ISO 13485 Quality: Medical
Quality Management for Medical Device Manufacturers
ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of medical devices.
When medical device manufacturers are active in the world market, the focus on international standards like ISO 13485 is not only advantageous - it may be stipulated by customers or legislations; therefore, a number of countries have incorporated ISO 13485 into their regulatory systems because compliance with this standard can be used in support of regulatory compliance.
LRQA is 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 hundreds of medical companies around the world to ISO 13485.
What is ISO 13485?
ISO 13485:2003 is an international standard that defines quality management system requirements for manufacturers of 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 9001:2000. In particular, the requirements for customer satisfaction and continual improvement have been modified to make them more appropriate for regulatory purposes.
ISO 13485:2003 provides an effective base model for compliance with the European Directives (MDD - 93/42/EEC; IVDD - 98/79/EC); Canadian Medical Device Regulations; and requirements of other regulatory bodies located in countries around the world.
For further detail, copies of the ISO 13485 standard can be obtained from www.iso.org.
Benefits of ISO 13485 Certification
Certification to the quality management system standard ISO 13485 provides medical device organizations a process-based model and approach towards developing, implementing and improving the effectiveness of a quality management system in order to meet customer and global regulatory requirements.
In addition, ISO 13485:
Is recognized globally as the best quality practices from organizations within the medical device industry
enables you to work within many countries where it is a regulatory requirement and with many organizations where it is a contractual obligation or expectation
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 measurable in key metric areas such as increased sales, increased timeliness in getting products to the global marketplace, reduced costs, fewer errors, less waste, better use of time and resources and lower product failures
Why Choose LRQA?
Respected and world renowned for our market leading assurance services for over 20 years, many of the world’s leading medical companies choose LRQA.
Our medical assessors are industry specialists and experts who are matched with your business needs, enabling an effective and robust assessment of your systems and processes.
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.
Beyond certification, LRQA provides an extensive range of services to support your business’ future growth and development, including training solutions and integrated management systems assessment.
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