ISO 9001 Objective Evidence Requirements: Part 1 Documentation

ISO 9001:2015 is an incredibly poorly written “entry-level” QMS standard littered with ambiguous / vague requirements that have resulted in subjective interpretations and inconsistent implementation. This article discusses the minimum “Objective Evidence” actually required by the standard. Any interpretations beyond these minimum requirements (e.g., by an internal or external auditor) are based purely on subjective opinion.

The first confusing point to address is which documentation (e.g., procedures) are actually required by ISO 9001:2015.

ISO 9001:2015, Annex A states:

A.6 Documented Information

Where ISO 9001:2008 used specific terminology such as “document” or “documented procedures”, “quality manual” or “quality plan”, ISO 9001:2015 defines requirements to maintain documented information.

A row number below in Bold indicates either “Tips” or “Interpretations” are associated with the requirement(s).

All of the ISO 9001:2015 implied, suggested, and/or specifically required “documented information” to be “maintained” include:

# “Maintain” as Documented Information (Documents) Sec.
1 To the extent necessary, the organization shall:
a. maintain documented information to support the operation of its processes;
[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)… NOT the auditor.]
2 The scope of the organization’s quality management system shall be available and be maintained as documented information. 4.3
3 Quality policy 5.2.2.a
4 Quality objectives 6.2.1
5 The organization shall “determine” and “maintain” documented information “to the extent necessary:”
1. to have confidence that the processes have been carried out as planned;
2. to demonstrate the conformity of products and services to their requirements;
[SUBJECTIVE requirement - to be determined by the ORGANIZATION (as per 7.5.1b)… NOT the auditor.]
6 Controlled conditions shall include, as applicable:
a. the availability of documented information that defines:
1. the characteristics of the products to be produced, the services to be provided, or the activities to be performed;
2. the results to be achieved;
[This documented information may be provided by the customer (e.g., Drawings)]
# 2
Guidance from ISO on crafting an acceptable QMS “scope” can be found online in the: ISO 9001 Auditing Practices Group Guidance on: "Scope of ISO 9001, Scope of Quality Management System (QMS) and Scope of Certification"
# 2 thru 4
While ISO 9001 does NOT require a “Quality Manual”, it is generally a good idea to do so as a “defensive measure” because:
1. Addressing all of the requirements of ISO 9001:2015 in a “Quality Manual” (at a policy level) the business can argue that it has addressed the more subjective requirements (contained throughout ISO 9001:2015) that do not specifically require “objective evidence”, and
2. Including references to the sources for the business's interpretations can immediately dismiss many subjective interpretations that an auditor may have.

Also, a “Quality Manual” can improve efficiency through providing a single source addressing items 2 thru 4 from the above chart.
# 6
When asked whether clause no. 8.5.1a) of ISO 9001:2015 “availability of documented information” means “maintain documented information”, the ” Official ISO 9001:2015 Inerpretations from ISO TC/176/SC2“ stated “No”. And explained ”The terms “available” and “maintain” are not synonyms, and the use of “availability” was deliberate. “Available” means “able to be used or obtained, or accessible”, whereas “maintain” means “cause or enable to continue”. The “maintenance” of documented information is not explicitly required by Clause 8.5.1(a), but is addressed by other parts of ISO 9001:2015. Clause 8.5.1 (a) requires the documented information to be “available” so that it can be used, not just “maintained” (i.e. preserved). The documented information that needs to be available under Clause 8.5.1(a) is part of the quality management system documentation, and therefore has to be managed in accordance with Clause 7.5.“.