Identifying Quality Management System Processes and Procedures

SQA Advisory Number 13

Original date: June 20, 2005
Revision date: June 20, 2005
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Introduction:

ISO/TS 16949:2002 and AS9100, as well as their base standard ISO 9001:2000 require that a certified organization adopt a process approach to their quality management system and document a minimum of 6 – 7 operating procedures depending on the particular system. Business, or management system processes are normally structured around the business that is unique to them and the company’s particular inner-workings. Furthermore, in order to become certified to either of the aforementioned standards, enough business processes must be identified to address all the requirements of the applicable standard. While minimal, all ISO 9001:2000 based standards stipulate that certain procedures are documented.

Discussion:

Business processes and documented procedures are likely to be distinctive to the organization to which they apply and dynamic in order to accommodate improvements, corrections, changes in the marketplace, changes in products/services, etc. In the past, SQA had required that the management system processes be documented on the SQA “QMS Process Identification Matrix” and that the documented management system be reflected on a similar form. A more robust system would continuously capture the dynamics mentioned previously and complement the audit planning of process-based systems.

SQA Position:

Smithers Quality Assessments has created a form in MS Excel that can reflect the most current business/management system processes and basic procedures in place at a certified organization. The Comprehensive Requirements Workbook is meant to be maintained by the certified organization during the life of the certification. Approximately 30 – 45 days prior to an audit, the assigned lead auditor will request the workbook so that the upcoming audit can be planned. The intent is that the organization will review and update their management system processes, procedures and business conditions with the workbook and then e-mail it to the auditor.

This form will be required by auditors performing initial assessments, surveillance and recertification audits of the aforementioned systems on or after July 18, 2005. In other words, any audit conducted on or after July 18, 2005 must utilize a Comprehensive Requirements Workbook for planning and auditing purposes.

The workbook form is expected to be maintained by the certified organization and will then be routinely requested prior to every subsequent audit.

The Comprehensive Requirements Workbook also comes with directions for filling it out. The directions are in MS Word format.

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