IQC - The ISO Pros
of Rutland, VT & ISO 9001 Experts
In case you continue to be intrigued about what the ISO 13485 standard is all about – you should never mind it unless your business or your organization is involved and engaged in the medical device and the pharmaceutical industry or supply chain. If otherwise, then this is not the standard that can help you improve, enhance, and further develop the quality of your products and your services.
Akin to how most, if not all ISO standards are, the ISO 13485 or the Medical Devices standard is not a mandatory standard that all businesses and companies need to have. However, it is worth noting that there are some countries and some states that consider it as a requirement – therefore, disabling and ceasing facilities’ operations if caught non-compliant or with no certification.
What is the ISO 13485 For?
For businesses and organizations in the Medical Devices industry, being Certified against the ISO 13485 is one of the fewest but the most effective ways in proving to your clients and the market that you are working to meet their expectations and their needs.
In the event that you find yourself in dire need of help, assistance, and guidance in the ISO 13485, you can bank and count on us here at IQC – the ISO Professionals to help you with it! Our company or our organization has been deemed and considered as the most trusted, the most reliable, and the most comprehensive in providing the training & implementation for the standard.
ISO 13485 and ISO 9001
The most common mistake that people think about, with regard to the ISO 13485 is that it’s exactly the same as the ISO 9001. Although the ISO 13485 is the set of guidelines, requirements, and policies of businesses, facilities, and organizations in the pharmaceutical and the medical device industry, it is actually the same as the ISO 9001 – but the latter is just in general.
To further clarify this claim, the requirements that the ISO 13485 standard has included:
- Work Environment Requirements
- Documentation Requirements for Medical Device Files
- Production Requirements for Products’ Cleanliness
- Contamination Control Requirements
- Reporting to Regulatory Authorities
- Production Requirements For Sterile Medical Devices
When you choose and decide to work with us here at IQC – the ISO Professionals, you will never have a stagnant and a stale moment. Everything that you need to know about ISO 13485 will be given to you holistically and comprehensively.
Why Choose Us?
There are plentiful of ways why you should choose and consider us as your main go-to or option when it comes to the Training and Implementation of the ISO 13485 – some of which include:
- Lower costs and expenses
- Higher quality of training programs and lessons
- More effective and seamless program and standard integrations
- And many more!
Give us a ring or a buzz and we will be more than happy to help you with your needs of integrating and implementing the ISO 13485 to your business or your organization!
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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
- Automotive Core Tools
- 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