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 Quality Works' clients illustrated this deficiency. The home office manual documented majority of the applicable requirements. At the same time, one of their Mexico facilities did not reference required ISO 14001 standard, another missed a commitment to customer satisfaction, yet the third one forgot to document their training program 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.
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 model proved to be effective for a single-location company. This approach will also work for a multi-site business, but only for common documents that are used at all locations. For example, such procedures as Internal Audit, Management Review, Corrective and Preventive Action, and others may be the same for your all facilities and therefore be referenced in the quality manual as shown above.
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.
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 element
Manual Reference Matrix Table of Contents (ToC)
Site-specific 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
Corporate Office (Salt Lake City, UT USA)
Ontario (Canada)
Cleveland, OH (USA)
Lima (Peru)
Portland OR USA
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.
Our experience shows that a Manual Reference Matrix works well as a 3-column form with the 1st column titled Corp. Manual section, the 2nd column Corp. References, and the 3rd column called Site References. For the element 6.2.1, for example, the St. Petersburg's Matrix indicates that manual references Training Procedure HO for the home office and Training Procedure SP for the St. Petersburg site.
Looking for samples of a quality Manual Reference Matrix for ISO 9001 QMS? Check links below. - 15246
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 Quality Works' clients illustrated this deficiency. The home office manual documented majority of the applicable requirements. At the same time, one of their Mexico facilities did not reference required ISO 14001 standard, another missed a commitment to customer satisfaction, yet the third one forgot to document their training program 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.
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 model proved to be effective for a single-location company. This approach will also work for a multi-site business, but only for common documents that are used at all locations. For example, such procedures as Internal Audit, Management Review, Corrective and Preventive Action, and others may be the same for your all facilities and therefore be referenced in the quality manual as shown above.
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.
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 element
Manual Reference Matrix Table of Contents (ToC)
Site-specific 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
Corporate Office (Salt Lake City, UT USA)
Ontario (Canada)
Cleveland, OH (USA)
Lima (Peru)
Portland OR USA
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.
Our experience shows that a Manual Reference Matrix works well as a 3-column form with the 1st column titled Corp. Manual section, the 2nd column Corp. References, and the 3rd column called Site References. For the element 6.2.1, for example, the St. Petersburg's Matrix indicates that manual references Training Procedure HO for the home office and Training Procedure SP for the St. Petersburg site.
Looking for samples of a quality Manual Reference Matrix for ISO 9001 QMS? Check links below. - 15246
About the Author:
If you are tuning up your 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 need help with implementation of your Corporate Manual, check our Quality Management ISO 9001 consulting services and documentation sets.
