ISO 13485

You need a trusted auditor for your (Medical Device/ Pharmaceutical) certification. Choose Smithers Quality Assessments (SQA) for personal, expert assessment services, tailored to your business needs.

ISO 13485 was established in 2003 as an international standard for the design, manufacture and distribution of medical devices. While compatible with the quality management standard ISO 9001, ISO 13485 requires proof of implementation and maintenance, but not continuous improvement.

SQA offers ISO 13485 certification to organizations worldwide. Companies achieving ISO 13485 certification benefit from:

  • enhanced safety controls in the work environment
  • documentation for preventive and corrective actions
  • alignment with FDA and other regulatory regulations
  • improved products and services
  • enhanced communication with suppliers

An audit performed by SQA resulting in ISO 13485 certification provides your business:

  • Clear and well-communicated best practices for design, manufacture and distribution of medical and pharmaceutical devices
  • Established supplier quality, implementing a process that facilitates supplier quality programs
  • More consistent auditing performance. 

Why choose SQA as your ISO 13485 auditor?

SQA auditors maintain open communication with you throughout the entire certification process. We welcome your feedback and discussion in an objective manner. Our auditors provide easy-to-follow ISO 13485 audit checklists and worksheets. We get to know your business and help you thoroughly prepare. Finally, we conduct a closing meeting where findings, recommendations and improvement plans (if necessary) are discussed.

Call SQA today to discuss your ISO 13485 auditor needs.

You also can transfer your certification to SQA. Contact us  or call 400 928 2677​ today!