Quality Management

ISO 13485

ISO 13485 is the medical device industry’s most widely used international standard QMS.

Issued by the International Organization for Standardization (ISO), the ISO 13485 standard is an effective solution to meet the comprehensive requirements for a QMS in the medical device industry.

Just like with ISO 9001, ISO 13485 starts with ensuring management support of, and identifying the customer requirements for, the QMS.

ISO 13485, as you may suspect, is a much more stringent standard than ISO 9001. Specifically, where ISO 9001 lets you determine what is applicable to your business, there are certain Procedures and Documents that you must have in order to show adherence to the ISO 13485 standard.

These include, but aren’t limited to:

  • Quality Policy,
  • Quality Objectives,
  • Quality Manual
  • Computer software validation procedure
  • Corrective & Preventative Actions
  • Medical Device File
  • Control of Non-conforming Hardware
  • Document Control
  • Material and Product Verification
  • Product Traceability
  • Calibration

Here at New England Lean Consulting, our Quality Team has helped dozens of companies achieve and maintain ISO 13485 certification.

We can assist you and your team in understanding and applying the standard so that it serves its intended purpose: to help streamline processes, build more reliable and robust products while helping organizations meet regulatory requirements.