Posts Tagged ‘iso9001:2000’
AS 9100 Separating the “whats” from “how tos”
AS9100 defines additional areas within an aerospace business process management system that must be addressed when implementing an ISO 9001:2000-based quality system. Typically, these requirements are included within robust aerospace quality systems. The industry experts who wrote the standard and the representatives who approved it all agree that these additions are essential to ensure product, process and service safety and quality.
Although the standard outlines industry “whats” for a quality management system, the “how tos” were deliberately left out and remain the system designers’ responsibility. This reflects the AS9100 writing team’s belief that how-to information stifles continuous improvement.
All quality systems must be designed to meet the specific needs of the users. And although AS9100 identifies areas to address within the aerospace industry, system designers are encouraged to first establish a robust quality system that’s both effective and efficient. This system should be a holistic entity with practices spanning multiple functions and processes within the business.
When implementing a quality system compliant with AS9100 one must ensure that the additional requirements of their customers, regulatory agencies (such as the FAA and the JAA) and local, state and national laws are also referenced within the system’s documentation.
Auditing Your Management Review Process
ISO 9001:2000 requires top management to review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. The review could be carried out at a separate meeting but this is not a requirement of the standard. There are many ways in which top management can review the quality management system such as receiving and reviewing a report generated by the management representative or other personnel, electronic communication or as part of regular management meetings where issues such as budgets and targets are also discussed.
The management review is a process that should be conducted and audited utilizing the process approach.
ISO 9001 clause 5.6.2 specifies the inputs to the management review process and these topics shall be included. However, these are not the only subjects that can be included in a review. Internal auditors should be aware that inputs could be in many forms such as reports, trend charts and so on.
As output from the management review process, there should be evidence of decisions regarding:-
· change of quality policy and objectives,
· plans and possible actions for improvements,
· change of resources,
· revised business plans,
· budgets.
Output is not only related to improvements or changes but could include decisions on other important issues such as plans to introduce new products.
Records of management reviews are required but the format of these is not specified. Minutes of meetings are the most common type of record, but electronic records, statistical charts, presentations etc. could be acceptable types of records.
Auditors should look for evidence that the inputs and outputs of the management review process are relevant to the organization’s size and complexity and that they are used to improve the business. Auditors should also consider how the organization’s management is structured and how the management review process is used within this structure.
Does ISO 9001:2008 Have Additional Requirements Beyond ISO 9001:2000?
This latest (4th) edition of ISO 9001 contains no new requirements compared to the (3rd) year 2000 edition, which it replaces. What it does is provide clarification to the existing requirements of ISO 9001:2000 based on eight years experience of worldwide implementing of the standard and introduces changes intended to improve consistency with the environmental management system standard, ISO 14001:2004.
The clarifications and changes in ISO 9001:2008 represent fine-tuning, rather than a thorough overhaul. It focuses on changes that organizations might make to better comply with the spirit of the standard without adding, deleting, or altering its requirements. The changes are minor in nature and address such issues as the need to clarify, provide greater consistency, resolve perceived ambiguities, and improve compatibility with ISO 14001. The numbering system and the structure of the standard remain unchanged. As a result, the new standard looks much like the old standard.
So don’t let the new standard scare you away from you iso 9001 certification plans. If you are struggling with whether or not the time is right for your company, there are many business process management tools to help you along. If you are sitting on the fence, now is the time to act before the economy really gets going again. Just a question: Who would you rather buy from, a company with a proven quality system or one that doesn’t have a clue and isn’t willing to learn? The whole world can’t be wrong.