Quality Management System

Lead Implementer Course

Course Duration: 3 Days
Course Synopsis
This three-day awareness course enables participants to develop the necessary
knowledge to managing a Quality Management System (QMS) based on ISO
9001:2008. This course can enable participants with a fundamental appreciation of
the management systems necessary operate an organization in compliance with
ISO 9001:2008

Course Audience/ who should attend the Course

Project managers or consultants wanting to prepare and to support an
organization in the implementation of a Quality Management System (QMS)
ISO 9001 auditors who wish to fully understand the Quality Management
System implementation process
Persons responsible for the Quality or conformity in an organization
Members of an quality team
Expert advisors in Quality Management Systems
Technical experts wanting to prepare for an quality function or for a QMS
project management function

Detailed Course Out line

Day 1
1. Introduction
a. RICI
b. Tutor
c. Students/ Participants
2. Introduction to Q-M-S
a. What is Quality?
b. What is Management?
c. What is Management System?
3. Introduction to PDCA - Deming Cycle
a. Significance of PDCA
b. Inputs of PDCA
c. Outputs of PDCA
4. Introduction to Quality Management System
5. Purpose and Benefits of QMS

6. Eight principles of QMS

7. Introduction to ISO
8. ISO 9001:2008
a. History of QMS (ISO 9001)
b. ISO 9000 Series
c. Relationship of ISO 9001 and other standards
d. Fundamentals and Vocabulary
9. QMS Case Study
10.Documentation
a. What is Document?
b. What is Controlled Document?
c. What is Record?
d. Documentation Hierarchy
e. Mandatory Documents of QMS

Day 2
1. Quick Review of Day 1
a. Quiz
2. QMS Process Approach
3. Organization Scope for QMS
4. ISO 9001:2008 Requirements Clause by Clause
a. Clause 4 Quality Management System
b. Clause 5 Management Commitment
i. Management Responsibilities
ii. Management Review
iii. Quality manual
iv. Quality plan
v. Quality Policy
vi. Quality Objectives
A. Qualitative Objectives
B. Quantitative Objectives
C. SMART Objectives
5. Individual Exercises:
a. Exercise Policy making
b. Exercise Measureable objectives
6. Clause 6 Resource Management
a. Human Resource
b. Infrastructure
c. Work Environment

Day 3
1. Quick View of 2 days
a. Quiz
2. Clause 7 Product Realization
a. Planning of Product Realization
b. Customer Related Processes
c. Design and Development
d. purchasing
e. Production and Service Provision
f. Control of monitoring and measuring equipment

3. Clause 8 Measurement, Analysis and Improvement

4. Implementation of ISO 9001 in an Organization
a. Gap Analysis
i. Gap Analysis Report
b. Defining Scope, Policy and Objectives of QMS
c. Documentation with in organization
d. Procedures Implementing QMS in organization processes
e. Control of Records
f. Internal Audit
g. Preparation for Certification Audit
5. Certification process
a. Accreditation and Certification
b. Concept of Accreditation bodies, certification bodies, and international
traceability of certificate
c. Certification flow chart
6. Trainee Assessment