In Part 2, the definition of objective evidence was clarified and examples were given. The ISO/TC 176 guidance document on ISO 9001:2008 continues to clarify and explain how conformity with the standard can be achieved. It goes on to state:
“Objective evidence does not necessarily depend on the existence of documented procedures, records or other documents, except where specifically mentioned in ISO 9001:2008. In some cases, (for example, in clause 7.1(d) Planning of product realization, and clause 8.2.4 Monitoring and measurement of product), it is up to the organization to determine what records are necessary in order to provide this objective evidence.
Where the organization has no specific internal procedure for a particular activity, and this is not required by the standard, (for example, clause 5.6 Management Review), it is acceptable for this activity to be conducted using as a basis the relevant clause of ISO 9001:2008. In these situations, both internal and external audits may use the text of ISO 9001:2008 for conformity assessment purposes.”
By examining the intent of the standard, it is clear to see that a good amount of flexibility was built in to allow a company to make the standard work for them. A big fear of ISO implementation is the phobia of having to change an organization from top to bottom to have it meet requirements. The guidance document put out by ISO/TC 176 does a great job of putting these fears to rest.
For more help with ISO standards, contact G3 Solutions today!