1. Quality Management System BY CDR ALOK MOHAN
Note: QMS requirements in the standard are complimentary to contractual & applicable statuary & regulatory requirements Should there be any conflict the latter shall take precedence

2. What is Quality ?
Degree to which a set of inherent characteristics fulfill requirements
Characteristics include
Distinguishing features
Inherent & or Assigned requirements
Qualitative or Quantitative
Stated implied or Obligatory requirements

3. Many Facets of Quality Quality of Work Quality of services
Quality of information
Quality of process
Quality of system
Quality of People
Quality of Objective
Quality of Company

4. Quality Management Principles
Customer Focus (5,7,8)
Leadership(5,8)
Involvement of People(5,6)
Process Approach (4,7)
System Approach to management (4,5,8)
Continual Improvement (5,8)
Factual Approach to decision making (8)
Mutually beneficial supplier relationship (7.4)

5. Evolution of QA Standards
As a measure to standardize in 1972 November came BS 4891 A
(A guide to QA)
In 1975 BS 5750 was published in three parts
This led to formation of technical committee in QA which drafted ISO 9000 series Members from 81 countries formed this technical committee India is one of the member of this technical committee

6. Evolution of QA Standards
It started consequent to lessons learnt during the world War II
This led to a revolutionary approach to quality.
During war though the products were meeting the standard specifications but were failing in the functionality consistency from product to product was missing This led to
Quality Ordinance was formulated in USA
In Europe as NATO AQAP – republished as DEFSTANS

7. Evolution of QA Standards
Systematic way of managing an organization’s QMS
Based on Plan-Do-Check-Act Model (PDCA)
Focused on Improvement of QMS

8. Process Approach
A quality system is based on processes Any activity or group of activities that takes inputs add value to it and provides an out put to an internal or external customer Processes use organizations resources to provide definitive results ( Purchasing, Marketing, Training, Manufacturing, QA, QC Storage Designing r processes) A process approach treats QMS as a set of interrelated processes covering not only the manufacture of a product or provision of a service, but also management processes and support processes. A "process" is something that transforms a collection of inputs into outputs.

9. Model of Process
EMS documentation 4.4.4

10. QMS Model is Based on the P-D-C-A Model, Plan-Do-Check-Act which is an iterative four-step management method used in business for the control and continuous improvement of processes and products. It is also known as Deming Cycle
Policy
Planning
Management
Review
Implementation
Checking
Corrective Action

11. What is a Process ?
Any activity or group of activities that takes an input add value to it and provides an out put to internal or external customer is called a process.
Processes use resources & blend or transform them to produce desired results. A business consist of following processes: Purchasing, Marketing, Training, Manufacturing, QA,QC,Storage,Designing

12. PLAN - objectives and processes necessary to
deliver results in accordance with
expected output ie the target or goals &
customer requirements
DO Implement the plan, execute the process,
make the product.
CHECK Monitor & Measure processes against
objectives/policiesCollect data for charting
and analysis Study the actual results & compare
against the expected results
ACT Carry out corrective actions on significant
differences between actual and
planned results. Analyze the differences to
determine their root causes. Take action for continual improvement

13. Why Implement QMS?
Struggling to stay in compliance and keep track of regulations/laws
QMS is just one of many responsibilities
Establish a framework to move beyond compliance
Vehicle for positive change; improved employee morale, enhanced public image
Employee turnover
Last but not least – To check whether the product/services meet the customer requirements

14. Quality Management Principles
QMS is based on
System approach to management
Improvement
Factual approach to decision making
Mutually beneficial supplier relationships
Customer focused organization
Leadership
Involvement of people
Process approach

15. To Whom Do these Standards Apply?
Standard is Voluntary
Large and Small Business & Industry
Service Sectors (hospitals, hotels, etc.)
City and County Government
Applicable to all types of organizations, of all sizes anywhere in the world

16. Expected changes during 2015 from previous standards
1 ISO 9001:2015 QMS standard shall align with high-level organizational structure
2 Greater emphasis on risk-based thinking
3 Focus on achieving value for the company and its customers
4 Increased flexibility regarding use of documentation

17. Quality Management Principles
These 8 principles manifest themselves through four main clauses of
management responsibility
Resource management
Product realization
Measurement Analysis and improvement
Documentation of processes
All these clauses are structured around PDCA cycle

18. Introduction
A good QMS, if integrated into goals, provides a way to reduce variation which may provide financial benefits such as reduced scrap and general process efficiencies. A well-functioning QMS makes good sense from a business and financial perspectives.

19. ISO is an acronym
It is a greek word – meaning equal consistency
ISO International organization for standardization
ISO initially traces its evolution from US military quality MIL-Q.9058A
The NATO-AQAPI & BS 5750
Created by the International Organization of Standardization, a non- governmental organization (NGO) established in 1947
ISO is a worldwide federation of national standards bodies from over countries; American National Standards Institute (ANSI) is US representative. They have created many standards

20. QMS Requirements
ISO 9001:2008 QMS standard specifies the requirements where in an organization need to demonstrate its ability to provide a product that meets customer’s & applicable statutory & regulatory requirements & must aim to enhance customer satisfaction through effective application of the system All requirements are generic in nature & applicable to all types of organizations. Any requirement which can not be applied to any organization due nature of an organization may be considered for exclusion.