Medical Devices Quality Management Systems
ISO 13485 is based on ISO 9001 with a particular focus on medical devices. The United States has the highest uptake of ISO 13485 in the world commanding 30% of all certifications worldwide. Quite an accomplishment and it shows that the USA is leading the way in.
Most industrialized countries have some forms of medical device regulation, i.e., the US Food and Drug Administration [FDA]. Before this standard, there was no single standard to harmonize the regulations for quality management systems globally making exporting difficult and precarious.
Some regulators around the world directly require certification to ISO 13485. While this is not currently a requirement in the US, there is a US law that is similar in almost all aspects to ISO 13485, which is 21 CFR Part 820. Most US companies looking to send product outside of the US will also get ISO 13485 Certification.
Putting the regulatory considerations aside, implementing an ISO medical management system into your business represents good management and manufacturing practice.
By implementing ISO 13485, an organization becomes a better bet for their suppliers. Not only have they implemented important controls directly related to medical device manufacturing, but also they have provided efficiencies, effective management and training.
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