Medical Devices ISO 13485
IQC-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.
Where else can you get the best and the most reliable phase of certification that we here at IQC – the ISO Professionals? We have been looked at and considered by many as their go-to company for all of their ISO 13485 needs – whether it’s for regular auditing, training, accreditation, and certification, you can count on us and our team!
We here at IQC – the ISO Professionals 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.
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 IQC – the ISO Professionals, 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.
With over 150 years of combined experience and knowledge, there will be nothing you have to ask for further. 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.
Not all companies have the capacity like we do here at IQC – the ISO Professionals. 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.
The Best Company You’ll Work With
It sounds cliché but that’s what most companies and organizations view us – as the best and the most dependable in the Medical Devices Certification field. We’re not doctors nor are we medical experts, but we are experts on how you can properly implement a standard for your operations to run as smoothly as possible.
Here at IQC – the ISO Professionals, you will never have a problem with how you’ll implement and execute a particular standard, in this case, the Medical Devices standard. All you will ever stress is that you did not get us for the other standards you need to implement with your company or organization.
You can send us an email or you can dial us – we keep all our lines open and there would never be a problem with it in case you want to work with IQC – the ISO Professionals again in the future.
With IQC – the ISO Professionals, you’ll get all of the information and the proper training that you need to go on with the industry you are in! Here are the ISO Standards we can help you with:
- Asset Management ISO 55001
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- Automotive IATF 16949
- Body Armor BA 9000
- Capability Maturity Model Integration
- Counterfeits AS6081
- Energy ISO 50001 and SEP
- Environmental ISO 14001
- Ethical Sourcing SQFI
- Facility Management ISO 41001
- Food Safety Modernization Act FDA FSMA
- Food Safety ISO 22000
- Forestry SFI ATFS
- Gluten-Free Certification
- Info Security ISO/IEC 27001
- International Traffic in Arms Regulations, ITAR
- IT Service ISO/IEC 20000-1
- Laboratory Accreditation ISO 17025
- Medical Devices ISO 13485
- Occupational Health and Safety Management System
- Packaging ISO 15378
- Quality ISO 9001
- Responsible Care RC14001
- Supply Chain ISO 28000
- Telecommunications TL 9000