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

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

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

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)

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

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

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

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.

Model of Process EMS documentation 4.4.4

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

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

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

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

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

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

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  

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

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.

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 100 countries; American National Standards Institute (ANSI) is US representative. They have created many standards

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.