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.
On completion of this training course you will be able to:
· Describe the role of internal audit in the maintenance and improvement of management systems
· Explain the purpose and structure of ISO 9001:2015.
· Plan and prepare for an internal audit, gather audit evidence through observation, interview and sampling of documents and records.
· Write factual audit reports that help to improve the effectiveness of the QMS.
· Suggest ways in which the effectiveness of corrective action might be verified.
1. How to adapt your auditing technique to accommodate the new and amended requirements in ISO 9001:2015.
2. How to audit the new requirements concerning organizational context and the application of a risk-based approach.
3. How to audit top management commitment and leadership.
4. How to audit processes and their interaction with other processes.
5. The importance of quality management for the organization and its customers.
1. Delivery of the conceptual framework together with a demonstration of how systems and its components tie up and form a complete whole.
2. Once a concept is understood, practical application is applied.
3. Once application is made clear, implementation can be executed at work place.
4. Spoon-feeding (Delivered in a Take-Back-and-Do Approach).
Who Should Attend
· All existing internal and external auditors that wish to be able to audit ISO 9001:2015.
· Quality managers, process owners and anyone that needs to understand the ISO 9001:2015 audit process.
· Anyone involved in the implementation or transition of ISO 9001:2015.
* It would be beneficial for you to have knowledge of ISO 9001:2015 prior to attending this program and have conducted audits based on the ISO 9001:2008 revision.
Part I – Audit Requirements for ISO 9001:2015.
• Annex SL detailed framework ?context of the organization, leadership, managing risks & improvement.
• Quality management fundamentals and principles.
• New quality terminology.
• Planning and managing top management involvement.
Part 2 – Auditing the ISO 9001 Quality Management System
· The differences in the clauses of ISO 9001:2008 and ISO 9001:2015.
· Relationship between internal and external issues, risks, opportunities and the processes within the management system.
· Implications for the auditor and the organization.
· New skills needed to audit against ISO 9001:2015.
Part 3 – Auditing the Quality Management System.
· Moving away from a prescriptive approach to process approach and the use of checklists in performing audits.
· Identifying the types of skills required towards interviewing techniques.
· Understanding the changes to competencies and compares them to the current auditor references, experiences and training.
· Requirements for documented information and how this impacts the audit process including the identification of audit evidence.
· How to audit those requirements in ISO 9001:2015 that are less prescriptive, where audit evidence may be more difficult to obtain:
§ Methodologies for auditing the new requirement for Risk Management (Risk Based Thinking).
§ Methodologies for auditing the new requirement for Organizational Knowledge.
For registration please Contact :Email : firstname.lastname@example.org
Contact Person : Esther Yong
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Office Tel : 03-762598621, 03-76259862