ISO 13485 Consultants : Can They Jumpstart Your Certification

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ISO 13485 Consultants will help you get certified faster and make sure that you’re actually compliant with standards.

You may be toying with the idea of building an in-house team to get you certified. You think this will be a wise and cost-effective decision. Why pay someone else to do what you can do yourself?

Here are 4 Reasons ISO 13485 Consultants will get your certified faster.

Looking to get ISO 13485 certification for your business?

ISO 13485 Consultants are Specialists

Take a look at your company. You are a team of specialists. That’s why people pay you to do the work you do. Think about the kinds of simple mistakes amateurs make in your industry—and all the extra work that makes for you.

How much time and pain do customers save themselves when they come to you first?

That’s why consultants are an important part of the business ecosystem. We use them to fill in gaps whenever we don’t have the internal resources or skill set to accomplish a goal.

ISO 13485 consultants will come to your business to do one specific thing which they are very good at. They understand how to put implement quality management systems regardless of the industry.

…So they Make Fewer Mistakes

Since ISO 13485 consultants are specialists, they make fewer mistakes. An in-house team will be learning on the job and trying to master new information. They don’t know what the Global Harmonization Task Force recommends.

That doesn’t mean they’ll fail.

But you rest assured, mistakes will be made.

Paying your employees to learn makes sense when you are trying to break into a new market or build up their skills to suit your needs. But does bankrolling these failures make sense to get ISO 13485 certified? Ask yourself whether the time and effort your team will invest in learning the ropes will be worth any potential savings.

ISO 13485 Consultants Can Focus

If you want your company to successfully implement ISO 13485, you are going to have to divert employee time and resources. They’ll need to stop focusing on other projects in order to learn about and then implement standards.

Ask yourself what will suffer when your team members are working on ISO compliance.. Will customer satisfaction decrease? Will targets that you expected to hit in March move to September? How accurate of a timeline can your inexperienced in-house team give you?

Your ISO 13485 consultants will have clear priorities. They will be able to keep their eye on the prize and give you accurate timelines.

What questions do you have and how can we help?

ISO 13485 Consultants Don’t Have Competing Interests

Even with the best of intentions, your in-house team is not going to be impartial when looking at your organization. They have ties to people and projects which will cloud their vision.

ISO 13485 consultants are going to walk into your company with fresh eyes. They won’t have allegiances to any departments or individuals. There will be no need for them to cover up a job poorly done in the past to protect themselves.

Because they’re an objective third-party, ISO 13485 consultants will be great at seeing the flaws and loopholes in your system.

Can an In-House Team Get the Job Done?

Companies have put together successful in-house teams. That is an option. If you want to do that, take a look at our cheat sheet to get your team started. You can even give us a call and we’d be happy to answer any questions you have.


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