Equipment maintenance is commonly forgotten during audits. Do you have a Facility, Plant and Equipment Maintenance Procedure (SYS-005)?
Facility, Plant, and Equipment Maintenance Procedure (SYS-005) and Webinar Bundle ($299)
To meet the requirements for ISO 13485:2016, Clause 6.3, you need a facility, plant, and equipment maintenance procedure. This is one of the most commonly forgotten quality system requirements by auditors, but why? There are several reasons. Maintenance is usually not included in your management reviews as an input unless your company is tracking compliance with your preventive maintenance schedule as a process metric. Another reason why auditors overlook maintenance is that they spent too much time in conference rooms and not enough time looking at the equipment and facilities. The third reason is that most companies have a reactive approach to maintenance instead of a proactive approach. Using similar approaches to equipment maintenance and calibration helps ensure that there is a routine monitoring of equipment, but auditors need training on the process approach to auditing.
What is included in the Facility, Plant, and Equipment Maintenance Procedure?
- SYS-005 v0.6 Facility, Plant, and Equipment Maintenance Procedure
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LST-006 v0.3 Equipment Register
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Native Slide Deck
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Training Webinar Recording
If you would like to ask specific questions about the facility, plant, and equipment maintenance procedure, please submit them via email or schedule a call using the calendar app on our contact us page. All deliveries of content will be sent via AWeber emails to confirmed subscribers. If you don’t receive the content automatically, please check your spam folder.
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To view all available procedures click here
To review a sample Medical Device Academy procedure click below:
About Your 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 +1.802.281.4381 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.