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ISO 13485
Achieving and maintaining certification
When manufacturers are active in the world market, the focus on global or international standards like ISO 13485 is not only advantageous - it may be stipulated by 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 over 130 organizations and over 190 sites to ISO 13485.
What is ISO 13485?
With very few exceptions, 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.
How can certification to ISO 13485 benefit my organization?
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
How can we gain certification to ISO 13485?
We provide a range of services, including assessment and training courses, to prepare you for certification. Our certificates are truly earned and are a reliable and transparent symbol of management achievement and a commitment to continual improvement.
- Contact one of our business advisors at 866-563-4654.
- Alternatively, complete the inquiry form on this website.
Our assessment process involves these primary stages:
Why Choose LRQA?
At LRQA, we are passionate about what we do, and we understand what's at stake for your business. We work hard to apply our expertise to make your management systems more efficient and effective. This is why we are one of the world's most trusted management system assessment companies providing assurance for your business and in turn, your clients.
- Reputation and Experience – We have issued over 135 approvals at more than 190 sites to the ISO 13485 standard. We are recognized and respected worldwide for our own high standards of technical competence, impartiality and independence.
- Assessor Expertise – We use a unique qualification coding system that matches our assessors' industry knowledge and expertise with your business needs enabling them to conduct an effective and robust audit of your system.
- Assessment Methodology – Our assessments focus on the area and issues that are important to your business. We view the process as more than just certification; we view it as a Business Assurance process that helps you assure key stakeholders that you can deliver on the promises and goals you make.
- Assessment Reports – We will provide helpful and insightful overviews in the Executive Summary, tracking of improvements in key areas in the Continual Improvement logs, and advanced views of your long term assessment plan.
- Extensive range of services – We can provide your organization with assessment, certification and verification services to support your organization's future growth and development. In addition, our comprehensive training courses offer the tools you need to prepare, implement, maintain and improve your management system.
- Integrated Assessments – We will work with you to reduce costs through the effective integration of management system assessments.
- Global Capabilities – We have over 2,000 employees offering assessments in over 30 languages. We operate a single system worldwide, which ensures that our certification process is consistent from any of our offices around the world.
LRQA Business Assurance Approach
Our Business Assurance approach to management systems assessment and reporting is unique; it's an approach that enables you to demonstrate how your system is helping to drive your business forward in a measurable and verifiable way. We believe that building trust stretches far beyond the issuing of certificates. It's about us enabling you to deliver on your promises, to be confident in your capabilities and to stand out from the crowd.
Through Business Assurance, we can help you determine whether your management system:
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