I am a trainer and consultant in lean manufacturing, Six Sigma, quality management, and business management.
ISO 9001 Requirements for a Quality Management System
What are the ISO 9001:2008 quality manual and quality policy requirements? ISO 9001 is an international standard that defines the requirements for a quality management system with which to control your company processes to ensure that they are controlled in a manner that ensures products and services are delivered conforming to specifications.
Some of the more important parts of the ISO 9001 requirements are your quality manual and your quality policy.
ISO 9001 Documentation
Typical ISO 9001 Quality Management System Documentation Structure
A Quality Management System requires some form of documentation to define it, the amount of documentation however does not have to be excessive. Too many companies feel that they have to have detailed instructions and descriptions of every function of their business to “control” every process. ISO 9001 however tells us that “the extent of the quality management system documentation can differ from one organization to another due to a/ the size of the organization and type of activities, b/ the complexity of the processes and their interactions, and c/ the competence of the personnel.”
Most companies organize their documentation in a pyramid fashion, the top tier is the policy, objectives and the quality manual, the second tier are the procedures defining what will be done and who, the third tier are the standard operating procedures showing detailed instructions of how to do things, followed by the records and forms.
The only documentation required by ISO 9001 to satisfy the standard are as follows;
Documented statements of a quality policy and quality objectives,
A quality manual,
Documented procedures and records required by the ISO 9001 Standard (There are only 6 compulsory procedures!)
Documents, including records, determined to be necessary
ISO 9001 Quality Manual and Quality Policy
What is an ISO 9001 Quality Policy
The ISO 9001 quality policy is top management’s statement of their intentions and direction with regard to quality for the organization. Again this is not an overly long document but a simple few paragraphs giving the top level view of what the top management of a company wishes to achieve, usually starting with something along the lines of;
“The policy of widget inc is to be recognized by all of its customers and potential customers as world leaders in the development, production and delivery of widgets throughout the world..”
There are a few other required statements that are required within your policy;
ISO 9001:2008 Quality Policy Contents
ISO 9001 states that the quality policy shall;
a/ is appropriate to the purpose of the organization, so your policy should not be talking about space rockets if you manufacture widgets.
b/ includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system, this is usually achieved through a statement such as, “the management of widget inc state that all employees shall comply with the requirements of our quality management system which is based on the requirements of ISO 9001:2008, this system shall be subject to a process of continual improvement through our quality management review system and objectives process..”
c/ provides a framework for establishing and reviewing quality objectives, a statement such as, “Quality objectives will be set at the annual management meeting and will be subject to review at the weekly and monthly management meetings..”
d/ is communicated and understood within the organization, it is not enough to just have a pretty copy of your quality policy stuck on the wall in your reception area where your customers will see it, you need to ensure that all of your staff are aware of it and understand it. Make it part of your employee induction, put on notice boards within the organization, include it as part of your monthly or quarterly staff briefings.
e/ is reviewed for continuing suitability, ensure that the requirement to review your quality policy is within your process for your quality management review meetings.
The ISO 9001:2008 quality policy should only cover a few paragraphs and cover all of the above points, many companies add additional paragraphs and even pages with regard to their treatment of employees, the environment, health and safety etc. as part of an overall set of company policies.
ISO 9001 Quality Manual
What is an ISO 9001:2008 Quality Manual
I have over the years seen quality manuals that are a few sides of A4 paper and others that are huge tomes of material that would have put Tolstoy to shame. The ISO 9001 Quality manual needs to be a description of your quality management system, what the processes are and how they interact as an overall system. It needs to show what your overall aims are your, policies and objectives.
It does not have to be a step by step instructions manual for every little process and form filling routine in your company. The amount of documentation should be relevant to the size and complexity of your operations. It is possible to produce a Quality Manual that covers one sheet of A4 paper, but would that really be enough for your organization?
ISO 9001 Documents
ISO 9001:2008 Quality Manual Contents
ISO 9001 says that you shall establish and maintain a quality manual that includes;
a/ the scope of the quality management system, including details of and justifications for any exclusions.
b/ The documented procedures established for the quality management system or reference to them.
c/ A description of the interactions between the processes of the quality management system.
So the actual requirements for the quality manual are very “small”, the scope can be a simple one paragraph statement saying what your company does and the system covers, i.e. “The manufacture and testing of widgets for the overseas widget industry”. Exclusions refers to only section 7 of the standard, if your company does not perform a specific task mentioned under section 7 then it is permissible to exclude those subsections from the scope of your system, i.e. “Excluding section 7.3, Design and Development, as the company does not perform any design and development”.
As to the procedures, many companies have a brief statement within their quality manual stating their policy and intent for each specific process and just a reference to the ISO 9001 procedure, the minimum requirement for a conforming quality manual would be just a simple list of your individual procedures.
The interactions of the processes can be a simple diagram showing how each process within your business feeds into the next, the diagram should be clear enough for anyone to realize how the different processes in your business interact with each other.
In “theory” a quality manual could be just a single piece of paper! The “average” quality manual in my experience however is around one or two dozen pages, usually containing a description of each process in the company (departments) stating the policies and aims of each process and the responsible person. These manuals usually follow the layout of ISO 9001 with similar headings and layout.
Generic ISO 9001 Quality Manuals and Policies
Pre Prepared Quality Manual and Policies for ISO 9001
Because of the structure of ISO 9001 it is possible to create generic Quality Manuals, Policies and procedures that can then be modified to match your companies profile, structure and processes.
Whilst these may not be perfect they are an ideal way to kick start a system, it saves a huge amount of work in creating them completely from scratch. If you consider the approach of most consultants; this is exactly how they work, putting your information into a set of pre-prepared documents that they have either developed themselves or purchased to use.
Once you have the basics of a system in place you can use your auditing process to build on and improve your system.
However, should you use a company that offers this service and certification; check that they are approved by UKAS (links below) as there are a number of disreputable companies that offer this service and give you a worthless ISO 9001 certificate at the end of it! Certification companies should be registered through UKAS, such as Lloyds, and BSI.
Quality Management System
ISO 9001 quality support
The following are some useful links that will help you gain additional information regarding the ISO 9000 standards;
International Organization for Standardization; The ISO home page where you can find information regarding all of the ISO 9000 series of standards.
Lloyds Register Quality Assurance Lloyds Register Quality Assurance is probably the oldest of the certification bodies who will audit your quality management system to ensure your quality manual and policies meet the requirements of ISO 9001. They also offer training for developing your system and auditing.
British Standards Institute; British Standards Institute is a similar organization to Lloyds and has been heavily involved in the earlier development of ISO 9001 when it was BS 5750. They also offer certification and training for ISO 9001.
The American Standards Organization; (ANSI) American Standards Organization are similar in operation to BSI and Lloyds above.
International Register of Certified Auditors (IRCA); International Register of Certified Auditors will be able to let you discover if your auditor / trainer is qualified.
UKAS; The United Kingdom Accreditation Service is the body responsible for monitoring the certification bodies and trainers.
Chartered Quality Institute (CQI); The Chartered Quality Institute (Formerly the Institute of Quality Assurance) is a body that can provide you with a vast amount of help and resources with regard to any aspect of quality.
American Society for Quality (ASQ); The American society for quality has resources similar to the CQI in the UK.
The above links can help with ISO 9000 Standards, ISO 9001, ISO 9004, Certification, auditing, Training, quality management systems, continuous quality improvement, and your ISO 9001:2008 Quality manual and quality policy.
Tony (author) from At the Gemba on July 30, 2012:
Glad to provide you with some useful information, good luck with your quality manual and ISO implementation.
ajit jha on July 30, 2012:
I t is very useful for me because I had not idea at all how to make schedule & implement ISO9000-2008 and quality manual.Thank you
Tony (author) from At the Gemba on September 30, 2010:
Thank you for reading and commenting Jeddex, nice to get positive feedback about the ISO 9001 Quality manual and quality policy hub.
jeddex on September 30, 2010:
your article is very helpful in providing readers an insight as to what shall be done in order to conform to ISO 9001:2008 standards! hi-five for you LEanMan!
Tony (author) from At the Gemba on September 16, 2010:
I have written a few Quality Manuals and Quality Policies over the years as I have had a few jobs in Quality Management as well as business improvement. Thanks for your comments Dobson.
Dobson from Virginia on September 16, 2010:
It is ovious you use this stuff on a regular basis as you speak from experience and with authority. Interesting to know how our industries are regulated.