What are the biggest challenges of  ISO 13485 implementation in your business?

These challenges can be separated into two broad categories:

(1) Hurdles faced by building Quality Management Systems in general; and
(2) Challenges in ISO 13485 implementation in specific. These are troubles you face if you’re involved in any stage of the medical device life cycle

Challenges of QMS Implementation

Here are three of the biggest challenges in ISO 13485 implementation no matter which Quality Management System you wish to conform to.


Management needs to have a clear understanding of requirements. Leaders will set the tone for how the rest of the organization approaches changes.

Leaders need to understand that QMS is not a side project. Focusing solely on certification to meet the requirements of a customer is a bad idea. If your view remains narrow, your effort to conform to standards will stall and ultimately fail.

Instead, leaders need to view their QMS as an essential part of the business process. Focusing on standardization, improvements, and customer satisfaction will benefit your company in the long run.

Rumors and Gossip

Most workplaces experience an uptick in rumors and gossip when they implement a QMS. The primary concern for most of your employees is that they will lose their job. Upper management should communicate the purpose of the changes to their workforce to quickly allay fears. Bringing in specialists can help to clear up popular misconceptions.

Too Much Theory and Documentation

In an attempt to be perfect, organizations will go overboard with details. They’ll focus on theory over practice, stalling successful implementation. They will create documentation processes that don’t facilitate communication, improve operations, or make proof of compliance easier.

Don’t let perfect be the enemy of good, or good the enemy of done. You are building your QMS to improve over time and use resources more efficiently. Don’t allow perfectionism and useless paperwork to become challenges in ISO 13485 implementation.

Contact us to get a specialist’s opinion.

Challenges of ISO 13485 Implementation

Maybe you head an organization that is already ISO 9001 certified. Maybe you have already dealt with those problems. So you are more interested in the particulars of compliance within the medical device industry.

Here are two of the biggest challenges for ISO 13485 Implementation.

Risk-Based Decision Making: One of the Biggest Challenges of ISO 13485 Implementation

In our personal and professional lives, we constantly perform risk-based decision making. What can go wrong? How likely are those events to happen? Is this level of risk tolerable?

One of the challenges in ISO 13485 implementation is that you have to standardize this process. You know that your organization has responsibility for the safety of product/service realization. But you also need to monitor and ensure control  the process throughout the entire product life cycle.

Are your suppliers certified? What are the risks associated with employee’s misinterpretation of processes? How will you gather feedback from users and stakeholders to ensure continued improvement?

You should put a Failure Modes and Effects Analysis into place. If you have one, expanding it to include the entire product/service life cycle will help you deal with safety issues head-on.

Have questions about implementation? Ask us!

High Standards

One of the challenges in ISO 13485 implementation is meeting more rigid standards. These standards exist in the medical device industry due to the international regulatory environment. Recent revisions to these standards force companies to devote a lot of time and resources to evaluating their supply chain.

To meet standards, hire a consultant, get a in-depth gap analysis conducted.

Overcoming these hurdles will be easier for you than the average person. Maybe you are already asking yourself, “Where problems can arise and how can I prevent them?”

Looking to get ISO 13485 certification for your business?

What questions do you have and how can we help?


Wondering where the Gaps are in your ISO Certification Or CMMI Appraisal plans?

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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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