Quality management is evolving

ISO 9001:2015 Documentation

Time and tide wait for no man and so it seems neither do the good folk at ISO's Technical Committee (TC 176/SC 2). They are responsible for the content of the current revision of ISO 9001 and have spent 3 years planning its next iteration.

Our range of ISO 9001:2015 quality manuals and integrated manual templates cover the requirements of ISO 14001:2015 and OHSAS 18001:2007, and offer an easy way to implement and document your organization's quality management system or integrated management system.

Existing ISO 9001:2008 documentation

In ISO 9001:2008, the quality manual helped to establish and document the framework of your organization's quality management system while articulating those aspects of the QMS to any interested parties.

While there is no requirement for a quality manual or documented procedures in ISO 9001:2015, it is suggested that if they add value, then they should not simply be binned. You will be expected to maintain the integrity of the QMS during the transition process.

You do not need to renumber your existing documentation to correspond to the new clauses. It is down to each organization to determine whether the benefits gained from renumbering will exceed the effort involved.

Neither do you need to restructure your management system to follow the sequence of and titles of the requirements. Providing all of the requirements contained in ISO 9001:2015 are met, your organization’s quality management system will be compliant.

  1. If your quality manual fits your business and your customers require it, keep it!
  2. If your procedures are effective and define how your key processes operate, keep them!
  3. If the quality policy and related objectives align with business strategy, and they are communicated and adding value, keep those too!

The type and extent of documented information that your organization should retain and maintain, in order to be compliant with ISO 9001:2015, clearly depends on the nature of your organization’s products and processes.

The following criteria can be used to assess the different types of ISO 9001:2008 documents and information that your organization should retain and maintain as documented information by determining whether the information:

  1. Communicates a message internally or externally;
  2. Provides evidence of process and product conformity;
  3. Provides evidence that planned outputs were achieved;
  4. Provides knowledge sharing.

If any of the above criteria apply to any type of document or information within your organization's domain, then it should be retained and maintained as a form of 'documented information' as per Clause 7.5 of ISO 9001:2015.

ISO 9001:2015