Clause 8.4: Control of records

What the clause asks for

Clause 8.4 requires the laboratory to establish and retain legible records that demonstrate fulfilment of the standard (8.4.1). It also implements controls for the identification, storage, protection, back-up, archive, retrieval, retention time and disposal of its records (8.4.2). Records are retained for a period consistent with contractual obligations, and access to them is consistent with confidentiality commitments and readily available.

Technical records under 7.5 add a related expectation: amendments are traceable to previous versions, with the original and amended data and the date, the person responsible and what was changed.

What assessors sample

Assessors ask for older records to test retrieval, for example the calibration certificate of an instrument from two years ago, or the minutes of the last management review. They ask how long you keep records and on what basis. Common findings:

• Retention periods not defined, or defined but not followed.
• Records held on one person’s laptop with no back-up.
• Changes to records with no trace of the original value.

Where this lives in AccreditBook

Requirement	How AccreditBook meets it
Identification and retrieval	Every record has a page, a search box and filters; evidence files are attached to the record they support
Storage and protection	Private storage, access by role, tenant isolation; see Security
Back-up	Daily database backups and point-in-time recovery, weekly copy of stored files
Amendments traceable	An append-only audit log keeps the previous and new values, who changed them and when; shown in each record’s Activity tab
Retention time	Retention rules per record type in Settings, with a basis field for your accreditation body’s requirement; six years by default
Disposal	Records past retention appear on the due list for you to confirm; nothing is deleted automatically

Deleting a record in AccreditBook is a soft delete: it disappears from lists but stays in the database and the audit log until its retention period has passed and you confirm disposal.

See Settings, Data export and Clause 8.3.