Quality Policy Template - ISO 13485

Quality Policy Template - ISO 13485

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ISO 13485:2016 QMS Template - Quality Policy (QMS.5.3.0 – QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Quality Policy template, expertly crafted by the professionals at Patient Guard. Our Medical Device Quality Assurance and Regulatory Affairs document templates are developed by experienced experts, ensuring they meet the specific requirements of each clause and section of the relevant standards or regulations.

Why Choose Our Template?

  • Expertly Designed: Created by seasoned Quality Assurance and Regulatory Affairs specialists, our templates ensure full compliance with ISO 13485:2016 standards.
  • Easy Customization: Fully editable in Microsoft Word, our templates allow you complete control to modify and tailor them to your specific business needs and branding.
  • Compliance Assurance: Utilizing our template helps you maintain an effective Quality Policy, demonstrating robust quality management as required by ISO 13485:2016.

What is a Quality Policy?

A Quality Policy is a document within the Quality Management System (QMS) that should state your organisation's:

  • Purpose and strategic direction
  • Framework for Quality Objectives
  • Commitment to any applicable statutory and regulatory requirements

The Quality Policy Template will aid top management in developing this policy to express these directives.

How Does the Quality Policy Fit Into the QMS?

The Quality Policy forms part of your evidence demonstrating your compliance with clause 5 of ISO 13485, along with other documents such as:

  • The Management Responsibilities Procedure
  • The Quality Objectives
  • The Management Review Meeting Procedure

This template ensures that the Quality Policy is relevant to your organisation, aligns with your objectives, and fits within the scope of the QMS.

How Will Having a Quality Policy Help My Organisation?

The Quality Policy serves a pivotal role within your organisation’s QMS and contributes to the business’s commitment to quality. It:

  • Defines the main purpose of your QMS, guiding quality-related decisions and actions within its scope.
  • Acts as a primary driver for continuous improvement within your QMS and organisation.
  • Should be approved by top management and accessible to everyone within the organisation. It can also be shared with interested third parties or displayed on your company’s website to highlight your dedication to quality.

Why Patient Guard?

Stay ahead with Patient Guard’s consultancy services, offering a cost-effective solution for all your Quality Management System needs. For more templates and services in Medical Device Quality Assurance and Regulatory Affairs, or to provide feedback, contact us at qmsregs@patientguard.com.

Visit our blog for updates on regulatory and quality assurance news, and take the next step in enhancing your Quality Management System with Patient Guard.

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