ISO 9001 & ISO 13485 Certification: A Professional’s Future

ISO 9001 and ISO 13485 certification both offer significant benefits to an individual. We’ve covered ISO 9001 certification in great detail on our blog before. ISO 13485 certification, according to the International Organization for standardization, covers quality management for medical devices. It’s immediately apparent that these certifications may be linked. ISO 13485 certification can trace its roots back to the ISO 9001 standard, but the processes used within the standard are defined specifically for medical devices. If someone were to be qualified with both ISO 9001 and ISO 13485 certification, they would be an asset to their business. But what would their future be if they leave the company?

Trained Staff Is Crucial for ISO Certification

If a business is trying to achieve ISO certification, it needs to start with qualified personnel. Several companies have put a lot of time and effort into educating and training their employees to take up positions as internal auditors. These auditors are a crucial part of the certification process. In ISO 13485 certification, a business must constantly inspect its products to ensure they meet a certain minimum standard. As with most ISO certification processes, the idea is to establish a system of self-improvement within the manufacturing process. Most individuals who have had experience with the ISO certification system would have immediately spotted the process flow of the Plan-Do-Check-Act (PDCA) cycle. Unfortunately, this isn’t immediately obvious to a new trainee.

A professional with both ISO 9001 and ISO 13485 certification can be a priceless addition to any business seeking its own accreditation. Aside from being a pillar of the business’s certification push, the expert can guide others to becoming auditors themselves. It’s crucial to have someone who understands the process of ISO certification within a company’s hierarchy. Without this intimate knowledge of the standard, a business risks making mistakes. While this might not seem like a massive deal in the grander scheme of things, these mistakes can take a toll on a company. Minor errors in implementing a standard could have severe knock-on effects in terms of cost and time. Achieving certification can take a lot longer if the business isn’t sure what it’s doing.

ISO 13485 Certification Requires Constant Monitoring

Both ISO 9001 and ISO 13485 certification have self-improvement as a core function of the standard. Trained personnel know how to best apply the tenets of the standards towards improving the business’s processes regarding quality. ISO 9001 helps develop a quality management system (QMS) that the company can rely on in a general sense. ISO 13485 certification focuses on medical device production specifically. In tandem, they could make a business globally competitive, but only if it has a qualified person to guide them towards achieving this goal.

Constant monitoring forms a core part of all ISO standards. Self-improvement and internal audits are helpful in determining where the company’s shortcomings are. With skilled, trained personnel dedicated to performing audits, a business can reliably find its weaknesses and shore them up. The goal of implementing and ISO standard is to allow a business to be competitive globally. To maintain this competitiveness over the long term and retain certification requires trained staff. But internal personnel need to have support from consultants. There’s such a thing as being too close to the forest to see the trees, after all.

External Help Can Be Useful

As with most certifications, it may be impossible to achieve relying entirely on internal personnel. ISO 9001 and ISO 13485 certification requires external auditors to verify the business’s attempts before becoming certified. SyncResource has been offering support to businesses on the road to ISO certification for years. Contact us today to get professional guidance on achieving the elusive goal of ISO 13485 certification.

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founder of sync resource

About Author

Sunita Verma, Founder and President of Sync Resource started the company in 2009 with a vision to provide management consulting to small & medium size businesses around the country.
Sunita holds a Master’s Degree in Mechanical Engineering from Cleveland State University, Cleveland, Ohio, Bachelors in Mechanical Engineering(India) with prestigious gold medal by then President of India and renowned Scientist Dr. A.P.J. Abdul Kalam.
As an active philanthropist she believes in pay it forward and is a contributing member of charitable organizations like St. Jude’s Foundation and North Fulton Charities.


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