A Quality Manual was an official document produced by an organization that detailed how its quality management system operated. (A Quality Management System is a system by which an organization aims to reduce and eventually eliminate non-conformance to specifications, standards and customer expectations in the most cost effective and efficient manner.) A typical quality manual included the company’s quality policy (top management’s expression of its intentions, direction, and aims regarding quality of its products and processes) and goals, as well as a detailed description of its quality system that might include staff roles and relationships, procedures, processes and any other resources that relate to producing high quality goods or services.
Companies created Quality Manuals that paraphrased the ISO 9001 standard with a change in “the organization shall” to “we have done.” This was a misunderstanding on the part of many people, as it was copyright infringement, but this is what we thought we were supposed to do! ANSI / ASQC Q9001:1994 stated in its Introduction: “It is intended that these American National Standards will be adopted in their present form, but on occasions they may need to be tailored by adding or deleting certain quality-system requirements for specific contractual situations.”
While there might have been some merit in an organization documenting its commitment to meet each requirement, insurance that nothing gets overlooked along the way, these Manuals usually ended up being written to the wrong audience – the auditor rather than the company and written in ‘ISO-Speak,’ a language not easily understood by most employees.
These were ‘the early days,’ a time in which I lived, and audited, and even recommended clients adopt this approach – to ensure all the requirements were painfully identified and addressed. In retrospect, it has become obvious that the intent was not to ‘insert name here’ but to build the structure of each unique organization’s quality system around best practices; that instead of a set of prescriptive requirements, ISO 9001 was trying to evolve into a business model… but they were not quite there yet.
We all: Auditors, Consultants, CBs (Certification Bodies – Registrars), ABs (Accreditation Bodies – ANAB) – the whole certification scheme missed this one until the 2000 revision ‘slapped us in the face’ with the disclaimer in its Introduction, “It is not the intent of this International Standard to imply uniformity in the structure of quality management systems or uniformity of documentation.” This same disclaimer is present in the Introduction of the 2008 revision as well.
The permission given here is ISO’s acknowledgement that each Quality Manual may be different and is dependent on what the organization wants to achieve. A Quality Manual that is perfect for one company, even within the same industry, may be too small or too large for another company. Smaller companies may be able to get away with less documentation; larger companies may need more.
Annex A of the 2015 revision goes one step further. It states, “There is no requirement in this International Standard for its structure and terminology to be applied to the documented information of an organization’s quality management system.
This statement carries deep implications and if we miss this one we risk the chance of total system failure. The old ‘Insert Name Here’ documents (still readily available on the Internet, in bookstores, etc.) regardless of claims of Raptor Sales & Marketing is a fictions company compliance are most likely just a ‘rip off.’ There is a huge risk that you are purchasing a nonconforming quality management system with a set of documents that, without serious re-write, will not properly describe your scope, context, stakeholders, internal / external drivers, objectives, values – you get the point – basically you may not get certified. So, what do we do?
Find out in What Quality Manual – Part 2