Stages of the laboratory accreditation process

The process for laboratory accreditation has four main stages:

• initial enquiry
• information dossier evaluation
• audit
• decision. 

Assessment of laboratories is guided by a set of clear principles:

Internationally-recognised standards: All laboratories must demonstrate a robust quality management system and compliance with ISO/IEC 17025 General requirements for the competence of testing and calibration laboratories.

Roles and responsibilities: Roles and responsibilities of all personnel involved in carrying out the audit and assessment are clearly defined so that expectations can be met and the accountability of each is understood.

Competence of the inspection team: Inspectors are selected based on auditing skills, education and experience in the regulatory environments that are appropriate for the inspections and audit tasks assigned to them.

Consistency: Assessment and audit procedures are performed according to defined guidelines, so that WHO can ensure consistency during the inspection. Guidelines are codified in the publicly available WHO standard operating procedures: SOP 007 How to assess a laboratory for IMD-PQS accreditation and SOP 008 How to re-evaluate a WHO IMD-PQS-accredited test laboratory.

Confidentiality and standard of conduct: authors maintain confidentiality with regard to information and documentation related to inspections and must comply with WHO standards of conduct.

Stages of laboratory accreditation

Stage 1: Initial enquiry

A laboratory may submit an unsolicited application for accreditation, or WHO may invite a laboratory to apply for accreditation. The laboratory must communicate which types of testing and/or categories of products it wishes to be accredited for and whether it can demonstrate its competency by conforming to accepted standards, as witnessed by a competent third-party accreditation body. These include quality standards such as ISO 9001 Quality management systems — Requirements and IEC 17025 General requirements for the competence of testing and calibration laboratories.

Stage 2: Information dossier evaluation

Following the initial enquiry, IMD-PQS or an appointed representative will request the laboratory to forward a detailed information dossier for evaluation. The dossier will contain further information about the type(s) of testing the laboratory wishes to carry out, copies of relevant certifications and registrations, and details of facilities, competencies, staff and referees.

Stage 3: Audit

In most cases, a laboratory will need to undergo a full audit before accreditation status can be granted. The audit should take one to two days and will cover all aspects of the laboratory's operation, including quality, testing and personnel. A mock-up of every relevant test must also be observed by the auditor(s).

Towards the end of the audit, the auditor will generally provide a draft evaluation to the laboratory (for example, in the form of a short, written summary) and the full report to IMD-PQS. Audits may reveal non-compliances but if these can be addressed within a set time frame, the outcome of the audit may nevertheless be positive.

A full audit may be waived for laboratories that are accredited by signatory bodies to the International Laboratory Accreditation Cooperation (ILAC) in particular in case of an urgent need to test some specific products and if the laboratories concerned can satisfy the information dossier requirements. Laboratories that are accredited by ILAC signatories should receive a surveillance visit by that signatory every 12 to 18 months and a full audit every four to five years.

Stage 4: Decision and accreditation

The final decision to accredit a laboratory is taken by the IMD-PQS Secretariat on the basis of the information dossier evaluation and the audit report (where relevant). Relevant details of the accepted laboratory are published on this website as a laboratory information sheet.