Requirements for the Cleanliness of Product Procedure - ISO 13485

ISO 13485:2016 QMS Template - Requirements for the Cleanliness of Product (QMS.7.5.2 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Requirements for the Cleanliness of Product 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 cleanliness procedure, demonstrating robust quality management as required by ISO 13485:2016.

When Do I Need to Establish Requirements for the Cleanliness of My Medical Device?

 The ISO 13485 standard requires that your organization document requirements for product cleanliness or contamination control if:

• The product requires cleaning by your organization prior to sterilization or use.
• The product is supplied to users in a non-sterile condition but must undergo a cleaning process before sterilization or use.
• The product cannot be cleaned before sterilization or use, but its cleanliness is crucial when in use.
• The product is supplied to customers to be used non-sterile, but its cleanliness is crucial when in use.
• Process agents must be removed from your product during manufacture.

How Do I Use This Template?

This template will help you produce a procedure that establishes your organization’s requirements for cleaning products before use, depending on the type of device provided to the end user. You can use information from your Design and Development Process (see QMS.7.3.0 – Design and Development Process) to establish the need for product cleanliness and create work instructions or procedures to ensure these requirements are met.

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.

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