QUALITY SYSTEMS AND

DOCUMENTATION
QUALITY MANAGEMENT SYSTEM
• The Quality Management System is defined as the
organization structure, responsibilities, activities, resources
and events that together provide organized processes and
techniques of implementation to ensure the capability of the
organization to meet quality requirements
• As per ISO 9000, Management system to direct and control an
organization with regard to quality.
• As per ISO 8406, the totality of features and characteristics of
a product or service that bear on its ability to satisfy stated or
implied needs.
QUALITY SYSTEM
 QUALITY MANAGEMENT SYSTEM
DOCUMENTATION
• The organization shall establish, document, implement and
maintain a quality management system and continually
improve its effectiveness in accordance with the requirements
of this international standards.
• Documentation is a set of documents . Ex- specifications and
records
• Document contains the information ( meaningful data ) and
its supporting medium.
• Quality manual is the document specifying the quality
management system of any organization.
DOCUMENTATION PYRAMID
• Quality manual – level 1
As a highest level document at the peak of a pyramid outlining the
quality system and acting as a directory for the documents and
procedures

• Operation procedure – level 2

A second tier set of departmental procedures detail how that
commitment is applied to the company operations and lay down
procedures for the management to control the system.

• Work instructions – level 3

This third tier of work instructions details the day-to-day operating
instructions to provide control of quality and being applied in the
manner laid down in operations – written/spoken direction what is to
be done incl. information given in the training
HIERARCHY OF DOCUMENTS
 Level “A” – Policies
 What to do - Address Key Elements

 Level “B” – Processes

 How it happens - Address the path of workflow
Describe how things happen here

Generally, process development is made by Flow Charts or Table,

Benefits of Flow Charts:

 Identify essential steps
 Shows dead ends
 Redundancies
 Identify overly complex flows
 Identify responsibility
 HIERARCHY OF DOCUMENTS
• Level “C” – Procedures
» How it’s done - Address specific steps
- Layout that enables the user to perform task
correctly

• Others
» Forms
» Records
 Document
Control

Document
Management
Document
Development
 DOCUMENT CONTROL

• Master index

• Master file

• Document numbering / revision

• Distribution

• Archiving