Tag: iso13485

Supply Chain Management – Webinar Review

Our Tampa office worked with the local ASQ section and Hillsborough Community College’s Institute for Corporate and Continuing Education and coordinated and instructed a series of webinars that will run through this month.  The webinar scheduled for today discusses Supply Chain Management, which many in our industry recognize is a broad topic. As a brief introduction, the following components are discussed:

Supplier Selection

  • Conduct a needs analysis (brainstorm and consider long-term growth expectations).
  • Conduct preliminary interviews and/or surveys.
  • Evaluate samples.
  • Perform on-site audits (general quality systems management, ISO based, social responsibility, security, etc.).
  • Use a grid analysis for objective decision making.

Supplier Evaluation (Performance)

ISO 13485:201X Preparation (Medical Device Audits)

iso13485ISO 13485:2003 is a standard issued by the International Organization for Standardization that specifies requirements for a medical device manufacturer to maintain a quality management system. According to the standard, these requirements “can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development and provision of related services.”

Every few years, ISO issues standard revisions with 13485 originally scheduled for release this year.  However, due to the high volume of comments received by the ISO Technical Committee, the 13485 revision is planned for early 2016. It is currently referred to as ISO 13485:201X, or DIS (Draft in Standard).

The proposed revisions are significant, and it is important for medical device organizations to start preparing now.  Three changes that are speculated include:

1) Due to to the increasing complexity of the international regulatory environment for medical devices, it is expected that ISO 13485:201X will incorporate EN ISO 13485:2012 elements and reflect more current requirements by the EU.