Small and medium size businesses with a single location that utilize ISO 9001 quality management system have developed solid models for the top level documentation. At the same time, information on quality manuals for multi-facility companies was not addressed in professional publications. This publication proposes a model of a quality manual for establishing the top-level documentation structure that allows a business with more than one site to use common ISO 9001 quality management system manual.
Through my work as a Lead Auditor with major registrars, I observed dozens of large multi-location companies struggling with connecting their corporate ISO 9001 quality manuals with the supporting, location-specific, documents. To develop a quality manual for a company with numerous facilities, organizations take two routes. Some organizations create site-specific quality manuals as copies of the corporate manual; others create site-specific ISO 9001 quality manuals that are entirely different from the corporate manual.
In reality, these solutions do not provide for a consistent representation of the organization's position on quality. The first approach, when a copy of the home office quality manual is used, techniques for controlling local quality manuals are usually not determined. Differences in the corporate manual and the site's quality manual are because the corporate office manuals are managed by the home office, while site's manuals are controlled by individual sites.
In the case of the second approach, when organizations allow their satellite locations to have their own quality manuals independent from the corporate manual, differences in quality manuals may create major disconnect of the corporate and local ISO 9001 quality manuals.
If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.
As an example, we can examine one of our international clients with facilities in the United States, Mexico and Europe. This organization established pretty complete quality manual for their corporate office in the US. When we visited their plant in Mexico, we found that their quality manual did not include reference to Canadian regulations; the facility in Italy did not address the design process, etc.
As one can see, both approaches above to development of site quality manuals as copies of the corporate manuals or independent quality manuals do not appear to be practical or economical.
Fortunately, there is a solution. Let's review an example of ISO 9001 2008 quality manual model that references procedures. Our quality manual references supporting documents within the text of the manual. For example, element 4.2.1, Documentation requirements, general, may read: Your Company, Inc.'s QMS documentation includes: documented statements of the quality policy per the Quality Policy and quality objectives per the Key Indicator Matrix,
This method of referencing supporting procedures is very common for quality manuals for companies with single location. Interestingly, it also works for a multi-site business for those documents that are common for all sites. For instance, Audit Procedure, CAPA Procedure, and others may be the common for your all sites and be referenced in your quality manual as demonstrated in previous paragraph.
But, what if your sites use their own service procedures, incoming procedures, in-process test criteria and other unique documents different form corporate procedures? Let's examine how an organization's ISO 9001 quality manual can reference corporate and site-specific procedures.
The same document reference structure as for a single-location company that we discussed above, can be used if the number of locations is small, let's say two or three. In this case, clause 5.5.1 of our corporate ISO 9001 quality manual may state: QW Enterprises, LLP's Management Team ensures that the responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure, Organizational Chart HO and Organizational Chart Ontario. This example shows references to the common Resource Management Procedure and site-specific organizational charts for the Home Office (HO) and the Ontario locations. While this model works well for a limited number of facilities, it becomes impractical when the number of locations is significant.
When an enterprise has significant number of facilities and needs to reference in its manual numerous procedures including those controlled by its sites, we have another choice. We can develop a matrix to connect our quality manual elements with the location-specific supporting documents. We will title this document a Manual Reference Matrix and establish the following documentation reference structure.
Corporate ISO 9001 Quality Manual section
Manual Reference Matrix Table of Contents (ToC)
Facility Manual Reference Matrix
Corresponding site-specific document
We will structure our Manual Reference Matrix as a list of all facilities and their corresponding Manual Reference Matrixes, as shown below:
Manual Reference Matrix Table of Contents
Corporate Office (Salt Lake City, UT USA)
Toronto (Canada)
St. Petersburg (Russia)
Guanajuato (Mexico)
Los Angeles, CA, USA
etc,
Let's see how this model works. We will document element 8.4, Analysis of data: Sunrise, LLP has established and maintains documented Management Review Procedure and site-specific data analysis procedures per the Manual Reference Matrix ToC to determine, collect and analyze appropriate data to determine the suitability and effectiveness of the Quality Management System to evaluate areas where continual improvements of the effectiveness of the ISO 9001 QMS can be made This element states that the company uses common Management Review Procedure and site-specific data analysis procedures. To locate a site-specific data analysis procedure, we simply need to consult the Manual Reference Matrix ToC.
Finding the location in the Matrix ToC and locating, let's say, St. Petersburg's Matrix, we will identify a site-specific Manual Reference Matrix. Locating a specific element in the location's Manual Reference Matrix, we will find a particular, location-specific procedure title that addresses our clause.
A Manual Reference Matrix may be formatted as a three-column form. The first two columns are titled Corporate Manual Section No. and Corporate References; the third column is called Location references. For the element 5.5.1, for example, the Matrix indicates that our manual references Organizational Chart HO for the corporate office and the Organizational Chart Ontario for the Ontario facility.
For more details on this topic and examples of the Manual Reference Matrix for ISO 9001 quality management system manual, follow the links below:
About the Author:
If you are working on an ISO 9001 Quality Manual for a large corporation and wish to keep your documentation simple, check our Quality Assurance Manual Reference Matrix. If you need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services and documentation sets.
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