Internal Audit SOP

COMPANY NAME Standard Operating Document Control
Procedure for
ISO9001:2015 AND FSSC Date of Issue:
22000
Managing of Internal
Revision Date :
Audits
Document No: SOP-15- Internal audit Approval Signature and date:

Version: 0
1. PURPOSE:
The purpose of this Standard Operating Procedure (SOP) is to describe the process for conducting of
internal audits to assess the effective implementation of ISO 9001:2015 Practices and where necessary
propose and implement corrective actions.
2. SCOPE:
The scope of this SOP applies the applies to the conducting of ISO 9001:2015 internal audits.
3. DEFINITIONS:
NIL
4. REFERENCES:
• ISO 9001:2015 : here are three main components to completing an Internal audit ISO 9001
and finding the Gap Analysis:
• Step 2: Scheduling the Gap Analysis
• Step 2: Conducting the Gap Analysis
• Step 2: How to use the Results of the Gap Analysis: The Report
• Food Safety Management: Applicability and Scope of FSSC 22000

• Hazard Analysis and Critical Control Points (HACCP): Implementing a systematic approach
to identify and control food safety hazards specific to your processes and products.
• Good Manufacturing Practices (GMP): Establishing robust protocols for hygiene, sanitation,
and operational controls to maintain a clean and safe environment.
• Prerequisite Programs: Defining and implementing essential measures such as personnel
hygiene, training, equipment maintenance, and traceability to create a solid foundation for
food safety.
• Allergen Management: Managing allergens effectively through segregation, labeling, cleaning
procedures, and staff training to prevent cross-contamination and protect sensitive consumers.
• Supplier Control: Establishing stringent supplier management protocols, including auditing
and monitoring, to ensure the safety and quality of ingredients and materials used in your
products.
• Product Authenticity and Food Fraud Prevention: Implementing measures to mitigate the risk
of food fraud, including supplier verification, traceability systems, and authenticity testing.
1/6
Procedure for
22000
Revision Date :
Audits

Version: 0
• Requirements for a Food Safety System based on Prerequisite Programmes and Hazard
Analysis and Critical Control Point (HACCP) principles
5. AUTHORITY AND RESPONSIBILITY:
Management ensures that ISO 9001:2015 internal audits are periodically conducted.
Employees
All employees are responsible to adhering to this SOP.
2/6
Procedure for
22000
Revision Date :
Audits

Version: 0
METHOD:
5.1 Audit team
Internal audits are carried out by personnel independent of the activity being audited. Internal Auditors
need to be trained before being assigned for internal audits.
6.1 Planning of internal audits
When planning the internal audits, consideration is given to the status and importance of the processes
and areas to be audited, changes affecting the organization, as well as the results of the previous audits.
Internal audits are conducted Thrice a year as per (GMP SOP015- Form 01 Annual Internal Audit
Calendar).
The audit criteria should be in line with the ISO 9001:2015 and the FSSC 222000 programmes
The organisation’s own requirements will also form part of the audit criteria.
An Annual Internal Audit Calendar should be maintained. The calendar may be revised after each audit
on the basis of the audit findings.
6.2 Audit process
Audits are carried out against audit criteria other relevant standards. Non-conformance reporting is based
on objective evidence.
When an actual/potential non-conformance is observed during an audit, both auditee and auditor must
agree on the following:
 Objective evidence
 Nature of observed deviation (Major/Minor)
 Corrective / preventive actions and due date, and
 Need for follow-up audits or verification and the due date.
3/6
Procedure for
22000
Revision Date :
Audits

Version: 0
6.3 Recording the Results of quality audits
Auditors record the observed non-conformities, deficiencies, and improvement opportunities in the area
/ department being audited on the GMP SOP015- Form 02 Internal Audit Findings Notification. A
formal audit report is compiled within 5 working days after completion of the internal audit.
6.4 Follow up audits
When a non-conformance detected during audits is not addressed during the audit, follow up audits shall
be conducted. Responsible personnel shall be assigned to keep track of open audit findings and ensure
that these are closed within the agreed time frame.
6.5 Closing of auditing findings
Once the corrective actions are completed and if further follow-up audit is not required, the audit findings
can closed.
The internal audit summary in the is also discussed in the subsequent management review meetings.
4/6
Procedure for
22000
Revision Date :
Audits

Version: 0
6. RECORDS:
The following records are maintained.
Retention Custodian(s)
No. Record Title / ID Format Medium Period
1 Annual Internal Audit Calendar English, Electronic 1 year Quality
(SOP015- Form 01 Annual Internal Text Control (QC)
Audit Calendar) Manager
2 Internal Audit Findings Notification English, Electronic 1 year QC Manager
(GMP SOP015- Form 2) Text
3 Audit Report English, Electronic 1 year QC Manager
Text
5/6
Procedure for
22000
Revision Date :
Audits

Version: 0
7. DOCUMENT AMENDMENT HISTORY:
Version Summary of changes from previous version of Changes Remarks

No. the document Requested By
0 First version released for implementation. N/A Nil
6/6

Internal Audit SOP

Uploaded by

Copyright:

Available Formats

Internal Audit SOP

Uploaded by

Document Information

Original Title

Copyright

Available Formats

Share this document

Share or Embed Document

Sharing Options

Did you find this document useful?

Is this content inappropriate?

Copyright:

Available Formats

Internal Audit SOP

Uploaded by

Copyright:

Available Formats

COMPANY NAME Standard Operating Document Control

Document No: SOP-15- Internal audit Approval Signature and date:

• Food Safety Management: Applicability and Scope of FSSC 22000

Document No: SOP-15- Internal audit Approval Signature and date:

5. AUTHORITY AND RESPONSIBILITY:

All employees are responsible to adhering to this SOP.

Document No: SOP-15- Internal audit Approval Signature and date:

5.1 Audit team

6.1 Planning of internal audits

6.2 Audit process

Document No: SOP-15- Internal audit Approval Signature and date:

6.3 Recording the Results of quality audits

6.4 Follow up audits

6.5 Closing of auditing findings

Document No: SOP-15- Internal audit Approval Signature and date:

The following records are maintained.

Document No: SOP-15- Internal audit Approval Signature and date:

7. DOCUMENT AMENDMENT HISTORY:

Version Summary of changes from previous version of Changes Remarks

You might also like