ISO 9001 compliance forms a solid foundation in quality management for any medical device company. Applying the first principles of quality that emerged from World War Two-era manufacturing, the standard was first implemented as a contractual requirement for purchaser-supplier relationships. The contract would ensure that suppliers were obligated to follow best practices in their manufacturing operations and that purchasers could trust the products that they bought. Today, ISO 9001 is one of the most popular international QMS standards, with over a million certificates issued around the world last year.
What makes ISO 9001:2015 unique among all quality standards and directives worldwide? What makes it different from ISO 13485:2016, the most recently updated international QMS standard for medical device companies?
The biggest difference is in the level of detail. ISO 13485:2016 was written specifically to guide the development of QMS in the medical device industry, while the latest version of ISO 9001 was written with more general language, such that it could be applied around the world and across industries.
Still, the amount of overlap between the two standards is significant. For example, both standards require the inclusion of a quality policy document, quality objectives document, and criteria for the evaluation and selection of suppliers to be included in the QMS. Both standards also emphasize the establishment and documentation of design controls throughout the product development process.
When your medical device company is audited by the FDA or a designated notified body, you'll need to produce records of design controls, internal audit results, results of corrective actions, management reviews, and more. Many of the myriad documents required by ISO 9001 are also part of the 21 CFR Part 820 mandate, as well as the ISO 13485:2016 QMS standard. Greenlight Guru's QMS Software helps you stay organized by ensuring that your documents are organized, complete, and up-to-date.
Greenlight Guru's QMS Software also supports enterprise collaboration and sharing, helping to ensure that the seven principles of quality are understood, adopted, and practiced by all members of your organization.