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Quality Manual

Use this Quality Manual template to define and communicate your organization’s Quality Management System (QMS) structure, quality policy, objectives, and key processes as required by ISO 13485 and related medical device standards. This document is essential for demonstrating regulatory compliance, establishing company-wide quality expectations, and should be completed and maintained as a foundational step in your QMS implementation or certification process.
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Quality Manual

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1. Purpose

The Quality Manual describes the Quality Management System (QMS), its documented procedures or reference to them, and a description of the interaction between the processes of the QMS. The quality manual is used to communicate the company’s quality policy and objectives to the organization and to provide an overview of the quality management system.

2. Scope

The QMS described in this Quality Manual applies to all products of the manufacturer and applies a risk based approach to the control of the appropriate processes needed for the quality management system.

3. Applicable Standards

The following standards are considered applicable to the QMS:

  • ISO 13485:2016 Medical devices - Quality management systems - Requirements for regulatory purposes
  • ISO 14971:2019 Medical devices - Application of risk management to medical devices
  • IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices

4. QMS Exclusions

The following sections of ISO 13485:2016 will be excluded due to the product characteristics:

  • 7.5.5 Particular requirements for sterile medical devices
  • 7.5.7 Particular requirements for validation of processes for sterilization and sterile barrier systems
  • 7.5.9.2 Particular requirements for implantable medical device

5. Company

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6. Quality Policy and Objectives

6.1 Quality Policy

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6.2 Quality Objectives

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7. Processes

The quality management system contains procedures that comply with the regulatory requirements listed in this manual.

  • Control of documents
  • Control of records
  • Management review
  • Human resources
  • Infrastructure
  • Work environment
  • Design and development (System, Hardware, and/or Software)
  • Customer-related processes
  • Design verification and validation
  • Purchasing
  • Traceability
  • Measurement, analysis and improvement
  • Control of non-conforming product
  • Internal audit
  • Corrective and preventative action
  • Feedback and complaint handling
  • Improvement

8. Process Management

To ensure that the quality management system and its processes are effective, the process will be evaluated at regular interviews through:

  • internal audits;
  • management reviews;
  • other means found to be useful

9. Process Interactions

The diagram below provides an overview of the interactions between the QMS processes.

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10. Responsibility, Authority and Communication

10.1 Management

Top management is responsible for ensuring that the quality policy and objectives are established and that the QMS is communicated to the organization. Additionally, they shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. Top management shall document the interrelation of all personnel who manage, perform and verify work affecting quality and shall ensure the independence and authority necessary to perform these tasks.

The management team is defined in the table below:

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10.2 Quality Management

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Top management shall appoint a member of management who, irrespective of other responsibilities, has responsibility and authority that includes:

  • ensuring that processes needed for the quality management system are documented;
  • reporting to top management on the effectiveness of the quality management system and any need for improvement;
  • ensuring the promotion of awareness of applicable regulatory requirements and quality management system requirements throughout the organization.

Relevant Documents

All documents related to QMS processes including their references to the appropriate sections of ISO 13485:2016 that they satisfy can be found in the Quality Management System Document Traceability Matrix.

Medical Device Certification Made Easy.