Did you know?

Occupational safety, hygiene, radiation protection, technical safety, pharmacy, transfusion medicine

Start now
Updated on 26 February 2025

1 Purpose and objective

Description of the audit scope, objectives and responsibilities.

2 Scope of application

An audit plan is drawn up by the audit manager of the IQ-Institute before the start of an audit.

3 Description

The audit plan must be approved by the client. It should be made known to the audited organisation and the audit team. If the audited organisation does not agree with any of the stipulations in the audit plan, these objections should be communicated to the audit manager immediately. The objections should be clarified between the audit manager, the audited organisation and the client before the audit is carried out.

The audit plan should be kept flexible enough to allow for shifts in emphasis based on information gained during the audit.

The plan includes the following information:

  • Order number with which the audit is identified
  • Title of the audit
  • Reason for the audit, e.g:
  • Initial assessment of a test centre or laboratory (before contract conclusion)
  • Testing for compliance with the quality requirements of GCP, ICH, GLP
  • Data verification for compliance with the test conditions
  • Special events
  • Review of the final report of a clinical trial
  • Tracking of corrective measures
  • Testing of analytical methods
  • Audit objectives can be answers to the following questions:
  • Is the QA system able to fulfil the specified requirements effectively?
  • Are the requirements of the GCP or GLP for test planning fulfilled?
  • Have the requirements for data collection been met?
  • Are the reporting requirements of the GCP fulfilled?
  • Audit scope
  • Definition of the selected quality system (GCP, ICH, GLP, DIN ISO EN 9002, 45000 or similar)
  • Proportion of the organisation and/or functions subject to the audit.
  • Reference to working documents (checklists, sampling plans, reporting forms)
  • Names of persons who have significant responsibility for the audit objectives and scope (at least the auditor, the representative at the client and a responsible person at the audited organisation)
  • Members of the audit team with task assignment
  • Language of the audit
  • Date and location of the audit
  • Identification of the organisation or parts of the organisation to be audited
  • Schedule for the audit (expected start date, duration of the sections)
  • Times for meetings with the management of the audited organisation
  • Confidentiality requirements
  • Distribution list for the audit report
  • Expected date of publication of the report.

4 Risks and opportunities

5 Documentation

Correspondence with client and audited organisation (if applicable)

Audit plan with checklists, sampling plans (if applicable)

6 Resources, time required

up to 10 hours (depending on the scope and depth of the audit)

7 Responsibility, qualification

The audit manager draws up the audit plan and agrees it with the client. He incorporates any objections raised by the audited organisation into the audit plan after consultation with the client. The audit manager obtains written approval of the audit plan from the client.

8 Notes and comments

9 Applicable documents

9.1 Literature, guidelines

Contract IQ Institute / Client

DIN ISO 10 011, Part 1

Standards and guidelines applicable to the specific audit, such as DIN ISO EN 9001, GCP, GLP

9.2 Terms

Not applicable

10 plants

Appendix l: Audit plan

en_GB
de_DE fr_FR es_ES en_GB