Quality Manual Template - ISO 13485

ISO 13485:2016 QMS Template - Quality Manual (QMS.4.2.2 - QM)

Enhance your Quality Management System with our ISO 13485:2016 compliant Quality Manual 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 Manual, demonstrating robust quality management as required by ISO 13485:2016.

Why Do You Need a Quality Manual?

A Quality Manual provides an introduction to your company’s scope, applicable standards, and regulations. It details the structure of your QMS, lists procedures, includes your organisational chart, and serves as a central index library for internal and external documents, records, and forms.

• For Auditors: Essential for both external and internal auditors to gain an overview and insight into your system.
• For Management Reviews: A useful starting point for your Management Review Meetings to ensure your system and scope are up to date.

What Should Be Included in the Quality Manual?

• Scope of the QMS: Clearly defined scope and justifications for any exclusions or non-applicable clauses.
• Documented Procedures: A table of documented procedures in place for the QMS or reference to the master document list.
• Process Interaction: Description of the interaction between the processes of the QMS.
• Documentation Structure: Outline the structure of the documentation used in the QMS.

Which Clause Does This Template Help With?

The Quality Manual assists in compliance with clause 4.2.2 of ISO 13485, which requires a quality manual to include all the outlined details.

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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