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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.

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 practice, neither one of these approaches result in a consistent result. In the 1st instance when a modified quality manual is used for a location, methods for updating local quality manuals are not defined. This disconnect arises from the fact that the corporate office manuals are controlled by the home office, while local quality manuals are facilities’ responsibility.

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!

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.

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.

As with a single-location company, a business can still use the same reference structure if the number of locations or sites is small; let’s say not to exceed three. For example, element 8.5.1 Continual improvement, may read: Yellow Submarine Company has established and maintains documented procedures to continually improve its QMS through the use of its Quality Policy, Quality objectives per the Quality Objectives Matrix HO and the Quality Objectives Matrix BA This example references the common Quality Policy and site-specific Quality Objectives Matrix HO (Home Office) and Quality Objectives Matrix BA (Buenos Ares). This model serves well quality management systems with limited number of facilities, but it becomes ineffective when the number of company’s locations increases.

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 section

Manual Reference Matrix Table of Contents (ToC)

Location 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

Main Office (Washington, DC USA)

Toronto (Canada)

Jacksonville, IL (USA)

Lima (Peru)

Portland OR USA

etc,

To show how this approach works, we will document element 6.2.1, Human resources, general: Your Company, Inc.’s Management ensures that personnel performing work that affects quality of product are competent on the basis of appropriate education, training, skills and experience per the Resource Management Procedure and facility-specific training procedures per the Manual Reference Matrix ToC. This clause indicates that the organization uses the corporate Resource Management Procedure and facility-specific training procedures. To locate a facility-specific training procedure, one simply needs to go to 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.