A quality manual is supposed to describe a quality management system (QMS), a system of processes working together to output product. A quality manual defines a QMS, whether or not ISO 9001 certification is among management’s objectives.
OPERATIONS AT THREE LEVELS
A work instruction (level three QMS documentation) describes operations at an activity level. It describes how specific activities are supposed to be carried out. “Insert nut A onto bolt B and torque to 20 lbs.” Defining operations according to ISO 9001 requirements at this level, instead of defining them according to internal processing requirements, is not useful to anyone, nor is it necessary.
A procedure (level two QMS documentation) describes operations at a process level. It describes how activities of a process are sequenced and how they interact to complete the process (they describe the criteria and methods for processing). “Assemble the unit according to the steps appearing on the Traveler, and according to the blueprint.” Defining operations according to ISO 9001 requirements at this level, instead of defining them according to internal processing requirements, is not useful to anyone, nor is it necessary.
A manual (level one QMS documentation) describes operations at a system level. It describes how processes of the system are sequenced and how they interact to output quality product. “Our system begins with a Sales process, followed by a Purchasing process, followed by a Receiving process, followed by a Production process, followed by a Shipping process.” Defining operations according to ISO 9001 requirements at this level, instead of defining them according to internal processing requirements, is not useful to anyone, nor is it necessary.
QUALITY MANAGEMENT ISN’T DEFINED BY ISO 9001
If there were no ISO 9001 and management wanted to define its system for outputting quality product, a system already operating every day, management would naturally define the system as it sits. The system would naturally be described as it actually operates. Then along comes ISO 9001 and management abandons the idea of defining its own operations sensibly and opts to define their own system according to some international standard intended merely to assess their system.
If management wants to describe its own operations according to ISO 9001 requirements, well, okay, they’ve been doing that since ISO 9001 came out. A manual intended to describe conformity to ISO 9001 requirements does just that–it describes how a system complies with requirements. This is like raising procedures to address requirements instead of raising procedures to describe actual processing. Such documentation is focused on demonstrating conformity to requirements, not to describe processing. It’s designed to pass audits, not to manage quality.
A process-based manual, like process-based procedures, doesn’t depend on ISO 9001 for its existence. A process-based manual, like process-based procedures, doesn’t change with every new revision of ISO 9001. A QMS, like the manual describing it, should be influenced by (as it depends upon) organizational operations, not on ISO 9001. Process-based documentation at any level describes processing first, addressing ISO 9001 requirements in process fashion, thus demonstrating that internal processing requirements conform to ISO 9001 requirements without allowing ISO 9001 to obscure the definition of processing.
Instead of writing QMS documentation first to make ISO 9001 conformity clear (yet confusing definition of any system), it might be time to start demanding ISO 9001 auditors who don’t need systems to be defined in terms of ISO 9001 in order to find conformity. Defining QMSs in manuals structured according to, and using terms of ISO 9001, seems to promote a cock-eyed view of quality management—quality management merely seen through the lens of ISO 9001.
Bio:
Why wait until the 2015 standard undeniably requires it to enjoy the benefits of a well-designed quality management system? Stop expecting ISO 9001 to drive quality and put Deming in the driver’s seat. He’ll take you where you want to go.
T. D. (“Dan”) Nelson is a quality management consultant, author, and trainer specializing in the process approach, ISO 9001, and related sector schemes. Dan has roughly 20 years of experience with ISO 9000 and over 15 years’ experience with the process approach. Dan holds an MA in Business Administration from the University of Iowa. Dan can be reached at:
dan@tdnelson.com
319.210.2642