WHAT IS ISO/IEC 17025?
ISO/IEC 17025 is the global quality standard for testing and calibration laboratories. The current version was published in 2017. ISO/IEC 17025 certification guarantees the ability to consistently produce reliable and trustworthy results.
The management requirements relate to the operation and effectiveness of the quality management system within the laboratory and are broadly equivalent to the ISO 9001 standard.
The distinctive feature of ISO/IEC 17025 is its focus on the technical requirements. It encompasses the qualification of the equipment used and the validation of the methods performed in terms of their accuracy, robustness and reproducibility. A prerequisite for the professional execution of the tests is, of course, highly trained personnel.
In contrast to ISO 9001, ISO/IEC 17025 is only valid for designated activities for which the laboratory is accredited. A distinction is made between Type A (defined test procedures, e.g. according to standards), Type B (defined test procedures, e.g. according to standards, but which can be slightly modified) and Type C (defined measurement principles, own test procedures can be validated).
Main advantages of aN ISO/IEC 17025 accredited laboratory
Analytical testing laboratories that are ISO/IEC 17025 accredited are required to document in a traceable and reproducible manner.
Non-accredited laboratories often do not fully document test results. ISO/IEC 17025 accreditation requires formal documentation of virtually all aspects. The process ranges from sample collection and sample handling to data security and integrity.
Implementing ISO/IEC 17025 as a quality initiative continuously improves data quality and laboratory effectiveness.
ISO/IEC 17025 creates confidence in test results and test reports. It is about being as close to reality as possible and not about generating as many decimal places as possible.
Flexibility of the scope
Suisse Technology Partners AG is accredited with ISO / IEC 17025, Type C in many areas This allows the highest level of flexibility.
Type C accredited laboratories have the verified competence to introduce and develop new test methods, including the assessment of the corresponding risks and the validation of the methods. Such an assessment presupposes that the characteristic quality features of a test method are known. The accredited testing laboratory is also expected to understand the customer’s problem and to be competent to handle the test order with a suitable test method.
TYPE A
Accreditation based on defined test procedures The definition of the scope of type A is based on clearly defined standardized or self-developed test procedures. Modifications of accredited procedures as well as new procedures must be assessed by the SAS. before inclusion in the scope of accreditation.
TYPE B
Accreditation based on defined test procedures, which can be modified As with type A, the definition of the scope of type B is based on clearly defined standardized and self-developed procedures. The correct implementation is comprehensively checked during the assessment. These procedures can be adapted at short notice, without consultation with the SAS. Adaptations are slight modifications. Under no circumstances may they lead to new measuring principles or fundamental changes of the test procedures. The existing and verified competence to assess the risks associated with the modifications made, is a prerequisite. New test procedures must be applied for at the SAS.
TYPE C
Accreditation based on defined test types and measurement principles The definition of the scope of type C is based on the test types and measurement principles for which the competence to introduce or develop new test methods. This includes the assessment of the corresponding risks. The validation of the methods are available and have been verified. Such an assessment presupposes that the characteristic quality features of a test method are known. The accredited testing laboratory is expected to understand the customer's problem and to be competent to handle the test order with a suitable test method.
Certificate and SCOPE OF APPLICATION
All details about the accreditation and its respective scope can be found in the links below.
