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.

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.

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.

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 we can see, both approaches to creation of location’s ISO 9001 quality manuals as copies of the corporate manuals or independent manuals do not appear to be practical. Besides, if a company has already spent time on developing a quality manual, why should another employee in the same organization spent more time to create a similar or duplicate document?

If a business wishes to establish a quality manual that will serve all its facilities, we need to consider a different route. Let’s start from an example of a clause 5.4.1, Planning, Quality objectives. This clause may state: ABC Corporation’s Management Team ensures that quality objectives, including those needed to meet requirements for product, are established for relevant functions and levels within the organization per the Management Review Procedure and the Quality Objectives 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.

However, what if our locations need to use different organizational charts, product realization procedures, and other site-specific quality management system documents? If we use the model above and want to keep a common ISO 9001 quality manual, we have to reference in the manual corresponding documents for all locations which may not be practical. Below we will explore how a corporate quality manual can practically reference location-specific documents to support commitments of the company’s common ISO 9001 quality manual.

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.

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 section

Manual Reference Matrix Table of Contents (ToC)

Site-specific 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

Home Office (Denver, Colorado, USA)

Ontario (Canada)

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.

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:

If you are developing 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.