ISO 13485 Quality: Medical
Quality Management for Medical Device Manufacturers and Related Service Providers
ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices.
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Poor manufacturing management and processes can have dire consequences resulting in inconsistency in the quality of products, where non-conforming devices can filter through the production line and into the market.
However, when manufacturing processes are adequately managed under a quality system certified by ISO 13485, medical device manufacturers are better equipped to ensure that quality system requirements positively influence and protect all phases in the medical device life span.
What is ISO 13485?
ISO 13485:2003 is the international standard that defines quality management system requirements for organizations that design and develop, manufacture, install and service medical devices and design, develop, and provide related services, including manufacturers of materials or component parts that are used in medical devices. The primary objective of the standard is to facilitate harmonized quality management system requirements for regulatory purposes within the medical device sector.
It is derived from the same basic principles as ISO 9001, but places additional emphasis on areas such as documentation, the work environment, risk management, design control and medical device reporting to meet regulatory requirements.
ISO 13485:2003 also provides an effective base model for compliance with:
Benefits of ISO 13485 Certification
ISO 13485 certification from LRQA provides organizations a process-based approach towards developing, implementing and improving the effectiveness of a quality management system in order to meet customer and global regulatory requirements.
When applied to the manufacturing process, ISO 13485 certification helps ensure strict quality assurance criteria on every aspect of production, resulting in a tightly controlled manufacturing system that reduces the likelihood of non-conforming products. This provides consistency in product quality and provides a solid basis for greater reliability in device safety and performance.
Perhaps the most critical advantage of ISO 13485 is that it represents a preventive approach to assuring medical device quality as opposed to a reactive approach to inspection and rejection at the end of the manufacturing line.
In addition, ISO 13485:
is recognized globally as the best quality practices within the medical device industry
• meets regulatory requirements in many countries, as well as contractual obligations of many organizations, enabling you to do business with new customers
helps create a systematic framework in which organizations monitor, measure and analyze their processes and customer feedback
helps provide a framework for implementation of actions (where necessary) to ensure achievement of planned results and to ensure maintenance of effectiveness of those processes with applicable customer, quality and regulatory requirements
can provide improved performance in areas such as sales, product delivery, and process efficiency
can reduce costs as a result of minimizing product failures
Why Choose LRQA?
LRQA has been globally recognized for over 25 years and operates in over 120 countries, and our services to the medical device manufacturing community are unparalleled.
We are an internationally accredited and recognized Registrar / Notified Body offering quality management system and compliance assessment, registration and certification services to the global medical device industry, certifying many of the world’s leading medical companies around the world to ISO 13485, MDD and IVD.
Our medical assessors are industry specialists and experts who understand the requirements of ISO 13485 and its impact on your critical manufacturing processes; our assessors are matched with your business needs, enabling an effective and robust assessment to help ensure your organization operates based on internationally recognized best practices in medical device manufacturing.
Our Business Assurance approach ensures our assessments focus on the areas and issues that are important to your business. As the first certification body to gain accreditation for issuing quality management system certificates, we understand system requirements and can therefore tailor our approach to help meet your objectives.
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