ISO 17025 Certification 

ISO 17025

ISO/IEC 17025 is for any organization that performs testing, sampling, or calibration. This includes all types of laboratories, industries, and sizes. The most recent version of the standard is ISO 17025:2017.

Who Wrote the ISO 17025 Standard?

ISO/IEC 17025 was developed by laboratory experts from all over the globe, with 18 liaison organizations, including the International Laboratory Accreditation Cooperation (ILAC), and many associations representing laboratories.

What are the Benefits of the ISO/IEC 17025 Standard?

• • Consistently generate valid results
  • Increased confidence from customers and stakeholders
  • Increased acceptance of the results without further testing
  • Improved and increased business and international trade

What are the Requirements for ISO 17025:2017 Compliance?

ISO 17025:2017 now follows the structure of ISO 9001:2015 and includes:

1. Scope – Discusses the objective of the standard, who can use it, and the purpose of  ISO 17025
2. Normative References – Highlights brief details on how certain guides and standards are referenced in ISO 17025
3. Terms and Definitions – Defines the terminology used in the standard
4. General Requirements – Covers the two main requirements of the standard which are:

• • Impartiality (laboratories won’t let any commercial, financial, or other pressuring factors manipulate, compromise, or alter the quality of the testing results)
  • Confidentiality (laboratories are required to ensure that the results and other key information are kept private)

5. Structural Requirements – Outlines a laboratory’s basic organizational structure and components, its processes, and its adherence to an efficient management system
6. Resource Requirements – Contains the 6 clauses that specify the necessary components a laboratory must have:

• • General
  • Personnel
  • Facilities and environmental conditions
  • Equipment
  • Metrological traceability
  • Externally provided products and service

7. Process Requirements – Provides 11 key processes on how to improve and implement the efficiency of the standard’s requirements:

• • Review of requests, tenders, and contracts
  • Selection, verification, and validation of methods
  • Sampling
  • Handling of test or calibration items
  • Technical records
  • Evaluation of measurement uncertainty
  • Ensuring the validity of results
  • Reporting of results
  • Complaints
  • Nonconforming work
  • Control of data and information management

8. Management System Requirements – Emphasizes the two options available for organizations complying with the standard, the differences between the two, and the various activities involved in this section:

Option A – Applies to laboratories that have separate QMS from any other management system

Option B – Applies to laboratories that are part of larger organizations or if they have their own established management systems aligned with ISO 9001:2015

• • Management system documentation
  • Control of management system documents
  • Control of records
  • Actions to address risks and opportunities
  • Improvement
  • Corrective actions
  • Internal audits
  • Management reviews

The most recent version of the standard has a stronger focus on information technologies. In recognition of the fact that hard-copy manuals, records, and reports are slowly being phased out in favor of electronic versions, it incorporates the use of computer systems, electronic records, and the production of electronic results and reports. The CORE Compliance Platform can assist your organization in effectively maintaining compliance.