ISO 17025



What is ISO/IEC 17025 Calibration and Test Laboratory Management

ISO/IEC 17025 is a standard which sets out quality management principles relating to laboratories performing calibration and test work. It provides a set of criteria which a laboratory may use as a framework for establishing an effective management system focusing on providing customers with assurance regarding the quality of data provided.

This standard overlaps to some extent with more generic standards such as ISO 9001 but contains much more in the way of technical requirements relating to laboratory operation such as method validation, uncertainty determination, quality controls and reporting of results.

Laboratories may wish to use the requirements of ISO/IEC 17025 to establish their own systems or may seek formal recognition from an independent accreditation agency such as the United Kingdom Accreditation Service (UKAS) who perform accreditation audits directly on laboratories. Such audits contain a substantial amount of technical assessment of methods and associated controls including witness audits of technical activities by specialists which enhances confidence in the assessment and accreditation process.


All courses can be run on an ‘in-house’ basis and modified to suit as required.

Introduction to ISO/IEC 17025: 2017 Course

Overview

ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories’ specifies general requirements which are used as the basis for independent accreditation.  The standard provides criteria for establishing an effective Laboratory quality management system which provides confidence in results and a structured basis for ongoing performance improvement.

This 1-day course comprises a series of interactive tutorials and workshops which describes the context and content of ISO/IEC 17025 to provide an understanding of the requirements and how they may be applied.

Key Topics

  • Quality Management and improvement overview
  • Relationship between ISO 9001 & ISO/IEC 17025
  • Risks and opportunities
  • The difference between accreditation and certification
  • The requirements of ISO/IEC 17025:2017 (highlighting the changes from the 2005 version of the standard)
  • Decision rules
  • Structure of Laboratory Management System Documentation
  • Implementation steps
  • Obtaining Accreditation

Structure

This 1-day course comprises a series of interactive tutorials, examples and team-based exercises.  Each attendee will receive a set of course notes and, on successful completion, a certificate.


Introduction to ISO/IEC 17025: 2017 and the FSR Codes of Practice and Conduct Course

Overview

This course covers the requirements of ISO/IEC 17025 in the context of the Forensic Science Regulator Codes of Practice and Conduct along with ILAC G19 and UKAS documents relating to Forensic Laboratories.

Key Topics

  • Quality Management and improvement overview
  • Relationship between ISO 9001 & ISO/IEC 17025 as well as ISO/IEC 17020
  • Overview of the FSR Codes of Practice and Conduct as well as ILAC G19
  • Risks and opportunities
  • The difference between accreditation and certification
  • The requirements of ISO/IEC 17025: 2017 (highlighting the changes from the 2005 version of the standard)
  • Structure of Laboratory Management System Documentation
  • Implementation steps
  • Obtaining Accreditation

Structure

This 1-day course comprises a series of interactive tutorials, examples and team-based exercises.  Each attendee will receive a set of course notes and, on successful completion, a certificate.


Internal Auditing to ISO/IEC 17025: 2017 Course

Overview

ISO/IEC 17025 ‘General requirements for the competence of testing and calibration laboratories’ specifies general requirements which are used as the basis for independent accreditation.  The standard provides criteria for establishing an effective Laboratory Quality Management System which provides confidence in results and a structured basis for ongoing performance improvement.

This course gives guidance on establishing a successful internal audit programme and shows how to carry out each stage of an audit effectively within a laboratory in an ISO/IEC 17025 context.

It comprises a series of interactive tutorials and workshops which provide a brief overview of the content of ISO/IEC 17025 and an in-depth insight into conducting an effective laboratory management systems internal audit.

Key Topics

  • Quality Management and the need for audit
  • Overview of ISO/IEC 17025
  • Establishing an audit programme
  • Selecting and training internal auditors
  • Planning an audit
  • Preparing checklists
  • Performing an audit
  • Conducting the audit
  • Auditing ‘Risk’
  • Reporting audit findings
  • Reviewing and verifying corrective action
  • Dealing with difficult audit situations
  • Auditing for improvement

Structure

This 2-day course comprises a series of interactive tutorials, examples and team-based exercises.  Each attendee will receive a set of course notes and, on successful completion, a certificate.


Transitioning to ISO/IEC 17025: 2017 Course

Overview

This course specifically covers the changes made from the 2005 edition of ISO/IEC 17025 to the 2017 version. This ISO/IEC 17025 transition training course will provide attendees with the details of the changes to the standard and suggestions for consideration in meeting the new requirements.

Key Topics

  • Brief background to the changes to the Standard
  • Relationship with other standards (such as ISO 9001 and ISO/IEC 17020)
  • Revised structure and format of the Standard
  • Changes and additional requirements from the current 2005 version
  • Impartiality Risk Assessment and ‘Risks and Opportunities)
  • Decision rules
  • Discussion session on the implication of the key changes to laboratory management systems

Structure

This 5-hour course comprises a series of interactive tutorials, examples and team-based exercises.  Each attendee will receive a set of course notes and, on successful completion, a certificate.


Introduction to Measurement Uncertainty Course

Overview

Numerical measurement results have little meaning unless the uncertainty of the test or calibration process is known. Many standards, such as ISO/IEC 17025, require that the uncertainty of measurement be taken into account when performing measurement activities and apply decision rules utilising uncertainty where statements of compliance are made. This workshop will acquaint delegates with the requirements of ISO/IEC 17025 and particularly the salient principles contained in ISO Guide 98-3 Guide to the expression of Uncertainty in Measurement and UKAS guidance document M3003. Methodologies to calculate uncertainty budgets are defined as well as the basic statistics required. The course provides practical exercises and all of the activities are supported with examples of typical uncertainty budgets.

Key Topics

  • The importance of uncertainty of measurement
  • Basic concepts: traceability, uncertainty and terminology
  • Impact of uncertainty on results and compliance with specifications
  • Errors, effects and corrections
  • Type A uncertainties and statistical tools
  • Type B uncertainties, identification and use
  • Combined uncertainties
  • Expanded uncertainties and confidence intervals
  • Reporting of uncertainties and decision rules
  • Sources of uncertainty in different calibration fields
  • Worked examples
  • Attribute Studies
  • Sources of further information

Structure

This 1-day course comprises a series of interactive tutorials, examples and team-based exercises.  Each attendee will receive a set of course notes and, on successful completion, a certificate.