Action Point 9 - Improve the QMS of National Quality Control Laboratories


Laboratories are essential to ensure that NRAs are able to assess the quality of medical products. The reliability of the tests performed and the credibility of their results, depends on the quality of the work performed by the laboratories.

A variety of tools is available to support laboratories in improving and demonstrating their quality. These include WHO pre-qualification, accreditation according to ISO 17025, WHO-NNB Network and WHO assessment as per GBT.

Participation, implementation and information sharing in relation to these tools can contribute to improve the performances of laboratory testing in the region and facilitate reliance.

To achieve this goal, the Assembly of SEARN adopted on 8 June 2022 the SEARN Work Plan 2022-2023 which includes the action point 9, led by Working Group 1 (WG1) Quality: ‘Draft a strategy to support laboratory benchmarking in the region’.

Scope and definitions

To support NCLs in improving their Quality Management Systems, several tools have been identified:

  • WHO Benchmarking: A formal process of evaluation of a process or system, preferably quantitative, but sometimes necessarily qualitative (1).
  • Accreditation: a formal process of assessment by an independent body, internationally recognized, which provides an assurance of the compliance with a specific standard, usually ISO 17025 for testing and calibration laboratories, by means of a certificate, stating the scope of the activities for which evidence of provision of valid and reliable results are found.
  • Inter-Laboratory comparison: Organization, performance and evaluation of measurements or tests on the same or similar items by two or more laboratories in accordance with predetermined conditions (4).
  • Proficiency Testing / External Quality Assessment: Evaluation of a participating laboratory performance against pre-established criteria by means of multiple interlaboratory comparisons.
  • WHO External quality assurance assessment scheme (WHO EQAAS): a scheme organized and coordinated by WHO with the assistance of the European Directorate for the Quality of Medicines & HealthCare (EDQM) with a view to evaluating the technical performance of pharmaceutical quality control laboratories designated by WHO (3).


General objective

To support national control laboratories (NCL) in improving their Quality Management System.

Specific Objectives

  1. To facilitate the conduct of proficiency testing in the region;
  2. To facilitate inter-laboratory visits and placements in the region;
  3. To define the information required about other NCLs to enable/facilitate reliance.

Tools to test and improve NCL’s QMS

As highlighted in the Global Benchmarking Tool (1), ‘The laboratory testing regulatory function is intended to ensure that the National Regulatory Authority (NRA) is able to assess the quality of medical products by performing quality tests on them in certain situations’. ‘If a country is able to provide all the resources needed, a laboratory under the responsibility of the NRA or a governmental laboratory represents the best choice. Commonly, this governmental laboratory is a national control laboratory (NCL). As an alternative option, the regulatory system may have access to external laboratories, either inside or outside the country, to perform the required tests on behalf on the NRA/NCL. When external laboratories are used, regulatory decisions and actions remain at the discretion of the NRA/NCL and the NRA/NCL retains accountability’.

To support their mission, a robust Quality Management System is essential for  NCL. The QMS ensures that the NCL produces valid and reliable tests result consistently. Especially, it contributes to:

  • Ensure compliance with regulatory requirements
  • Ensuring validity and reliability of test results
  • Facilitate continuous improvement
  • Enhance customer satisfaction

This section provides an overview of the main tools available to test and improve NCL’s QMS


The International Organization for Standardization (ISO) defines audit as a “systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which required criteria are fulfilled”.

Each laboratory must implement, as part of the QMS, an internal audit system which covers all  management and technical requirements.

The laboratory should also be prepared to accept external audits, such as from clients (any UN agency using that laboratory, for instance).

A network of laboratories can also implement a Peer-audit system, led by duly qualified auditors, with demonstrated technical competence. This system should be preferably be led by WHO prequalified laboratories or accredited labs, as long as they have in their team qualified auditors. Such system may be supported by WHO and development partners.

Prequalification and accreditation mechanisms

WHO Prequalification process

The WHO Pre-Qualification is an advice from WHO based on a standardized quality assessment procedure on the acceptability, in principle, of public and private quality control laboratories (QCLs) that are found to meet WHO-recommended quality standards as set out in Good practices for pharmaceutical quality control laboratories (GPCL) (5).

The laboratory submits an expression of interest to the WHO, in accordance to WHO TRS 1003 (2017), providing the necessary documentation, in order to demonstrate its compliance with WHO Good Practices for Pharmaceutical Quality Control Laboratories, as well as with the relevant parts of WHO Good Manufacturing Practices. A preliminary assessment of the submitted documentation is performed, in order to determine the eligibility and readiness of the candidate laboratory for a WHO Prequalification Inspection. If the laboratory is eligible, which is the general case for NQCLs and is found to need to develop or further strengthen their current capacities, then technical assistance is provided before assessing readiness for inspection.

In the outcome of a successful inspection, the NQCL will be listed as a WHO Prequalified Pharmaceutical Quality Control Laboratory, enabling its acceptability to be used by United Nations Agencies, but also demonstrating the reliability of the work performed in that laboratory, promoting also reliance.


An accreditation is a formal process of assessment by an independent body, internationally recognized, which provides an assurance of the compliance with a specific standard, usually ISO 17025 for testing and calibration laboratories, by means of a certificate, stating the scope of the activities for which evidence of provision of accurate and reliable results was found.

For testing laboratories, such as NQCLs, accreditation to ISO/IEC 17025 plays an important role in supporting the provision of accurate and reliable results from laboratory testing, calibration, sampling and measurement. It also helps facilitate cooperation between laboratories and other bodies by generating wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another, promoting reliance.

The technical competence of a laboratory depends on a number of factors including:

  • The qualifications, training and experience of the staff
  • The right equipment – calibrated and maintained
  • Adequate quality assurance procedures
  • Proper measurement of uncertainty
  • Adequate validity and reliability of results
  • Adequate handling and management of the samples
  • Following good sampling practices or its enforcement (as applicable)
  • Appropriate, Validated and Reliable Test Methods
  • Traceability of measurements to established and approved standards
  • Accurate recording and reporting procedures
  • Suitable and adequate testing facilities

Capacity building for human resources

Several tools targeting development of human resources from NCLs were identified:

  • Visits (e.g. 2-3 days) to observe how another NCL is organized and functions
  • Placement, i.e. a staff from one country would temporarily work in another country NCL to gain experience
  • Participation in the benchmarking of another country as observer to learn about other systems and benchmarking procedures

These tools allow to understand other NCL’s QMS, contribute to building trust towards increasing communication, information sharing between NCLs and to strengthen collaboration.

In addition, several needs for trainings were identified, including Quality Management System, Good documentation practices, Verification and Validation of test methods, Quality control tools, Equipment qualification, Basic and advance training for developing laboratories.

External quality control tools

These tools are used to identify areas where training may be required by NCLs in the region and identify gaps. Regional agreements need to drafted to define the terms or reference including areas for training. This should be developed in reference to ISO 17025 and WHO GBT.  Proficiency testing and Inter-Laboratory Comparisons are important part of this exercise.

Interlaboratory comparisons

The process of carrying out interlaboratory comparison should be discussed further and developed.  Its analysis and application should be explored further for the purpose of improving the QMS.

Proficiency Testing

Several proficiency tests are available, namely from EDQM, WHO EQAAS and WHO-SEARO, but also from commercial providers. A regional participation plan could be established, in order to improve access to PT Schemes for NQCLs and attract funding.

The Global Benchmarking Tool

WHO benchmarking or assessment is a formal process of evaluation of a process or system, preferably quantitative, but sometimes necessarily qualitative (1).

The Global Benchmarking Tool (GBT) represents the primary means by which the World Health Organization (WHO) objectively evaluates regulatory systems, as mandated by WHA Resolution 67.20 on Regulatory System Strengthening for medical products. The tool and benchmarking methodology enables WHO and Regulatory Authorities to:

  • identify strengths and areas for improvement.
  • facilitate the formulation of an institutional development plan (IDP) to build upon strengths and address the identified gaps;
  • prioritize IDP interventions; and
  • monitor progress and achievements.

Benchmarking is the continuous process of measuring and comparing one’s own operations with those of a valid, reference peer group. The general idea in this approach is to establish a reference level, upon which improvement may be strived for and quantified.  National regulatory authorities are entrusted for the availability of quality medical products in the country.  Benchmarking Tool assists the Pharmaceutical Laboratories to access their own strengths and their areas of weakness.

Memorandum of understanding and outsourcing

A memorandum of understanding (MOU) is an agreement between two laboratories or parties which outlines the responsibilities of each party in the agreement. It can limit itself to establishing the ground rules for some partnership activities or have a more legally binding and contractual nature, which depends on its content and the signatories' position. It is also one of the means through which an NCL may outsource some activities to another foreign NCL or other designated laboratories.

NCL capacities often do not allow them to conduct all types of tests or test all types of products, and pursuing exhaustive capacity may not be an optimal use of limited financial, material and human resources.

The MoU should define the roles and responsibilities of each of the NCL or involved parties. Further guidance can be found in the WHO good practices for pharmaceutical quality control laboratories (section 9 Contracts) and in the description of the Global Benchmarking Tool’s sub-indicators RS05.09, RS10.01, and LT10.01.

Beyond outsourcing of testing, MoUs can also be a means to provide a framework and encourage larger collaboration, such as training, visits, placements, and information sharing.

Survey on the Capacities of NCL in the region to support each other

In order to map the existing capacities of NCLs in the region in implementing the tools identified to improve QMS and to support each other, a survey was circulated.

Overall, the survey identified that several countries in the region have documented certification or technical capacity:

Technical capacity Country
ISO 9001:2015 Indonesia, Thailand
ISO/IEC 17025: 2017 for laboratory testing Bangladesh, Indonesia, Myanmar, Thailand
ISO/IEC 17025: 2017 for laboratory instrument calibration Indonesia
ISO 17034:2016 for Reference Standard Indonesia, Thailand
WHO Prequalification Bangladesh, Indonesia, Thailand
GBT ML3 or ML4 for LT Indonesia, Thailand
GBT ML3 or ML4 for LR Indonesia, Thailand


Capacity to conduct proficiency testing Country
Certified ISO 17043:2010 for Proficiency Testing Provider Myanmar, Thailand
Ongoing ISO 17043:2010 Indonesia
Planned ISO 17043:2010 (with dates) Bangladesh, Thailand
No ISO 17043:2010 certification nor plan Bhutan, Maldives, Nepal, Sri Lanka, Timor-Leste


Further, the responding NCLs generally indicated that they had some capacity to accommodate for:

  • Visits from other NCLs (e.g. 2-3 days)
  • Placements (i.e. a staff from one country would temporarily work in another country NCL to gain experience)
  • Trainings
  • Inter-laboratory testing
  • Memorandum of Understanding

There were also willingness from the NCLs to support each other. However, to achieve this the following challenges would need to be overcome:

  • Financial resources
  • Lack of programme/ framework and uncertainty on higher management support
  • Technical capacity

Next steps

  • Develop and pilot a regional collaborative capacity development programme between NCLs, including capacity building for the supporting NCL and identification of funding mechanisms
  • Develop and pilot a worksharing mechanism on establishing a list of reliable laboratories


  1. WHO. WHO Global Benchmarking Tool (GBT) for evaluation of national regulatory systems of medical products, revision VI [Internet]. 2021. Available from:
  2. International Organization for Standardization. Certification [Internet]. ISO. n.d. [cited 2023 Mar 15]. Available from:
  3. WHO. External quality assurance assessment scheme [Internet]. n.d. [cited 2023 Mar 15]. Available from:
  4. World Health Organization. WHO manual for organizing a national external quality assessment programme for health laboratories and other testing sites [Internet]. Geneva: World Health Organization; 2016 [cited 2023 Mar 15]. 64 p. Available from:
  5. WHO. Prequalification of quality control laboratories: procedure for assessing the acceptability, in principle, of quality control laboratories for use by United Nations agencies - In: WHO Expert Committee on Specifications for Pharmaceutical Preparations - Fifty-first report [Internet]. WHO technical report series ; no. 1003; 2017. Available from: