ISO / IEC 17025:2017 General Requirements for the Competence of Testing and Calibration Laboratories

ISO/IEC 17025 is useful for any organization that performs testing, sampling or calibration and wants reliable results. This includes all types of laboratories, whether they are owned and operated by government, industry or, in fact, any other organization. The standard is also useful to universities, research centres, governments, regulators, inspection bodies, product certification organizations and other conformity assessment bodies with the need to do testing, sampling or calibration.

ISO/IEC 17025 enables laboratories to demonstrate that they operate competently and generate valid results, thereby promoting confidence in their work both nationally and around the world. In addition, it helps to facilitate cooperation between laboratories and other bodies by generating a wider acceptance of results between countries. Test reports and certificates can be accepted from one country to another without the need for further testing, which, in turn, improves international trade.

What are the main changes in the 2017 version?

• The ISO/IEC 17025:2017 version covers technical changes, vocabulary and developments in IT techniques. It also takes into consideration the latest version of ISO 9001.
• The process approach now matches that of newer standards such as ISO 9001 (quality management), ISO 15189 (quality of medical laboratories) and ISO/IEC 17021-1 (requirements for audit and certification bodies).
• The scope has been revised to cover testing, calibration and sampling associated with subsequent calibration and testing.
• The standard has now had a stronger focus on information technologies and incorporates the use of computer systems, electronic records and the production of electronic results and reports.
• It introduces the concept of risk-based thinking.

Prinsip Mahir can help your organization:

• To provide full consultation services that cover all the modules required for successful ISO / IEC 17025 accreditation.
• To carry out gap analysis in identifying your current level of compliance with various management and technical requirements of ISO/IEC 17025: 2017 standard.
• To provide guidance in developing documentation for both management and technical requirements including a quality manual, standard operating procedures, forms etc.
• To provide in-house training for awareness and internal audit. We will monitor on the system implementation to identify any defect for improvement purpose.
• To carry out an internal audit to evaluate the level of conformance and improvement opportunities in the established and implemented ISO / IEC 17025 standard. We will ensure on your readiness before the 3rd party audit by Department of Standard Malaysia.
• To ensure any non-compliance / observations raised out during the external party audit are properly addressed and closed.
• To provide system maintenance program upon completion of the accreditation in identifying improvement opportunities in the management system and ensure continued compliance to the ISO / IEC 17025 system so that the subsequent surveillance and reassessment can be carried out smoothly.