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.
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 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.
If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.
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 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.
But, what if your sites use their own service procedures, incoming procedures, in-process test criteria and other unique documents different form corporate procedures? Let's examine how an organization's ISO 9001 quality manual can reference corporate and site-specific procedures.
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.
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)
Location 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
Main Office (Washington, DC USA)
Millburn (Australia)
Cleveland, OH (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.
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.
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.
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 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.
If an organization wishes to deliver a consistent message regarding its quality policies, the deficiencies of discussed methods become obvious.
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 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.
But, what if your sites use their own service procedures, incoming procedures, in-process test criteria and other unique documents different form corporate procedures? Let's examine how an organization's ISO 9001 quality manual can reference corporate and site-specific procedures.
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.
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)
Location 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
Main Office (Washington, DC USA)
Millburn (Australia)
Cleveland, OH (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.
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.
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.
About the Author:
If you are developing an ISO 9001 Quality Manual for a company with multiple locations 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