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Process Capability Applications in ISO 13485 Following ISO/TR 10017 - Webinar by GlobalCompliancePanel

Added by davidross759 on 2010-10-21

Conference Dates:

Start Date Start Date: 2010-12-09
Last Date Last Day: 2010-12-09

Conference Contact Info:

Contact Person Contact Person: Webinars
Email Email:
Address Address: Online Training Webinar, Wilmington, DE, 19801, United States
Phone Tel: 800-447-9407
Phone Fax: 302-288-6884

Conference Description:

The webinar explains Process Capability Analysis (PCA) and shows how to apply it to various clauses of an ISO 13485. PCA can help you develop, implement, and improve your QMS.

You can improve the implementation and effectiveness of your Quality Management System (QMS) by using statistical techniques. The techniques are broadly applicable across the QMS. ISO provides a technical report that explains a number of statistical techniques. The report also lists the QMS where the specific techniques apply.

Why you should attend: Process Capability Analysis (PCA) is a powerful tool used to describe, troubleshoot, and improve (Quality Management System) QMS processes. This webinar will help you understand the concepts of PCA and show you applications in your QMS.

Your Quality Management System (QMS) should be able to address these questions quickly and easily. If not, then your team needs to attend this webinar!

* Do you report process capability indices at your Management Review?
* Do you use PCA and capability indices to help you identify and prioritize improvement activities?
* Have you validated processes and improved them to ensure a Cpk ? 1.33?
* Do you use PCA to help evaluate your suppliers and the product and services they provide?
* Have you planned your monitoring and measurement systems based on capability of the methods and instruments you use?
* Does your corrective action system use the PCA to support investigations to identify the cause of nonconformities?

Areas Covered In the Session:

* Statistical Techniques Documentation
o The relationship between ISO 13485 and ISO 9001
o The techniques in ISO/TR 10017
o Application of Process Capability Analysis (PCA) to ISO 13485 clauses
* Process Capability Analysis
o The concepts incorporated in PCA
o Calculating the process capability indices (Cp and Cpk)
o Estimating process parameters using SPC
* ISO/TR 10017 Information on PCA
o What it is
o What it is used for
o Benefits
o Limitations and cautions
o Examples
* Applications to ISO 13485
o Management Review
o Product Requirement Review
o Design & Development Verification
o Design & Development Validation
o Design & Development Changes
o The Purchasing Process
o Verification of Purchased Product
o Production and Service Provision
o Monitoring and Measurement
o Process Monitoring and Measuring
o Product Monitoring and Measuring
o Corrective and Preventive Actions Processes

Who will benefit: People in the following roles can especially benefit from the knowledge in this webinar:

* Quality Managers
* Quality Professionals
* Management Representatives
* Production Managers
* Production Supervisors
* Manufacturing Engineers
* Production Engineers
* Design Engineers
* Process Owners
* Purchasing Professionals
* Inspection and Test Managers
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