Process-Based Systems and Audits

SQA Advisory  Number 11

Original date: October 28, 2004
Revision date: October 28, 2004
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Introduction:

Since its inception, ISO 9001:2000 has mandated that certified organizations identify their management-system processes and provide a description of the interaction between those processes within their quality manual.

Discussion:

Fundamentally, management-system processes can be named or labeled in many ways that are acceptable to the organization and meet the standard’s requirements. Additionally, these processes may exist at all levels within the organization. For instance, a process for product design may include many departments and individuals; however, a process for documenting a corrective action may only involve one department and specifically, one person. In the end, an organization must identify enough of their businesses’ processes to address all the requirements of the standard. The transition from element-based systems to process-based systems, however, has made this seemingly simple task, overwhelming.

An easy but flawed means of making the transition to the newer standard would be to identify all 20 elements of the “old” standard as management-system processes. An equally easy, but also faulty approach would be to identify the organization’s departments as management-system processes. While there is no requirement for how a process is officially “named” or “labeled,” true management-system or business processes usually stand in contrast to the previous standard’s “elements” and typical company departments. That is, a “true” business-process will normally traverse several of the old ISO “elements” and an organization’s departments.

SQA Position:

Smithers Quality Assessments provides every customer with a process “matrix”. Using this matrix, SQA auditors will ensure that the “true” processes are identified and there are enough identified to address the standard’s requirements. In other words, auditors will look to ensure that the flawed approaches described in the aforementioned “discussion” section of this Advisory have not occurred.

In addition, SQA auditors will verify that the general characteristics of a process are in place and those characteristics include: a process name; input(s); a process flow; an output (e.g., a specific deliverable, record, etc.); measures, in most cases and; clearly stated objectives that are in line with upper level objectives such as the quality policy or mission.

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