The 2015 revision of ISO 9001 is no longer new. Everyone already knows about it and that it includes relevant changes. But as companies are migrating to the current version they are also faced with new situations and have questions that still do not have very clear answers.
One change is the new concept called “documented information,” which introduces a new approach to document management and requires significant changes in the way companies implement their management systems.
What initially most draws the attention of managers is the absence of the terms “documented procedures,” “quality manual,” “documents” and “records”. What am I going to do now? Where to start? What do I do with the quality manual?
ISO has empowered quality managers, and with power comes responsibility. Yes, they want documentation, but documentation that proves the effectiveness of the management system, and no longer just a list of required documents. And, to complicate matters a little more, this “documented information” can be in various formats and media.
The benefits expected from the adoption of this change in relation to documentation are:
- Flexibility. Enabling the integration of business process documentation with ISO requirements
- Reducing bureaucracy and unnecessary documents
- Simplification and consolidation of documented information
In some items, ISO 9001:2015 requires that organizations, to the extent considered necessary, keep documented information to support the operation of their processes and preserve documented information to be certain that processes are executed as planned. This is the case with scope, operational processes, policy and quality objectives.
In other cases, the term is not included, and the documents are not mandatory, but can add value, such as, for example: procedures, quality manuals, work instructions, forms, organizational charts etc.
It is in the hands of the managers. And also in the hands of the auditors. When the first companies begin to update their certificates, they will provide us with a basis of the criteria adopted for the audits in practice.
Would you like to learn more? Check this link to complementary material on ISO 9001:2015 where you can find lots of useful information: www.iso.org/tc176/sc02/public