ISO 17025 audit checklist about document control

ISO 17025 audit checklist about document control
Clause 4.3

General terms of document control

• What is the policy & procedure on document control?
• How is document amendment carry out?
• Who is authorized to approve the changes?
• Is there a record of change?
• Is there a distribution list?
• How do you issue out new doc and retrieve the obsolete copy?
• How do you dispose the obsolete copy?
• How do you track the revision number?
• Do you have a doc control number system?
• Where to you keep/file all obsolete copies for future reference?
• How long do you keep them?

4.3.1 General

• Are there documented procedures established and responsibilities defined to control all documents and data that form part of the quality system?

4.3.2 Document Approval & Issue

• Are these procedures defined for: (establishment, review, approval, identification and distribution) of (system-related, operation -related and governing) documents?
• Do policy and procedure documents have unique identifiers?
• Are these documents clearly marked?
• Do all documents carry revision status and date?
• Is it ensured the latest revision of document is available at the relevant places?
• Are obsolete documents: removed from all points of used; clearly marked as obsolete or destroyed;retained for legal or knowledge preservation and identified as such?
• Is all documents review periodically to ensure continuing suitability?

4.3.3 Document Changes

• Are procedures and responsibilities for handling changes defined and documented?
• Are all changes to controlled documents reviewed and approved by the same functions that performed the original review?
• If not, are there documented procedures for the designated functions/organizations to follow and do they have access to the background information?
• Are responsibilities and time for storage of quality system documents defined and documented?

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