GB Alliance

QUALITY SYSTEM PROCEDURE

DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 1 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

1.0 PURPOSE:
The purpose of this procedure is to implement a system for planned internal quality audits to verify
compliance of the quality activities and related result with the planned arrangement and to determine
effectiveness of the quality system as per MDR-2017, ISO 13485:2016, and potential opportunities for
improvement.

2.0 SCOPE:
This procedure is applicable to all activities of the quality system and requirements of the international
standards in the Organization.

3.0 RESPONSIBILITY:
MR & All HODs

4.0 ACCOUNTABILIY:
MR

5.0 PROCEDURE:

5.1 Audit are designed for one or more of the following purposes

(a) To determine conformity or nonconformity of the activities to the specified requirement

and elements of the International Standard/ Quality system.

(b) To determine effectiveness of the implemented quality system in achieving the specified
quality policy and quality objectives.

(c) To verify compliance of quality activities and related result with the planned
arrangements, documented quality system.

Internal quality audits are conducted at least once in year.

5.2 Audit planning and schedule

5.2.1 MR makes annual plan for internal audit in the beginning of the year.

5.2.2 Based on the annual plan, M.R. prepares audit schedule based on the status and
importance of the activity. He appoints the auditors for each area to be audited. Each

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 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 2 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

audit team is required to audit all applicable elements of the quality system in the
assigned department / function for audit.

5.2.3 M.R. informs the audit schedule to all auditors and the auditees.

5.2.4 Audit is conducted by the trained personal, independent of those having direct
responsibility for the area / activity to be audited, wherever applicable & practical.

5.3 Executing the audit

5.3.1 During audit the auditor covers entire scope of the audit or as advised by the MR

5.3.2 Before starting audit, the auditor properly prepares a checklist wherever required for
convenience in audit, to save wastage of time during audit and to follow a professional
approach.

5.3.3 MR conducts an opening meeting among the auditors and audit heads to ensure
availability of the resources and facilities required to conduct the audit.

5.3.4 Evidences are collected through interview, examination of document and observations of
activities & condition in the concerned area / function.

5.3.5 Clauses indicating nonconformity are noted, if they seem significant even through not
covered by the checklist and are investigated.

5.3.6 Information collected through interview is verified obtaining the same information from
other independent sources like physical observation, measurements and records.

5.3.7 All audit finding is documented at the end of audit; audit team and auditee head reviews
the entire finding to identify the actual nonconformity. Audit findings are documented on
the non-conforming report.

5.3.8 All the audit finding and nonconformity are acknowledged by the auditee or auditee head.

5.4 Audit Report

Audit report is prepared for identified nonconformity on Non conformity report for its
accuracy and completeness and submitted to the auditee.

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 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 3 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

5.5 Audit Completion

Audit is completed on submission of the audit report to the auditee.

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 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 4 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

5.6 Corrective action and follow-up:

5.6.1 Auditor is responsible only for identification of the nonconformity.

5.6.2 Auditee dept. is responsible to determine and initiate corrective action required to correct
the nonconformity or its cause and for closure of the raised non-conformity report.

5.6.3 Corrective action and its follow-up are completed within a time period, agreed by the
auditor and auditee dept. If required, MR is also consulted in this regard.

5.6.4 On the agreed completion date or earliest possible, auditor goes to the auditee dept. and
verifies the satisfaction & effective implementation of the corrective action taken.

5.6.5 Auditor records his comments regarding verification of the corrective action taken. On
satisfaction he signs and closes the nonconformity.

5.6.6 MR includes the audit report with details of the corrective actions taken in the agenda of
the next management review meeting.

6.0 RECORDS:
Master list of records (GB/F-01)

7.0 REFERENCE: Nil

8.0 REFERENCE DOCUMENT: Nil

9.0 ABBREVIATIONS:
QSP : Quality System Procedure
MR : Management Representative
HOD : Head of Department
ISO : International Organization for standardization
WHO : World Health Organization
GMP : Good Manufacturing Practice

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Proprietor
 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 5 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

10.0 Distribution list:

Issuance Receipt Retrieval Remarks

Date Dept./ No. of Date By Date No. of By

Person copies (Name (Name copies (Name/Sign)
/ Sign) /Sign)

11.0 Revision Detail:

Sr. No. Revision No. Revision Date Reason for revision Signature

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Prepared & Issued By: MR
Proprietor
 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 6 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

Checked & Approved By:

Prepared & Issued By: MR
Proprietor
 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 7 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

Format No: GB/F-06

Internal Audit Plan & Schedule (MDR-2017)
Sr. Date Departments Applicable Name of Sign Name of Sign
No of Clause Auditors Auditee/
Audit Concerne
d Head
1. Quality Management System (Quality 4.0, 4.2.2, 4.2.3,
manual, control of documents, control 4.2.4, 5.3
of records) Quality policy
2. Purchasing, Purchasing Process, 7.4 ,7.4.1, 7.4.2
Purchasing Information, Identification ,7.5.3,
and traceability,
3. Human Resources (competence, 6.2, 6.2.2, 6.3,
awareness and training, 6.4
Infrastructure, Work environment)
4. Customer related processes, customer 7.2, 7.3, 8.5.2,
communication, Design and 8.5.3
development, corrective action,
preventive action

1- Next Audit will be conducted on or before: -

2-The result and effectiveness of the implementation of action shall be checked of the last
audit finding
3-The scope of the audit will be the scope of the organization and the scope of the work of the
concern department, of the company, departmental procedure, work instruction, legal and
customer requirement of the standard MDR-2017, EN ISO 13485-2016.

Checked & Approved By:

Prepared & Issued By: MR
Proprietor
 GB Alliance
QUALITY SYSTEM PROCEDURE
DEPARTMENT: MR Function
Title: Procedure for Internal Audit Page 8 of 8
Issue No.: 01 Issue Date: 10/09/2021 Effective Date: 10/09/2021 Controlled copy
Rev. No.: 00 Review date: 10.09.2023 Doc. No. : GB/ QSP/03 Stamp here

4- verification of the documented statement in the farm of procedure, manual, WI, plan, Check
sheet and the interview of the auditee shall be noted in the plane paper and signature of the
auditee shall be taken as an evidence if any.
5-The Observation and raised non conformities shall be reported in the prescribed format to
get CAPA from the auditee.
Approved By MR
Date: - As per MDR-2017, EN ISO 13485:2016

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Prepared & Issued By: MR
Proprietor