Knowledge in the field of laboratory accreditation according to DIN EN ISO 17025

Both standards are central pillars of quality management, but pursue different goals and areas of application. 

DIN EN ISO 9001 specifies the requirements for a quality management system for organizations in all industries. The aim is to ensure the ability to provide products and services in accordance with customer-specific requirements. 

The result is the certification of the management system. 

DIN EN ISO 17025 is specifically aimed at testing and calibration laboratories. It defines requirements for technical competence and the quality of test and calibration results. The goal is the accreditation of the laboratory. 

By complying with ISO 17025, laboratories can demonstrate their ability to produce valid results, which creates trust at national and international level. Accreditation ensures that the laboratory has a management system in place that is focused on the quality of the measurement process and is audited by national accreditation bodies.

The time required for successful accreditation depends on the maturity of the existing management system and the complexity of the laboratory. Depending on the initial situation and the availability of internal resources, a minimum of one year of preparation time can be expected before the application is submitted. After the application has been submitted, it is processed by the German Accreditation Body (DAkkS). 

For accreditation, a management system must be created that builds trust in the laboratory and its calibration or testing activities. Various procedures (SOPs) are created for this purpose. Among other things, the following topics are considered: 

Resource requirements 

• Ensuring the validity of results: Participation in proficiency tests to demonstrate   competence
• Personnel and facilities
• Ensuring the qualification of employees
• Ensuring the traceability of measuring equipment (calibration certificates) 

Process requirements 

• Review of commercial processes (quotes, contracts)
• Determination of measurement uncertainties (MU)
• Development of testing and calibration instructions 

Requirements for the management system 

• Control of management system documents
• Control of records
• Management review

The costs depend greatly on the maturity of the existing management system and the commitment of the employees involved. 

Testo Industrial Services can provide support at various stages. Ideally, we accompany the accreditation process from the outset with the following project schedule: 

• Gap analysis:  
  Assessment of the current situation and derivation of recommendations for action
• Project planning based on the gap analysis:
  Creation of an individual project plan to prepare for accreditation.
• Implementation of requirements:
  Development and implementation of a QM system, creation of the necessary documents, process descriptions, and work instructions.
• Education and training:  
  Conducting training courses on the contents of ISO/IEC 17025 and the calculation of measurement uncertainty budgets according to GUM. User training for the newly developed management system.
• Internal audits:  
  Review of the effectiveness and conformity of the implemented processes.

You can find out more about our consulting services for ISO 17025 accreditation preparation here:

Preparation for accreditation according to ISO/IEC 17025

• Application to DAkkS (German Accreditation Body)
• Document review
• DAkkS audit by auditors
• Implementation of any corrective measures
• Granting of accreditation and regular surveillance audits