Friday, December 18, 2015


The Quality Management Standards were born in the US military, during and after World War II, when a need was felt for systematizing manufacturing processes that were used to produce materiel purchased by the Department of Defense of the US Government. The military standard was called MIL Q 9858. Q 9858 found its way into Europe through NATO, where it was called AQAP (Allied Quality Assurance Program). This was later adopted in the UK and transformed into a civilian standard, which was called BS 5750.

Current ISO
The current ISO standards are published by the International Organization for Standardization. ISO is Greek word, loosely translated to mean “standard”, and also serves as the informal synonym for the organization it comes from.
The first Quality Management System (QMS) standards in 1987 and 1994 had three parts: ISO 9001, 9002, 9003. 9003 had only Inspection of product, 9002 had inspection and production, and 9001 and inspection, production and design. 9003 fit into 9002, and 9002 fit into 9001.

1987 and 1994
The 1987 version being a direct descendant of the (US) military standard had a command and control touch and feel to it. It was prescriptive. It was a rather small document. The 1994 version was essentially similar to the 1987 version, but had much more detail that was very helpful for implementing the requirements. The full version (ISO 9001) had 20 elements.

2000 and 2008
The 2000 version made a radical departure from previous versions. Quality Management System QMS standards till 2000 were quite blatantly focused on the manufacturing industry. The prevalent idea was that the pursuit of quality, and “quality control”, was applicable only to tangible products, typically produced in a factory with (usually) large teams of people involved. By far, the principal goal of a Quality Management System QMS was to ensure that (customer specified) requirements were met.
The 2000 version expanded the goal of Quality Management System QMS to include “customer satisfaction” as the principal goal, and the pursuit of a “Process based approach” and “continual improvement” as a principal Modus Operandi.  The underlying look and feel of a manufacturing standard was erased as much as possible. Another significant change was the elimination of 9002 and 9003, but making the provision for taking exclusions as applicable. The general tone, look and feel was more relaxed, and organizations had much more explicit freedom to decide the details of their Quality Management System QMS. A major change was in the mandatory requirements for documented procedures. The 1987 and 1994 standards required documented procedure for almost all clauses. The 2000 version needed only six.
The 2008 version of the standard had no significant changes from the 2000 version.

ISO 9001:2015
The Draft International Standard (DIS) stage of the process was completed in May 2014, and the Final Draft International Standard (FDIS) was published last week on July 09, 2015. As expected, there were no significant material changes from the DIS to the FDIS. The final International Standard was published in October 2015, and there are no material differences from the FDIS.
The ISO 9001:2015 QMS standards can boast the most radical changes ever. The biggest change is of the structural and philosophical variety.
The ISO 9001:2015 standard follows a harmonized structure that all management system standards will follow. This structure has 10 sections, in which all but one (section 8) apply uniformly to general management system requirements (quality, environment…etc). Section 8 (Operation) will apply to the specific discipline.