How to control documents under ISO/IEC 17025

Every document that affects laboratory activities is controlled, whether the laboratory wrote it or received it from outside. The usual types:

• Quality manual: The quality policy, objectives and the structure of the management system.
• Procedure: Who runs a process and in what order (sample receipt, CAPA, internal audit).
• Instruction: The bench steps of a single task (instrument use, sample preparation, cleaning).
• Form: A template that becomes a record once filled in (sample receipt form, temperature log).
• Method: A method the laboratory developed, or an in-house method written to apply a standard method.
• External document: Standards, regulations, manufacturer manuals and reference documents cited in methods.

Settle the code structure for each type at the start (for example PR-004 for a procedure, FR-018 for a form). A document keeps one code for its whole life; the revision number goes up by one with each new revision.

Every revision passes through four states: draft, approval, in force and withdrawn. A document has only one revision in force at a time.

A typical case: the sample reception instruction needs a new acceptance criterion for the cold chain. The quality manager opens the Rev.04 draft, an analyst writes the text and enters "Cold chain acceptance criterion added" as the change summary. If the review finds a mistake, the revision goes back to draft with a reason, is corrected and submitted again. On the day Rev.04 comes into force, Rev.03 is withdrawn.

Fill in the change summary on every revision; it is how a reader sees what changed (§8.3.2 c).

In the approval flow the preparer writes the text, the reviewer checks it, and the approver decides that the document is fit for purpose and releases it. Clause 8.3.2 a only asks for approval by authorised personnel; giving the three roles to different people means at least two people have read the text.

• Preparer: The person who knows the work. A test instruction is often prepared by the analyst who runs the test, together with the section head.
• Reviewer: Reads the text for technical and quality points. There can be one step or several: first the section head, then the quality manager.
• Approver: The authorised person who releases the document, often the laboratory manager or the quality manager.

The flow can differ by document type. A form may need only the quality manager's approval; a test instruction is prepared by an analyst and the section head, reviewed by quality and approved by the branch manager. Write down which type goes through which flow in the quality manual or the document control procedure.

The segregation of duties rule is short: one person signs only one step of a revision, and the approver is always someone other than the person who wrote or edited the text. When you change a flow, finish the revisions already in approval under the flow they were submitted with, so every signature stays tied to the rule it was given under.

A controlled copy is one whose location the laboratory knows and which it updates when the revision changes; an uncontrolled copy is no longer tracked once it is printed or downloaded. An uncontrolled copy is for information: check it against the revision in force before you use it.

In a paper system, controlled copies are numbered and entered on a distribution list; when a new revision arrives, the old copies are collected and struck off the list. In an electronic system the controlled copy is the revision in force in the system. Every printed or downloaded copy is uncontrolled and says so on the page: who printed it, when, and that the current revision must be checked before use.

Putting the document code, revision number and page number (for example 3 / 7) on every page shows which document a loose page belongs to (§8.3.2 e). An assessor may compare the instruction at the bench with the revision in the system; Rev.02 at the bench and Rev.03 in the system can be written up as a finding against §8.3.2 d and f.

A read-and-understood record shows that a new revision has reached the people who will apply it. ISO/IEC 17025 leaves the form of this record to the laboratory; §6.2 asks for competent staff and records of their competence, and §8.3.2 d asks for relevant documents at points of use. When an instruction changes, this record is the simplest evidence that the analyst knows the new step.

• Decide who must read by role, job title or name: the analysts who run a test read its instruction; everyone with a task in a process reads its procedure.
• Give the task a deadline (for example 14 days) and have the quality manager follow up overdue reads.
• Have each person confirm with their own signature; that is where the evidence gets its value.
• Keep reading records with training records; an assessor can look at both in the competence file.

You check external documents by looking at the publisher's catalogue at set intervals and recording each check with its date, result and the person who made it. For standard methods, the laboratory uses the latest valid version unless that is not appropriate or possible (§7.2.1.3), so it needs to notice when a new edition of a standard cited in a method is published.

• Keep a list of standards: standard number, edition year, publisher (such as ISO, CEN or a national standards body) and the methods that use it.
• Set a check interval for each standard (for example 12 months) and show the next check date on the list.
• Record the result of every check: current, new edition available or withdrawn. For a new edition, note which edition was published.
• If a new edition has been published, plan the move: read the changes, decide whether the method needs to be verified again and update the internal documents it affects.
• Use the same list for regulations and manufacturer manuals.

In a periodic review the document owner compares the text with current practice and records one of two outcomes: no change needed, or a new revision will be opened. The laboratory sets the interval and writes it in its procedure (§8.3.2 b); a change in regulations, a new instrument or an assessment finding can bring a review forward.

Questions to ask in the review:

• Does the text describe how the work is done today? Are the instruments, screens and responsibilities the same?
• Are the standards and documents it cites still in force?
• Do recent CAPAs, complaints or internal audit findings touch this document?
• Is a form missing a field, or carrying one nobody fills in any more?

Even when no change is needed, record the review with its date and outcome; that record is what shows it took place.

Common findings appear where documents are used and where their records fall short.

What these findings share is evidence: who did it, when and with which revision should be answerable from the record.

In PureField LIMS every document belongs to a category, and the category's approval flow sets who prepares a revision, which review steps it passes and who approves it. The rules are enforced in the database; segregation of duties is checked again at every signature.

The revision history shows each revision on a timeline, with who did what, when and why; text saves and signatures go into the audit trail. If the AI assistant is switched on for your laboratory, Ask the assistant on a document in force adds that document to your question; the assistant reads the revision in force and answers with code, revision and page.

At the bottom of a document's page, project cards linked to it are listed under Cards linked to this record (project management in the laboratory).