Quality Manual · QM-01
Quality Manual
Top-level description of the management system against every clause of ISO/IEC 17025:2017.
Purpose
This Quality Manual is the top-level document of the management system of [LABORATORY NAME] (referred to throughout as "the Laboratory"). It states the Laboratory's policies and describes, clause by clause, how the Laboratory meets the requirements of ISO/IEC 17025:2017, *General requirements for the competence of testing and calibration laboratories*. Detailed methods of implementation are contained in the procedures (SOP series), calibration procedures, forms and records referenced from each section.
What is inside
12 sections, about 16 pages when printed.
- 0. About this manual
- 1. Scope of the management system
- 2. Normative references and guidance
- 3. Terms and definitions
- 4. General requirements
- 5. Structural requirements
- 6. Resource requirements
- 7. Process requirements
- 8. Management system requirements
- Appendix A - Clause cross-reference
- Appendix B - Procedure index
- Appendix C - Quality policy statement
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.
Related documents
- SOP-01
Control of Documents
Creation, review, approval, issue, change and withdrawal of internal and external documents.
- 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.
- SOP-04
Management Review
Annual top-management review with every input and output the standard requires.
- SOP-05
Corrective Action and Improvement
Raising, investigating, implementing and verifying corrective actions; capturing improvement opportunities.
- SOP-06
Risk and Opportunity Management
Identifying, evaluating, treating and reviewing risks and opportunities, including risks to impartiality.
- SOP-07
Complaints Handling
Receipt, validation, investigation, response and closure of complaints, independent of the people involved.
- SOP-08
Control of Nonconforming Work
Identifying, evaluating, containing and resolving work that departs from procedures or customer requirements.