ISO 13485 Certification, Maintains the Quality Standard of Medical Device

Posted by Christian Silmaro on November 20th, 2017

The ISO 13485 is a chain of requirements which help the instrument makers to develop a quality management system. The main purpose of ISO 13485 is to make sure that the medical devices that are produced must have the quality, effectiveness, and safe to use. These requirements are needed by the organization to develop its design, installation, production, and servicing of the medical devices. It is also used in other related services.

Benefits of ISO 13485

The ISO 13485 Certification is a successful way out to meet the complete requirements for a QMS. The ISO 13485 is a practical solution for the manufacturers to establish the Medical Device Directives, their responsibilities, and regulations along with a commitment to the safety and quality of medical devices.

Quality control is an important measure which helps to produce improved quality productions. You need to make sure of the systems that can handle input on everything from contact to resolution management. You can get a clear picture of the customer’s impression. With the help of this certification, your organization can establish its business in a right direction. A handy feature for finding the documents was published after the latest ISO audit of the documentation.

What Is AS9100?

The companies like space and defence products need AS 9100 Certification for the design, and development, and produce aviation. It is needed by the organizations that are providing support, along with the provision of upholding and protection, extra parts, or materials, of the products. In the year 2000 when ISO 9001 was released in a rewritten way; the AS Group was working closely with ISO organization to get it done. In that revised version of ISO 9001, a major philosophical and organization change had been taken and AS 9001 underwent to rewrite as well. It was published as ISO 9001 to the aerospace industry along with a new version of ISO 9001.

AS 9100 is a widely acclaimed and adopted and standardized quality management system.  Before adopting this AS 9001 many corporations had used ISO 9001 and their own complementary requirements like Boing’s D1- 9000 or the automotive Q standard. AS 9100 fulfils their immediate needs. The standard AS9100 includes the quality system requirements and specifies additional requirements for the quality system of the aerospace industry. It is highlighted that the excellent system requirements specified in AS9100 are complementary to the contractual and applicable law and regulatory requirements. You can avail the recent version of the standard you can select AS 9100A.