“Guidelines for regulatory auditing of quality systems of medical device manufacturers - Scope

This document provides guidelines for auditing organisations responsible for establishing, planning, carrying out and documenting audits of quality systems to address regulatory requirements for manufacturers of medical devices. In addition, it describes the competence criteria that the audit team should meet.
The document also covers related requirements on the audit report and follow-up on corrective actions.
Non-regulatory quality management issues, as may be part of total quality management activities, are excluded.

Definitions
Reference should be made to the definitions given in:
- the relevant regulatory requirements,
- ISO 8402:1994 and ISO 10011-1:1990, together with those below.
All the definitions below are for the purpose of these guidelines.
Note 4. Some terms in ISO 8402:1994 are repeated here and the source is indicated in square brackets [ ].
4.1 Audit
A systematic and independent examination to determine whether quality activities and related results comply with planned arrangements and whether these arrangements are implemented effectively and are suitable to achieve objectives [ISO 8402].
For the purpose of these guidelines, "audit" means audit of the auditee’s (see 4.2) quality system to determine compliance with the relevant regulatory requirements.
Note 5. When addressing the regulatory requirements the term 'inspection' has been used to indicate the same meaning as the term 'audit'.
4.2 Auditee
Any organisation whose quality systems are to be audited for compliance with the relevant medical device regulatory requirements.
Note 6. This can be the manufacturer and/or their subcontractor(s).

4.3 Auditing organisation
A body designated, on the basis of specific regulations, to carry out audits according to assigned tasks.
Note 7. Relevant auditing organisations responsible for enforcement of the regulations listed in Annex B are given in Annex C.
4.4 Auditor
A person with relevant qualifications and competence to perform audits or specified parts of such audits and who belongs to, or is authorised by, the auditing organisation.
4.5 Lead auditor
An auditor designated to manage an audit (also known as an audit team leader).
4.6 Manufacturer
The legal entity subject by regulation to quality system requirements.
Note 8. In several international standards the term 'supplier' is substituted for the term 'manufacturer'.
Note 9. Definitions of 'manufacturer' applicable to the regulations listed in Annex B are given in Annex D.
Note 10: In some internationally recognised Standards and Guidelines on auditing, specific responsibilities are assigned to the client (i.e. a person or the organisation requesting or commissioning the audit). These responsibilities are assigned on the basis that the client, as the financial supporter and primary customer of the audit, has the ultimate authority regarding the audit.
The ultimate authority for the audit of medical device manufacturers is the auditing organisation and the term “client” is not used therefore in these guidelines. .
4.7 Nonconformity
The non fulfilment of specified requirements within the planned arrangements.
Other terms may be used to mean the same as nonconformity (e.g. 'non compliance', 'deficiency').
4.8 Objective evidence
Verifiable information or records pertaining to the quality of an item or service or to the existence and implementation of a quality system element, which is based on visual observation, measurement or test.
4.9 Quality audit observation
Statement of fact made during a quality audit and substantiated by objective evidence.

4.10 Quality system
The organisational structure, responsibilities, procedures, processes and resources for implementing quality management [ISO 8402].
For the purpose of these guidelines 'implementing quality management' is taken to include both the establishment and maintenance of the system.
4.11 Regulatory requirements
For the purpose of these Guidelines any part of a law, ordinance, decree or other regulation which applies to quality systems of medical device manufacturers.
Note 11. Guidelines, notes, draft documents, or the like should not be used as regulatory documents and are not to be construed as such unless formally promulgated.
4.12 Subcontractor
An entity, separate from the manufacturer, that provides to the manufacturer either a material, product or sub-assembly (or a component) to a proprietary specification which is incorporated into or used in the manufacture of the finished medical device or a service (e.g. testing, sterilisation) to enable the medical device to meet defined requirements. If the separate entity is owned by the manufacturer, it may or may not be considered a subcontractor, depending upon the control exercised by the manufacturer.