The Most Common ISO Certification For Medical Device Manufacturers

The medical device manufacturing industry is perhaps an industry where quality management is most consequential for human life. Maintaining quality standards is important for all industries to ensure uniformity and conformity in service.

While ISO 9001: 2015 is commonly used by all industries as a set of general standards to be maintained in products or services, there is a certification that caters to the special case of medical devices.

ISO 13485 is a certification specifically devised for businesses that want to prove they have effectively developed, implemented, documented, and improved their policies and systems to ensure uniform conformity and safety of their medical equipment.

A medical oximeter attached to the index finger of a hand

ISO 13485: A Refinement Of ISO 9001

ISO 13485 certification is acquired to guarantee that a company develops high-quality clinical products with reliable warranties. ISO-accredited companies directly benefit from the certifications as they reduce their product loss, reform organizational hiccups, generate trust amongst customers, and opens new doors for the business.

While ISO 9001 already lays down comprehensive terms for companies to meet international standards generally, ISO 13485 specially addresses the nuance and complications in the medical device manufacturing industry.

How Does A Company Get ISO 13485 Certified?

Upon deciding for a business to get ISO certified, the company focuses on its quality management system (QMS) and uses ISO standards as a blueprint for its improvement.

Planning And Implementing A QMS Reform

A successful QMS addresses gaps in training, procedural delays and how to reduce them, production costs, standardization of quality products, etc. As a plan is implemented, medical devices also need to meet the approval standards of the FDA as per its 21 CFR 820 charter.

The company will want to hire a certification consultant while developing and implementing a plan for QMS. The consultant should be hired based on their prior experience with medical device manufacturers.

Document The Processes

One of the main goals of implementing a QMS is to have the data to replicate a successful cycle. Optimizing the company’s processes helps standardize product quality and make it consistent. Documenting, in this case, is very crucial to have the policy and implementation methods in a sketch.

Everything from the training schedules and employee reports to success metrics and production processes has to be put on paper in detail. There is hardly any trivial information for the documentation process.

 A group of people discussing charts.

When you hire auditors later, they will refer to your documentation to determine whether you qualify for ISO certification.

Hire An Auditing Firm

ISO 13485 certification auditors are accrediting sources that analyze a company’s QMS to determine whether it meets ISO standards, after which the company is certified upon conformity. Choose your auditors carefully and ensure that the auditors are ISO accredited to perform this audit. Use their websites to see their experience and whether they have worked with similar clients before.

Benefits Of ISO 13485 Certification

Reliable Manufacturing

When products meet ISO standards, they are marketed with their certification, having the backing of a reputable quality standard. This makes the company and its products reliable players in the market. The company can open a business in other markets since ISO is an internationally recognized standard.

Customer Satisfaction

Medical device manufacturers also benefit from ISO 13485 because customers are more satisfied with their services. Good and consistent service coupled with an efficient QMS brings the business to attention for its exceptional performance as a service provider. Customer satisfaction drives more sales and increased revenue.


A Culture Of Accountability

Having policies and processes noted down within the company makes them official terms that all employees have to abide by. This creates a culture of accountability where all individuals, teams, and departments work to ensure a goal is met. Frequent audits also ensure that the service is consistent with no slacks.

Employee Satisfaction

Having employees engaged toward a similar goal boosts the morale of the team. Availability of training and opportunities for growth are sought by most employees today. With ISO 13485 certification, their credibility in their respective fields is also validated. High employee satisfaction is a great achievement for any business because it helps retain and bring in new talent.

ISO 13485 verifies the processes and products of medical device manufacturers to bring them new business opportunities in the complex global market of the present.

Blood glucose measuring device.

Get Certified

We are an ISO-accredited certifying body that provides ISO 9001, 13485, 14001, and 45001 certification audits to business clients in various industries.

Our associates have years of experience in auditing according to the ISO standard without having a quota for non-conformity, meaning your business gets certified as soon as you meet the standard and requirements. Contact us now to get started.

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