Quality Policy
| Procedure number | 02 |
| ISO/IEC 17025 reference | Clause 8.2 |
| Revision | 00 |
| Effective date | [Enter date] |
| Approved by | [Laboratory Director] |
1. Purpose
To establish, document, and communicate the laboratory's commitment to quality, impartiality, competence, and continual improvement. The quality policy provides the framework for setting quality objectives and guides all personnel in their daily work.
2. Scope
This procedure applies to:
- The quality policy statement itself and the process for its creation, approval, communication, and review.
- The quality objectives derived from the policy and the process for setting, monitoring, and reviewing them.
- All personnel who carry out laboratory activities or whose work affects the quality of results.
3. References
- ISO/IEC 17025:2017, Clause 8.2 — Management system documentation (quality policy)
- ISO/IEC 17025:2017, Clause 4.1 — Impartiality
- ISO/IEC 17025:2017, Clause 4.2 — Confidentiality
- ISO/IEC 17025:2017, Clause 8.6 — Improvement
- ISO/IEC 17025:2017, Clause 8.9 — Management reviews
4. Definitions
| Term | Definition |
|---|---|
| Quality policy | A formal statement by the laboratory's management that expresses the overall intentions and direction of the laboratory with respect to quality, impartiality, and competent performance of laboratory activities. |
| Quality objective | A specific, measurable goal derived from the quality policy. Quality objectives translate the policy's commitments into targets that can be tracked and evaluated. |
| Good professional practice | Performing laboratory activities in accordance with applicable standards, methods, and the requirements of customers, while exercising sound technical judgment. |
5. Responsibilities
In smaller laboratories, one person may fulfil multiple roles (e.g., the Laboratory Director may also act as Quality Manager). What matters is that the responsibilities are assigned and that the person is aware of each role they hold.
| Role | Responsibility |
|---|---|
| Laboratory Director | Approves the quality policy. Ensures that adequate resources are available to fulfil the policy commitments. Demonstrates management commitment to the QMS through leadership and active participation. |
| Quality Manager | Drafts and maintains the quality policy. Proposes quality objectives and monitors progress toward them. Ensures the policy is communicated to all personnel and understood. Presents policy performance to the Laboratory Director during management reviews. |
| Technical Manager | Ensures that technical activities are carried out in accordance with the quality policy. Contributes to setting technically relevant quality objectives (e.g., proficiency testing targets, method validation goals). |
| All personnel | Understand the quality policy and how it applies to their work. Carry out laboratory activities in accordance with the policy commitments. Report situations that may compromise quality, impartiality, or confidentiality. |
6. Procedure
6.1 Requirements for the quality policy
ISO/IEC 17025:2017, clause 8.2, requires that the quality policy statement be issued under the authority of the laboratory's management. At a minimum, the quality policy shall include commitments to:
- Good professional practice and the quality of testing and calibration results.
- Compliance with ISO/IEC 17025 and any other applicable requirements (regulatory, accreditation body, customer).
- Competent performance of laboratory activities — ensuring that personnel have the skills, training, and resources needed to produce reliable results.
- Impartiality — laboratory activities are free from undue commercial, financial, or other pressures that could affect technical judgment.
- Confidentiality — protecting customer information and proprietary data.
- Continual improvement of the management system.
The quality policy should be concise and written in plain language. It is not a description of the QMS — it is a statement of commitment. A good quality policy fits on a single page and can be understood by all personnel, regardless of their role.
6.2 Drafting and approval
- The Quality Manager drafts the quality policy, taking into account:
- The requirements of clause 8.2 (section 6.1 above)
- The laboratory's scope of activities
- The expectations of customers, accreditation bodies, and regulators
- Input from the Laboratory Director and Technical Manager
- The Laboratory Director reviews and approves the quality policy. Approval signifies management commitment to the policy and to providing the resources needed to fulfil it.
- The approved policy is controlled as a QMS document in accordance with Procedure 00 — Document and Record Control.
6.3 Quality policy statement
The statement below is a template. The laboratory shall adapt it to reflect its own scope, context, and commitments. Replace the bracketed placeholders with laboratory-specific information.
Quality Policy Statement
[Laboratory name] is committed to providing reliable, accurate, and impartial results in the chemical and physical characterization of lithium-ion battery cathode and anode materials. The laboratory maintains a management system in accordance with ISO/IEC 17025:2017 to ensure the consistent quality and reliability of its results.
To fulfil this commitment, the laboratory's management and personnel pledge to:
- Perform all laboratory activities in accordance with good professional practice and the requirements of ISO/IEC 17025:2017.
- Maintain competence through ongoing training, supervision, and access to appropriate equipment and resources.
- Ensure impartiality in all laboratory activities, identifying and managing risks to impartiality so that technical judgment is never compromised by commercial, financial, or other pressures.
- Protect the confidentiality of customer information, proprietary data, and test results.
- Comply with applicable legal, regulatory, and accreditation body requirements.
- Continually improve the effectiveness of the management system through the setting and review of quality objectives, internal audits, management reviews, and corrective actions.
All personnel are expected to be familiar with this policy, to understand how it applies to their work, and to carry out their activities in accordance with the quality management system documentation.
Approved by: [Name, Laboratory Director] Date: [Date]
6.4 Communication
- The quality policy shall be communicated to all laboratory personnel. Communication methods may include:
- Distribution of the policy document (paper or electronic)
- Display in common areas (e.g., laboratory entrance, notice board, intranet)
- Inclusion in new employee orientation and training programs
- Discussion during team meetings and management reviews
- The Quality Manager ensures that all personnel have received and acknowledged the quality policy. Acknowledgment may be recorded through signed attendance at a training session or an electronic confirmation.
- The quality policy shall be available to relevant interested parties upon request (e.g., customers, accreditation body assessors).
6.5 Quality objectives
- The Quality Manager, in consultation with the Technical Manager and Laboratory Director, establishes measurable quality objectives that support the commitments in the quality policy.
- Quality objectives shall be:
- Specific — clearly defined and unambiguous.
- Measurable — quantifiable or verifiable so that progress can be tracked.
- Achievable — realistic given the laboratory's resources and context.
- Relevant — aligned with the quality policy and the laboratory's scope.
- Time-bound — assigned a target date or review period.
- Quality objectives are documented in the Quality Objectives Register (Appendix 1).
- Examples of quality objectives include:
- Achieve satisfactory results in ≥ 90 % of proficiency testing rounds participated in during the year.
- Complete all scheduled internal audits within the annual audit program.
- Resolve all customer complaints within [X] working days of receipt.
- Ensure all personnel complete their assigned training within [X] months of appointment.
- Reduce turnaround time for routine test reports to ≤ [X] working days.
- Maintain equipment calibration compliance at ≥ 98 % (no overdue calibrations).
6.6 Monitoring and review
- The Quality Manager monitors progress toward quality objectives on an ongoing basis and reports results to the Laboratory Director.
- The quality policy and quality objectives are formally reviewed during the management review (at least annually) in accordance with Procedure 19 — Management Review. The review considers:
- Whether the quality policy remains appropriate to the laboratory's scope and context.
- The degree to which quality objectives have been met.
- Whether objectives need to be revised, replaced, or supplemented.
- Feedback from personnel, customers, audits, and corrective actions.
- When quality objectives are met, new objectives are established to drive continual improvement.
- When quality objectives are not met, the Quality Manager investigates the causes and initiates corrective actions as appropriate, in accordance with Procedure 14 — Complaints and Nonconformity.
- Any changes to the quality policy are approved by the Laboratory Director and communicated to all personnel following the same process as the original policy (sections 6.2–6.4).
7. Related documents
| Document | Reference |
|---|---|
| Appendix 1 — Quality Objectives | 02-App-01 |
| 00 — Document and Record Control | Procedure 00 |
| 01 — Project Plan | Procedure 01 |
| 03 — Quality Manual | Procedure 03 |
| 14 — Complaints and Nonconformity | Procedure 14 |
| 19 — Management Review | Procedure 19 |
8. Revision history
| Revision | Date | Description | Approved by |
|---|---|---|---|
| 00 | [Date] | Initial issue | [Name] |