Version 1.6.1
David Trew
Consulting Ltd
The Role of the Quality Plan in an ISO 17025 Laboratory
5 Review of Quality Management System Documents
Clause 8.3.2b requires all QMS documents are periodically reviewed and updated as necessary. It is recommended that all QMS documents are assigned a review period. All documents requiring review should be recorded in the quality plan; this should be accompanied by a review interval, the last and next review date, and the name of the person responsible for reviewing and, if necessary, updating the document.
6 Internal Audits
Clause 8.8 requires laboratories to carry out audits of its operations at planned intervals to obtain information that will provide a high level of confidence that the laboratory’s testing or calibration activities together with the activities that support the testing of calibration activities conform to the requirements of the laboratory’s quality management system and also to the requirements of the ISO 17025 International Standard.
Laboratories are also required to plan, establish, implement and maintain an audit program. The quality plan serves this purpose. It is recommended laboratories develop an audit strategy that should define the objectives of the audit program and include a discussion on the frequency, methods, planning and reporting requirements for internal audits. The development of the audit strategy should consider the importance of each laboratory activity, together with the associated risks; this should include consideration of the:
1. Laboratory’s activities
2. Sector(s) in which the laboratory operates
3. Final use of testing/calibration data
4. Turnover of staff
5. Experience and knowledge of the staff
6. Changes affecting the laboratory
7. Results of previous audits
Once the audit strategy has been finalised, the scope and criteria for each audit should be defined; this should identify:
1. The specific area to be examined
2. The records to be inspected
3. The information to be collected
4. The responsibilities for performing each audit
5. Any concerns or issues identified in previous audits which should be followed up
6. The timescale for performing each audit
7 Scheduling of Quality Activities
The activities discussed in this paper need to be accommodated as part of the laboratory’s routine work. It is recommended that a flexible approach is adopted to scheduling quality activities with appropriate time windows established for the completion of each activity. For example, equipment calibration and maintenance activities could be completed any time within a window of one month, or if audits are to be carried out quarterly, they could be carried out any time within a specific quarter, rather than on a specific date, this will provide an element of flexibility to accommodate business requirements. However, it is emphasised that not performing quality activities because of the business’s needs will not be accepted as an excuse by accrediting bodies.
It is recommended that each section of the quality plan should contain a schedule for activities within that section. It is also recommended that a monthly schedule of all activities be included within the quality plan. This plan will provide a means of estimating the resources required to be allocated to ensure the laboratory is always in conformance with the quality management system’s requirements. It is also recommended that all schedules incorporate a facility for recording each activity’s completion, as this provides a mechanism for ensuring conformance with QMS requirements and for readily identifying outstanding tasks.
8 Facilities and Infrastructure
As discussed in the introduction, Clause 6.3.2 requires laboratories to document their requirements for facilities and environmental conditions necessary for the correct performance of the tests or calibrations. The quality plan can afford a facility for conforming to this requirement.
8.1 Accommodation
This section should start by identifying the laboratory’s physical location and would usually be the street address; this should be followed by a description of the accommodation, including a list of rooms, their respective sizes and their use, together with any environmental requirements. This section should also discuss access controls to the laboratory and any necessary controls to prevent cross-
8.2 Utilities
This section should provide a brief description of each of the utilities used in the facility, including the following:
1. Deionised water (DI water)
2. Purified water
3. Ice
4. Chilled water
5. Pure steam
6. Compressed air and N2
7. Vacuum
8. Carbon dioxide
9. Electric power
10. Sanitary water
11. Heating, ventilation and air conditioning system (HVAC)
A brief description of how each utility is provided should be given with particular attention to the following:
The electric power supply will normally be obtained from the public supply. The quality plan should state the source of the supply, provide information on the laboratory’s usage, and discuss supply backup arrangements in the event of a public supply failure. It is also advantageous to explain the electric circuitry in the laboratory(ies). It is particularly helpful to establish a system of identifying each circuit; this is often done by identifying the circuit breaker that protects each circuit and labelling each power socket with the circuit breaker identifier. The system of identifying individual circuits should be discussed in this section of the quality. This section should also contain a list of circuits available in the laboratories, each circuit’s capacity, and the number of power sockets available. It is also helpful to keep a record of the load on each circuit to prevent accidental overloading.
Careful consideration often needs to be given to the heating, ventilation and air conditioning (HVAC) arrangements. Particularly when necessary to maintain temperature, humidity, and other environmental characteristics within appropriate specifications to ensure the validity of test and calibration results or prevent cross-
9 Control and Management of the Quality Plan
The quality plan is a quality document, and like any document, it needs to be controlled according to the laboratory’s document control procedures. However, the laboratory operates in a dynamic environment, and the quality plan is a living document. Therefore the laboratory’s requirements can be expected to change; considering this, the quality plan needs to be managed in such a manner that allows it to be easily updated.
It is recommended the quality plan is prepared annually, reviewed and approved before being executed. After all activities listed have been completed, the plan should be approved as completed at the end of the year.
As the quality plan is a living document, additional specific procedures may be necessary to effectively manage the plan while still exercising the necessary level of control. Specific procedures are required for controlling the incorporation of changes to the plan after the initial approval of the plan. Specific procedures are required for:
1. Defining authorities for initiating post-
2. Incorporating post-
3. Identifying and assessing the risks and consequences associated with a proposed change
4. Identifying and assessing the resource requirements associated with a proposed change
Records of all changes which should include:
1. Details of the change
2. Reason for the change
3. Risks, consequences and resources associated with the change
4. Approvals for the change
10 Concluding Comments
The discussion presented here describes just one option for systematically planning and managing the required activities to ensure accredited laboratories maintain conformance with their own quality management system and the requirements of the ISO/IEC 17025:2017 International Standard. There are, of course, many variations of the model presented here, and it should be adjusted and tweaked to meet the specific requirements of a particular laboratory. For example, it is completely acceptable to develop separate plans for each clause listed in the introduction.
A quality plan could also discuss the laboratory’s philosophy to verifying and validating test or calibration methods. In addition to defining the laboratory’s strategy and philosophy for establishing evidence that provides a high level of confidence, that ensures measuring equipment continues to deliver results suitable for the laboratory’s purposes.
Also, there may be other options for managing the requirements of the ISO/IEC 17025:2017 International Standard. It is the responsibility of individual laboratories to ensure they are always in conformance with the International Standard and create a management system that best suits their specific needs.
11 References
1. ISO 17025:2017 General Requirements for Competence of Testing and Calibration Laboratories, International Organisation for Standardisation, Geneva, 2017
2. Guide to the realisation of ITS – 90, International Bureau of weights and measures ( Bureau International des Poids et Mesures) https://www.bipm.org/en/committees/cc/cct/guide-
3. Kilogram: The Kibble Balance, National Institute of Standard and Technology, https://www.nist.gov/si-
4. ILAC-
5. ISO 17043:2010 Conformity assessment — General requirements for proficiency testing, International Organisation for Standardisation, Geneva, 2010
6. EA-
7. ILAC-
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