ISO/IEC 17025 was updated in 2017 and introduces risk-based thinking, a new definition of ’laboratory’ and greater flexibility in certain requirements. It still specifies the general requirements for the competence to carry out tests and/or calibrations including sampling (which is now fully within the scope of the system) and addresses the proficiency of the organization to perform testing and calibration using standard methods, non-standard methods, and laboratory-developed methods. It is applicable to all organizations performing tests and/or calibrations including first-, second- and third-party laboratories, and laboratories where testing and/or calibration forms part of inspection and product certification. The course focuses on imparting delegates with an understanding of all elements of a Laboratory Quality Management System in order to achieve or maintain Laboratory Accreditation.
On completing this course the participant will be able to:
- Understand the purpose, intent and underlying structure of ISO 17025:2017 and all elements of a Laboratory Quality Management System (LMS),
- Know how to transition from 17025:2005 to ISO 17025:2017,
- Develop an implementation plan to meet the requirements of ISO/IEC 17025:2017,
- Draft relevant LMS documentation,
- Identify relevant performance monitoring approaches,
- Understand importance of internal auditing, corrective and preventive actions.
- Quality management, the PDCA cycle, principles and application of quality control,
- Advantages of laboratory accreditation,
- Advantages of laboratory accreditation,
- Addressing confidentiality and impartiality,
- Requirements of ISO 17025:2017 General Requirements for the competence of testing and calibration laboratories and how to transition from ISO 17025:2005,
- How to implement a Laboratory Management System (LMS) and 17025:2017 requirements,
- QMS scope and policy and development of LMS Quality Plan(s),
- Risk-based thinking and identification of risks and opportunities,
- How to write a Laboratory Quality Manual and Procedures,
- How to set up a calibration system,
- Selection, verification and validation of test methods,
- Control of documented QMS information,
- Setting up a Laboratory Quality Control Programme,
- Performance-based monitoring for continual improvement of quality control processes,
- Internal audits and management reviews,
- Role of third party auditors/certification bodies and preparation for certification.
Practical examples, discussions and interactive, problem-based individual and group training exercises are used throughout the course to reinforce delegates’ learning.
Laboratory Managers, Supervisors, Analysts, and Technicians, Document Controllers and Internal Auditors who wish to increase their understanding of laboratory accreditation or implement a laboratory quality system in their laboratory.