What will the future bring???
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What will the future bring??? |
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ISO-9001-2000 news as of 4th Qtr - 2008:
As we approach the end on 2008, the release of ISO9001:2008 is coming soon. The changes to the ISO9001 Standard by TC176 representatives are only administrative changes made for clarification, and compatibility with ISO14001. There are no new requirements, only clarification to existing requirements. However, ISO9004:2008 is completely changed, and is titled "Managing for Sustainability - A Quality Management Approach". The format no longer follows the same format of ISO9001, and it addresses sustainability of an organization, rather than its previous focus on performance improvements. It provides some good ideas for the various requirements of ISO9001, but just does not follow the clause numbering format any longer. There are several Tables used to describe ideas for Strategic and Operational Maturity Levels.
Auditing to the ISO-9001:2008 Standard must be focused on performing PROCESS type audits versus the previous methods of auditing to a specific clause itself. Here are some ideas related to PROCESS Auditing:
Who is the primary process owner(s) and contributors of the processes that are considered for the audit.
Identify the various Inputs, Methods used for the process, and the associated Outputs that you expect to encounter during your process audit, as this will help you with 4.1 to verify the sequence and interaction of the processes (best shown in a functional process flow chart, or as I call it a "swim lane" chart). You can also identify the various functions that interact for the process; and should have some type of Key Process Indicator or method to verify the output you get is what was expected.
Identify the various resources (equipment, material, special tools, test equipment, etc.) necessary to complete the process, as these can provide samples for 6.1 and 6.3 requirements.
You can also include the measurable objectives that have been established, which are related to any of the pieces of the process, as a sample for 5.4.1 and 8.4 requirements.
Ensure that you include any documents and forms that are required for the process to sample 4.2.3 and 4.2.4 requirements. This gives you the option to check and verify Control of Documents and Records during your Process Audit.
For any employees that you interview, verify their defined responsibilities, and evidence they were communicated to the employee to sample 5.5.1 requirements; also verify their training records for the task they were performing when you interviewed them to sample 6.2.2
By interviewing various personnel involved in the process, you can determine their knowledge of the job task; ask them the quality policy (5.3) to determine their knowledge and understanding of their Quality Policy, and how do they personally contribute to the policy; who is the appointed management representative (5.5.2); knowledge of the job responsibilities (5.5.1) and related job training they have received (6.2.2). These are examples of some of the pieces of the ISO-9001:2000 Standard that you can sample during a “Process Audit.”
The process management approach is widely used in today's business world. This process-based structure is much better aligned with the “Plan-Do-Check-Act” activities, and a Continual Improvement cycle; and helps you focus better on more specific details when auditing.
Emphasis should be placed on employee training and awareness of the importance of the Quality Policy, Responsibilities, Customer Requirements, Continual Improvements, and Control of Nonconforming Product/Material. Ensure that each individual employee is aware of the relevance of their contributions to the overall process results, and the impact that they have on the final product, as this will help you to verify an effective quality system is in place.
If you have questions on “PROCESS Auditing”, or would like training on the changes, please contact us at ProcessAudits@getstellar.com
The ISO-9000-2008 Standard will be available through ASQ during the last quarter of 2008. You can order ISO-9000, ISO-9001:2008, and ISO-9004:2008 from them. It is also recommended to use the ISO-19011:2002 as a Guide, which provides information on planning, conducting and reporting of an audit. ASQ’s phone number is 1-800-248-1946.
Stellar Consulting can help you better understand the requirements of ISO9001:2008, and ensure you are compliant with the standard. There will be a transition period of one (1) year from the formal release of ISO9001:2008 for implementation for certification.
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