ISO 15189:2022 · Section 8 · Management system requirements
Clause 8.3: Control of management system documents
Check the exact requirement in your licensed copy of the standard.
Last reviewed
What this clause is about
Document control ensures that staff use the right instructions at the point of work. It applies to laboratory-authored procedures and relevant external documents, including manufacturer instructions and institutional policies. A controlled document needs an identifiable owner, an approved version and a reliable route to the people who use it. The system should make the current instruction obvious without requiring staff to compare several nearly identical files.
Define how documents are drafted, reviewed for suitability, approved and released. Assign identifiers and revision information that allow staff to distinguish versions. Before a revised procedure becomes effective, consider training, associated forms, equipment settings and any linked documents. A change to specimen acceptance, for example, may also require changes to collection guidance and communications to users. Control is therefore more than adding a signature to a file.
Review documents at planned intervals appropriate to their purpose and when relevant changes occur. Record whether the content remains suitable, even when no revision is necessary. Prevent unintended use of obsolete versions at benches, shared drives and remote locations. Retained historical copies should be clearly distinguished from current instructions while remaining retrievable when an investigation needs to establish what applied on a particular date.
External documents need attention too. Identify which editions or instructions are relevant, who checks for updates and how changes are evaluated locally. Emergency revisions should follow a defined approval route rather than becoming permanent handwritten exceptions. LabToolkit Pro can support controlled SOP drafting, e-signatures and revision records, but the laboratory must determine approval authority, review suitability and ensure that printed or locally saved copies do not undermine the controlled source.
What assessors typically ask to see
- Can a staff member immediately identify the approved current procedure at every place where the activity is performed?
- Who reviews technical suitability and approves release, and how is that authority assigned for each document category?
- How are revised procedures linked to training needs, changed forms and communication before the effective date?
- What prevents obsolete paper copies and locally saved files from remaining in use after a revision?
- How are external instructions monitored for changes and assessed for their effect on laboratory practice?
Documents and records that usually provide evidence
- Document-control procedure defining drafting, review, approval, issue, revision, withdrawal and retention of historical versions.
- Document register identifying owners, current revisions, effective dates, review status and relevant distribution locations.
- Approval records showing authorized review of technical content before a new or revised instruction becomes effective.
- Change records describing significant revisions and their effects on training, forms, equipment or related procedures.
- Distribution and withdrawal records covering controlled printed copies, remote locations and retained obsolete documents.
- External-document register identifying applicable manufacturer instructions, institutional policies and responsibility for checking relevant updates.
Ready-made forms mapped to clause 8.3: Document Attestation Form, Document Distribution and Retrieval Form, Document Change Request Log, Archiving and Removal Form.
Common findings to avoid
- Using a recent review date as evidence of approval when nobody has checked whether the technical content remains suitable.
- Leaving superseded procedures in shared folders where search results display them alongside the approved current version.
- Revising an SOP without updating its linked worksheet, creating conflicting instructions for the same examination step.
- Keeping manufacturer instructions without an assigned owner who evaluates updates and their implications for local practice.
How LabToolkit Pro maps documents to this clause
Each SOP, form and record in LabToolkit Pro can carry clause tags. When a document tagged 8.3 becomes effective, it counts as direct evidence on the readiness dashboard for ISO 15189:2022; links from other standards through the crosswalk are shown separately as indicative coverage. Gaps appear clause by clause, so you can see which parts of 8.3 still need a controlled document or a current record. Readiness is a planning aid — only an accreditation body confirms conformity.
Frequently asked questions
Must every document be reviewed annually?
Set and justify review intervals appropriate to the document and applicable obligations. Also review when methods, equipment, regulations or identified risks change. A calendar review should not delay a necessary technical revision.
Are printed procedures prohibited?
No. Printed instructions can be useful where electronic access is impractical. Establish how current copies are identified, distributed, checked and withdrawn, and make their status clear so staff do not rely on obsolete printouts.
Can approval use an electronic signature?
Yes, where the arrangement reliably identifies the authorized approver and preserves the approval record. Define access, approval meaning, timing and change protection, and check any legal or organizational requirements that apply locally.
Check the exact requirement in your licensed copy of the standard.
Put it into practice
Draft, approve and e-sign your SOPs with version control, or get the complete template pack.