ISO9001:2015

introduction

A change in the design and thinking in ISO 9001:2015 brings new challenges for auditors to apply their competencies to the accomplishment of audits. The change also brings great opportunity.

The changes to ISO 9001:2015 from ISO 9001:2008 incorporate input from manufacturers and service providers, change the focus to customers, and help organizations to use the process approach to achieve outcomes. These are great advances in standardization and, when combined with risk practices, should drive consistent outcomes with a greater confidence that the customer will be satisfied or even delighted.

If you have the opportunity to read the current ISO 9001:2015 International Standard, you will see that the clauses are less prescriptive and require the user to engage the process approach to implement the standard.

Moving away from a prescriptive approach to process approach requires new thinking on how to audit. The mere use of checklists aligned with a set of standard clauses will no longer work as auditing moves toward interviewing techniques rather than review of records, corrective action data, and policy. The writers of the ISO 9001:2015 standard are envisioning that audits will take place through a series of in-depth discussions and analyses against risk to determine whether customers will receive their expected outputs or services.

For an auditor, the types of skills required now move toward interviewing techniques—similar to investigators. It’s more about digging into the reasoning for the application of a process, rather than the demonstration of the process. For an audit team leader, focusing on team selection against process may mean more members to follow individual processes to completion rather than selecting clauses for auditing.

This programme will emphasize the concepts that will be difficult to audit including new requirements that are less prescriptive, including for example; not requiring procedures and records, risk based thinking, knowledge management, and many others.

TRAINING OBJECTIVES

  • How to adapt your auditing technique to accommodate the new and amended requirements in ISO 9001:2015.

  • How to audit the new requirements concerning organizational context and the application of a risk-based approach.

  • How to audit top management commitment and leadership.

  • How to audit processes and their interaction with other processes.

  • The importance of quality management for the organization and its customers.

other manufacturing programs :
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