Applying Process Capability Analysis to ISO 13485

Instructor: Daniel O Leary
Product ID: 701692
Training Level: Intermediate to Advanced
  • Duration: 75 Min

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This Process Capability Analysis webinar on ISO 13485 will help you understand the concepts of Process Capability Analysis (PCA) and shows how to apply it to various clauses of an ISO 13485.

Why Should You Attend:
ISO 13485:2003 forms the basis for a medical device Quality Management System (QMS). Derived from ISO 9001, the medical device QMS can benefit from the documents that support ISO 9001. One of them is the technical report on statistical methods, ISO/TR 10017:2003. This technical report describes about a dozen statistical techniques and tells which ones are most applicable to each ISO 9001 clause. One of the techniques is Process Capability Analysis (PCA).

This webinar explains process capability and shows how to apply it to ISO 13485! We start with an overview of the standards and technical report. This section shows how the standards link and identifies differences between them. The seminar explains process capability analysis using both a graphical approach that shows the how the concept works and an equation approach that show how to calculate the process capability indices. The webinar explains the application of the statistical techniques to the ISO 13485 clauses identified in the technical report.

For each applicable clause of ISO 13485, the webinar explains:

  • The requirements in the clause.
  • The need for quantitative data.
  • The relations to ISO 9001, explaining the differences.
  • A general explanation of the clause requirements.
  • A specific explanation of how PCA applies to the clause.
  • An example illustrating an application of PCA to the clause.

Areas Covered in the Seminar:

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

Related Technical Documents:

  • ISO 9001:2000 Quality management systems – Requirements
  • ISO/TR 10017 Guidance on statistical techniques for ISO 9001:2000
  • ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes
  • EN ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes

Who Will Benefit:

This seminar is designed for people involved in all aspects of the Quality Management System.
  • Quality Managers
  • Quality Professionals
  • Management Representatives
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Production Engineers
  • Design Engineers
  • Process Owners
  • Purchasing Professionals
  • Inspection and Test Managers

Instructor Profile:
Daniel O'Leary, is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

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