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The Role of the Quality Plan in an ISO 17025 Laboratory

Dr David Trew

BSc (Hons), PhD, CChem MRSC

A discussion is presented of a quality management system for ensuring the activities required to achieve conformance with requirements of the following clauses of the ISO/IEC 17025:2017 International Standard General Requirements for Competence of Testing and Calibration Laboratories are carried out in a timely manner:

1. Clause 6.2 Staff training

2. Clause 6.4 Equipment Calibration and maintenance

3. Clause 7.7 Performance monitoring

4. Clause 8.3 Document review

5. Clause 8.8 Internal audits

The author advocates accredited laboratories implement a quality plan to identify and record the completion of the activities necessary to maintain conformance with the listed clauses’ requirements.

1 Introduction

Maintaining accreditation to the ISO 17025:2017 International Standard General Requirements for Competence of Testing and Calibration Laboratories1 requires a laboratory to carry out the following quality activities on an ongoing basis:

1.  Staff training (Clause 6.2)

2.  Equipment calibration and maintenance (Clause 6.4)

3.  Performance monitoring (Clause 7.7)

4.  Document review (Clause 8.3)

5.  Internal audits (Clause 8.8)

Also, Clause 6.3.2 requires a laboratory to document its requirements for facilities and environmental conditions necessary for the laboratory activities’ correct performance.

These activities must be performed in a timely manner to ensure the laboratory continually conform to its quality management system (QMS) and the ISO/IEC 17025:2017 International Standard’s requirements. Any failure to complete the required quality activities in the manner required by the laboratory’s QMS would constitute a nonconformity and may invalidate any test or calibration results obtained.

A quality plan is one of the many systems that can be used to define, plan and manage the ongoing quality activities that a laboratory must carry out to ensure it always conforms with its quality management system and the requirements of the ISO/IEC 17025:2017 International Standard.

A quality plan can also be used to elaborate the laboratory’s quality policy and create a detailed ‘quality philosophy’ and strategy for ensuring the validity, reliability and trustworthiness of the results it delivers.

A quality plan serves as a:

1.  Roadmap for ensuring the quality of the results it delivers to its customers

2.  Document to define the activities carried out to fulfil the ISO/IEC 17025:2017 International Standard’s  requirements.

3.  Schedule defining when the quality activities will be performed.

4.  Discussion of the rationale for the selected activities and their performance interval.

5.  Record of the performance of the activities.

Also, the quality plan can document the laboratories facility and environmental requirements.

There are many benefits of a documented quality plan; the most important are:

1.  The laboratory’s approach to quality, together with its rationale, is clearly explained and recorded

2.  The activities to be carried out are clearly defined and justified.

3.  A schedule of activities is established

4.  A record of the completion of quality activities is created

This, in turn, will allow:

1.  Laboratory management to determine the resources necessary, both in terms of staffing and money, to maintain the laboratory’s quality program

2.  All members of staff to understand their responsibilities and their associated tasks

3.  All necessary activities to be planned into the schedule (no 11th-hour surprises!)

4.  The supporting elements (IT, quality, maintenance etc.)  will understand how to support the quality program

5.  Assessors to understand the laboratory’s approach to quality management

2 Staff Training

Clause 6.2.2 of the ISO 17025:2017 International Standard requires laboratories to document the competency requirements for each position within the laboratory that influences the results delivered by the laboratory; this includes requirements for knowledge of the laboratory’s quality management system, education, qualification, training, technical knowledge, skills and experience.

2.1 Training Fundamentals

Before identifying specific competency requirements, it is recommended that management develop a high–level description of the laboratory’s personnel requirements. The level of training required will depend not only on what the laboratory intends to deliver to its customers but also on legislative and regulatory requirements.

Personnel performing tests or calibration will always need to be able to perform the test or calibration, including operating associated equipment consistently and competently.

However, detecting potential invalid results and deviations often requires detailed knowledge of the fundamental principles underlying the methods used for testing or calibration.

It is recommended that laboratories identify all of the knowledge and skills that staff will require to fulfil their respective positions’ responsibilities and record this in the quality plan.

2.2 Quality Management System (QMS)

It will be necessary for all staff members to be familiar with the elements of the laboratory’s quality management system that apply to their respective roles. It is also recommended that staff periodically review the QMS requirements, such as procedures, that apply to their respective role to prevent forgotten or misremembered requirements. The elements of the QMS applicable to each role should be recorded in the quality plan, together with periodic review requirements.

2.3 Education and Qualifications

The minimum education and qualification requirements for each role should be established in the quality plan. Care needs to be taken when defining these requirements. Although graduates with a first level (e.g. Batchelor’s) degree in a specific subject can be expected to know the common core material of the subject. Most degree programs allow students to select optional courses, and it may be that these courses contain the education you specifically need for your laboratory. Therefore, you might like to specify the optional courses required

It may be necessary for new employees to acquire a knowledge of topics relevant to your specific laboratory’s activities, including knowledge of the regulations or legislation applicable to your sector, such as food, forensic or environmental testing, or, for a calibration laboratory, your jurisdiction’s weights and measures legislation and regulatory requirements. Alternatively, or in addition, it might be necessary for laboratory staff to understand the technical or scientific principles of the testing or calibrations being undertaken. For example, a calibration laboratory performing temperature calibration should consider whether staff should understand the International Temperature Scale of 1990 (ITS – 90)2, or a laboratory performing mass calibrations should consider whether staff understand the principles of the Kimble balance3. These requirements should be discussed in the quality plan, and a schedule established for completion.

Some jurisdictions may require persons performing certain testing and calibrations to obtain specific additional licencing or qualifications to be considered competent to perform them without supervision. Such licencing or qualifications may require the person to undertake additional study. Such a study may be available part-time or fulfilled by undertaking a selection of activities, such as attending training courses or seminars, appropriate reading, etc. These requirements should be recorded in the quality plan, together with a schedule for their completion.

2.4 Training and Skills

It may be necessary to provide training on the operation of the specific equipment used in the laboratory. Depending on the type of equipment, new employees could be expected to understand various types of equipment. However, there are many manufacturers and models of the same equipment type for some types of equipment. For example, gas and high-performance liquid chromatographs and computer programs that collect and process laboratory data. Employees may need instruction on the use of specific models depending on previous experience.

New employees may have experience in a broad range of practical laboratory skills. However, some skills can be regarded as ‘very specialised’, in which case training may be necessary. These requirements should be recorded in the quality plan, together with a schedule for their completion.

2.5 Induction Training

Induction training is the training in key knowledge and skills required by all staff involved in laboratory activities. This training needs to be carried out before a staff member is authorised to independently work in the laboratory without supervision as required by Clause 6.2.3. To fulfil these requirements, the laboratory needs to identify a key knowledge and skill set required by laboratory staff to competently perform the tasks associated with their respective roles.

In addition to training in the laboratories quality management system and the knowledge and skills required to perform testing or calibrations. Induction training should also include the following:

1.  Safety procedures and safety equipment

2.  Fire precautions

3.  Evacuation procedures and evacuation routes

4.  Disposal of waste

2.6 Authorisation of Personnel

Clause 6.2.6 of the ISO 17025 International Standard requires laboratories to authorise personnel to perform specific laboratory activities. The activities that require authorisation should be recorded in the quality plan, together with the prerequisite qualifications for authorisation to be granted.

2.7 Recommended Content of Training Section of the Quality Plan

It is recommended the training section of the quality plan should contain the following elements:

1.  Discussion of knowledge and skills required by employees to be able to perform the tasks associated with their respective roles.

2.  Discussion of the education, skills, knowledge and training required to be appointed to each role.

3.  A list of all training topics to be provided throughout the employee’s time with the laboratory. Together with a discussion of how the training will be provided, e.g. reading QMS procedures, on the job training, reading appropriate texts, external courses

4.  A list of training topics to be provided during induction training and before undertaking testing or calibrations unsupervised

5.  Identification of the roles for which specific authorisation is required before a staff member can carry out the role unsupervised; this should also include a list of training requirements that must be completed by a member of staff before being authorised to perform the role.

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