Many people’s perception of ISO 9001, the international standard for best-practice quality management, is that it is all about documentation.
There are indeed a number of documents mandated by the Standard, and the requirement that the quality management system (QMS) includes documents “determined by the organization as being necessary for the effectiveness of the quality management system” is often read by many – implementers and auditors alike – as meaning that everything has to be written down. However, the optimum number of documents will actually depend on the organisation and the extent to which documenting arrangements forms part of the controls on which it relies.
How to determine whether a document is required
The extent of documentation required in the QMS framework will depend on a number of factors, including the competence of the people involved and the extent of automation in place. Once all of the factors that provide assurance that requirements are met systematically have been considered, it will be easier to determine whether a document is required. More often than not, documenting a process helps to ensure it is communicated and understood, and will be executed in such a way that it is effective in achieving its intended objective. And then there is the capturing of records to ensure appropriate traceability and evidence where required.
The key to maintaining the QMS
Achieving the right balance of documentation, and developing it in a consistent and usable manner, is the key to ensuring it is used to help deliver the QMS and not lag behind it. Otherwise, updating documentation will be seen as a chore to be accommodated around the day job.
One of the biggest challenges in starting to develop QMS documentation is knowing where to start – how many documents, what look and feel should they adopt, what fields should be included to satisfy version control, authorisation, etc. Once this initial challenge has been overcome, the next hurdle is starting to populate the content; developing even the most obvious of processes can result in writer’s block.
About the ISO 9001 documentation toolkit
Tap into our expertise and use these practical, pre-written ISO 9001:2015 document templates found in our toolkit to update or implement your quality management system (QMS).
Designed to speed up your QMS implementation, this toolkit’s fully-compliant and expert-written documents ensure that every part of your ISO 9001 documentation is covered. They will need to be tailored to your organisation, but they solve the problem of where to start and provide plenty of valuable content for the essential aspects of any QMS.
The contents of this toolkit include:
- 72 pre-written documents, including all the mandatory documents needed for ISO 9001:2015 compliance.
- New project tools: ISO 9001:2015 Gap Analysis Tool; ISO 9001:2008 to ISO 9001:2015 Gap Analysis Tool; ISO 9001:2008 to ISO 9001:2015 Conversion Tool.
- Documentation vs ISO 9001:2015 requirements map.
- Documentation dashboard – track the progress of your QMS.