ISO 9001 Quality Management
The ISO 9000 series is probably the most widely recognised of the International Standards. It focuses on the delivery of products/services that are of consistent quality. It also requires the continual improvement of business processes that contribute to the delivery of a businesses products/services.
There are some important points to note, as there are some common misconceptions as to the intent of ISO 9001.
Firstly, quality as defined by the Standard, means conformant to customer, statutory and regulatory requirements. It is not a benchmark - as long as the output meets the requirements of the customer and passes applicable fitness-for-purpose and safety regulations, a two dollar watch from the flea market is just as compliant as a Rolex.
Secondly, there is nothing in the standard that says you have to continually improve your products/services - only the processes that deliver those products/services. In fact, Section 7.3 of the Standard - which covers design and development - is the one and only generally allowable exclusion of the Standard.
Of course, it is in your businesses best interest to improve products and services, but ISO 9001 does not require it.
Thirdly, continual improvement is a measure of intent, not outcomes. A business should aim to improve processes such that quality of output also improves, but there is no requirement to create an endless cycle of changing your processes just for the sake of changing them.
Fourth, the Standard is customer focused. In this, it only requires the inclusion and management of processes that contribute to quality of products/services. Many businesses make the mistake of documenting all processes - like payroll, administration and other ancillary services that may not relate to product/service delivery. This is an unnecessary overhead and often hinders the person(s) responsible for quality from working on what matters.
And lastly, the Standard does not require copious amounts of paperwork. You need a quality policy and objectives, you need a quality manual which defines the scope of the quality management system and provides a 'process map' of how your management system fits together, and there are six procedures that require documentation:
- Control of Documents
- Control of Records
- Internal Audit
- Control of non-conforming product
- Corrective Action
- Preventive Action
In many organisations, all of these documents can be kept in the quality manual. It is entirely possible for an organisation to have a compliant quality management system in 20 pages, or less.
The intent of the modern version of this Standard is to give your business a framework that provides the necessary structure for you to maintain consistency of quality. In this alone it is a valuable tool for improving your businesses performance. And if you choose to certify, you will also have the recognition that comes with certification to an International Standard.