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.

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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?

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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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