
In this first module, we discuss some basic principles of quality and quality management and the definition of the term quality and how this applies to a laboratory environment. A short exercise at the end of this module explores the needs and expectations of laboratory customers.
Developing the idea of customer focus established in the previous module, we go on to discuss 'core', 'support' and 'management' processes and how they inter-relate. The module culminates in an exercise allowing participants to explore the relationship between processes and develop a 'high-level' process description of a laboratory.
Having established a 'high-level' process description of the laboratory, we now go on to the concept of 'Quality Assurance' which underpins the basis of standards such as ISO/IEC 17025 and ISO 9001.
In this module we drill down from the 'high-level' processes discussed in the previous module and look at a specific process in terms of its suppliers, inputs, the process itself, outputs and deliverables and customers. This constitutes the 'process approach' on which many ISO management standards are based. We apply this concept to a laboratory test process and develop the concept of the 'Triple Role'.
We complete this overview of quality concepts by looking at situations where things go wrong, ie nonconformance handling and the immediate actions to be taken as well as the concept of corrective action, the assessment of risks and opportunities and concept of continual improvement.
In this module we will be discussing the role of the International Standardization Organization in the development of Standards and the activities that can be covered by ISO/IEC 17025.
In this module we will consider some other ISO and associated standards which are related, or linked to ISO/IEC 17025.
The ISO 9000 'Series' of quality management system standards.
This module discusses the ways in which an organisation can achieve independent recognition to quality management systems standards and the difference between ‘accreditation’ and ‘certification’ or ‘registration’.
A comprehensive training course on the requirements of ISO/IEC 17025: 2017 to provide participants with a detail understanding of the concepts and requirements of the standard together with an overview of the steps required to implement the standard with a view to becoming independently accredited. The course covers basic quality concepts such as customer focus, the process approach, continual improvement and risk management. The course addresses the relationship between ISO/IEC 17025 and ISO 9001; the difference between certification and accreditation, an overview of the content of ISO/IEC 17025 followed by an in depth examination of each clause of the standard. These include impartiality, confidentiality, organisation and responsibilities, personnel, facilities and environment, equipment, traceability, purchasing, subcontracting, contract review, methods, sampling, measurement uncertainty, quality control, reporting, complaints, nonconformance handling, IT systems, records, document control, risks and opportunities, corrective action, improvement, internal audit and management review.
The course also covers typical management system documentation structures and a roadmap of the steps required to implement the standard. The course also covers the role of accreditation bodies and the process of obtaining independent recognition as well as the subject of scopes of accreditation.
The course is supported with key pdf slides, a useful graphic representing the standard and features quizzes to allow participants to test their understanding of the content of the standard. Practical exercises are also included in the course for participants to apply specific concept to their own organisations. These are in the form of 'assignments' which can be completed by the participants, but please not that we do not provide direct feedback on these, however each assignment is discussed in the following modules and example answers provided.
We are unable to provide a copy of the ISO/IEC 17025 standard for copyright reasons, but it would be useful if participants could obtain their own copy for reference during the course.
For an introductory awareness course on for test laboratories please see our ISO/IEC 17025: 2017 Induction Training for Test laboratories course. There is no need to attend the induction training course before attending the 'Mastering ISO/IEC 17025' Training course.