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ISO 13485 – Medical Devices


ISO 13485 Certification

ISO 13485 is based on ISO 9001 with a particular focus on Medical devices (of course). 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 compliance.

Most industrialized countries have some form of medical device regulation i.e. 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. Enter stage right ISO 13485.

Some regulators around the world directly require certification to ISO 13485. While this is not currently a requirement in the US there is a new pilot program being implemented where medical device manufacturers are able to reduce the number of FDA inspections by being certified to ISO 13485. A June 2012 deadline has been set for this pilot program.

Putting the regulatory considerations aside, implementing an ISO management system standard into your business represents good management practice, or in the case of medical devices “Good Manufacturing Practice [GMP]”. By implementing ISO 13485, an organization becomes a better bet for their suppliers.  Not only because they have implemented important controls directly related to medical device manufacture, but also providing efficiencies and effective management through:

  • Having a documented approach to management
  • Policies, objectives, planning
  • Control of documents
  • Control of records
  • Reviews
  • Internal audits
  • Product non-conformances and continual improvement.

What about the customer in all of this? Of course the customer is also king, and all the regulations in the world make no difference to your business if you can’t attract and satisfy enough customers. Many companies can design product and promote, but it is the consistent quality and attention to customer satisfaction that brings long-term success in the market. Customer satisfaction of course is a prime goal of the ISO 13485 standard; no wonder it’s attraction to customers.

Proving yourself as a good and consistent supplier to your customer is greatly improved by certification to an ISO management system standard. As the importance of compliance and satisfaction grows, so too are the number of customers that will not work with non-ISO certified organizations. Many organizations are finding that no matter how good their product is, customers need more reassurance, they want their suppliers to be certified. And many organizations are finding that losing even one contract can well pay for the cost of implementing good management practice and getting certified. And if your management system was well documented and implemented you just might even enjoy life a little more with the knowledge that your business is in good hands and operating as it should.

As with other standards such as: ISO 9001 Quality Management Systems, ISO 14001 Environmental Management Systems and OHSAS 18001 OHS Management Systems, the requirements of each standard are designed to integrate well between each other. This means that dual certification with another management system standard is simplified.

Working with Compliancehelp to gain certification to ISO 13485 is an important step to realizing all of the above. Consider the following benefits:

  • Cost: low cost, high quality personalized work
  • Speed: up to 90 days from start to finish meaning you can stop procrastinating and start winning tenders
  • Use of internal resources: use of internal resources is minimized by our lean approach to consulting meaning every moment you spend with us is more effective
  • Quality: as a testament to our lean approach to consulting, all of our clients maintain certification to ISO standards without further need for a consultant. This alone can save $2000-$80,000 per year for a small to medium-size business. The savings just keep coming.

Give us a call and one of friendly consultants will be pleased to help you.


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