Quality manual, ISO 13485 and MDR, free template

The European regulation for medical devices requires manufacturers to write and maintain a quality manual that documents the quality management system implemented, as specified in Regulation (EU) 2017/745, Chapter I.2.2 and Annex XI.A.6.2 :

All the elements, requirements and provisions adopted by the manufacturer for its quality management system shall be documented in a systematic and orderly manner in the form of a quality manual and written policies and procedures such as quality programmes, quality plans and quality records.

In this article, you will find a quality manual template conforming to the requirements of Regulation 2017/745 and EN ISO 13485:2016 + A11:2021.

👉 This quality manual template can be set up according to your activities and products, using Qualitio online templates.

General information

Presentation of the company

Example:

(Name of your company) is a company created in XXXX. It creates, develops and markets innovative medical devices on the market of (your industry).

• Organisation: See the document “Organisation chart of the company”.
• Market: (by country and/or by zone: EU, US…)
• Customers: the devices are sold to (your customers: hospitals, individuals, health professionals, other MD manufacturers, etc.)
• Our mission: to provide (your users) with products that guarantee a high level of (e.g. quality, safety, performance), to enable them to (the purpose of use of the device, its clinical benefits).
• Our capabilities: (describe your main activities e.g. design, market, maintain) a (the type of device you offer).
• Address: (your postal address)

Regulatory role(s) of the company

Within the framework of the applicable regulatory requirements, the company assumes the role of :

Example:

Role of the manual and scope of the QMS

Role of the quality manual

This quality manual contains the activities undertaken by (your company name) to fulfil our commitments to our customers and the applicable regulations.

It has been written so that all parties involved (e.g. customers, staff, authorities, shareholders, suppliers) can easily understand our organisation.

Scope of the QMS

Example:
The QMS scope includes the activities of design, production, distribution, installation, maintenance, eliminationof (the reference or family of your devices).

ISO 13485:2016 requirements not applicable

The following table identifies the requirements of ISO 13485:2016 that are not applicable to our company and justifies these non-applicabilities :

Example:

ISO 13485:2016 requirements excluded

Example :

Management commitment

Management commitments and references to evidence of implementation are summarised below :

Example :

Quality policy

The quality policy includes :

• Compliance with regulatory requirements,
• Maintaining the effectiveness of the QMS, and
• The improvement of products and activities through monitoring activities.

The quality objectives are derived from this policy.

Example :

Our Quality Management System has been defined to comply with the applicable regulatory requirements for medical devices:

• Regulation (EU) 2017/745;
• National regulations “XXXXXX”.

Our policy is to serve the patient, to propose innovative devices using the latest advances in (your technical branch) to be able to (summary of intended use) and thus bring (summary of patient benefits) to the patient.

The implementation of this policy is based on the quality system put in place founded on:

• Customer satisfaction,
• Compliance with regulatory and legal requirements,
• Staff involvement and
• The sustainability of the company.

Quality objectives

The quality objectives are broken down by process and are associated with indicators described in the document “Table of quality objectives”.

Risk-based approach

The company applies a risk-based approach to the control of its activities. The resources implemented are proportionate to the level of risk assessed according to appropriate criteria.

This risk-based approach is detailed in the ▶️ Procedure • Risk-based approach.

Process approach

The processes are described in the “Process sheets”.

Interactions/Process mapping

Example:

Process management

The methods used to ensure the effective operation and monitoring of processes use indicators described in the “Quality Objectives Table” document and are based on, but not limited to:

Example:

• Meetings;
• Internal audits;
• Management reviews; and
• Any other useful means.

Resources

Management makes every effort to ensure the availability of resources.

These resources include :

• Human resources, the management of which is described in ▶️ Procedure • Human Resources Management.
• Infrastructure and working environments, the management of which is described in ▶️ Procedure • Infrastructure and Working Environment.
• Purchases, the management of which is described in ▶️ Procedure • Purchasing Management.
• The information necessary for the operation and monitoring of the processes is available through the documents and records managed in accordance with the ▶️ Procedure • Document Management procedure.

Outsourced processes

The outsourced processes having an impact on product conformity are monitored and controlled according to the ▶️ Procedure • Measurement, Analysis and Improvement and ▶️ Procedure • Purchasing Management.

Where applicable: arrangements are contracted with the subcontractor.

List of QMS documents

The list of QMS documents is recorded in document XXX which contains the following fields:

Example :

• Type (procedure; review; operating mode; report; form; indicator; guide; list…);
• Reference;
• Title;
• Current version;
• Date of application;
• Location of the original;
• Location of copies;
• Retention period of outdated versions;
• Retention period of associated records;
• Method of destruction.

Document structure

The document system is organised as follows :

• The Quality Manual describes the Quality Management System;
• The Procedures describe the breakdown of the process and guarantee its quality;
• The Work Instructions and Operating Procedures describe the tasks of the process;
• The Forms and Documents are the media used to record data;
• The Records are used to provide evidence of conformity to requirements and effective operation of the quality management system.

The identification of records is described in the ▶️ Procedure • Document Management.

Management review

Management reviews the QMS according to ▶️ Procedure • Management Reviews to ensure that it is still appropriate, adequate and effective.