QMS PRINCIPLES

Any organization can benefit from implementing ISO 9001

as its requirements are underpinned by 8 management
principles:
 A customer focused organization
 Leadership
 The involvement of people
 Ensuring a process approach
 A systematic approach to management
 A factual approach to decision making
 Mutually beneficial supplier relations
 Continuous improvement.
4 LEVELS OF DOCUMENTS
QUALITY MANUAL?
A Quality Manual is the main, top-level
document which establishes the quality
policies and objectives of an organization.
WHAT WILL A QUALITY MANUAL
PROVIDE TO A COMPANY?
 Overall it provides evidence of what
specific controls are implemented to
ensure product/service quality.

 Who will benefit ?

• Customers
• Suppliers
• Employees
• The Company
A QUALITY MANUAL SHOULD….
1. Address all Quality System elements

2. Contain or refer to quality procedures

“Documentation”
THE IMPORTANCE OF DOCUMENTATION
BENEFITS OF DOCUMENTATION:
QUALITY MANUAL
 The Key is to move towards:

 Consistently repeating the best practices

and

 Improving those processes which are lacking

BASIC QUALITY MANUAL OUTLINE
 Introduction
 Policy and Objectives
 Definitions
 Quality System
 Organization
 Authority and Responsibilities
 Compliance
 Internal Review and Audit
 Documentation and Change
 Purchasing
 Inspection and Testing
 Training
ADVANTAGES OF QUALITY
MANUAL
1. To prevent risks
2. To detect deviations
3. To correct errors
4. To improve efficiency
5. To reduce costs
6. To meet customer needs
7. To market company
PROCEDURES
 Procedure is defined as-an established or official
way of doing something.
 In this case we will follow the standard operating
procedures .
WORK INSTRUCTIONS
 A work instruction is a tool provided to help someone
to do a job correctly. This simple statement implies that
the purpose of the work instruction is quality and that
the target user is the worker.
DOCUMENTS , FORMS , RECORDS….
 It includes data sheets, lab results sheets ,
customer feed back forms, evaluation forms of
employees etc.
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 A systematic and independent examination to
determine whether quality activities and related
results comply with planned arrangements, and
whether these arrangements are implemented
effectively and are suitable to achieve objectives

1
 To collect objective evidence to permit an informed
judgment about the status of the systems or product
being audited

1
 Internal (First Party, Self)

 This type includes audits by company employees,

consultants and contractors

5
 External
i. Supplier Audit
○ Second Party
 Customer employee(s) audit your company
or
 Your employee(s) audit a company which
supplies your company with a product or
service

6
ii. Independent Organization

 Third Party Audit

○ A customer wants an audit of your company