ISO STANDARDS
ISO 13485
Medical Device Quality Management System
ISO 13485
CERTIFICATION
ISO 13485 or Medical Device Quality Management System (MDQMS) is designed to be used by organizations involved in the design, production, installation and servicing of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help them with their auditing processes. ISO 13485 is a stand-alone QMS standard, based on ISO 9001.
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Medical device manufacturing is one of the most regulated sectors in which significant quality systems and product requirements must be satisfied. The regulatory requirements are intended to ensure that manufacturers consistently design, produce and place onto the market medical devices that are safe and fit for their intended purpose.
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Patient safety is at the very heart of ISO 13485, with its main purpose being to ensure the consistent design, development, production, storage and distribution, installation or servicing and disposal of medical devices.
BENEFITS &
REQUIREMENTS
Advantages for your organisation to achieve ISO 13485 certification through CertSure UK include:
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Improve the company’s credibility and image
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Improve your processes
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Improve decision-making
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Create a culture of continual improvement
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Better employee engagement
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Improved medical product quality control and management
The requirements of ISO 13485 include:
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Clause 1: Scope– Define the physical or service boundary to implement the MDQMS
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Clause 2: Normative References
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Clause 3: Terms & Definitions
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Clause 4: Quality Management System – General QMS requirements, as well as the documentation requirements of the standard. It includes the requirements for the Quality Manual, Control of Documents, and Control of Records, all of which are required documents in the QMS
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Clause 5: Management Responsibility - especially top management
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Clause 6: Resource Management – includes the necessity to control all resources
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Clause 7: Product Realization – The product requirements deal with all aspects of the planning and creation of the product or service. This section includes requirements on planning, product requirements review, design, purchasing, creating the product or service, and controlling the equipment used to monitor and measure the product or service. ISO 13485 allows for requirements in the section to be excluded if they are not applicable to the company (such as a company that does not design products or services)
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Clause 8: Measurement, Analysis and Improvement - includes assessing customer satisfaction, internal audits, monitoring products and processes, dealing with non-conforming product, and corrective and preventive actions
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Contact us today to see how CertSure UK and the Vault UK Group can help you achieve ISO certification quickly and efficiently