Internal Audits

 Biodata Quality Policy > Documented Procedures > Internal Audits

February 2018

The Quality Manager plans and carries out the internal quality audit according to a defined schedule (see Works Instructions 7.7). Its purpose is to ensure the continued effectiveness of the various systems, procedures, working practices and controls.

Each of the four audits covers a different area.

  1. Audit of documents relating to the completion of an order for catalogue only items.
  2. Audit of documents relating to the completion of an order for customised product (software and/or hardware).
  3. Audit of documents relating to repair of equipment.
  4. Audit of documents relating to Quality Control procedures.

Audits 1–3 follow the progress of an order through the system, checking that all the relevant Work Instructions have been followed. The fourth audit checks Quality Documents which are not usually accessed during the order process.

The results of the audit are recorded on an Audit Report (reproduced in Work Instructions 7.7). A record of which Works Instructions have been audited is made on the Audit Chart (audit.ods - also reproduced in Work Instructions 7.7).

The responsibility for instigating audits lies with Quality Control. A report written by Quality Control, or other authorised department (depending on the area of audit) will be issued to all levels of management and other relevant personnel. All audit procedures are reviewed at regular Management Review meetings.

Corrective and preventative actions are addressed by the management responsible for the area audited, checked by the Quality Manager who also ensures that these actions are carried out without delay.

The Audit Report Form will identify deficiencies, suggest corrective and preventative actions, responsibilities and timescales. At the start of the next audit the outstanding non-compliance will be reviewed by the audit team for implementation of corrective and preventative action, and the effectiveness of the action.

A record of the audit reports and subsequent action will be maintained by the Quality Department and used for future analysis purposes. This will also enable improvements to be made to the procedures as necessary.

ISO9001-2015 Audit

An audit is undertaken to ensure that the Quality System conforms to the requirements of ISO9001:2015. The spreadsheet qualityauditcheck.xls helps find which part of the manual refers to which clause.

(Clause 2015:9.2)

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Biodata Ltd
10 Stocks Street, Manchester, M8 8QG, UK
Tel: +44 (0)161-834 6688
Fax: +44 (0)161-833 2190
E-mail: quality@microlink.co.uk
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