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The following are common misconceptions concerning ISO 9001 implementation.
Misconception: All activity requires documentation!
ISO 9001:2008, clause 7.5.1c requires that an organization utilizes
Work Instructions (WI) to ensure that its activities are conducted under
controlled conditions. However a key word in the standard is as
applicable. It is up to the organization, and not the registration
auditor, to determine whether such are needed. A good approach is to
determine the minimum documentation necessary to provide control, if any is
required, then collect data from the process, analyze the data including
nonconformities and then create additional work instructions to address the
concerns. This way only necessary work instruction documentation is created
ensuring a lean robust system to manage the organization's quality.
Misconception: All calibrated equipment requires
labels.
ISO 9001:2008, clause 7.6c requires that monitoring and measuring devices (M
& M) are identified in order to determine its calibration status. The
standard has NEVER required that all equipment have a calibration label.
It may be convenient to have each item labelled, but ensure that the master log
or calibration file is the place where the calibration status is recorded or
maintained. That way if a label goes missing, the identification can be used to determine its
calibration status and the system will be in conformance to ISO 9001:2008.
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