Control of Measuring and Monitoring Equipment Procedure - ISO 13485

ISO 13485:2016 QMS Template - Control Measurement and Monitoring Equipment Procedure (QMS.7.6.0 - QP)

Enhance your Quality Management System with our ISO 13485:2016 compliant Control Measurement and Monitoring Equipment 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 effective control over measurement and monitoring equipment, demonstrating robust quality management as required by ISO 13485:2016.

How Will This Template Help My Organisation?

This template will assist your organisation in documenting procedures to ensure the appropriate calibration and maintenance of equipment used in all components, manufacturing processes, subassemblies, and final assemblies that affect product quality. It covers:

• Comprehensive Coverage: Includes all equipment used in product realisation, whether held by your organisation or subcontractor manufacturers/suppliers.
• Supplier Integration: Allows subcontractors/suppliers to provide their control of measurement and monitoring equipment documentation, which can be integrated into quality agreements.
• Procedure Implementation: Ensures equipment is calibrated or verified at specified intervals, adjusted as necessary, and protected from damage and deterioration during handling, maintenance, and storage.

What Are the Requirements of the Standard?

The ISO 13485:2016 standard requires your organisation to document procedures that:

• Monitoring and Measurement: Determine the monitoring and measurement activities to be undertaken.
• Equipment Requirements: Identify the monitoring and measuring equipment needed to provide evidence of conformity for your medical device.
• Validation: Ensure monitoring and measurement processes are carried out in line with requirements, including validation of computer software used for monitoring and measurement.

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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