ISO 9001

ISO 9001 was one of the first quality management systems (QMS) standards created by the international standards organization and gets to the very core of what it means to have an effective QMS.

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 within the ISO 9000 family, with over a million certificates issued around the world last year.

Seven Quality Management Principles Of ISO 9001

  1. Customer Focus - The customer focus is at the heart of every QMS - after all, the whole point of QMS is to help you create a product that is safe and effective for the customer. This starts with establishing user needs and translating them into design inputs for your device.
  2. Leadership - Great leaders create unity of purpose and direction within a company. Your QMS acts as a single source of truth, containing the policies and procedures that drive everything your medical device company does.
  3. Engagement of People - Great organizations need great people, and a fully engaged staff is one that puts their abilities to use in a way that benefits the organization.
  4. Process Approach - A business is a set of processes that generate a profit. By adopting a process approach throughout your organization, you can manage the quality of each process, directly changing the quality of the end result.
  5. Improvement - Improvement should be a permanent objective of every medical device company. Process improvement through CAPA, internal audits, and management review are all crucial QMS components.
  6. Evidence-based Decision Making - Effective decisions are made based on the careful analysis of data and information. Using the right tools can improve analysis and decision-making practices at your company.
  7. Relationship Management - Companies need partners to succeed, but relationships with suppliers, contractors and service providers need to be properly maintained to achieve mutual benefit.

ISO 13485 VS 9001 And Other Quality Standards

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.

Greenlight Guru's QMS Software Helps Manage Mandatory Records Required By ISO 9001

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 the ISO 9000 family and quality assurance are understood, adopted, and practiced by all members of your organization.

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