| qms_version | 2.2.0 |
|---|---|
| sop_version | 1.0.0 |
| Document ID | CSC PR.027 |
| Author | |
| Approval | |
| Revision | 1.0.0 |
| Regulatory References |
Internal Quality Audits are carried out on a regular basis to provide evidence of the effectiveness of the Quality System and to ensure compliance with relevant Quality System standards (ISO 13485). All relevant areas of work activity and responsibility related to Quality Management System shall be audited to ensure that stated policies and procedures are being effectively implemented and maintained.
The Quality Manager will:
- Plan and organise audit schedules.
- Co-ordinate audits, issue audit documentation and maintain audit records.
- Ensure auditors have received adequate training.
- Provide a summary of audit results at Management Review meetings.
The Head of the Section being audited will:-
- Ensure audits can proceed as scheduled.
- Ensure staff are available to accompany the audit team.
- Ensure necessary corrective actions are taken when nonconformities are identified.
- Consider the need to address any observations/risks identified.
| Quality Problems and Corrective Action Procedure | D PR.003 (QPulse) |
| Internal Audit Checklist | D F.005 (QPulse) |
a) The Quality Manager shall schedule internal audits to encompass all relevant elements of the Quality System on an annual basis.
b) The schedule will be agreed with the relevant Heads of Section.
c) The audit programme shall take due account of organisational changes and areas found to have repeated or significant nonconformities. The audits may be postponed due to operational reasons, based on risk to the Quality Management System.
d) Unscheduled audits may be conducted at the discretion of the Quality Manager, to verify an element of the Quality System giving concern.
e) Follow-up audits are performed to monitor progress of nonconformities raised from audits and the effectiveness of corrective actions taken in order to close off audits.
a) At least the lead auditor shall be formally trained in Internal Audits. Audit teams may include auditors-in-training.
b) The team shall be composed of one or more members chosen by the Quality Manager. Auditors will be independent of the area being audited.
The audit team members shall be notified of the scheduled dates of the audits and the area(s) to be audited. Before each internal audit, audit checklists will be circulated to the team leader who is required to:-
a) Become familiar with the scope of the audit and the activities to be undertaken.
b) Confirm the date and time of the audit with the relevant Head of Section. Inform the Quality Manager if a change to the scheduled date is necessary.
c) If necessary, inform the audit team of the areas to be audited, detail the purpose and scope of the audit and issue the relevant checklists.
a) The audit team shall meet with the personnel responsible for the area/s to be audited. The purpose, itinerary and duration of the audit will be confirmed.
b) Documents and items required to be audited will be requested where necessary.
c) Escorts for the team will be agreed. Personnel responsible for the area/s being audited shall also be invited to accompany the team during audit.
a) Auditors shall use the checklist as a guide and record of the findings. The relevant standards may be used as a checklist.
b) The record shall identify any nonconformities and any risks/observations.
a) A review shall be undertaken by the audit team after the audit to evaluate the audit findings.
a) A meeting shall then take place with the relevant Head of Section and/or Quality Representative and be chaired by the audit team leader.
b) The audit findings shall be presented by the auditors/ team leader.
c) Any short term follow up needed by the team leader is agreed.
d) Nonconformities shall be agreed with the Head of Section/Q. Rep.
e) Any risk/observation will be discussed and evaluated/actioned by the HOS as appropriate.
a) The team leader produces an Audit Report and signs it.
b) For Sectional audits two hard copies are required. One copy only for Department audits.
c) The copies are sent to the Head of Section with a note to sign and distribute as in e) below.
d) The copies are, if agreed, signed by the Head of Section. If the Head of Section disagrees with the report and the team leader is unable to resolve the problem then the matter will be resolved by the Quality Manager, and if this is not possible then by the HOMP.
e) When signed, the Head of Section returns one copy to the Team Leader and for Sectional audits sends one copy to the Section Quality Representative.
f) The team leader checks all audit documentation for completeness prior to forwarding to the Quality Manager.
g) The Quality Manager signs off the audit report and organises any longer term follow-up.
h) Follow-up audits are performed to monitor progress of nonconformities raised from audits and the effectiveness of corrective actions taken. The nonconformities will be signed off when corrective actions are completed and implemented effectively. The audit will then be signed off.
The Section Quality Rep. maintains:
- A copy of the Audit Report stored in records > Internal audits
The Quality Manager maintains:
- Copy of Audit Report and
- Internal Audit Checklists / Internal Audit schedule / Supplementary information
The Audit Team Leader does not retain any audit documentation on completion of the audit.