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ISO 13485:2016 Certification
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ISO 13485: 2016 is an international standard that represents the requirements for a comprehensive quality management system for the design and manufacture of medical devices. Though it is tailored to the industry’s quality system expectations and regulatory requirements, an organization does not need to be actively manufacturing medical devices or their components to seek certification to this standard. ISO 13485: 2016 applies to the design, development, production, installation and servicing of medical devices. Compliance is a measure of your ability to meet customer and legal requirements.
ISO 13485 is an internationally recognized standard of quality, which articulates the stringent requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. Based on better-known ISO 9001 standards, ISO 13485 requires heightened attention to the regulatory requirements associated with the design, development and manufacture of medical devices. Proven Process first earned its ISO 13485 certification in 2002.
The standard ISO 13485:2016 was created specifically for medical devices and supplies and is based on ISO 9001. The standard has been made into a tool for the manufacturer to use in creating preconditions through which to cater for the regulatory safety and performance necessities as well as client requirements at various stages of product life.
Medical Device component manufactures, finished good manufactures, Medical Software developers, Medical Device designers and Developers and pharmaceutical suppliers interested in enjoying worldwide presence has to prove there plans are manufactured under certain auditable standards which means itâs safe and effective. ISO 13485:2016 Certification is a solution for this issue.
Benefits of ISO 13485 Certificate
- Ability to win more business â particularly where procurement specifications require certification as a condition to supply in a highly regulated sector.
- Proven business credentials â through independent verification against recognized standards
- Reduced operating costs â through continual improvement of procedures and resulting operational efficiencies
- Improved stakeholder relationships â including staff, clients and suppliers
- Customer satisfaction â through delivery of products that consistently meet customer requirements as well as quality, safety and legal necessities
- Legal compliance â by understanding how statutory and regulatory necessities impact the organization and its clients
- Improved risk management â through greater consistency and traceability of products and use of risk management techniques
- ISO 9001:2015 Certification
- ISO 14001:2015 Certification
- ISO 18001:2007 Certification
- ISO 27001:2013 Certification
- ISO 13485:2016 Certification
- CE Marking Certification
- TS 16949 Certification
- SA 8000 Certification
- ISO 22000:2005 Certification
- Six Sigma
- RoHS Certification
- Total Quality Management
- IEC 17025 Certification
- GOST R Certification
- GMP Certification
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RoHS is a result of the Waste Electronic and Electrical Equipment (WEEE) Directive, which addresses end of life issues on electrical components.Read More
Six Sigma is one of the most important developments in the field of business improvement. It is one of the most over-hyped and misunderstood initiatives.Read More
GOST R Certification
GOST is the Russian word for “norm”, and R stands for Russia. For most products, certification is required if you wish to sell them in Russia.Read More