Since introduction of ISO 9001 Standard for quality management systems the market has developed numerous practical models of quality manuals for organizations with single sites. At the same time, formats for management system structures for multi-facility businesses are limited at best in technical publications. This paper discusses a model for structuring a top-level documentation that allows an organization with multiple sites to use common ISO 9001 quality management system manual. Discussed approach noticeably improves consistency of the organization's quality policies.

As a professional QMS assessor with leading certification organizations, I audited many large multi-site enterprises that had problems with aligning their corporate ISO 9001 quality manuals with the supporting documents issued by their locations. To fill this gap, some companies create quality manuals for their locations as copies of the main quality manual; other businesses develop location-specific quality manuals that are completely independent form the home office quality 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.
The 2nd approach, when companies choose their sites to establish their own quality manuals, differences in all those quality manuals lead to noticeable disconnect between the corporate and site-specific quality manuals. From the corporate identity and simply business consistency points of view, an organization should not find itself in a position of having different or conflicting commitments of its facilities to quality, customer satisfaction, design approaches and other requirements of ISO 9001 standard.
One of Quality Works' clients illustrated this deficiency. The home office manual documented majority of the applicable requirements. At the same time, one of their Mexico facilities did not reference required ISO 14001 standard, another missed a commitment to customer satisfaction, yet the third one forgot to document their training program all together!
Summarizing my consulting experiences, I am convinced that these approaches to design of the corporate quality manual and sites' manuals do not provide a solid consistent way to document organization's quality manuals.
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 model proved to be effective for a single-location company. This approach will also work for a multi-site business, but only for common documents that are used at all locations. For example, such procedures as Internal Audit, Management Review, Corrective and Preventive Action, and others may be the same for your all facilities and therefore be referenced in the quality manual as shown above. 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.
A method identical to a single-site organization can be used when the number of facilities is relatively small, let's say 2 - 3. For example, clause 5.2, Customer focus, of our ISO 9001 quality manual may state: Your Company, Inc's Management Team ensures that customer requirements are determined and met with the objective of enhancing customer satisfaction per the Design Management Procedure, Contract Review Procedure HO and the Contract Review Procedure SP. This example references to the common Design Management Procedure and facility-specific Contract Review Procedure HO (Home Office) and Contract Review Procedures SP (St. Petersburg). This approach works well for a company with limited number of locations, but it becomes unworkable when the number of facilities grows.
For companies with a large number of locations, where we need to reference numerous documents in the manual, including those controlled by satellite locations, we have another option. We can establish a document to connect corporate quality manual commitments with the site-specific supporting documents. Let's name this document a Manual Reference Matrix and consider the following document reference structure.
Corporate ISO 9001 Quality Manual clause
Manual Reference Matrix Table of Contents (ToC)
Facility Manual Reference Matrix
Facility-specific document
The Manual Reference Matrix is simply a list of all facilities and their Manual Reference Matrixes, as shown below:
Manual Reference Matrix Table of Contents
Main Office (Washington, DC USA)
Millburn (Australia)
St. Petersburg (Russia)
Buenos Aires, (Argentina)
Portland OR 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.
Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location's Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 quality manual.
Quality Manual Reference Matrix may be formatted as a three-column table with the Manual Clause in the first column, HO References in the second and Location References in the third column. For example, for the element 8.4, Data Analysis, the Los Angeles plant's Matrix indicates that the manual references Data Analysis Procedure HO for the corporate office and Data Analysis Procedure LA for the Los Angeles plant.
For more details on this topic and examples of the Manual Reference Matrix for ISO 9001 quality management system manual, follow the links below:

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Article Submitted By: MarkKaganov
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