportunities, plan to achieve quality objectives and to change QMS in a planned manner.

Third, the ISO 9001:2015 has replaced the 6.0 Infrastructure Management of old version by 7.0 Support which cover the wider scope that consists of Calibration (7.1.5), documented information (7.5). The rest that worth to be highlighted is, scope of training being expanded to “gain & retain the organization knowledge”, and “communication”.
  Fourth, the ISO 9001:2015 has replaced the 7.0 Product Realization of old version by 8.0 Operations. We found that the release of product & services (8.6) and control of nonconforming outputs being re-classified into this section. Thus, new version has treated QC activities as part of the operations processes. For purchasing, the scope of purchased has been extended to externally provided processes, products and services acquired. Besides, there is no clause for “Validation of Processes” anymore.  
Fifth, the ISO 9001:2015 has replaced the 8.0 Measuring, Analysis & Improvement of old version by 9.0 Performance Evaluation and 10.0 Improvement. Scope of Data Analysis has been expanded, such as effectiveness of actions taken to address risks & opportunities. Management Review Meeting being reclassified in this section with additional of 5 more agenda to be reviewed. Preventive Action Request being withdrawn from this version, but Improvement becomes one of the key attentions to be focused by all the ISO certified companies.

So after the Structure Change of ISO 9001:2015, how does it impact your documentation? We do believe that, you may have to conduct a substantial changes on your current documentation, such as Quality Manual, and Training/HR related Procedures. Besides, we also suggest to create a procedure for “Risks & Opportunities Analysis” & Turtle/Process Diagram to address the clause of 4.0 & 6.0. For the rest, you may just have to align back to the clause requirements, such as Purchasing, Management Review, etc.

Should you have any comments/inputs/topics that wish us to put in this Sharing Session, please feel free to drop us an email.

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