Quality Management System

ISO 9001: 2015

 What is Quality?

 Quality is a product that meets the customers requirements or

expectations

 Fitness for purpose

 Getting it right the first time

Management System

 System to establish policy and objectives and achieve those

objectives

 Exists in every organization

Quality Management System

 Ensure that its products or services satisfy the customer's quality

requirements

 Comply with any regulations applicable to those products or

services.

 Enhance customer satisfaction

 Achieve continual improvement of its performance

ISO 9001:2015

ISO 9001:2015 is a generic standard and can be applied:

 To any organization, large or small, whatever its product or service

is

 In any sector of activity

 Whether it is a business enterprise, a public administration, or a

government department
ISO 9001:2015

 Do what you document and document what you do

 Quality is not what you do as much as how you do it

 The standards are like a checklist

Purpose of ISO 9001:2015

Specifies requirements for organization to:

 Demonstrate its ability to consistently provide product that meets

applicable requirements

 Enhance customer satisfaction through system processes for

improvement & conformity

 Prevent non-conformity
Terms and Definitions

 Customer: Organization or person that receives a product

 Requirement: Need or expectation

 Product: Result of a process

 Process: Set of interrelated activities which transforms inputs to

outputs

 Procedure: Specified way to carry out an activity or a process

Benefits of ISO 9001:2015

 Increase efficiency and effectiveness

 Model for continual improvement

 Model for satisfying customers

 Build quality into products and services

 Sustainable business

 Transfer of good practices

 Increases credit in the market

Benefits of ISO 9001:2015

 Ensures quality and after sales service to customers

 Due to increased confidence of customers in you, you get more &

more orders

 Improves housekeeping

 Reduces rejection/rework

 Increases morale of the company

 Improves team work

Clauses of ISO 9001:2015

 Clause 1: Scope
 Clause 2: Normative Reference
 Clause 3:Terms and Definitions
 Clause 4: Context of Organization
 Clause 5: Leadership
 Clause 6: Planning
 Clause 7: Support
 Clause 8: Operation
 Clause 9: Performance Evaluation
 Clause 10: Improvement
Mandatory Documents ISO 9001:2015
Imp Documents
 Quality Policy
 Quality Objectives
 Quality Manual

imp Procedures
 Control of documents
 Control of record
 Internal audit
 Control of nonconforming product
 Risk & Opp Register
 Expectation of interested parties
 Quality Management System Cycle
10 Where are we Where should 1
now? we be?

9 Quality policy & 2

Management
Quality
Review
Objectives
Quality
8 Internal Quality Management 3
Audit Planning
System Cycle

7 Corrective & How are we 4

Preventive going to get
Action over there?

What progress 6 Implementation 5

are we making? & Operations
 PDCA Cycle
 Four-step management method used in business for the control
and continuous improvement of processes and products
Eight Quality Management Principles
QMS Summary

 Say what you do

 Write it down in standard format

 Do what you say

 Keep excellent records

 Audit to verify

 React to gaps

 Review at Top Management level

 Build in continual improvement