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

(EN 46001/2) Implementation

This ISO 13485/13488 CE Mark for Medical Industries Implementation Course is designed to familiarize the participant with the ISO standard and how it applies to the medical devices industry. To provide an understanding of the registration process and explore how to achieve ISO 9000 while improving the quality of your products. This course will also explore a 10-step process for getting new elements of your quality system up and running quickly.

Who should attend?

Executives, quality managers, supervisors, professionals, audit team members, and anyone desiring to understand the implementation process for attaining the ISO CE Mark for medical devices.

Key Topics

The ISO 9000 standard and how it applies to your organization

• An introduction to ISO 9000
• The elements of the ISO 9001 standard
• Differences between ISO and GMPs
• Summarizing your gaps

Requirements for implementing ISO 9000

• Create an environment for change
• Educate the organization
• Structure the implementation effort to capitalize on executive leadership
• Structure the implementation effort to capitalize on middle management knowledge
• Set implementation goals
• Communicate commitment, expectations, and progress
• Plan the implementation based on clearly identified gaps
• Commit resources
• Manage the implementation process through line management
• Align accountability and recognition mechanisms
• Track progress

Present a 10-step model for putting missing elements of a business & quality management system in place quickly and with permanent results.

Course Duration

This is a 2 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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