Roles and responsibilities - System Audit for Medical device manufacturers

Auditing organisation
The auditing organisation has the regulatory authority or is designated by the regulatory authority to perform audits, the results of which are evidence of compliance or non-compliance with the regulatory requirements for quality systems. Associated with this authority are the responsibilities for management and performance of all audit activities .
The responsibilities of the auditing organisation for audit management include:
a) complying with relevant regulatory requirements for audit management;
b) complying with these Guidelines;
c) training, selecting and supervising auditors;
d) establishing methods to ensure consistency in the interpretation of the regulatory requirements;
e) maintaining the means of providing prompt guidance which may be required by the audit team during the audit;
f) safeguarding the confidentiality of all documents and information obtained in association with the audit;
g) establishing and complying with a code of ethics;
h) informing the appropriate authority on decisions taken when required by the regulatory requirements.
Audits do not result in a transfer of the responsibility to achieve quality objectives from the manufacturer to the auditing organisation.
In conjunction with the lead auditor, the responsibilities of the auditing organisation for audit performance include:
i. complying with relevant regulatory requirements for auditing;
ii. agreeing on the scope of the audit, including the standards or other documents to be used, with the manufacturer as necessary to comply with and as permitted by the regulatory requirements;
iii. planning, organising, evaluating and reporting on the audit;
iv. selecting the auditors;
v. agreeing to the language of the audit;
vi. decision making with regard to applicable regulatory requirements resulting from nonconformities discovered during the audit and subsequent verification of corrective actions

Auditors
The responsibilities of auditors include:
a) complying with the applicable regulatory requirements for auditing;
b) helping the manufacturer understand the regulatory requirements;
c) planning and carrying out assigned responsibilities objectively, effectively and efficiently within the audit scope and in accordance with a code of ethics for auditors established and documented by the auditing organisation;
d) co-operating with and supporting the lead auditor;
e) collecting, analysing and, where appropriate, documenting objective evidence that is relevant and sufficient to permit the establishment of conclusions regarding compliance of the quality system with regulatory requirements and the effectiveness of its implementation in meeting quality objectives;
f) establishing the extent to which the procedures, documents and other information describing or supporting the required elements of the quality system are known, available, understood and used by the auditee’s personnel;
g) remaining alert to any indications or evidence that can influence the audit results and possibly require more extensive auditing;
h) informing the lead auditor of quality audit observations in a timely manner;
i) assisting the lead auditor in preparing the report of the audit;
j) informing the lead auditor of any major obstacles encountered in performing the audit;
k) safeguarding the confidentiality of all documents and information obtained in association with the audit:
i) when submitting such documents to the auditing organisation through the lead auditor;
ii) treating privileged information with discretion;
l) verifying that corrective actions have been taken and have been effective:
i) as a result of a previous audit;
ii) during the audit, as feasible;
iii) based on experience gained with devices on the market (e.g. post market surveillance);
iv) based on incidents of a serious nature;
m) minimising disruption to the auditee’s personnel and processes during the audit while attaining the audit's objectives.
n) complying with any health and safety or other applicable requirements of the manufacturer

Lead auditor
The lead auditor is ultimately responsible to the auditing organisation for all phases of the audit. The lead auditor shall have authority to make final decisions regarding the conduct of the audit and any quality audit observations.
The responsibilities of the lead auditor include, in addition to those of the auditors:
a) identifying the requirements of each audit assigned to the lead auditor by the auditing organisation;
b) assisting the auditing organisation with the selection of the other audit team members;
c) previewing the manufacturer’s quality system description (where appropriate) for adequacy in meeting applicable regulatory requirements, prior to the on-site audit;
d) preparing the audit plan and working documents and briefing the audit team;
e) representing the audit team with the auditee’s management;
f) communicating any nonconformities to the manufacturer as soon as possible after they are identified and indicating whether such nonconformities may affect compliance with the regulatory requirements;
g) reporting to the manufacturer and to the auditing organisation any major obstacles encountered in performing the audit as planned;
h) preparing and presenting the audit results clearly and conclusively to the manufacturer at the closing meeting;
i) preparing and submitting the audit report to the auditing organisation in a timely manner

Manufacturer
The responsibilities of the manufacturer include:
a) defining the scope of the audit as permitted by the regulatory requirements;
b) determining the method of compliance with the regulatory requirements;
c) informing relevant employees about the objectives and scope of the audit;
d) appointing responsible members of staff to accompany members of the audit team and ensuring that audit team members are aware of health, safety and other applicable requirements;
e) providing all resources needed for the audit team in order to ensure an effective and efficient audit process;
f) providing access to the facilities and evidential material pursuant to the regulatory requirements as requested by the auditors;
g) co-operating with the auditors to permit the audit objectives to be achieved;
h) receiving the quality audit observations;

i) determining what follow-up corrective actions are to be taken to address nonconformities and other quality audit observations identified during the audit, implementing such actions in a timely and effective manner and informing the audit organisation as required;
j) informing the auditing organisation of any significant change to the quality system as required by the regulatory requirements;
k) informing any other auditees that may be affected by the audit, of its objectives, scope and any other relevant arrangements

Auditees
Where auditees, other than the manufacturer, are involved in the audit (i.e. subcontractors), clause 9.3, sections (c) to (g) apply. In such cases, the responsibilities for the other items remain with the manufacturer