Getting ISO 13485 Certified in Harrisburg, Pennsylvania (PA)
If you’re constantly wondering where the best place is to get ISO 13485 certification, then you’re just on the right page! We here at The ISO Pros, are deemed and known to be Harrisburg’s top choice for all ISO 13485 certifications.
Our experience in the industry dates back years ago when we first started providing training sessions. Now, we’re crowned as the best and the most trusted ISO certification body and training agency in Harrisburg, PA!
What is ISO 13485?
The ISO 13485 is a standard that has been written and published supporting medical device manufacturing procedures in the medical industry. It talks about a quality management system or a QMS that is consistent in maintaining the effectiveness of processes of designing, sourcing, manufacturing, and producing medical devices.
In the finality of being ISO 13485 certified, it needs to pass and address the European Medical Device Directive or the MDD, as well as the European MDR, or the Medical Device Regulation. There are other standards, too, but these two take up a whole.
Requirements to get the ISO 13485 Certification Many Organizations Want
There are certain requirements of the ISO 13485 in order for a company or for an organization to be successfully tagged as “certified” and to be able to produce medical devices and perform medical services.
The Food and Drug Administration, more commonly referred to as the FDA has a couple of processes that harmonize the requirements of the U.S. quality system to match that of the ISO 13485 in general.
Structure of the ISO 13485
In getting certified, you need to be aware of what the general structure of the standard is. This is for you to have backside knowledge on what needs to be done and about what’s discussed within the specific standard.
The typical structure of the ISO 13485 is categorized and organized into eight (8) different sections, namely:
- Scope – Purpose and Standard Use
- Normative References – Confirmation of Nomenclature and Introductory Info
- Terms and Definitions – Terminologies Used Throughout the Standard
- Quality Management System (QMS) – Documentation Requirements of a Medical Device Manufacturer’s QMS
- Management Responsibility – Requiring of Management Involvement, Including the Person Who Makes Financial Decisions.
- Resource Management – Assurance of Adequate Facilities
- Product Realization – Everything Required to Realize or Produce a Product
- Measurement, Analysis, and Improvement – Instructions on Incorporating Feedback
Wherever you are in Harrisburg, PA, we, at The ISO Pros, are just a call or an email away! You can also make use of the contact form that we have on our website to help you with what you need!
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IQC The ISO Pros can help you implement, train on, consult, and have your company and/or organization certified on the following ISO Certifications: