We are working with a water laboratory on implementing a ISO 17025 Laboratory Management System. During our pre-assessment, *** highlighted that we needed to appoint a Technical Manager and highlighted that he needed to have specific qualification (including CPD, chartership etc.)
So I am looking for the definition of technical manager under ISO 17025 or any other relevant Laboratory guidance/regulation, his role and responsibilities and competency required.
Could you kindly advise?
If the accreditation body have indicated a need for an specific appointment, this may be a requirement of a particular program, perhaos due to legislature. They need to clarify and reference the basis of this requirement for you. Certain sectors have professional registration or certified person requirements. An example is registration as a veterinary technician, or certified metrologist through professional bodies. ISO 17025:2017 as a standard, however, does not have a mandatory requirement for an appointed position of Quality Manger or Technical Manager.
What is does require is the identification of management for overall responsibility of the laboratory, i.e. the functional tole of laboratory manager. This person could however be appointed and have the title of director, operations manager or technical manager. Furthermore personnel must be assigned and have the authority and resources for the implementation, maintenance and improvement of the management system. This is typically a quality role, which could be held by a quality manager or responsibilities shared amongst personnel. Either way the responsibility, authority and inter-relationships of all personnel including management; must be defined to ensure technical competency for the tests a laboratory performs. In a larger laboratory this may necessitate the appointment of a technical manager; however the structure may accommodate a number of lead scientists or technicians as responsible for different activities (such as method development). These authorised personnel would report directly to the laboratory manager. Each laboratory should identify personnel and management needs based on risk; and ensure that there are procedures and records for determining competence requirements; as well as selecting, training supervising, authorising and monitoring all personnel. On a technical note
Our company are currently applying for ISO 17025: 2017 we are a SME so not a large headcount, i am a manager with responsibility for mulitple areas including quality and i report directly to the MD. We are looking to employ somone to take on the "technical" role however they will not be a manager, my question is can the "technical" person report to myself? so ultimatley i would have responsibility for the quality and technical aspects
can the "technical" person report to myself? so ultimatley i would have responsibility for the quality and technical aspects
Yes, that is in order. As long roles, responsibilities and authorities are clear. Impartiality must be safeguarded to support policy and objectives. Competence of personnel and activities must be assured to produce valid, consistent results. This is achieved through knowing ISO 17025, customer, regulatory and accreditation requirements, knowing process risks and controlling them through standard operating procedures.
For more information on ISO 17025 requirements have a look at