REVITAL HEALTHCARE (EPZ) LIMITED Doc. No.

: Z/F/02/10
L.R. No. 5025/1239 TAKAUNGU Issue Date: 15.12.2023
80100 MOMBASA, KENYA Rev. No.:00

SUPPLIER AUDIT PLAN.

1. Audit Overview

Type of Audit Supplier Audit

Audit criteria
Audit period (on site)
Auditee (s) / Location(s)
Audit Responsible
Lead Auditor / Auditor
Audit Language
☒ ISO 9001:2015
☒ ISO 13485:2016
☒ ISO 14001:2015
☒ Defined processes and documentation of the auditee’s
Quality Management System
☒ MDSAP with additional country-specific requirements:
March 26th 2024
Anhui Tianrun Medical Packaging Materials Co., Ltd
No.2 of Tianrun Industrial Park Dagiao Development Zone,
Anqing, Anhui Province, China.
Sanny Ye
Dr. Akash Sharma/ Chandra Prakash
English

2. Audit Objectives
The objectives of this Audit are:
- Determine conformance of the Management System with the Audit Criteria
- Verify that the supplied materials meet the required quality standards and specifications.
- Assess the quality control processes to ensure consistency and reliability in the delivered
materials.
- Ensure compliance with relevant industry regulations, standards, and legal requirements.
- Evaluate the production capacity to meet the Revital Healthcare (EPZ) Limited demand.
- Assess the technical capabilities, including equipment, technology, and expertise.
- Identify and assess potential risks associated with the involved processes, materials, or
location.
- Develop strategies to mitigate risks related to the supply chain, such as disruptions, quality
issues, or changes in regulatory requirements.
- Evaluate the historical performance of the supplier in terms of on-time delivery, quality
consistency, and responsiveness to issues.
- Assess the supplier's communication and collaboration processes.
- Encourage continuous improvement by identifying areas for enhancement in the supplier's
processes.

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 REVITAL HEALTHCARE (EPZ) LIMITED Doc. No.: Z/F/02/10
L.R. No. 5025/1239 TAKAUNGU Issue Date: 15.12.2023
80100 MOMBASA, KENYA Rev. No.:00

- Collaborate with the supplier to implement corrective and preventive actions based on
audit findings.
- Verify maintenance of accurate and up-to-date documentation related to materials,
processes, and quality control.
- Evaluate the effectiveness of communication channels between the supplier and Revital
Healthcare (EPZ) Limited.

3. Audit Plan
 Within the Audit Scope, include the applicable ISO clauses, process name, task name and
task number (If applicable). If regulations or directives are applicable, then explicitly
document their coverage in the plan.
 If more than one department is being audited, it shall be clearly documented which
department is being addressed in each element listed in the audit plan.
 If the audit is conducted remotely and/or utilizes ICT technology, then the specific tools
used (e.g. Zoom) within each process must be detailed.

Date / Time Audit Scope (Process) Participants

Auditor, Expert, Auditees
Trainee
DAY 1- March 26th 2024
08:30- 09:00 EAT Opening Meeting All Process owners
Auditor and audit
Plant Visit
responsible
5.1 Management commitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.4.1 Quality objectives
5.4.2 Quality management system planning
5.5 Responsibility, authority and communication All Process owners
5.5.1 Responsibility and authority
5.5.2 Management representative
5.5.3 Internal Communication
5.6 Management review
8.4 Analysis of data
8.5.1 General / Improvement

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REVITAL HEALTHCARE (EPZ) LIMITED Doc. No.: Z/F/02/10
L.R. No. 5025/1239 TAKAUNGU Issue Date: 15.12.2023
80100 MOMBASA, KENYA Rev. No.:00

Control of Production -
7.1 Planning of product realization
7.5.1 Production control
7.5.2 Cleanliness of Product
7.5.6 Validation of processes for production and service
provision
7.5.8 Identification
7.5.9 Traceability
7.5.10 Customer property
7.5.11 Preservation of products All Process owners
8.3.4 Rework
6.3 Infrastructure
6.4 Work environment and contamination control
6.4.1 Work environment
6.4.2 Contamination control
 Identification of test equipment.
 Traceability of components.
 Test steps in production.
Documentation of verification results
Documentation & Record Management process & Product
Documentation
4.1 General requirements
4.2 Documentation requirements
All Process owners
4.2.2 Quality manual
4.2.4 Control of Document
4.2.5 Control of Record
4.1.5 Outsourced processes
Resource Management / Training
6.1 Provision of resources All Process owners
6.2 Human resources
LUNCH BREAK
Corrective Actions & Preventive Action process
8.5 Improvement
All Process owners
8.5.1 General
8.5.2 Corrective Action

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REVITAL HEALTHCARE (EPZ) LIMITED Doc. No.: Z/F/02/10
L.R. No. 5025/1239 TAKAUNGU Issue Date: 15.12.2023
80100 MOMBASA, KENYA Rev. No.:00

8.5.3 Preventive Action

8.4 Analysis of Data

8 Measurement, analysis and improvement

8.1 General
8.2 Monitoring and measurement
8.2.1 Feedback All Process owners
8.2.2 Complaint Handling
8.2.3 Reporting to regulatory authorities
Risk Management
7.1 Planning of product realization, Risk Management
7.2 Customer related process
7.2.1 Determination of requirements of the product
7.2.2 Review of requirements of the product
All Process owners
7.2.3 Customer communication
8.2.1 Customer feedback
8.4 Analysis of data
8.2.5 Monitoring & Measurement of processes
8.2.6 Monitoring & Measurement of Product
8.3 Control of Non-Conforming Product
8.3.1 General
All Process owners
8.3.2 Actions in response to nonconforming product detected
before delivery
8.3.3 Actions in response to nonconforming product detected
after delivery
7.4 Purchasing & Supplier Management process
7.4.1 Purchasing process
7.4.2 Purchasing information
All Process owners
7.4.3. Verification of purchased products
Supplier Qualification, evaluation
4.1 Outsource processes, Control of outsourced processes
Maintenance, Calibration
All Process owners
7.6 Control of monitoring and measuring equipment.
Closing meeting All Process owners

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 REVITAL HEALTHCARE (EPZ) LIMITED Doc. No.: Z/F/02/10
L.R. No. 5025/1239 TAKAUNGU Issue Date: 15.12.2023
80100 MOMBASA, KENYA Rev. No.:00

A room for the Audit Team should be provided to ensure undisturbed communication as well as
safe keeping of documents. The Auditors are accompanied by the Audit responsible during the
Audit. The Audit Plan can be adjusted during the Audit.
Opening and closing meeting are fixed.
Please note: The departments and the auditors should discuss any personal protective
equipment needed for the audit well in advance before the start of the Audit. Protective
equipment (cleanroom clothes) must be provided by the company.

I confirm that the audit plan was initially provided to the auditee on March 20, 2024. I confirm
that the auditee has the necessary infrastructure to support the audit process.

Revital healthcare(EPZ) Limited Lead Anhui Tianrun Medical Packaging Materials

Auditor Co., Ltd

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