ISO 13485 Consultants

ISO 13485 is based on ISO 9001 with additional requirements relating to design, unique processes, environmental control, traceability, documentation records, and regulatory actions.

The primary object of an ISO 13485 certification is to standardize medical device regulatory requirements for quality management systems. ISO 13485 includes particular requirements for medical devices but excludes some of the requirements of ISO 9001 that may not be appropriate in a regulated environment.

The primary difference between ISO 13485 and ISO 9001 is that ISO 9001 requires the organization to demonstrate continuous improvement. In contrast, ISO 13485 requires only that the organization demonstrates that the quality system is implemented and maintained. Thus, many organizations maintain dual registration against both standards.

For most companies, ISO 13485 registration allows the company to focus its resources and understand its roles, rights, and authorities. It helps management organize in a consistent way that is recognized on a global scale.   The advantage of being ISO 13485 registered is that it is a prerequisite if you want to sell your products outside of the United States.

BCS can help you attain ISO 13485 certification for medical device manufacturing. For further details on ISO 13485 consulting and certification, get in touch with us.


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Learn More About ISO 13485

ISO 13485 is a management system for medical device manufacturers. Specialized Consultants can work with your company to help you understand this quality management system. The main emphasis of the system is on meeting all of the regulations along with the customers’ requirements, implementing effective risk management practices, and maintaining and monitoring the manufacturing, distributing, and safe design of all medical equipment. Basically, it is meant to bring about a company’s compliance with the system, as well as try to match up requirements all over the World.


Understanding the ISO 13485 Certification Process

ISO 13485 for medical firms helps companies establish a framework that aims to conform to the regulations in the medical industry worldwide.

 Any medical device manufacturer that wants to be certified must learn about the various requirements of both the regulators and the customers and how this kind of management system will improve their process. The system takes several months to implement, and it’s best if you get the expert help of a consultant.

They can help the business understand what is needed to conform to the ISO standard. One of these ISO 13485 consultants is David Barile. He has an MBA degree and experience putting these systems into place. Through his expertise, he has helped businesses get certified since 2005.


What is the first step in ISO 13485 Certification?

The first step in building an ISO 13485 management system is developing a quality manual that lists your company’s goals and requirements needed to comply with the ISO 13485 management system. This is something that consultants like David Barile can help you to put into place because he has the expertise and knowledge of the ISO standards needed.

After helping your company develop this manual, BCS can help you to find an accredited certification registrar that can start the certification process. They will ensure that the registrar has all the needed credentials and references required by the medical industry.

ISO consultants like David Barile understand that companies are different and his firm has the knowledge to handle ISO standards for all different types of medical businesses. BCS is focused on creating a system that meets ISO 13485 requirements and one that improves your business.


Further Steps toward ISO 13485 certification

The steps to achieving certification are comparable to ISO 9001. First, there must be a review of the company’s business documents, and then it has to be assessed by the consultant to see if everything is in order. This process can take time, depending on the company’s size and scope.


What factors influence the implementation of ISO 13485 certification?

If senior management at your company does mot take the implementation of ISO 13485 certification seriously, this can greatly slow down the entire process. Your company needs to have total support from everyone, including the senior management in your organization.

Cost is also a big factor in getting ISO certification implemented in a timely fashion. An organization has to dedicate enough of its budget to make the process go smoothly. Hiring an ISO 13485 consultant to speed up the process is a wise decision so that your company is ready to pass an audit.

If your company is large, it may also take longer to become ISO 13485 certified since the system would be more complex than in a smaller business. BCS can make sure the whole process is done as quickly and efficiently as possible regardless of size.


What is ISO 13485 Medical Certification?

If your business is involved in the production of anything to do with medical devices, then ISO is a topic you need to get familiar with. ISO 13485 is a Management Systems Standard specifically created for medical device manufacturers. 13485 is based on ISO 9001, but it differs in the fact that it removes ISO 9001’s emphasis on constant improvements and client satisfaction. Instead, it stresses the importance on complying with required industry regulations, plus risk management procedures and ensuring the effectiveness of the processes used in the safe design, manufacturing, and distributing of all medical equipment.


Benefits of ISO 13485 certification?

  • Customers are happy with the ordering, delivery, quality, safety and ability of the company to follow existing rules and regulations.
  • Less operation costs due to the continued system of improvements of existing processes leading to more efficiency.
  • Better interactions with share holders, clients, and employees
  • Compliant with all legal requirements due to being clear on the manner in which rules and regulations affect the business and its clients.
  • Better risk management due to a better tracking system and the implementation of risk management procedures.
  • Established business qualifications due to self-regulated confirmation based on clear ISO standards.
  • Able to acquire additional companies, especially those in which procurement requirements need to be certified before the products can be supplied to certain sectors that are regulated.

Need More Information About Us?

Call us at (440) 628-8271 or contact us by clicking the button.

Need More Information About Us?

Call us at (440) 628-8271 or contact us by clicking the button.