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 changes reinforce 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. The presentation explains the changes to ISO 9001, and recommendations in the guidance document. We take 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.

This webinar explains the changes in ISO 9001:2008 related to outsourced processes. While the literature says this new version only contains clarifications, this clarification can have a big impact on a Quality Management System. We look to ISO s guidance document on outsourced process to ensure we understand the intent.

Why you should attend: ISO 9001:2008 clarifies the concept of an outsourced process and expects that you will manage any outsourced process using the purchasing methods in Clause 7.4. The new definition of an outsourced process includes the cases where you obtain a service from your parent company or from a sister division. This broadens the definition to bring in suppliers that are not traditional external companies.

Moving the management of outsourced processes to purchasing brings in the concepts of supplier evaluation, selection, and monitoring/measuring. This broader definition includes cases without monetary transactions! You will also learn about the ISO guidance document that explains the change in the standard.

In addition, the new concepts mean that you may have a new set of questions (and requests for records) from your ISO 9001 registrar.

If your Quality Management System (QMS), through its documented procedures, cannot answer these question quickly, and without hesitation, then you, and your team need to attend this webinar!

Do you know all the processes required for your quality management system?
Do you know who performs each process, i.e., can you identify the process owner by job title and name?
Can you list the QMS processes that you have outsourced?
Do you have records of the requirements for this supplier, potential supplier evaluation, and your selection criteria?
Can you show how you monitor and measure the QMS process the supplier provides?
Do you have records monitoring, measuring, and feedback for the supplier performing the outsourced process?

Areas Covered in the Session: