This management review procedure is an example of the procedures and webinars that we created for our turnkey quality system.
Who should attend the Management Review Procedure Webinar?
The management representative should watch the 36-minute procedure webinar, included at the top of this page, to help them implement this management review procedure. The longer training webinar is recommended for everyone else in top management. OEMs and contract manufacturers both need to conduct management reviews to ensure the effectiveness of the quality management system. The ISO 13485 standard and 21 CFR 820 both require that your company conduct a management review. Therefore, everyone in top management at a medical device company should watch this 41-minute management review webinar. If you are the management representative, you can’t afford to miss this opportunity. If you hate management reviews, you will like this method better.
How will this training webinar help you?
Does the CEO and CFO of your company complain about the length of management review meetings? The advice in this management review training webinar is intended to keep senior management engaged during management review meetings. Our speaker has performed hundreds of management reviews this way since 2003 and audited over one thousand management reviews. There are dozens of ways to conduct a management review, but only a few methods are simple, efficient, and foolproof. We recommend using our management review procedure and the corresponding template. They are free, and they will make your meetings shorter and more effective.
In 2012, the FDA Issued 219 findings against management responsibilities and the management review process. The management review meeting minutes may be officially “out of reach” until 2026, but there are FDA inspectors that will ask for this document anyway. Do you really want to be perceived as hiding something? Update your management review procedure now.
What’s included in this management review procedure bundle?
The webinar explaining the requirements for management reviews is being updated for 2024. Anyone that registered previously for the management review procedure and webinar will receive a free update. If you submit a new registration, you will get:
What you will learn from the management review training webinar:
Did you receive a nonconformity during your last audit, because you forgot to include one of these required items?
- Twelve Inputs
- Four Outputs
- Review of the Quality Policy
- Review of the Quality Objectives
- Review of the QMS effectiveness
This management review training webinar will teach you how to document the management review requirements in your meeting minutes and it will teach you how to delegate meeting preparation more effectively. The management team will not be bored in your next management review, and your meetings will improve quality AND the bottom line. You will also receive a copy of our management review procedure and the management review procedure webinar to help you implement the new procedure.
Do you want to learn more about procedure writing?
This management review procedure is just an example of how we created procedures for our turnkey quality system. If you are interested in learning more about how to write your own procedures (e.g., for manufacturing work instructions, installation, or service), we recommend reading our procedure case study on writing the management review procedure. We also include a procedure template as part of our Document Control Procedure (SYS-001).
About the Author & Webinar Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at 802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.