ISO/IEC 17025: 2017

General requirements for the competence of

testing and calibration laboratories

Presenter: Tim Alcock

www.Qualimetric.co.uk
• Quality, Quality Management and Assurance
• The ‘process’ approach
• Quality improvement
• Background to Quality Management Standards
• Relationship between ISO/IEC 17025 and other standards
• ‘Accreditation’ vs ‘Certification’
• Structure of ISO/IEC 17025: 2017
• Detail requirements of ISO/IEC 17025
• Documentation of the quality management system
• Implementation of the standard
• Applying for and maintaining accreditation
 ISO 9001 – Quality Management Systems - Requirements
Specifies quality management system when an organization:
a) needs to demonstrate its ability to consistently provide products and services that meet
customer and applicable statutory and regulatory requirements, and
b) aims to enhance customer satisfaction through the effective application of the system,
including processes for improvement of the system and the assurance of conformity to
customer and applicable statutory and regulatory requirements.
All the requirements of this International Standard are generic and are intended to be applicable
to any organization, regardless of its type or size, or the products and services it provides.

ISO/IEC 17025 – General requirements for the

competence of testing and calibration laboratories
Specifies general requirements for the competency, impartiality and consistent operation of
laboratories. Applies to laboratories who perform sampling, testing and calibration laboratories

ISO 15189 – Medical Laboratories – Requirements for

Image by peggy_marco Pixabay quality and competence
Specifies requirements for quality and competence in medical laboratories

Quality ISO 22870 – Point-of-care testing (POCT) – Requirements

for quality and competence

Standards Specifies additional requirements applicable to Point-of-care testing – used in conjunction

with ISO 15189