Getting ISO 13485 Certified in Charlotte, North Carolina (NC)
ISO 13485 approval, an international standard that defines specifications for suppliers of medical equipment in a quality management system ( QMS). The primary aim of the specification is to promote harmonized QMS standards in the Medical Devices industry for regulatory purposes.
It applies to medical device manufacturers and to those organizations which assist manufacturers of medical devices. Manufacturers have a responsibility to ensure they reliably satisfy consumer expectations and fulfill any regulatory specifications relevantly. This standard is based on the process model ISO 9001. It does, though, contain unique specifications for medical equipment, which adds to the ISO 9001 criteria. In particular, customer service and quality management standards have been updated to make them more suitable for regulatory purposes.
What ISO 13485 does, is it facilitates worldwide harmonization of the legislative criteria for medical product manufacturers. Several countries incorporated ISO 13485 into their regulatory frameworks. Operation with ISO 13485 should be used to encourage conformity with the regulations. It integrates all of the concepts of quality control and provides the advantages of a QMS focused on ISO 9001.
What is the ISO 13485 certification?
ISO 9001:2015 is structured to identify the QMS specifications when an enterprise needs:
- To show the ability to deliver medical equipment and services that can reliably satisfy the patient’s needs when meeting with relevant legislative and regulatory guidelines.
- Concentrating on patient safety and ensuring that the goods they produce follow the quality criteria while maintaining model compliance depending on the role it is meant to fulfill.
The specifications laid down in ISO 13485 are all unique. This standard may be utilized by manufacturers or third parties engaged in the industry of medical equipment, even those delivering QMS based services.
What are the benefits?
Some of the advantages of having a certified ISO 13485QMS includes:
Recognition and brand credibility
With QMS applications for ISO 13485 Medical Devices introduced in your company, you will show the trustworthiness of your clients and consumers in doing business with you. A strong ISO 13485 QMS provides a perfect marketing tool in many countries, as it has become a necessity for manufacturers of medical equipment to demonstrate adherence to legislation. This helps you find more opportunities.
Helps improve decision-making
A QMS under ISO 13485 allows for decision-making which is based on evidence. You then use the evidence and information to make rational choices, which you’ll typically match with your company goals. What your gut tells you isn’t necessarily going to be right; often it can place you in deep trouble. The added benefit here is an insight into the health of your company because you can monitor any change you may create and its effects.
As you know, the vertical medical device industry is highly regulated. The ISO 13485 QMS for the medical devices industry must satisfy regulatory standards that allow manufacturers to design and produce secure and appropriate medical devices for their intended purpose.
ISO 13485 standard was developed to assist manufacturers of medical devices in the creation and implementation of quality control systems that meet and exceed regulatory requirements. ISO 13485 is extracted from the standards family ISO 9000 defined by the International Organization for Standardization ( ISO).