Archive for July 3rd, 2009
How Does Your Organization Provide for Objective Evidence of Conformance?
Conformance to ISO 9001:2008 requires an organization to be able to provide objective evidence of the effectiveness of its processes and its quality management system. Objective evidence has been defined as data supporting the existence or variety of something and may be obtained through observation, measurement, test, or other means.
§ 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.
How does your organization handle objective evidence in support of your quality management system?