Procedure · SOP-01
Control of Documents
Creation, review, approval, issue, change and withdrawal of internal and external documents.
Purpose
To define how the Laboratory creates, reviews, approves, issues, distributes, changes, re-reviews and withdraws the documents that make up its management system, and how it controls documents of external origin, so that only current, approved documents are available at the point of use and the unintended use of obsolete documents is prevented.
What is inside
11 sections, about 5 pages when printed.
- 1. Purpose
- 2. Scope
- 3. References
- 4. Definitions
- 5. Responsibilities
- 6. Process overview
- 7. Procedure
- Records generated by this procedure
- Monitoring and performance indicators
- Assessment readiness notes
- Related documents
Records it generates
Applying this procedure produces the following records, which are the evidence an assessor samples.
- –Master Document Register (internal and external)
- –Document Change Requests with review and approval evidence
- –Distribution and acknowledgement records
- –Obsolete document archive
- –External document currency checks
What an assessor looks for
The document closes with these points, so you can check your own practice before someone else does.
- –Sampling documents at the bench and in on-site kits to confirm they are the current revision listed in FRM-01.
- –Tracing one recent change from FRM-02 through review, approval, issue, withdrawal and staff notification.
- –Checking that external standards and UKAS publications referenced in procedures are the current edition, and that the currency check is recorded.
- –Confirming that the person who approved a calibration procedure is technically competent to do so (link to FRM-16).
- –Looking for hand amendments, annotated printouts and personal copies of procedures on desks.
Before you use it
- Replace every square-bracket token, starting with [LABORATORY NAME], [ADDRESS] and [EFFECTIVE DATE]. The full token list is in GD-01 Read Me First.
- Have the content technically reviewed against how your laboratory actually works, then approved by the responsible manager before it becomes a controlled document.
- Update the Word fields after editing so the table of contents and page numbers are correct: select all, then press F9.
- Record the document in your own document register and set its review date.
- Delete the assessment readiness notes if you do not want them in your controlled version; they are guidance for you, not requirements.
Related documents
- QM-01
Quality Manual
Top-level description of the management system against every clause of ISO/IEC 17025:2017.
- FRM-01
Master Document Register
Register of every controlled internal and external document with revision, status and distribution.
- FRM-02
Document Change Request
Request, impact assessment and approval of a change to a controlled document.
- CHK-01
ISO/IEC 17025:2017 Gap Analysis and Self-Assessment
Clause-by-clause self-assessment with evidence, gap and action columns.
- GD-04
Master Document List
Controlled index of every document in the pack with ID, title, type, clauses and status.
- GD-06
Quality Policy and Objectives Statement
A signed one-page quality policy with measurable objectives for display and induction.
- SOP-02
Control of Records and Technical Records
Identification, storage, protection, retention, amendment and disposal of quality and technical records.
- SOP-03
Internal Audit
Planning, conducting, reporting and following up internal audits of the management system and technical activities.