ISO/IEC 17025 clause 8.4: retain and protect laboratory records

What clause 8.4 requires in practice

Clause 8.4 requires the laboratory to create and keep legible records that demonstrate it meets the standard. Controls are also needed over how records are identified, stored, protected and backed up, how they are archived and found again, and how long they are kept before disposal.

Retention is tied to the laboratory's contractual obligations. Access to records fits the confidentiality commitments the laboratory has made, and records are readily available. A note directs readers to clause 7.5 for the extra requirements on technical records.

The clause applies under Option A and works as a framework. It does not state which records exist; other clauses do that. It sets the standard of care for any record the laboratory must keep, so that evidence can be found, read and relied on whenever it is needed, by staff, customers or assessors, for as long as the laboratory has promised to keep it.

Decide what must remain available

Identify technical and management-system records, their owners and where they are held. Include instrument files, calculations, issued reports, competence records, audits and management decisions where applicable. The detailed clauses determine what evidence is required; clause 8.4 provides the preservation and access framework.

Set retention arrangements using contracts and other applicable legal or recognition requirements. The clause does not specify one universal number of years for all laboratory records. Keeping everything forever is not automatically a better control and can conflict with other obligations or make retrieval harder.

Preserve legibility and context

A record must remain understandable, not merely stored as a file. Retain the identity, version and relevant links needed to interpret it. Consider whether software, formats or encryption arrangements will remain usable through the retention period.

For paper records, protect against physical loss, damage and deterioration. For electronic records, address loss, unauthorised access and recovery. Backups should support the required availability; practical restore checks can provide confidence, although the standard does not prescribe a particular backup product or universal test schedule.

Control access, retrieval and disposal

Make records readily available to authorised people while respecting confidentiality commitments. Define how archived information is retrieved and how access changes when roles or providers change. An archive that only one absent employee can open may undermine the required availability.

Dispose of records through an appropriate controlled process once retention and other obligations allow. Check linked records before deletion: removing a raw file can make a retained report impossible to support. Coordinate technical-record amendments under clause 7.5.2 with retention of original and revised information.

Why retaining and protecting records matters

Records are how a laboratory proves what it did when a customer, regulator or court asks. If a record cannot be found, cannot be read or has been altered, the work behind it is effectively unprovable, however good it was.

Good control reduces the cost of audits and disputes, since evidence can be produced quickly. It also protects confidential customer information from loss or exposure. Retention that matches contracts avoids two opposite problems: destroying something a customer expected the laboratory to hold, and keeping information far longer than necessary, which adds storage cost and confidentiality risk.

How to implement clause 8.4

Decide what you keep and why before you decide where you keep it. Keep an eye on practicality. A record that exists but cannot be opened, read or trusted at the moment someone needs it has not met the purpose of this clause. Test one retrieval from the archive each period to prove it still works.

1. Make an inventory of technical and management system records, with an owner and a current location for each.
2. Set retention arrangements from customer contracts and any other applicable obligations, instead of one blanket rule.
3. Choose storage that keeps paper safe from damage and electronic files safe from loss, with backups that someone has actually tried to restore.
4. Make sure records stay legible and interpretable, including software formats that must be readable later.
5. Define who may see which records, consistent with confidentiality commitments, and how archives are retrieved when staff leave.
6. Set a controlled method of disposal and keep a note of what was destroyed and when.

Two illustrative retention decisions

Evidence and common mistakes