Iso 9001 Corporate Manual
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.
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.
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.
If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.
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?
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 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.
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
Location-specific procedure
Our Manual Reference Matrix ToC is simply a list of company's locations or sites' Manual Reference Matrixes, as shown in the illustration below:
Manual Reference Matrix Table of Contents
Home Office (Denver, Colorado, USA)
Ontario (Canada)
Jacksonville, IL (USA)
Lima (Peru)
Port Williams (Chile)
etc,
To illustrate this model, let's document element 5.5.1 of our corporate ISO 9001 quality manual with references to site-specific organizational charts: 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 site-specific Organizational Charts per the Manual Reference Matrix ToC. This statement tells us that the company uses common Resources Management Procedure and site-specific organizational charts. To locate a site-specific organizational chart, we need to refer to the Manual Reference Matrix Table of Contents (ToC).
Let's say we need to locate a Data Analysis Procedure for our Los Angeles plant. When we find this location in our Manual Reference Matrix table of contents, we actually will connect to the location's Manual Reference Matrix. Finding the corresponding clause number in the site's Manual Reference Matrix, we will find a site-specific procedure title that addresses our clause of the quality manual.
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:
by: Mark Kaganov
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