The Quality Manual

In the previous blog we talked about the reasons for implementing a quality management system. Once management decides that they want to implement the management system, there are several basic cornerstones that must be put into place.

As I discussed in my previous blog, management needs to identify their business processes. Management now must identify the business structure (organizational chart and job descriptions). The business process map describes, in brief terms, the individual business processes (i.e. business planning / management review, sales / quote, quality planning, manufacturing / provision, etc.) and their interrelationships. 

The organizational chart describes the reporting structure and authority for the company and the job descriptions describe the responsibilities of the individual positions.  

Management must define, develop and put in place the "quality manual".  But what exactly is a "quality manual"? The ISO-9001:2008 standard stipulates that the quality manual must be a controlled document and the content of the quality manual must include:

• the scope of the quality management system. This describes the range of activities and products of the company that are covered by the quality management system
• the details and justification for any exclusions to the standard (only applicable to clause 7 Product Realization) . Management needs to clearly explain why the exclusion is not applicable to the company.
• reference to the documented procedures required by the ISO-9001;2008 standard (4.2.3, 4.2.4, 8.2.2, 8.3, 8.5.2, 8.5.3) and any additional procedures that the company feels is required. (The company may include the procedures as a part of the quality manual).
• a description of the interaction between the processes. This can be either the Business Process Map we discussed previously, or describe in text how the quality management system meets each of the requirements contained in the standard.

At Foster and Associates, Inc., we believe that an important part of any quality manual is including the statement of the Quality Policy. The Quality Policy is the cornerstone of the quality system and should really describe the philosophical goals that your organization expects to achieve.
   
The quality manual is a clear statement by management that describes the business philosophy of the company. This manual describes what management believes in and what it works to accomplish. So what should the manual look like?

The following contains a sample table of contents and brief description of those contents for a quality manual developed for a small manufacturing company: 

• TITLE PAGE, including revision level and date
• Quality Manual table of contents
• Page 2--------Introduction / history / profile
• Page 3--------Scope
• Page 4--------Policy statement
• Page 5--------Procedures
• Page 6--------Business Process 
• Page 7--------Philosophy
• Page 8--------QMS clause / Process / Procedure Documentation Matrix
• Exhibit A - Business Process Map
• Exhibit B - Organizational Chart
• Exhibit C - Roles and Responsibilities
• Exhibit D - Documents and Records Index
• Exhibit E - Procedure / Work Instruction Index 

INTRODUCTION /HISTORY / PROFILE:
The purpose of the introduction is to familiarize the reader with the company and its history. Describe the approach and philosophy of the company regarding the control of the Quality Management System, the technical competence of the company and ensuring valid results that meet the needs and expectations of the customers, governmental and regulatory requirements.
The manual is intended as a statement, by executive management, of the philosophy underlying the way the company conducts its business. 

SCOPE:
A description of specifically what the company does, including its products and processes.The scope also details the specific standard (ISO-9001:2009, TS-16949:2009, etc.) that the management system is addressing as well as any "exceptions" taken to the requirements. (The only exception acceptable in ISO-9001:2008 is the responsibility for product design [clause 7.3]).

POLICY:
A statement of the formal Quality Policy of the company.

PROCEDURES:
Description of the criteria used to generate formal documents and documentation needed for the company to ensure the effective planning, operation and control of its processes.

• When required by the standard.
• When more than one person is held responsible for the accurate execution of the process.
• When failure to execute the activity in a certain sequence could result in customer dissatisfaction.
• When consistant execution of the activity, or process is considered to be critical to accomplishing the established objectives or the quality policy.
• When safety of a person or the facility could be jeopardized.
• When consistency in training is critical 

There are only six (6) required procedures for ISO-9001:2008 (control of documents, control of records, internal audit, control of non-conforming product, corrective action and preventive action). However, management will have to review all of the processes and develop additional procedures / work instructions to ensure "effective planning, operation and control" of the processes.

BUSINESS PROCESS:
Link to the Business process map as well as a description of the processes.

PHILOSOPHY:
Discussion of the the eight management principles and their application to the company operating philosophy.

A clear description of the eight management principles is contained in the ISO-9004:2009 standard  - Annex B.

CLAUSE / PROCESS / PROCEDURE MATRIX:
A matrix that describes the standard clauses and the applicable process, procedures, and work instructions addressing the specified requirements.

EXHIBITS:
The attachment of any documents that reinforce the quality manual.

These exhibits could include the Quality Policy, Business Process Map, Identification of the Quality Objectives and performance, Organizational chart, Documents and Records Index, etc.