Medical Devices ISO 13485
The ISO Pros
The Medical Devices Industry, no matter what age or what types of advancements we have, will never go out of style. For as long as health is a problem in the globe, it will stay important and relevant for people.
ISO 13485 is known as the international standard for the quality management of the medical device industry. With all obviousness, it is a standard set out and published by the International Organization for Standardization (ISO) and is seen and used as an effective resolution to meet the requirements of the medical device industry.
The standard talks about everything from the needs of the customer and clients, the capabilities and the abilities of the support and management, the quality and the effectiveness of products and components, the documentation of the policy, objectives, manual, and the like – the list goes on.
Is ISO 9001 the Same as ISO 13485?
Many people have the misconception that ISO 9001 is the usual and the regular standard that is applicable to all types of business industries – and that’s where most of them go wrong. ISO 13485 is a standalone international standard, however, it is based on ISO 9001.
This is because of the fact that ISO 9001 is a standard that is RECOGNIZABLE by any business industry but in general; it’s not specific, and the usual procedures and requirements there would be generic.
ISO 13485 provides a more direct and specific set of requirements and standards. Some of which include, but not limited to the following requirements:
- Requirements for the regulatory authority reporting
- Contamination control requirements
- Medical devices documentation requirements
- Production requirements for product hygiene and cleanliness
- Production requirements for sterile medical devices
- Work environment requirements
- And many more!
What ISO 13485 is For?
If we were to look at all the different standards, lay them out on a table – they would have particular goals and objectives. However, they would all be pointing to one (1) thing – improvement and overall development of a certain company or organization’s Quality Management System (QMS).
The purpose of ISO 13485 or the International Standard for Medical Devices is to provide a framework of the company in relation to the business they’re engaging in. This can start with the identification of customer requirements for the management system, polishing and assessing the policy, objectives, and manuals, define the scope, action, and the implementation, of the QMS, and many more.
ISO 13485 as Mandatory?
Though it’s set and considered by many as the grail of the Medical Devices industry, an ISO 13485 Certification is neither required nor mandatory. Companies can decide to set up and establish their own set of management systems that they find more effective; they can do so as long as the QMS processes meet regulatory and legal standards.
We all want for us to have some type of safety and security in the medical devices that we purchase and patronize – and it’s just right for companies and organizations to have some proof of them being legitimate.
Different ISO 13485 Courses
We offer quite a few courses and programs in the ISO 13485 course. Whether you want to learn how you can properly audit a company or an organization engaged in the medical devices industry, or whether you aim to be an internal auditor for a company, or if you want to have awareness and skill in ISO 13485.
Whatever you want and need, we are 100% sure that our experts, professionals, trainers, and coaches are all ready and prepared to partake in the learning path you would want to journey through.
High-Quality Learning
All other learning institutions that offer Medical Devices ISO 13485 have a generic view of the standard. Most of which focus on how they teach and train people, not how companies and organizations can implement it. With TRAMANSA, you will never have to think about knowledge and skill. Under our employ are the most experienced, most talented, and the most dedicated experts and professionals you will ever work within the industry.
We know the ways, the extensions, and even the shortcuts for you to be able to get the certification or the standards you need for your organization.
In-Depth Knowledge on ISO 13485
Not all companies have the capacity like we do. Some of them provide good training strategies and techniques but lack the material needed. All our consultants, experts, professionals, and coaches are skilled and adept in the ISO 13485 standard, leaving nothing behind. If you want a thorough, complete, and full-service program, you should be considering us all the way.