What is the Quality of a Quality Management System

ISO 9000:2014 defines quality as the degree to which a set of inherent characteristics of an object fulfils requirements, where an object is anything perceivable or conceivable. The term object is added since the previous version the standard. According to this definition, the quality of a QMS is the degree to which a set of inherent characteristics of the QMS fulfills requirements. So, in the context of this blog, the QMS is the object. ISO 9001:2014 distinguishes the next characteristics of the object QMS:

1. Accordance with or conformity to the international standard
2. Adequacy
3. Completeness
4. Conformity to the organization’s requirements
5. Effectiveness
6. Integrity
7. Scope
8. Suitability

See table 1. In the list of characteristics, the term efficiency is not mentioned. I think that a QMS should, next to effective, also be efficient. The term efficiency is, however, more or less covered by the characteristics adequacy and suitability. Table 1 List of characteristics and required state of the QMS.

Characteristic	Required state	Section
Accordance with the ISO standard	EstablishedImplemented Maintained Improved	4.4
Completeness		7.5.1
ConformityEffectiveness		9.1.3.c
Conformity to organization’s requirements and the international standard		9.1.3.a
Conformity to the international standard		5.3.a
Contribution to the effectiveness		7.3.c
Effectiveness		5.1.1.a
Effectiveness		5.1.1.i
Effectiveness	Evaluated	9.1.1
Effectiveness	ImplementedMaintained	9.1.3.b
Integrity	Maintained	5.3.e
Integrity	Considered	6.3.b
Scope		8.4.2
SuitabilityAdequacy Effectiveness	Reviewed	9.3.1
SuitabilityAdequacy Effectiveness	Improved	10.3

According to the Object-oriented Quality and Risk Management model (Van Nederpelt, 2012) each characteristic of an object should be defined. In ISO 9000:2014, not all characteristics of the QMS are defined. Only the term effectiveness is defined in ISO 9000:2014. It is defined as the extent to which planned activities are realized and planned results achieved. If we apply this definition to a QMS, than the effectiveness of a QMS is the extent which planned activities of the QMS are realized and planned results of the QMS are achieved. This definition makes sense. Some of the characteristics may be self-evident, such as conformity to the International Standard. Other characteristics, such as integrity, are less self-evident. The requirement of the QMS or the characteristics of the QMS are defined in ISO 9001:2014. The standard requires that the QMS or characteristics of the QMS ‘shall’ be in a specific state, such as established, implemented, maintained, improved, evaluated and reviewed. See also table 1. Conclusion is that the clarity of the standard could be enhanced by defining seven out of eight characteristics of the QMS. Moreover, adding requirements for the efficiency to the QMS would make the standard more complete. References

• ISO/DIS 9000:2014 Draft. Quality management systems – Fundamentals and Vocabulary.
• ISO/DIS 9001:2014 Draft. Quality management systems – Requirements.
• Van Nederpelt, Peter W.M. (2012). Object-oriented Quality and Risk Management (OQRM). A practical and generic method to manage quality and risk. Alpen aan den Rijn/New York: MicroData.