ISO 9000 Quality Management System (CQP Module 2) (PDF)

Certified Quality Professional (CQP) is an excellent program on 'Quality Management' brought out by Quality Professionals Group (QPG). The contents of this program are now available for download on as different Modules. These documents in pdf consist of different lessons of the various Modules of the program.

There are 5 different modules of the program and cover the most relevant topics on quality management for current use by the industry. The program is useful both for application in the manufacturing as well as in the service sector. The language & contents of the program are well researched and are given in a format that is easy to understand & comprehend. The modules are available as separate documents as well as a bundle document.

This document is the 2nd in the series of the program and covers the Module-2 titled,
Quality Management Systems (QMS)

The Module covers the following topics on the subject of 'QMS':
1. Strandards and ISO
2. ISO 9000 Quality Management System Standards – An Introduction
3. Process Approach
4. Documentation for Quality Management System
5. Quality Management System Audits

In this document you will learn about the following:
a) what are standards and who is ISO (the International Organization for Standardization),
b) what are the ISO 9000 family of standards on Quality Management Systems (QMS),
c) what is the process approach to QMS and how to use it,
d) how can you document your QMS, and
e) how the audits for QMS can be conducted.

The details of the sub-topics covered in the document are:

Lesson 1: Standards & ISO
1. Why standards matter
2. Who ISO is
3. What ISO's name means
4. What 'international standardization' means
5. How to recognize an ISO standard
6. The big, wide world of ISO standards
7. What makes ISO 9000 and ISO 14000 so special
8. What makes conformity assessment so important

Leasson 2: ISO 9000 Quality Management System Standards – An Introduction
1. Introduction
2. History of ISO 9000
2.1 Pre ISO 9000
2.2 Version 1987
2.3 Version 1994
2.4 Version 2000
2.5 Version 2008
2.6 Version 2015
3. ISO 9000: 2015 family of standards
4. Certification
5. Debate on the effectiveness of ISO 9000
5.1 Advantages
5.2 Problems
5.3 Summary

Lesson 3: Process Approach
1. What is a process?
2. Process Approach
a. Risk-based Thinking
b. PDCA
3. Benefits of Process Approach
4. Understanding the Process Approach
5. Implementing the Process Approach

Lesson 4: Documentation for Quality Management System
1. What is a "document"?
2. Documented Information
3. Objectives of QMS documented information
4. ISO 9001:2015 Documentation Requirements
a) Maintaining Documented Information
b) Retaining Documented Information
5. QMS Documentation structure
Tier 1: Quality Manual
Tier 2: Procedures
Tier 3: Work Instructions
Tier 4: Forms – Records – Other Documents
6. System documentation relationship

Lesson 5: Quality Management System Audits
1. Introduction
2. What is an audit?
3. Types of quality audit
4. Auditing process
4.1 Audit Initiation
4.1.1 Scope of Audit
4.1.2 Frequency of Audit
4.1.3 Audit Programme
4.2 Audit Preparation
4.2.1 Appointment of the audit team
4.2.2 Preparation of Audit Schedule/Plan
4.2.3 Document review
4.2.4 Checklists
4.2.5 Confirmation of audit logistics
4.3 Audit Execution
4.3.1 Opening meeting
4.3.2 Examination & Evaluation
4.3.2.1 General
4.3.2.2 Audit Sampling
4.3.2.3 Collecting evidences
4.3.2.4 Interviewing techniques
4.3.2.5 Taking notes
4.3.2.6 Team meetings
4.3.2.7 Daily Review Meeting ("Wash-up Meeting")
4.3.2.8 Reporting non-conformance
4.3.2.9 Grading of non-conformities
4.3.3 Closing Meeting
4.4 Report Writing
4.5 Audit Follow-up