ISO 13485 is based on the ISO 9001 format with additional requirements relating to design, special processes, environmental control, traceability, documentation records, and regulatory actions. The primary object of ISO 13485 is to standardize medical device regulatory requirements for quality management systems. As a result, it includes some particular requirements for medical devices but excludes some of the requirements of ISO 9001 that are not 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, whereas ISO 13485 requires only that the organization demonstrate 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 with being ISO 13485 registered is that it is a prerequisite if you want to sell your products outside of the United States.
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 requirements of the customers, and 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 to the system, as well as try to match up requirements all over the World.
Understanding the ISO 13485 Certification Process
When a company gets ISO 13485 certification, it still does not fulfill FDA or foreign regulations, but instead it lines up that company’s management system so that it builds a framework that helps to create conformity to the regulations found in the medical industry Worldwide.
Any medical device manufacturers that want to be certified have to learn about the various requirements of both the regulators and the customers and how this kind of management system will improve their manufacturing process. The system takes several Months to put into place and it’s best if you get the expert help of an consultant. They can help the business to understand what is needed so they can conform to the ISO standard requirements. 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 coming up with a draft of a new quality manual for your business that lists your company’s goals and the things it needs to do in order to comply with the ISO 13485 management system. This is something that consultants like David Barile can help you to put into place because they have all the expertise and knowledge of the ISO standards needed.
After helping your company develop this manual, David Barile 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. For example, if you operate in North America, you will need a certification body that is accredited through the ANSI/ASQ National Accreditation Board (ANAB). Every country has its own accreditation boards to review the certification bodies and make sure they meet all requirements.
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. David Barile will not develop a bloated system that will be difficult to maintain, Barile Consulting Services LLC 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 several weeks, depending on the company’s size, how many people work there, and the kind of medical products manufactured.
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, especially 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. A consultant like David Barile can make sure the whole process is done as quickly and efficiently as possible no matter the size of your company.
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 the manufacturers of medical devices. 13485 is based on ISO 9001, but it differs in the fact that it removes ISO 9001’s emphasis on constant improves 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 both ISO 13485 and ISO 9001 dual certification
There is a benefit to those that make medical devices to have both ISO 13485 and ISO 9001 certification even though it is not required. This can be beneficial because it focuses on things good for all types of businesses, such as client satisfaction and a need for constant improvements, which ISO 13485 does not.
What Does ISO 13485 implement?
The ISO standard has in it the precise requirements for the manufacturing, servicing and installing medical devices. It also specifies there must be:
• Execution of an enhanced Quality Management System
• An in-place Risk Management way of developing the products
• A justification of processes and procedures
• Observation of all applicable rules and regulations
• An efficient way to trace product placement and any existing recall procedures
It is also vital for the company seeking ISO 13485 certification to know where they plan to sell their products. For example, if they plan to offer their medical device for sale in the U.S., then they need to get their certification done through someone who is accredited in the U.S. in order for them to meet that country’s requirements.
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.
Who must comply with ISO 13485?
ISO 13485 affects any organization that works at any level in the manufacture or supplying of medical equipment and pharmaceuticals. Those companies that support the manufacturers of medical gear or who want to show which regulations are applicable are especially affected by ISO.
In order to meet ISO standards so they can qualify for ISO 13485 certification, an organization must:
• Complete an application questionnaire
• Be assessed by the NQA and show that the company’s quality management system has been in place for at least 90 days and has had a complete run of required internal audits.
• The NQA then grants certification and the company has to maintain it. Every three years it must re-certify through inspection visits and re-certification audits.
What happens during the Initial Certification Audit?
The Initial Certification Audit is done in two steps. Step one is done to make sure the company is ready to be assessed. It is checked to see if it meets the requirements of ISO 13485, is ready for implementation, has complied with all legalities, has meet the scope of certification, has produced a report showing any possible instances of not complying or potential for this to occur and if needed, put in a plan for corrections, as well as producing a plan for assessment and confirming the date for Step 2.
During Step 2 the company’s quality management system is inspected to ensure it complies fully with ISO standards. If any problems are found, they are documented, plus how well their quality system complies with the system is documented. A date is then set up for a future inspection. As long as all goes well and the organization meets the required ISO standards, they are then certified. Certification can be given by an accreditation organization after all the inspections are complete. This process may take anywhere from a few weeks to a few Months, depending on the size of the organization and whether or not it met all the ISO standards in the first audit.
The requirements for ISO 13485 certification are expected to increase in the future, as well as a possible increase in regulations. There is a move by the Global Harmonization Task Force, which has members such as registrars and government agencies, as well as heads in the medical device industry, to get ISO 13485 certification to replace the regulations that are specific to each Country.