ISO 9001 / 13485 Training for Medical Device and Pharmaceutical Professionals

This training is ideal for kicking-off an ISO compliance project. Aimed at key stakeholders in an organisation, it will:

Provide sufficient background information to clearly communicate the project’s advantages to the company and their individual areas.
Provide a clear vision of the finished product they will develop and install as a team, using documentation examples from other registered companies.
Clearly define the intent and specific application of the requirements of the standard to the current operation.

The training will also review the sequence and nature of the tasks listed in the project plan including:

The communications strategy for informing and updating all employees;
Establishing the quality system documentation structure and document control techniques after reviewing samples from templates;
Reviewing the changes/additions recommended by the consultant for the quality manual and procedures;
Review internal documentation and practices against the requirements of the standard.
Undertaking PharmOut’s questionnaire for gap analysis review.