Get A Quotation
Documented Information for ISO 9001:2015
With the ISO 9001:2015, many companies are still asking themselves what documentation is required. Back with the 2008 release, most companies were comfortable with the six mandatory procedures that were expected of them as well as the need for a quality policy and manual. The update to 2015 has however removed the requirement for a quality manual and blurred the distinction between procedures and records.
With the new release, both documents and records are termed “documented information” and must be controlled and maintained. This is what will form the evidence required to show that you are conforming to the requirements of your quality management system.
Clause 4.4 of ISO 9001 requires your organization to maintain the documented information that is required to support the operation of your processes and to retain that information to be able to have confidence that those processes are being completed as planned.
So what is required by the standard?
The following is a clause-by-clause breakdown of what is required by the standard. However, some of these clauses can be excluded if the company does not perform the relevant processes:
Other Mandatory Documents:
So what does this mean?
Although they have blurred the requirement of quality manual and distinction between documents and records, you should still tailor your quality management system to meet the requirements of your own business and all of the interested stakeholders.