Audit team composition
The audit team shall include a lead auditor who shall be in overall charge of the audit team. Where the audit team is comprised of one individual then this person shall be the lead auditor. The lead auditor should have the capability and experience to manage an audit.
The audit team shall include one or more persons with experience of assessing the relevant medical device technology incorporated in the manufactured products and the associated manufacturing processes. Decisions with regard to the extent of inclusion of such expertise in the audit team should be made case by case (see also clause 10.2.1).
As permitted by the regulatory system the audit team may be accompanied by:
a) audit trainees or other personnel from the auditing organisation;
b) audit trainees or other personnel from the regulatory bodies involved;
c) observers acceptable to the manufacturer, auditing organisation and auditors.
These accompanying persons are not considered to be auditors but are bound by the same obligations of confidentiality.
As permitted by the regulatory system, when the auditing organisation chooses the audit team it may take into account the manufacturer’s opinion on the suitability of the auditor(s), in particular when a conflict of interest may exist
10.2 Audit team competence
10.2.1 Audit team competence criteria
The competence requirements for all auditors in the team should be based on the qualification criteria for quality system auditors (ISO 10011-2:1991, Qualification criteria for quality system auditors) as well as personal attributes (e.g. tact, diplomacy, effective communication skills).
The competence of the team as a whole should be appropriate to cover the scope of the audit. In particular:
a) The team should have competence (i.e. training and knowledge/experience) in the following:
i) assessment of the quality system for medical device manufacturers and determination of the effectiveness of its implementation;
ii) understanding the regulations and applicable standards specific to quality system requirements for medical device manufacturers;
iii) intended use of and risks associated with the devices being produced;
iv) the assessment of the design, manufacturing processes and the technologies involved.
b) The competence must be present within the audit team as a whole but not necessarily by each member of it. In assessing the quality systems of manufacturers the audit team may include additional experts in processes and technology relevant to the scope of the audit and ideally these experts should meet the requirements of clause 10.2.1 (a). The experts authorised by the auditing organisation and who are not qualified as auditors should only assess the processes related to their specialised knowledge and under the supervision of an auditor.
Alternatively, the members of the audit team may be given additional training and/or specialised knowledge related to those processes and technology (e.g. the achievement of a controlled environment and validation of the sterilisation process).
c) The lead auditor shall be competent to plan and direct the team members so that in carrying out their separate tasks, the appropriate competence is applied effectively and fairly.
10.2.2 Audit team competence records
The auditing organisation shall maintain records to demonstrate the competence of its auditors.
10.2.3 Auditor qualifications, training and experience
In addition to basic auditing skills (clause 10.2.1), the competencies specifically required for auditing medical device manufacturers may be achieved through a variety of means including a combination of qualification and one or more of the training or experience elements listed below.
Auditor qualification is most likely to be in one or more of the following:
i) biology or microbiology;
ii) chemistry or biochemistry;
iii) computer and software technology;
iv) electrical, mechanical or bioengineering;
v) human physiology;
viii) physics or biophysics.
Special programmes may be established for training technically qualified staff in the following:
i) understanding the regulatory requirements and related laws/ordinances/statutes etc.;
ii) auditing of medical device manufacturers’ quality systems;
iii) understanding the design and manufacturing processes and the technologies involved;
iv) safety aspects relating to the intended use of medical devices.
Auditor experience is most likely to be in the following:
i) working in closely related industries and the workplace such as research and development, manufacturing;
ii) working in the application of the device technology and its use in health care services and with patients;
iii) testing the devices concerned for compliance with the relevant national or international standards;
iv) conducting performance testing, evaluation studies or clinical trials of the devices.
These competencies are to be regarded as the tools to address the relevant safety and performance aspects of the quality system being audited arising from the way in which the devices:
• are made, and
• how they work, and
• how they are used.