8.3 Control of Management System Documents (Option A)

The laboratory shall control the documents, both internal and external, that relate to the fulfilment of this document.

8.3.1 Document Control Requirements

The laboratory shall control the documents (internal and external) that relate to the fulfilment of this document.

Note:

In this context, "documents" can include policy statements, procedures, specifications, manufacturer’s instructions, calibration tables, charts, textbooks, posters, notices, memoranda, drawings, plans, etc. These documents may exist in various media, such as hard copy or digital format.

8.3.2 Document Control Requirements

The laboratory shall ensure that:

  1. Documents are approved for adequacy prior to issue by authorized personnel.
  2. Documents are periodically reviewed and updated as necessary.
  3. Changes and the current revision status of documents are identified.
  4. Relevant versions of applicable documents are available at points of use, and, where necessary, their distribution is controlled.
  5. Documents are uniquely identified.
  6. The unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose.