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Documentation for ISO 9001:2015 Standard

There is a lot of buzz around documentation for ISO 9001:2015 standard. Many people wonder that the so-called “Document Information” concept, the new version is heading away from the traditional and formal documentation. However, in reality it means that the formats will be more flexible as far as format and type are concerned. Unlike the earlier versions, they need not formally document a procedure mandatorily. It will be an optional one, they are supposed to keep each evident in electronic or physical or pictorial or any other form for future reference, though.

According to experts, it is difficult to compare it with existing procedure because there is not enough information available. There is more openness in the language, and it is not skewed towards manufacturing industries only. Rather, the language and presentation is balanced so that service organizations find it familiar and friendly.

Those who are transitioning from the existing version to the new version may carry forward the same documentation formats with required changes and compliances as per new requirements.

Main summary of documentation as per ISO 9001:2015 QMS

Auditing and verification won’t be diluted in the new version

As the new version becomes further flexible, it doesn’t mean that there is a compromise on auditing and verification processes. Since the scope of documentation gets widened, training becomes mandatory. In the new version also, each document (even in physical, electronic, audio or video format) has to be verified by the auditor. Thus, the responsibility of the auditor increases further. Auditors will be keenly looking at the documentation to ensure compliance. Documentation will not lose the relevance and criticality because it is the only way management has control over the processes. Management has to know that people are following the procedures and maintaining the standards.

Adequate time is given for a smooth transition

Since there is a conceptual change in the documentation process and many other things, experts are confident that adequate will be given for smooth transition. In the last update, there were transition training imparted to the auditors, and it took almost three years for the transition. The same is expected this time also. A planned implementation schedule will be released soon by the ISO Technical Committee.

Some people feel that the cost of transition may be high this time because there is a high level of understanding needed at all levels. Right from auditors to implementers and from team members to ISO leads, everyone has to be trained enough to understand the salient aspects. Certainly, there is an additional cost of training, restructuring and implementation of the new documentation process. However, the actual impact will not be as high as it looks.

What is costly, re-certification or a fresh certification?

Since it is allowed to use existing documentation process, those who are looking for re-certification will not need quite a high cost. There will be some cost for the reorganization of documents, though. It means that the new version is not throwing away the documentation, but changing its structure. Hence, the impact is not quite devastating.



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