IQC - The ISO Pros
of Cedar Rapids, IA & ISO 9001 Experts
As we all are aware, the International Organization for Standardization, or more commonly called the ISO, is the organization responsible for studying and publishing standards for all businesses and organizations from all across the globe.
Their standards are so prominent to the point that even some government agencies and institutions abide and observe it. One of the most important standards, per se, would be the Medical Devices Standard, also known as the ISO 13485.
ISO 13485, in case you’re not aware of it, is the widely used international standard for the Quality Management of businesses, companies, and organizations in the Medical Devices and Pharmaceuticals Industry.
ISO 13485 Explained
When you know about the famous and the ever-popular standard, what is the first thing that comes to mind? How well do you grasp the idea of the ISO 13485? For formality purposes, it is one of the few standalone documents in the entire book of the ISO.
For the best and the easiest way to explain it, it is the standard that takes it to place as an effective solution to meet the requirements to have a QMS in the medical devices industry; it is the document that details and sets out the rules, regulations, and policies that medical companies and businesses need to have.
The primary purpose of the standard is to stand as a barrier between what things and activities medical device companies should do, from what they cannot do.
What Being ISO 13485 Certified Means
So what will it mean if you obtain the ISO 13485 Certification? What good does it give and provide your business or your organization?
Being ISO 13485 Certified basically means that an organization has been checked, evaluated, and assessed and that they have the skill and the overall adeptness of maintaining and sustaining an effective QMS in accordance with the medical devices industry.
In other words, being certified against this standard puts all medical devices companies and organizations in the position of them having supreme knowledge about how to effectively and efficiently run and perform their services.
In case you are interested to gain certification, you can freely give us here at IQC – the ISO Professionals a call; or you can also send us an email. We’re the institution or the organization considered as the best in the industry as we never failed to meet or even exceed the expectations of our clients.
What You Get With Us
You’ve decided to work with us – what good can it bring your company or your organization? How would the ISO 13485 impose beneficial advantages to your business processes and operations?
That can be traced and tracked from the early beginnings of our establishment. Since day one, we’ve provided assistance to over 3,500 companies and organizations across all the standards we are skilled at.
When it comes to the Training and the Certification for the ISO13485, you will never regret your decision of working with IQC – the ISO Professionals. Don’t hesitate to work with the best, to experience the best!
We service multiple cities throughout the state of Iowa. We provide all the services listed below and more in every city.
If you don’t see your city listed, don’t worry. Just contact us by giving us a call or filling out the form, and we’ll dive deep to discover what are the best solutions for you and your business. See our areas of service:
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