CRITERION TECH PRIVATE LIMITED

PROJECT PLAN
for Implementation of the Quality Management System

Code:

Version: 0.1

Created by:

Approved by:

Date of version:

Signature:
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Change history
Date Version Created by Description of change

0.1 13485Academ Basic document outline

y

Table of Contents
1. PURPOSE, SCOPE AND USERS................................................................................................................3
2. REFERENCE DOCUMENTS......................................................................................................................3
3. QMS IMPLEMENTATION PROJECT......................................................................................................3
3.1. PROJECT OBJECTIVE..........................................................................................................................3
3.2. PROJECT RESULTS..............................................................................................................................3
3.3. DEADLINES...........................................................................................................................................4
3.4. PROJECT ORGANIZATION.................................................................................................................5
3.4.1. Project sponsor...............................................................................................................................5
3.4.2. Project manager.............................................................................................................................5
3.4.3. Project team....................................................................................................................................5
3.5. MAIN PROJECT RISKS........................................................................................................................5
3.6. TOOLS FOR PROJECT IMPLEMENTATION, REPORTING............................................................6
4. MANAGING RECORDS KEPT ON THE BASIS OF THIS DOCUMENT...........................................6

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1. Purpose, scope and users

The purpose of the Project Plan is to clearly define the objectives of the Quality Management System
(QMS) implementation project, documents to be written, deadlines, and roles and responsibilities in
the project.

The Project Plan is applied to all activities performed in the QMS implementation project.

Users of this document are members of top management and members of the project team.

2. Reference documents
 ISO 13485:2016 standard
 ISO 9001:2015 standard
 Medical Device Regulation 2017/745 (MDR)
 [decision or any similar document prescribing project launching]
 [methodology for project management]

3. QMS implementation project

3.1. Project objective

To implement the Quality Management System in accordance with the ISO 13485:2016 standard by
[date] and become compliant with the EU MDR 2017/745 by [date] at the latest.

3.2. Project results

During the QMS implementation project, the following documents (some of which contain appendices
that are not expressly stated here) will be written:
 Quality Manual – basic document that demonstrates how the organization meets the
requirements of the QMS and references to procedures
 Quality Policy – basic document that provides a framework for establishing and reviewing
Quality Objectives
 Quality Objectives –document in which the objectives of the organization are stated, and a
plan for their realization
 Procedure for Document and Record Control – procedure prescribing basic rules for
writing, approving, distributing and updating documents and records
 Procedure for Human Resources – procedure prescribing basic rules for management of
human resources

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 Procedure for Infrastructure and Work Environment – procedure defining requirements

for infrastructure and work environment
 Procedure for Risk Management – defines risk management process and methodology for
risk assessment
 Sales Procedure – procedure that defines the sales process and responsibilities within this
process
 Procedure for Customer Communication, Feedback and Complaints – defines process of
communication with customers, gathering feedback, and handling customer complaints
 Procedure for Design and Development – procedure prescribing the whole process of design
and development from provision of resources to release of product or service to production or
market
 Procedure for Purchasing and Evaluation of Suppliers – defines how to evaluate and select
suppliers and how to execute the purchasing process and inspection of receiving product
 Procedure for Production and Service Provision – describes how the production and
service provision process is managed
 Procedure for Sterile Medical Devices – defines process of sterilization of the products
 Procedure for Validation of Computer Software – describes the activities for the
documentation and validation of computer software used in the Quality Management System
and production and service provision
 Warehousing Procedure – defines all necessary activities regarding the warehousing
process.
 Procedure for Control of Non-Conforming Product – prescribes how to report and handle
non-conforming product
 Procedure for Adverse Event Investigation and Reporting – describes reporting,
investigating, and communicating of adverse events and notification of complaints that meet
specified reporting criteria of adverse events
 Procedure for Equipment Maintenance and Measuring Equipment – describes the
process of maintaining equipment and measuring equipment
 Procedure for Post-market Surveillance – describes how to implement and conduct the
process for post-market surveillance according to the MDR
 Procedure for Clinical Evaluation – describes how to conduct clinical evaluation,
responsible persons, and necessary reporting according to the MDR
 Technical File Procedure – describes how to prepare a Technical File according to the MDR
 Procedure for Internal Audit – defines how auditors are selected, how audit programs are
written, how audits are conducted and how audit results are reported
 Procedure for Corrective and Preventive Action – describes the process of implementation
for corrective and preventive actions
 Procedure for Management Review – prescribes how to review the QMS in order to ensure
its continuing adequacy, suitability and effectiveness.

The documents need to align with the ISO 13485 standard requirements and should incorporate the
practices of the organization. Where the practices of the organization do not meet the ISO 13485
standard requirements, the practices will need to be modified.

3.3. Deadlines

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Deadlines for acceptance of individual documents in the course of QMS implementation are as
follows:

Document Deadlines for document

acceptance

Final presentation of project results is planned for [date].

3.4. Project organization

3.4.1. Project sponsor

Each project has an assigned "sponsor" who does not actively participate in the project. The project
sponsor must be regularly briefed by the project manager about the project status, and intervene if the
project is halted.

[Name, job title] has been appointed project sponsor.

3.4.2. Project manager

The role of the project manager is to ensure resources necessary for project implementation, to
coordinate the project, to inform the sponsor about the progress, and to carry out administrative work
related to the project. The project manager's authority should be such as to ensure uninterrupted
project implementation within set deadlines.

[Name, job title] has been appointed project manager.

3.4.3. Project team

The role of the project team is to assist in various aspects of project implementation, to perform tasks
as specified in the project, and to make decisions about various issues that require a multidisciplinary

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approach. The project team meets each time before the final version of a document from section 2 of
this Project Plan is completed, and in all other cases when the project manager deems it necessary.

Table of participants in the project

Name Organizational unit Job title Phone E-mail

3.5. Main project risks

The main risks in the implementation of the project are the following:
1. Extension of deadlines in phase of establishing process approach
2. Extension of deadlines during forming process procedures
3. Extension of deadlines due to bad selection of exclusions from the ISO 13485:2016 standard

Measures to reduce the above-mentioned risks are the following:

 The project manager monitors that all activities in the project are performed within defined
deadlines, and seeks intervention by the project sponsor in a timely manner.
 Hiring a consultant to ensure that time or resources are not spent on activities that are not
important for the project, and that individual activities are not headed in the wrong direction.

3.6. Tools for project implementation, reporting

A shared folder including all documents produced during the project will be created on the local
network. All members of the project team will have access to these documents. Only the project
manager [and members of the project team] will be authorized to make changes and delete files.

The project manager will prepare a project implementation report on a monthly basis and forward it to
the project sponsor.

4. Managing records kept on the basis of this document

Storage
Record name Code Responsibility
Retention
Location Protection
time

Shared folder Only the project

Project
for project- manager is Project
implementation report 00 3 years
related authorized to edit manager
(in electronic form)
activities data

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[job title]
[name]

_________________________
[signature]

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