The purpose of this 5-page data analysis procedure is to meet the requirements for monitoring and measurement of processes, data analysis and establishing quality objectives.
What is the Data Analysis Procedure (SYS-017)?
This procedure meets the requirements for clause 8.4 of ISO 13485:2016, but this procedure also addresses the requirements of clauses 8.2.5 and clause 5.4.1. The title of this procedure is actually, “Monitoring, Measurement and Data Analysis Procedure.” The procedure is in its third draft. There are no specific forms or lists associated with this procedure. The procedure is 5 pages in length.
The purpose of this procedure is to define the process for monitoring, measuring, and analysis of processes within your company’s quality management system. The procedure was updated to include references to the applicable ISO 13485:2016 clauses, and Matthew Walker added color coding (i.e., blue font) and symbols (i.e., #) to facilitate auditors identifying where the requirements for each sub-clause are found. The procedure also explains where the requirements for monitoring and measurement of processes can be found for each process.
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When is the live webinar scheduled for this procedure bundle?
The live webinar is scheduled for Saturday, October 5, 2024 @ 9:30 a.m. ET. If you purchased the procedure before September 30, you will receive login information to participate in the live webinar. The webinar will be hosted on Streamyard.com. If you are unable to participate in the live webinar, please send us your questions in advance so that we can be sure to address your questions in the live webinar. You will be able to download the recording from the Dropbox folder after the live webinar and you can watch it as many times as needed.
What do you get when you purchase the Data Analysis Procedure?
Scope of the Data Analysis Procedure
The scope of the procedure explains how monitoring and measurement processes shall be documented for each process in your quality management system. The procedure also defines how quality objectives will be established and maintained. The procedure defines how data analysis shall be performed for the metrics for each process and the quality objectives, and finally the method for communicating the conclusions of the data analysis to top management are defined.
This procedure does not include the requirements for statistical techniques as required by 21 CFR 820.250. That requirement is addressed by our Statistical Techniques Procedure (SYS-022).
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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 510k 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 Instagram.