ISO 9001:2015 does not identify any required documented procedures, at least not as it was required in the 2008 version of the standard. The new standard refers to requirements of “documented information” and in the clause 7.5 it states that:
The organization’s quality management system must include:
- Documented information required by this International Standard;
- Documented information determined by the organization as being necessary for the effectiveness of the quality management system.
Throughout the new version of the standard, there are a number of references for organizations to maintain and retain documented information. It can be inferred that where the standard states that the organization is required to maintain documented information sufficient to support the operation of processes it is implying the need of documented procedures.
The specific procedures required for the quality management system will depend on the organization itself. The standard also states that:
The extent of documented information for a quality management system can differ from one organization to another due to the:
- Size of organization and its type of activities, processes, products, and services;
- Complexity of processes and their interactions;
- Competence of persons
Each organization will need to identify which procedures are essential for the correct operation of their processes in order determine which ones they’ll need to create. If an organization does not have any documented procedures, it will need to demonstrate how people know what to do and show acceptable evidence to support that their processes are carried out effectively without them.
Organizations that have already implemented ISO 9001 will not need to throw away the procedures that are in place. If these procedures serve as a useful tool within the organization, they should be maintained. However, the new standard presents an opportunity for organizations to take a second look at the procedures that are part of their management system in order to determine which add value to the system and which don’t.
Organizations wishing to be certified with ISO 9001:2015 must meet all of the requirements within a standard, including those regarding documented information, and they must be able to show evidence that they have all the necessary procedures in place.
To the novice quality manager, ISO jargon can be extremely overwhelming. What is an NCR? What do you mean by OFI? Are we certified or accredited? But before you go and pull out your hair, let’s take a moment to go over some of the most frequently used terms and their definitions with regards to ISO and Management System Certification.