ISO 13485/13488 Medical Industry (EN 46001/2)

QSR Documentation

This ISO 13485/13488 CE Mark for Medical Industries Documentation is designed to provide the participants with the skills needed to prepare user-friendly documentation that is ISO and GMP compliant. Working in teams, participants will draft procedures using flowcharting and graphical methods to display work flows. The documentation of critical processes is the key to consistent quality and efficiency. Effective documentation presents needed information visually in a consistent format.

Who should attend?

Individuals who write documentation1 e.g. development engineers, manufacturing managers, engineers and operators; QNQC managers. Quality and Documentation Managers who need to make their company's documentation more consistent and easy-to-use.

Key Topics

ISO and new GMP requirements for documentation

Motivating employees to write documentation

Writing the quality manual

Guidelines for creating user-friendly document

• Level of detail
• Who should write it?
• Guidelines for writing

Writing a procedure

• Content sections
• Using flowcharts to visualize the process
• Using tables to depict steps
• Participants write all sections of a procedure

Document control requirements for GMPs and ISO

Course Duration

This is a 1 day course and can be held at your site or at a venue close to your site. Please call us for a no-obligation, no-cost quote at 877-415-0191.

Thank you for your interest in BQPM Training!

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