Quality Management System Training | Consulting | Auditing

ISO 13485 Implementation

As consultants, we can provide guidance and expertise to assist your steering committee or team in interpreting, implementing, and obtaining certification to ISO 13485. Our approach results in a value-adding, self-sustaining management system.

Steudel and Mann LLC, can help your company through the implementation process by:

  • Educating management and helping to gain commitment to a value-adding quality management system implementation process.
  • Establishing a steering group and facilitating the definition of the company objectives and scope of ISO 13485 implementation.
  • Conducting a thorough "gap analysis" to define precisely what needs to be accomplished to bring the quality management system and documentation into compliance.
  • Establishing an implementation program and corrective action plan.
  • Preparing and revising the quality management system documentation.
  • Providing training for internal auditors and leading internal audits.
  • Helping to select a registration agency that meets your organization's needs.
  • Performing a pre-certification audit.
  • Instituting any pre-assessment corrective actions (if required).
  • Monitoring the official third-party assessment to ensure successful registration on the first attempt.

After registration, we can continue to serve you with on-going internal audits, reviews, training, and support to sustain continual improvement, but our primary goal is to help develop a quality management system which your organization understands and can operate independently.