ISO 9001 for Laboratories
Issued by
MAS Management Systems
Earners of this badge understand the ISO 9001 Standard, why it should be used and how to apply the requirements to their laboratory. They’ve discussed each of the clauses of the Standard and their implementation and examined focus clauses in detail to ensure understanding and compliance. They’ve taken part in discussions on risk-based thinking and how it affects implementation of the Standard. They have gained the confidence to defend their implementation of the Standard during an assessment
- Type Learning
- Level Advanced
- Time Hours
- Cost Paid
Skills
Earning Criteria
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Actively participate in an interactive training course covering the elements of the ISO 9001 Standard, it’s purpose and implementation. Apply ISO 9001 to the organisation. Develop systems to respond to ISO 9001 requirements. Articulate understanding of major areas covered by ISO 9001 and how these are applied in a laboratory setting.
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Interact with other laboratory professionals during the training course, sharing knowledge and experience. Gain insights into how other industry professionals solve their compliance issues.
Standards
ISO 9001 sets out the criteria for a quality management system. It is based on a number of quality management principles including strong customer focus, motivation of top management, the process approach and continual improvement.
This Standard specifies the general requirements for the competence, impartiality and consistent operation of laboratories. It is applicable to all organisations performing lab activities, regardless of the number of personnel. Customers, regulatory authorities, accreditation bodies and others use it to confirm or recognise the competence of labs.
This Standard can be used by medical laboratories in developing their quality management systems and assessing their own competence. It can also be used for confirming or recognising the competence of medical laboratories by laboratory customers, regulating authorities and accreditation bodies.
ISO/IEC 17020:2012 specifies requirements for the competence of bodies performing inspection and for the impartiality and consistency of their inspection activities. It applies to inspection bodies of type A, B or C, as defined in ISO/IEC 17020:2012, and it applies to any stage of inspection.