by Mark Kaganov
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 companies choosing their facilities to develop their own ISO 9001 manuals, discrepancies in numerous quality manuals result in visible differences between the home office and facilities’ 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!
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.
To solve this problem, let’s review an ISO 9001 quality manual model, specifically supporting document reference structure. As a common practice, a quality manual references supporting documents within the text of the manual. For example, clause 5.5.1 of the quality manual, Responsibility and authority, may read: QW Enterprises, LLP’s Management Team ensures that the responsibilities and authorities are defined and communicated within the organization per the Resource Management Procedure and the Organizational Chart.
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.
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.
If we need to work with a company that has significant number or offices and wishes to reference in the quality manual procedures controlled by its sites, we may take a different approach. For example, we can prepare a matrix to associate the corporate quality manual clauses with the site-specific procedures. We can name this tool Manual Reference Matrix and consider the following reference model:
Corporate ISO 9001 Quality Manual element
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)
Cleveland, OH (USA)
Guanajuato (Mexico)
Port Williams (Chile)
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 company with multiple locations and wish to keep your documentation simple, check our
Quality Assurance Manual Reference Matrix. If you have questions or need help with implementation of your Corporate Manual, check our
Quality Management ISO 9001 consulting services
