Project Plan

Procedure number	01
ISO/IEC 17025 reference	Clauses 5, 8.1, 8.2
Revision	00
Effective date	[Enter date]
Approved by	[Laboratory Director]

1. Purpose

To define the plan, timeline, and responsibilities for implementing and maintaining the laboratory's quality management system (QMS) in accordance with ISO/IEC 17025:2017, with the objective of achieving and sustaining accreditation from a recognized accreditation body.

This procedure ensures that:

• The implementation effort is planned, resourced, and monitored.
• Roles and responsibilities are clearly assigned for each phase.
• The laboratory follows a structured path from current state to accreditation readiness.
• Ongoing maintenance of the QMS is addressed after initial accreditation.

2. Scope

This procedure applies to the entire lifecycle of the QMS implementation project, including:

• Initial assessment of the laboratory's current practices against ISO/IEC 17025 requirements (gap analysis)
• Planning and resource allocation
• Development of QMS documentation (policies, procedures, forms, and records)
• Training and deployment of the QMS
• Internal auditing and management review
• Preparation for and participation in the accreditation assessment
• Post-accreditation surveillance and continual improvement

This procedure is relevant to all personnel involved in establishing, implementing, and maintaining the QMS.

3. References

• ISO/IEC 17025:2017, Clause 5 — Structural requirements (management commitment and organizational structure)
• ISO/IEC 17025:2017, Clause 8.1 — Management system options (Option A or Option B)
• ISO/IEC 17025:2017, Clause 8.2 — Management system documentation
• ISO/IEC 17025:2017, Clause 7.1 — Review of requests, tenders, and contracts (scope definition)
• ISO/IEC 17025:2017, Clause 6.2 — Personnel (competence and training)
• ILAC P10 — ILAC Policy on Traceability of Measurement Results (for planning metrological traceability)

4. Definitions

Term	Definition
Gap analysis	A systematic comparison of the laboratory's current practices, documentation, and capabilities against the requirements of ISO/IEC 17025:2017, identifying areas that need development or improvement.
Accreditation body	An authoritative organization that evaluates and formally recognizes a laboratory's competence to perform specific tests or calibrations (e.g., ANAB, UKAS, ENAC, OAA).
Scope of accreditation	The specific tests, calibrations, or types of tests/calibrations for which the laboratory seeks or holds accreditation, including the methods, ranges, and measurement uncertainties involved.
Management system option	ISO/IEC 17025 offers two options for establishing a management system: Option A (implementing clauses 8.2–8.9 of the standard) or Option B (operating a management system in accordance with ISO 9001 that fulfils clauses 8.2–8.9).
Pre-assessment	An optional evaluation conducted by the accreditation body (or a consultant) before the formal assessment, to identify remaining gaps and improve readiness.
Surveillance	Periodic reassessments conducted by the accreditation body after initial accreditation to verify continued compliance with ISO/IEC 17025 requirements.
Corrective action	Action taken to eliminate the cause of a detected nonconformity or other undesirable situation, and to prevent its recurrence.

5. Responsibilities

info

In smaller laboratories, one person may fulfil multiple roles (e.g., the Laboratory Director may also act as Quality Manager and project lead). What matters is that the responsibilities are assigned and that the person is aware of each role they hold. Where impartiality could be compromised by combining roles, appropriate safeguards should be in place.

Role	Responsibility
Laboratory Director	Champions the project at the organizational level. Secures resources (budget, time, personnel). Approves the project plan and major milestones. Makes the final decision on scope of accreditation and management system option.
Quality Manager	Leads the day-to-day implementation effort. Coordinates the gap analysis, documentation development, and training. Tracks progress against milestones and reports to the Laboratory Director. Serves as the primary liaison with the accreditation body.
Technical Manager	Ensures technical procedures, methods, and equipment meet ISO/IEC 17025 requirements. Leads the development of technical documentation (test methods, calibration procedures, measurement uncertainty budgets). Supports the gap analysis for technical clauses.
Project team members	Personnel assigned specific tasks within the project (e.g., drafting procedures, validating methods, calibrating equipment). Participate in training and provide feedback on the practicality of new processes.
All personnel	Participate in QMS training. Follow implemented procedures and report issues or improvement opportunities. Cooperate with internal audits and assessments.

6. Procedure

6.1 Project initiation

1. The Laboratory Director formally authorizes the QMS implementation project by approving this Project Plan. This demonstrates management commitment as required by ISO/IEC 17025, clause 5.7.

2. The Laboratory Director appoints the Quality Manager (or equivalent role) to lead the project. If the Quality Manager role does not yet exist, it is established at this stage.

3. The laboratory selects its management system option:

   • Option A: Implement the management system requirements of ISO/IEC 17025 clauses 8.2–8.9 directly.
   • Option B: Establish and maintain a management system in accordance with ISO 9001 that also satisfies clauses 8.2–8.9 of ISO/IEC 17025.
   tip

   Option A is generally more straightforward for laboratories that do not already hold ISO 9001 certification. Option B may be preferred by laboratories that are part of a larger organization already certified to ISO 9001.

4. The Laboratory Director and Quality Manager define the intended scope of accreditation — the specific tests, calibrations, or types of tests/calibrations for which the laboratory will seek accreditation.

5. The Quality Manager identifies the target accreditation body and obtains its specific application requirements, fees, and assessment process.

6.2 Gap analysis

1. The Quality Manager, supported by the Technical Manager, conducts a gap analysis comparing the laboratory's current practices against each clause of ISO/IEC 17025:2017.
2. The analysis shall cover, at a minimum:
   • Structural and organizational requirements (clauses 4–5)
   • Resource requirements (clause 6): personnel, facilities, equipment, metrological traceability
   • Process requirements (clause 7): review of requests, method selection and validation, sampling, handling of items, technical records, measurement uncertainty, reporting
   • Management system requirements (clause 8): documentation, control of records, actions to address risks, improvement, corrective actions, internal audits, management reviews
3. For each requirement, the gap analysis records:
   • Current status (compliant, partially compliant, or not compliant)
   • Evidence of compliance where it exists
   • Actions needed to achieve compliance
   • Estimated effort and priority
4. The completed gap analysis is documented using the Gap Analysis Checklist (Appendix 1).
5. The Quality Manager presents the gap analysis findings to the Laboratory Director for review.

6.3 Planning

1. Based on the gap analysis results, the Quality Manager develops a detailed implementation timeline (Appendix 2) that includes:
   • Each phase of the project (sections 6.4–6.8) with start and end dates
   • Key milestones (e.g., documentation complete, first internal audit, assessment date)
   • Assigned responsibilities for each task
   • Dependencies between tasks
2. The Laboratory Director allocates the necessary resources:
   • Personnel: dedicated time for the Quality Manager and project team members; external consultants if needed
   • Budget: accreditation body fees, equipment purchases or calibrations, training costs, standards and reference materials
   • Infrastructure: any facility modifications identified in the gap analysis
3. The Quality Manager establishes a reporting cadence (e.g., monthly progress meetings) to track the project against the timeline and escalate issues.
4. The project plan and timeline are approved by the Laboratory Director.

6.4 Documentation development

1. The Quality Manager coordinates the development of QMS documentation in the following order:
   1. Quality Policy (Procedure 02) — the laboratory's commitment to quality, impartiality, and competence.
   2. Quality Manual (Procedure 03) — the overarching document describing the QMS structure and how it addresses each clause of ISO/IEC 17025. (Note: ISO/IEC 17025:2017 no longer explicitly requires a quality manual, unlike the 2005 edition. However, maintaining one is strongly recommended as it provides a single reference point for assessors and personnel to understand the QMS structure.)
   3. Procedures (this series, 00–21) — detailed instructions for each element of the QMS.
   4. Appendices (forms, templates, checklists, and registers) — the tools that support each procedure and generate records when completed.
   5. Work instructions and SOPs — step-by-step instructions for specific technical activities (test methods, calibration procedures, equipment operation).
2. Each document is created, reviewed, and approved following Procedure 00 — Document and Record Control.
3. The Technical Manager leads the development of technical documentation, including:
   • Test and calibration methods (with validation or verification as applicable)
   • Measurement uncertainty budgets
   • Equipment calibration and maintenance procedures
4. The Quality Manager tracks documentation progress against the implementation timeline and ensures all documents are assigned to a responsible author.

6.5 Implementation and training

1. As procedures and work instructions are approved, the Quality Manager coordinates their deployment:
   • Documents are distributed to personnel at their points of use (per Procedure 00).
   • Personnel are trained on new or revised procedures relevant to their roles.
2. Training is planned and recorded in accordance with Procedure 04 — Competence and Training. At a minimum, training shall cover:
   • Overview of ISO/IEC 17025 and why the laboratory is pursuing accreditation
   • The structure and key elements of the QMS
   • Specific procedures relevant to each person's role
   • How to create and maintain records
   • How to report nonconformities and improvement opportunities
3. The Quality Manager allows a reasonable period (e.g., 2–3 months) of operating under the new QMS before proceeding to the internal audit, so that:
   • Personnel become familiar with new processes
   • Records are generated to demonstrate implementation
   • Issues are identified and addressed in normal operation

6.6 Internal audit and management review

1. The Quality Manager plans and conducts at least one full internal audit of the QMS in accordance with Procedure 18 — Internal Audit.
   • The audit shall cover all clauses of ISO/IEC 17025 and all elements of the QMS.
   • Auditors shall be independent of the activities they audit. In small laboratories, this may require using external auditors or cross-auditing between roles.
2. Audit findings (nonconformities, observations, and opportunities for improvement) are documented and communicated to responsible personnel.
3. The Laboratory Director conducts a management review in accordance with Procedure 19 — Management Review, covering at a minimum:
   • Results of the internal audit
   • Status of corrective actions
   • Feedback from personnel and customers
   • Adequacy of resources
   • Effectiveness of the QMS and progress toward accreditation readiness
4. The management review outputs include decisions and actions to address gaps identified during the audit.

6.7 Corrective actions and pre-assessment

1. The Quality Manager ensures that all nonconformities identified during the internal audit and management review are addressed through corrective actions in accordance with Procedure 14 — Complaints and Nonconformity.
2. Corrective actions are implemented, verified for effectiveness, and documented before proceeding to the accreditation assessment.
3. (Optional) The laboratory may request a pre-assessment from the accreditation body or engage an independent consultant to conduct a readiness review. This provides an opportunity to identify remaining gaps before the formal assessment.
4. Any findings from the pre-assessment are addressed and closed.

6.8 Accreditation assessment

1. When the Quality Manager and Laboratory Director are satisfied that the QMS is fully implemented and effective, the Quality Manager submits the formal application to the accreditation body, including:
   • Completed application forms
   • Quality Manual and supporting documentation (as required by the accreditation body)
   • Scope of accreditation requested
   • Application fee
2. The accreditation body conducts a document review (desk audit) of the QMS documentation. The Quality Manager responds to any queries or requests for additional information.
3. The accreditation body schedules and conducts an on-site assessment. During the assessment:
   • The Quality Manager coordinates logistics and personnel availability.
   • Designated personnel demonstrate their competence and the implementation of procedures in their areas.
   • The Laboratory Director participates in opening and closing meetings.
4. The accreditation body issues an assessment report identifying any nonconformities. The Quality Manager coordinates corrective actions and submits evidence of closure within the accreditation body's required timeframe.
5. Upon satisfactory resolution of all nonconformities, the accreditation body grants accreditation.

6.9 Ongoing maintenance

1. After initial accreditation, the laboratory maintains the QMS through:
   • Surveillance assessments: The accreditation body conducts periodic reassessments (typically annual). The Quality Manager prepares the laboratory for each surveillance visit.
   • Internal audits: Conducted at planned intervals (at least annually) per Procedure 18.
   • Management reviews: Conducted at planned intervals (at least annually) per Procedure 19.
   • Continual improvement: Opportunities for improvement are identified through audits, reviews, customer feedback, and day-to-day operations, and acted upon in accordance with Procedure 21 — Continuous Improvement.
2. The Quality Manager monitors changes to ISO/IEC 17025, accreditation body requirements, and applicable regulations, and initiates updates to the QMS as needed.
3. The accreditation cycle typically spans 4–5 years, after which a reassessment is conducted for renewal. The Quality Manager plans for reassessment well in advance.

7. Related documents

Document	Reference
Appendix 1 — Gap Analysis Checklist	01-App-01
Appendix 2 — Implementation Timeline	01-App-02
00 — Document and Record Control	Procedure 00
02 — Quality Policy	Procedure 02
03 — Quality Manual	Procedure 03
04 — Competence and Training	Procedure 04
14 — Complaints and Nonconformity	Procedure 14
18 — Internal Audit	Procedure 18
19 — Management Review	Procedure 19
21 — Continuous Improvement	Procedure 21

8. Revision history

Revision	Date	Description	Approved by
00	[Date]	Initial issue	[Name]