Quality Manual
| Document number | 03 |
| ISO/IEC 17025 reference | All clauses |
| Revision | 00 |
| Effective date | [Enter date] |
| Approved by | [Laboratory Director] |
1. Purpose
To describe the overall structure and scope of the laboratory's Quality Management System (QMS) and demonstrate how the laboratory meets the requirements of ISO/IEC 17025:2017.
2. Laboratory scope and description
Laboratory name: [Laboratory Name]
Location: [Address]
Current scope (in operation):
The laboratory provides testing and characterization services for lithium-ion battery cathode and anode materials. Current services include:
- Elemental composition analysis (ICP-OES)
- Moisture content determination (Karl Fischer titration)
- Particle size distribution (laser diffraction)
- Specific surface area (BET analysis)
- Organic impurity analysis (HPLC-UV)
Laboratory type: Materials characterization; testing only.
Planned scope (future): Calibration services (timeline: [to be defined]).
Personnel:
- Laboratory Director: [Name]
- Quality Manager: [Name]
- Technical Manager: [Name]
- Technical staff: [Number] full-time analysts
3. Impartiality and independence
The laboratory maintains independence from any commercial, financial, or other pressures that could compromise the impartiality or objectivity of its testing results. All personnel are instructed that they must not allow personal, financial, or other interests to interfere with their professional judgment. The Quality Manager monitors impartiality through the management review process (Procedure 19).
4. Quality policy and commitment
The laboratory is committed to:
- Producing technically valid, reliable results that clients can trust
- Maintaining impartiality and independence in all testing activities
- Complying with all applicable regulatory requirements and ISO/IEC 17025:2017
- Continuously improving the quality and efficiency of our operations
- Providing transparent, professional service to our clients
This commitment is documented in detail in Procedure 02 — Quality Policy.
5. Quality objectives
The laboratory establishes annual quality objectives aligned with the Quality Policy. These objectives typically address:
- On-time delivery of results (target: 95% within agreed timelines)
- Accuracy and precision of results (zero out-of-specification results per 100 tests)
- Customer satisfaction (annual survey target: ≥90% satisfied)
- Staff competence (100% of technical staff current on training)
- Continual improvement (≥2 process improvements per year)
Current objectives are documented in Appendix 02-App-01 — Quality Objectives (to be created in Procedure 02).
6. Organizational structure and roles
| Role | Responsibility | Current person |
|---|---|---|
| Laboratory Director | Ultimate accountability for QMS; strategic decisions; approval of policy | [Name] |
| Quality Manager | Day-to-day QMS management; document control; record retention; internal audits | [Name] |
| Technical Manager | Technical method validation; equipment management; technical staff competence | [Name] |
| Technical staff | Perform testing; generate records; maintain equipment in working order | [Names] |
For details on all roles and responsibilities, see the specific procedures.
7. QMS structure and procedures
The laboratory's QMS consists of 22 interconnected procedures (numbered 00–21), organized around practical laboratory processes. Each procedure includes the actual process steps, responsibility assignments, and necessary forms or templates (appendices).
| # | Procedure | ISO Clauses | Purpose |
|---|---|---|---|
| 00 | Document and Record Control | 7.5, 7.11, 8.3, 8.4 | Control of all QMS documents and technical/management records |
| 01 | Project Plan | — | Implementation roadmap and timeline for QMS establishment |
| 02 | Quality Policy | 8.2 | Statement of quality commitment and objectives |
| 03 | Quality Manual | 8.1 | Overview of QMS structure and scope |
| 04 | Competence, Training and Awareness | 6.2 | Ensure all personnel are competent and trained |
| 05 | Risks and Opportunities | 8.5 | Identify and address risks to QMS effectiveness |
| 06 | Externally Provided Products and Services | 6.6 | Control and evaluate suppliers and external services |
| 07 | Facilities and Environmental Conditions | 6.3 | Maintain facilities and environment suitable for testing |
| 08 | Equipment Maintenance, Calibration and Verification | 6.4 | Manage laboratory equipment lifecycle and calibration |
| 09 | Customer Service | 7.1, 8.6 | Manage customer communication and satisfaction |
| 10 | Test and Calibration Methods | 7.2 | Select, validate, and verify test methods |
| 11 | Quality Assurance | 7.7 | Monitor validity of results through proficiency testing and QC |
| 12 | Sampling | 7.3 | Define sampling plans and procedures |
| 13 | Handling of Items for Testing | 7.4 | Receive, store, and handle test items properly |
| 14 | Complaints, Nonconformity and Corrective Action | 7.9, 7.10, 8.7 | Handle complaints and drive process improvements |
| 15 | Evaluation of Measurement Uncertainty | 7.6 | Evaluate and report uncertainty in results |
| 16 | Testing Reports | 7.8 | Prepare and issue test reports |
| 17 | Calibration Reports and Certificates | 7.8 | [Not currently applicable; included for completeness] |
| 18 | Internal Audit | 8.8 | Audit QMS compliance and effectiveness |
| 19 | Management Review | 8.9 | Review QMS adequacy at least annually |
| 20 | Research Projects Management | — | Manage research activities within QMS framework |
| 21 | Continuous Improvement | 8.6 | Drive ongoing process and system improvements |
8. How the procedures work together
The 22 procedures form an integrated QMS where:
- Procedure 00 (Document and Record Control) underpins everything — it governs how all other procedures are created, revised, and controlled.
- Procedures 01–02 establish the QMS foundation: the implementation plan, quality policy, and objectives.
- Procedures 04–07 address laboratory infrastructure: staff competence, risk management, suppliers, and facilities.
- Procedures 08–17 cover the core testing process: equipment, methods, sampling, handling, analysis, uncertainty, and reporting.
- Procedures 09, 14, 18–21 ensure QMS effectiveness: customer feedback, complaints, audits, management review, and continuous improvement.
Each procedure includes:
- The process steps (what to do and how)
- Responsibility assignments (who does it)
- Appendices with forms, templates, and registers (the tools)
9. Document and record control
All QMS documents and records are controlled under Procedure 00 — Document and Record Control. This ensures:
- Only current versions of procedures are in use
- All documents are approved before distribution
- Records are properly identified, stored, and retained
- Obsolete documents are removed and archived
- External documents (standards, regulations) are tracked for updates
10. Communication and access
- Internal: All personnel have access to current QMS documents via [method].
- External: This Quality Manual and key procedures are available to clients and auditors on request.
- Confidentiality: Customer information and sensitive operational data are protected according to [Procedure 00].
11. Effectiveness and review
The Quality Manager reviews this manual annually (at minimum) to ensure it remains accurate and reflective of current QMS operations. Significant changes (e.g., new testing methods, expanded scope) trigger a revision.
Management reviews the entire QMS at least annually (Procedure 19 — Management Review) to assess effectiveness and identify areas for improvement.
12. Related documents
- Procedure 02 — Quality Policy (Quality Policy and Objectives)
- Procedure 00 — Document and Record Control (Document management system)
- Procedure 19 — Management Review (Annual QMS review process)
13. Revision history
| Revision | Date | Description | Approved by |
|---|---|---|---|
| 00 | [Date] | Initial issue | [Name] |