While numerous successful models of ISO 9001 quality management systems have been developed and are being used in various industries, approaches to documenting top level management systems for multi-location enterprises are limited at best. This article discusses a method for establishing an ISO 9001 top-level documentation structure that allows a business with multiple facilities to use common quality management system manual. This model significantly improves consistency of the corporate message regarding quality policies, while reducing the number of documents within the organization’s quality management system.
Working as a QMS Lead Auditor for numerous international ISO registrars, I assessed numerous big multi-facility organizations that had difficulties with synchronizing their home office ISO 9001 quality manuals with the corresponding documents controlled by their sites. Designing quality manuals for companies with multiple sites, organizations develop their sites’ quality manuals as copies of the corporate quality manual; other enterprises create facility-specific manuals that are totally autonomous and do not correlate with the corporate ISO 9001 manuals.
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.
Those companies that adhere to the policy of maintaining a consistent corporate message regarding their position on quality will definitely experience a gap if they use methods that we discussed above.
One of our large customers demonstrated this point well. The corporate ISO 9001 quality manual addressed majority of the requirements of the standard and referenced appropriate regulations. At the same time, one of their US locations did not reference required ISO 13485 standard, Mexico facility missed a commitment to compliance with regulatory requirements, yet Costa Rica site failed to document their ISO 9001 quality policy all together!
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,
The same method will also work for a multi-site organization for those documents that are used at all locations. For example, such processes as Management Review, NC-CAPA Procedure, Documentation Management Procedure, Audit Procedure, and others may be the same for all locations 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.
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 element
Manual Reference Matrix Table of Contents (ToC)
Site-specific Manual Reference Matrix
Facility-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
Home Office (Denver, Colorado, USA)
Toronto (Canada)
Cleveland, OH (USA)
Lima (Peru)
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.
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.
If you are developing an ISO 9001 quality manual for a large corporation with multiple sites, check the links below for samples of Quality Manual Reference Matrix.
If you are working on an ISO 9001 Quality Manual for a company with multiple locations and do not want to reinvent the wheel, 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