Standard Operating Procedure

Internal Audits

Proc Ref: SOP 26 Ref: BS EN ISO 13485 8.2 Date: 26.7.12 Page: 1
Issue Level: Approved Ref: BS EN ISO 9001 8.2 Authorised by: of: 4
Issue No: 1 Ref: 93/42/EEC Annex II
Authored by: J Bloggs ……………………..
 Purpose: To ensure that the Quality Assurance Management System is operating
effectively, is being maintained and to ensure that personnel fulfil their
responsibilities and duties adequately. The activities in this procedure will
assure the company’s Quality objectives and requirements are met.
Responsibility: The overall responsibility is with the Managing Director.
Scope Personnel involved in quality related activities and the relevant
documentation.

1. Lead Auditor

1.1 The Lead Auditor is the person who is responsible for individually performing or
has charge of leading a selected team to perform an independent Internal Quality
Audit.
1.2 Where possible, the Lead Auditor will possess a recognised Internal Quality
Auditing qualification. Alternatively, the Managing Director can authorise the Lead
Auditor and/or a deputy to be trained by company personnel whom possess a
recognised qualification or have the relevant experience.
1.3 The Lead Auditor will have no direct responsibility for the areas/departments
where an audit is to be carried out and will not audit their own work.
1.4 It is the Lead Auditors’ responsibility to prepare an Internal Quality Audit Plan and
to submit an Audit Report.
1.5 The Lead Auditor and/or a deputy will be responsible for the “Closing Out” of any
Non-conformity raised upon the verification of a completed “Corrective Action”.

2. Audit Frequency

2.1 An Internal Quality Audit will be performed at intervened periods. The full Quality
System will be audited within a period of not less than 12 months. A 12-month
plan will be recorded on an “Internal Audit 12 Month Schedule Planner” (template
MLD 4.24a & MLD 4.24b).
2.2 Where necessary, the Managing Director and/or the Quality Manager can request
a Quality Internal Audit to be performed earlier or in addition. This will take effect if
a new process or activity has been implemented into the system or where a
decline in the quality of a product and/or process system has been identified.

3. Audit Plan

3.1 The Internal Audit will be scheduled as stated in section 2.0. The frequency of an
audit will be determined at the Auditors’ discretion and by the area/departments’
level of importance in the Quality Assurance System. In addition to the Audit Plan,
a follow up audit may be performed where a non-conformity was found in previous
audit or where a discrepancy is suspected.
3.2 In the planning of an audit, the timing of an audit will be considered to avoid any
disruption in a department during a busy period or for any other approved
appropriate reason. The Managing Director will sanction the timing.
3.3 The Audit Plan essentially consists of:
An agreed date(s) that the audit is to be conducted.

Proc Ref: SOP 26 Ref: BS EN ISO 13485 8.2 Date: 26.7.12 Page: 2
Issue Level: Approved Ref: BS EN ISO 9001 8.2 Authorised by: of: 4
Issue No: 1 Ref: 93/42/EEC Annex II
Authored by: J Bloggs ……………………..
 A dated Internal Audit 12 Month Schedule Planner.
An audit ‘checklist’ of what is to be audited.
Results of the previous audit will also be taken into consideration.
3.4 The Lead Auditor, Quality Assurance Manager, Managing Director and the
Departmental Managers will agree a date and time for the Internal Audit to be
carried out. All the relevant departments will be notified of the agreed time and
date of the audit with at least a one-week notice.
3.5 All relevant details of the Audit shall be recorded on a “Quality Audit Record”
(template MLD 4.26). This document (form) constitutes the audit ‘checklist’ (see
3.3) and the completed document, any non-conformance report sheets,
subsequent reviews, associated documents etc, the Audit Report.

4. Auditing Process

4.1 An Internal Audit will be carried out to verify that all process activities are being
performed in compliance with the requirements of the Documented Quality
System.
4.2 The Auditing activity will involve the examination of a selected process system.
The processing activities will be cross-referenced with the appropriate Standard
Operation Procedure for that area and the Quality Manual. All the relevant process
documentation and process records will be used as evidence for conformance to
the specified requirements.
4.3 Where necessary, a member of staff who is responsible for the area being audited
will be requested to accompany the Auditor.
4.4 Any Non-conformity that is found will be recorded. The accompanying personnel
and/or the Department Manager will be notified of the Non-conformity raised within
2 working days on a “Corrective Action for Non-Compliances” report (template
MLD 4.17). The management responsible for the area being audited will ensure
that any necessary corrections and corrective actions are taken without undue
delay to eliminate non-conformities and their causes.
4.5 Where appropriate, the Internal Auditor can record any processing activities that
could be improved. These records will be recorded on the “Quality Audit Record”
for discussion purposes only and will be used in the following Quality Audit review
meeting.
4.6 Where there are areas for improvement arising from the results of the Internal
Quality Audit, the recorded information will be processed in accordance with the
“Quality Management Improvement System” Procedure, SOP 30.

5. Audit Review

5.1 The Lead Auditor/Audit Team will review the results of the Internal Audit with the
Departmental Manager and/or representatives whose departments were audited.
5.2 All reported Non-conformities raised and their Corrective Actions will be reviewed
at the review meeting. The cause of the Non-conformity raised and the prevention
of re-occurrence or the possibility of any other occurrences will be reviewed. The
Corrections and Corrective Actions performed or proposed will be analysed for
their effectiveness in the Quality System. The Non-conformities raised will also be

Proc Ref: SOP 26 Ref: BS EN ISO 13485 8.2 Date: 26.7.12 Page: 3
Issue Level: Approved Ref: BS EN ISO 9001 8.2 Authorised by: of: 4
Issue No: 1 Ref: 93/42/EEC Annex II
Authored by: J Bloggs ……………………..
 reviewed for areas of improvement to the Quality System.
5.3 The results of the review meeting will be recorded on the “Quality Audit Record”.
5.4 The minutes of all completed Quality Reviews will be distributed to the relevant
Departmental Managers and the Managing Director.

6. Follow-Up Audits

6.1 On the notified completion of Corrections and Corrective Action(s) or where the
agreed time scale for the completion has ended, the Lead Auditor will arrange a
follow-up Internal Quality Audit with the Departmental Manager(s) who have
completed or proposed the Corrective Action(s).
6.2 The follow-up Internal Quality Audit will be performed to verify that the
implementation of the Corrective Action has been carried out. The effectiveness of
the Corrections and Corrective Actions performed will be monitored to ensure that
the Non-conformity has been eliminated. This may require further follow-up audits
and/or re-assessment on the next Internal Audit.
6.3 Upon verification, the Lead Auditor and/or team representative will “Close Out” the
Non-conformity that was raised on the department. This activity will be recorded
on the “Corrective Action for Non-compliance” document.
6.4 All Internal Quality Audit records will be retained as appropriate.

7. Customer Audits

7.1 Upon a customer’s request for contractual purposes, the Managing Director can
grant a customer the permission to carry out a Quality Audit on the company’s
Quality Assurance System. A convenient date and time for the Quality Audit will
be arranged between the customer, the Managing Director and the Quality
Assurance Manager.
7.2 Upon the completion of a Quality Audit performed by a customer, the released
results will be reviewed for information that may lead to implementing further
improvements to the Quality Management System. Such implementations made
for improvement will be processed in accordance with the “Quality Management
Improvement System” Procedure, SOP 30.

8. Quality Records

8.1 All Internal Quality Audit documentation, which includes Audit Reports, Non-
compliance records, Corrective Action documents and Quality Review minutes will
be retained and regarded as Quality Records and will be maintained accordingly
(see SOP 20).
8.2 All these records will be retained and be obtainable from authorised personnel
only. The Managing Director, Quality Assurance Manager or Lead Auditor, who
are authorised, will grant the authorisation.

Proc Ref: SOP 26 Ref: BS EN ISO 13485 8.2 Date: 26.7.12 Page: 4
Issue Level: Approved Ref: BS EN ISO 9001 8.2 Authorised by: of: 4
Issue No: 1 Ref: 93/42/EEC Annex II
Authored by: J Bloggs ……………………..