While numerous successful models of ISO 9001 quality management systems have been developed and are being used in various industries, approaches to documenting top level management systems for multi-location enterprises are limited at best. This article discusses a method for establishing an ISO 9001 top-level documentation structure that allows a business with multiple facilities to use common quality management system manual. This model significantly improves consistency of the corporate message regarding quality policies, while reducing the number of documents within the organization's quality management system.
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 the first case, when a site-specific quality manual is a copy of the corporate manual with modifications specific to a given site, mechanisms to keep these documents coordinated are rarely defined. Difficulties of keeping these documents in sync are due to the fact that corporate quality manuals are controlled by the home office, while local quality manuals are responsibility of site's documentation control departments.
The 2nd approach, when companies choose their sites to establish their own quality manuals, differences in all those quality manuals lead to noticeable disconnect between the corporate and site-specific 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?
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.
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.
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 clause
Manual Reference Matrix Table of Contents (ToC)
Facility 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
Main Office (Washington, DC USA)
Ontario (Canada)
St. Petersburg (Russia)
Guanajuato (Mexico)
Port Williams (Chile)
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.
Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location's Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 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.
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. - 15433
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 the first case, when a site-specific quality manual is a copy of the corporate manual with modifications specific to a given site, mechanisms to keep these documents coordinated are rarely defined. Difficulties of keeping these documents in sync are due to the fact that corporate quality manuals are controlled by the home office, while local quality manuals are responsibility of site's documentation control departments.
The 2nd approach, when companies choose their sites to establish their own quality manuals, differences in all those quality manuals lead to noticeable disconnect between the corporate and site-specific 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?
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.
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.
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 clause
Manual Reference Matrix Table of Contents (ToC)
Facility 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
Main Office (Washington, DC USA)
Ontario (Canada)
St. Petersburg (Russia)
Guanajuato (Mexico)
Port Williams (Chile)
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.
Clicking the hyperlink Ontario (Canada), for example, we will find a site-specific Manual Reference Matrix. Locating a specific element in the location's Manual Reference Matrix, we will find a particular, location-specific document that corresponds with this clause of out ISO 9001 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.
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. - 15433
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If you are developing an ISO 9001 Quality Manual for a large corporation and do not want to reinvent the wheel, 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
