Clause 8.3: Control of management system documents

What the clause asks for

Clause 8.3 covers the internal and external documents that relate to fulfilling the standard, such as the quality manual, procedures, work instructions, forms, methods and standards. The laboratory ensures that:

• documents are approved for adequacy by authorized personnel before issue,
• documents are periodically reviewed and updated as necessary,
• changes and the current revision status are identified,
• relevant versions of applicable documents are available at points of use and, where necessary, their distribution is controlled,
• documents are uniquely identified,
• unintended use of obsolete documents is prevented, and suitable identification is applied to them if they are retained for any purpose.

What assessors sample

The assessor takes a document from the bench or the shared drive and checks it against the master list: is this the current version, who approved it, when was it last reviewed. They also ask about external documents, typically the standard methods you use, and how you know you hold the current edition. Common findings:

• Periodic review dates long past.
• Superseded versions still in use at a workstation.
• No record of who approved a change or what changed.
• Standard methods referenced at an outdated edition.

Where this lives in AccreditBook

Requirement	Field in AccreditBook
Unique identification	Document code (for example QM-01, SOP-014) and title
Category, including external documents	Category: quality manual, procedure, work instruction, form, method, policy, external, other
Approval before issue	Each version: approved by, approved on, effective on
Changes and revision status	Version label and change summary; current version shown on the list
Periodic review	Review interval (12 months by default) and next review due, which feeds the due list
Obsolete documents	Previous version marked superseded when a new one is added; document status “obsolete”

Files are uploaded rather than edited in AccreditBook, so you keep authoring in the tool you already use. The version history and the Activity tab together show who changed what and when.

See Documents and Clause 8.4.