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Quality
Procedure
Internal Audit
 Quality Procedure
www.iso9001help.co.uk
Internal Audit

Table of Contents
1 INTERNAL AUDITS ....................................................................................................................................... 3

1.1 INTRODUCTION & PURPOSE ....................................................................................................................... 3

1.1.1 Process Activity Map ..................................................................................................................................................... 3
1.1.2 References ......................................................................................................................................................................... 3
1.1.3 Terms & Definitions ....................................................................................................................................................... 3
1.2 APPLICATION & SCOPE .............................................................................................................................. 4
1.3 RESPONSIBILITIES ...................................................................................................................................... 4
1.4 INTERNAL AUDIT PROCESS ......................................................................................................................... 4
1.4.1 Selecting Internal Auditors ......................................................................................................................................... 4
1.4.2 Developing the Audit Programme........................................................................................................................... 4
1.4.3 Preparing for the Audit ................................................................................................................................................ 4
1.4.4 Conducting the Audit ................................................................................................................................................... 5
1.4.5 Data Review & Initial Reporting ............................................................................................................................... 5
1.4.6 Monitoring ........................................................................................................................................................................ 5
1.4.7 Final Reporting ................................................................................................................................................................ 5
1.4.8 Review ................................................................................................................................................................................. 5
1.5 CONDUCTING AUDITS ................................................................................................................................ 5
1.5.1 System Audits .................................................................................................................................................................. 5
1.5.2 Process Audits.................................................................................................................................................................. 6
1.5.3 Supplier Audits ................................................................................................................................................................ 6
1.5.4 Legislation Audits ........................................................................................................................................................... 7
1.6 CORRECTIVE ACTION .................................................................................................................................. 7
1.7 FORMS & RECORDS ................................................................................................................................... 7
1.8 INTERNAL AUDIT PROCESS MAP ................................................................................................................. 8

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 Quality Procedure
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Internal Audit

1 Internal Audits
1.1 Introduction & Purpose
The purpose of this procedure is to define your organization’s process for undertaking QMS audits, process
audits, and supplier and legislation audits in order to assess the effectiveness of the application of our quality
management system and its compliance to ISO 9001:2015. This procedure also defines the responsibilities for
planning and conducting audits, reporting results and retaining associated records.

1.1.1 Process Activity Map

With what With who

• Internal audit programme • Audit team

• Status and importance • Quality Manager
• Risk and opportunities • Top Management

Input Activity Output

• Customer requirements Systematic, independent • Process improvement

• Statutory or legal and documented process to • QMS improvement
requirements obtain objective evidence • Conforming processes
• Areas of concern and to evaluate it to • Process corrective actions
• Audit considerations determine the extent to • System corrective actions
which audit criteria are met • Audit reports

How With what measure

• NC/CA process • No. of audits conducted

• Internal audit checklist • No. of open audit actions
• Process audit checklist • Repeated NCs
• Forms & reports • Audit score

1.1.2 References
Standard Title Description
BS EN ISO 9000:2015 Quality management systems Fundamentals and vocabulary
BS EN ISO 9001:2015 Quality management systems Requirements
BS EN ISO 9004:2000 Quality management systems Guidelines for performance improvements
BS EN ISO 19011:2011 Auditing management systems Guidelines for auditing

1.1.3 Terms & Definitions

Term ISO 9000:2015 Definition
Audit A documented process for obtaining and evaluating evidence
Conformity Fulfilment of a requirement (3.6.4)
Corrective action Action to eliminate the cause of a non-conformity (3.6.9) and to prevent recurrence

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 Quality Procedure
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Internal Audit

1.2 Application & Scope

The scope of this procedure is focused on assessing the effectiveness of your organization’s quality
management system. Where such processes are found to be deficient, the audit will lead to improvement in
those processes. By applying the principles of auditing, outlined by ISO 19011:2011, your organization
ensures that all internal audits are conducted with due professional care, integrity and independence. All
conclusions derived from the audit are based upon objective and traceable evidence.

1.3 Responsibilities
It is the responsibility of the Quality Manager <amend as appropriate> to coordinate the whole internal audit
programme. The Quality Manager <amend as appropriate> is required to:
• Determine the root causes of non-conformities;
• Maintain a system for reporting audit results;
• Determine conformity to planned arrangements;
• Determine proper implementation and maintenance;
• Provide the results of audits to top management;
• Review the effectiveness of corrective actions taken.

1.4 Internal Audit Process

1.4.1 Selecting Internal Auditors
To ensure impartiality and objectivity, the audit team will include personnel from departments not directly
associated with the area, process or department being audited. The Internal Auditors are selected on the
basis of their:
• Education: secondary or higher;
• Work Experience: more than 5 years;
• Relevant Training: provided in-house or externally;
• Audit Experience: demonstrable knowledge/skills.
1.4.2 Developing the Audit Programme
The Quality Manager <amend as appropriate>is required to:
• Determine the status and importance of each process;
• Establish audit frequency based on the status and importance of each process;
• Develop and communicate the audit schedule;
• Appoint audit team leader where required;
• Select audit team;
• Assign audit duties to the auditor team.
1.4.3 Preparing for the Audit
The Internal Auditors <amend as appropriate>are required to:
• Review relevant management system documents and records;
• Determine their adequacy with respect to the audit criteria and with ISO 9001;
• Review and prepare the internal audit checklist;

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 Quality Procedure
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Internal Audit

1.8 Internal Audit Process Map

Quality Manager Auditor Auditee Top Management

Audit Considerations Audit Considerations

• Standards • Legal requirements
• Customer feedback • Employee concerns
• QMS requirements • Management review
• Corrective actions • Risks
• 3rd party audits • Opportunities
• Process status • Policies
• Non-conformances • Objectives
• Process importance • PESTLE
• SWOT

Prepare Audit
Programme
Document Review Review
Recommendations
Assign Audit Duties

Prepare Audit
Checklist

YES
Non-compliances Initiate Corrective
Found? Actions

NO

Review Audit Close-out Corrective

Prepare Audit Report
Findings Actions

Update System
Verify Close-out
Metrics

Submit Audit Report

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