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Outsourced processes and ISO 9001:2008 - understanding the guidance changes and approach to take for supplier evaluation and assessment

Instructor: Daniel O Leary
Product ID: 701536
Training Level: Intermediate to Advanced
  • Duration: 70 Min

recorded version

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This ISO 9001:2008 webinar explains the changes in ISO 9001:2008 related to outsourced processes. Discussion on the ISO’s guidance document on outsourced process to have an understanding of the intent and develop methods for evaluation and selection of outsourced suppliers, methods for written supplier agreements.

Why You Should Attend:
In 2008, a new edition of ISO 9001 went into effect. The literature says the new version doesn’t introduce any new requirements but only clarifications to the existing requirements. One of the clarifications involves the use of Outsourced Processes in the Quality Management System. The changes clarify the organization’s responsibility for conformity to all customer, regulatory, and statutory requirements, the need for control over outsourced processes and recommend using the methods found in the ISO 9001 Purchasing clause. These changes also include suppliers who are part of the same parent organization, such as a separate department or division. To help clarify the requirements, ISO issued a guidance document on Outsourced Processes.

While the changes are explicit to ISO 9001, they also apply to medical device Quality Management Systems such as ISO 13485 and the FDA’s Quality System Regulation (QSR).

The presentation explains the changes to ISO 9001, and recommendations in the guidance document. Discussion will be on a practical implementation approach, showing how to evaluate and select outsource suppliers, especially service suppliers. We develop methods for written supplier agreements, which define controls and expectations. A critical element for success is monitoring and measuring of the delivered service. This presentation incorporates supplier scorecards as the most effective tools for this purpose.

Learning objectives:

  • Understand the evaluation of ISO 9001 to the current version.
  • Define a process, and its interactions, in the ISO 9001 sense.
  • Identify processes that included in the Quality Management System (QMS).
  • Identify QMS processes that are outsourced.
  • Explain the ISO 9001 requirements for supplier requirements, evaluation, and selection.
  • State the ISO 9001 requirements for process monitoring and measuring.
  • Identify the elements to include in a supplier scorecard.

Areas Covered in the seminar:

  • ISO 9001:2008
    • A short history
  • Changes from the 2000 edition to the 2008 edition
  • Outsourced Processes (Clause 4.1)
    • What is a process?
    • What is an outsourced process?
    • The ISO Guidance Document
  • Purchasing (Clause 7.4)
    • Requirements
    • Evaluation
    • Selection
    • Supplier Agreements and Other Controls
  • Monitoring and Measuring of Processes (Clause 8.2.3)
    • Principles
    • Supplier Scorecards

Who will benefit:

This seminar is designed for quality professionals, regulatory professionals, supply chain managers, process owners, and management representatives involved in the implementation of Quality Management System processes. The webinar will help clarify the understanding of processes and how they relate to each other and to the Quality management System. Since process management is a team effort, especially where processes interact, teams should attend to help ensure all members have the same information. People in the following roles can especially benefit from the knowledge in this webinar:
  • Management Representatives
  • Management Review attendees
  • Quality Managers
  • Regulatory Managers
  • Supply Chain Managers
  • Purchasing Managers
  • Commodity Managers
  • Process Owners

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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