ISO 13485 Consultants : Can They Jumpstart Your Certification

ISO 13485 Consultants : Can They Jumpstart Your Certification

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.


Why ISO 13485 Certification is an Amazing Idea

Why ISO 13485 Certification is an Amazing Idea

Why ISO 13485 Certification is an Amazing Idea

Imagine you are a small start-up specializing in the design and development of medical devices. Your team has engineered a rubber medical examination glove that has greater sensitivity than a latex glove. You want to hit the ground running when you bring your product to market.

  • What can you do to ensure quality consistently?
  • How can you get your team all on the same page for processes and standards?
  • What can you do to convince prospects that you are producing a high quality product?

You need ISO 13485.

Imagine you are an international company who sells raw material to a wide range of producers and are trying to become a supplier to the medical device industry.

  • How do you persuade potential new customers of your company’s commitment to quality?
  • What can you tell prospects that gives them confidence in your organization?
  • What can you tell prospects that gives them confidence in your products?

You need ISO 13485.

(Get your ISO 13485 cheat sheet here.)

ISO 13485 Certification Improves Internal Operation

Your quality management system (QMS) defines a set of internal rules that every level of your organization adheres to. A streamlined set of policies, processes, documented procedures and records assures that your company reliably and consistently creates and delivers quality products and services to your customers. Everyone follows set standards and knows what to expect. Your staff  is cross trained in ISO so that each member can review other team member’s results. This greatly increases adherence and your success.

Continuous Improvements

The routine measurement and analysis built into your ISO 13485 allows you to create a culture of continual improvement. You can look at individual processes in your organization and how separate elements interact. Then you can easily target the best areas for improvement and savings. You can make evidence-based decisions through the use of standardized documentation and procedures.

Engaged Workforce with ISO 13485 Certification

Your QMS clearly define policies and procedures so that each person in your workforce knows exactly what they’re responsible for. You put team members directly in control of the management and improvement of their processes. This allows each member to take responsibility for his or her output. They’ll invest more deeply in the outcomes of the organization. When employees feel empowered and more vested in a project, a team or the company, studies have shown their focus, dedication, and productivity all increase.

(Ready for a consultation? Click here.)

Image, and Market

When you become ISO 13485 certified, you show your commitment to producing quality medical devices to your customers and  regulatory bodies. Your prospects know you are a  professional organization dedicated to quality. Your marketing department and sales personnel get an advantage they can use in attracting and selling your products and or services.

Market Access

Getting ISO 13485 certified can increase your available markets. To access most major markets worldwide, you need to be ISO 13485 compliant. Certification is the first step to achieving compliance with any countries regulatory requirements.

Customers and Credibility

When you get certified, you signal your dedication to quality and customer satisfaction to the world. On the open market, you may even find customers who refuse to work with you without certification in place. Certification by a recognized certification body will improve your credibility and give you a competitive advantage over those who have chosen to forego certification.

One of the foundation principles of ISO 13485 Certification is improving customer satisfaction. Certification will allow you to meet and exceed customer expectations and continually identify new requirements.

Looking to get ISO 13485 certification for your business?

What questions do you have and how can we help?