Requirements for Servicing Activities Procedure - ISO 13485

Requirements for Servicing Activities Procedure - ISO 13485

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ISO 13485:2016 QMS Template - Requirements for Servicing Activities (QMS.7.5.4-QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Requirements for Servicing Activities Procedure 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 servicing activities procedure, demonstrating robust quality management as required by ISO 13485:2016.

How Will This Template Help My Organisation?

ISO 13485 requires that if servicing of the medical device is a specified requirement, your organization shall document servicing procedures, reference materials, and reference measurements, as necessary, for performing servicing activities and verifying that product requirements are met. This template provides you with a framework to establish the requirements needed for servicing your medical device products. If your medical devices do not require servicing, then this part of the standard is not applicable.

What Are the Requirements?

Requirements for Servicing Activities can include everything your medical device or customer needs to carry out servicing, such as:

  • Whether the medical device needs to be returned for servicing or a site visit is required.
  • Whether the medical device requires decontamination prior to servicing.
  • Relevant work instructions/procedures for servicing.

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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