Introduction to ISO 17043 Accreditation requirements

To consider conformity assessment, the ISO Committee on conformity assessment (CASCO) is responsible for the development of International Standards and Guides. ISO 17043 standard was developed by ISO committee on conformity assessment.

The ISO/IEC 17043:2010 accreditation specifies requirements of conformity assessment for proficiency testing. ISO 17043 Accreditation for proficiency test providers makes sure those customers of compliance with international standards and good practices. With ISO 17043 Accreditation, proficiency test providers gain increased confidence that the programs that depends on are being operated competently in accordance with the specified technical and management system requirements.

Proficiency testing is the one of mechanisms through which the performance of an organization can be checked to confirm its ability to stick to the organization’s procedures. Proficiency testing (PT) is a current requirement of accreditation programs offered by International Laboratory Accreditation Cooperation Mutual Recognition Arrangement signatory accreditation bodies and is a common requirement of regulatory and oversight programs. Proficiency testing is a quality control tool that can be utilized prior to achieving accreditation.

ISO 17043:2010 Accreditation demands technical competence assurance and good quality management practices, but also includes verification of the proficiency test management of the provider. ISO/IEC 17043:2010 recognizes proficiency testing as a participant performance as well as evaluation against pre-established criteria which is meaning of interlaboratory comparisons for the determination of laboratory performance.

Following are ISO/IEC 17043, Conformity assessment — General requirements for proficiency testing,

• Personnel
• Design of proficiency testing schemes
• Preparation of proficiency testing items
• Assigned values 
• Data analysis and proficiency testing evaluation scheme results
• Data analysis and their records
• Reports 

ISO/IEC 17043 states purpose of Proficiency testing,

1. Performance of laboratories evaluation for specific tests or measurements and monitoring laboratories' continuing performance;
2. Problems in laboratories of identification and initiation of actions for improvement, 
3. Establishment of the effectiveness of test and compare to them ;  
4. Inter-laboratory differences identification;  
5. Education of participating laboratories based on the outcomes of such comparisons;
6. Validation of uncertainty claims .

Proficiency testing programs exist in different formats. As well as in the most comprehensive form, proficiency testing involves three distinct entities: the participant of proficiency provider, the proficiency test provider, and the bodies that accredit the proficiency test providers. Anyways, the roles of each entity may overlap.

The accreditation programs require that the proficiency test user’s results are reported within the participant’s quality assurance system.

Different forms of Proficiency tests:

• Accrediting bodies may facilitate a proficiency test. 
• Users may create and administrate a proficiency test to internal and external users 
• Users may evaluate proficiency through alternatives such as observation or case presentation
• Proficiency tests may be purchased and results reported externally. 
• Proficiency tests may be created or purchased externally. 
• Proficiency tests results may be reported internally.