QMS- ISO9001:2008 QUALITY MANAGEMENT SYSTEM Dr Kalpesh Parikh, Director
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QMS-ISO9001:2008
QUALITY MANAGEMENT SYSTEM
Dr Kalpesh Parikh, Director
QMS-ISO9001:2008
System is for the organisation, and not organisation for the system.
AIM
Enhancing Customer
Satisfaction
Same Result irrespective of
Person Performing it.
QMS-ISO9001:2008
What is Quality?
“DEGREE TO WHICH A SET OF INHERENT CHARACTERISTICS FULFILS REQUIREMENTS”
Quality of a product is denoted by its
• Market Acceptance
• Appearance
• Usage
• Consistency
• Lasting Value
QMS-ISO9001:2008
H/W
S/W
Humanware
MS
IT Solution
Infrastructure
System
What is Management System?
“set of interrelated or interacting elements to establish policy and objectives and to achieve those objectives”
QMS-ISO9001:2008
Quality definitions
Deming: A predictable degree of uniformity and dependability at low cost and suited to the market.
Crosby: Conformance to the requirements.
ISO 8402: A totality of features and characteristics of a product or service that bear on its ability to satisfy stated or implied needs.
Source: www.intellisenseit.com
QMS-ISO9001:2008
Quality Management System
Quality Assurance : “Part of Quality Management System,
focused on providing confidence that quality requirements
will be fulfilled”
Quality ManagementCoordinated activities to direct
and control organization Wrt Quality
Quality Control : “Part of Quality Management,
focused on fulfilling quality requirements”
QMS requirements are complementary to technical requirements for product
QMS-ISO9001:2008
• System Approach
• Continual Improvement
• Factual Approach to Decision Process
• Mutually beneficial Supplier Relationship
• Process Approach
• Factual Approach
• Organization and Personal Learning (Knowledge)\
• Agility (To react Change)
• Creating Customer Value
• Focus on Social Value
• Visionary Leadership
• Understanding Core Competence (profound knowledge of business)
• Involvement of People
• Collaboration with partners
• Total optimization of system
• Autonomy (Empowerment)
Quality Management Principles
QMS-ISO9001:2008
Introduction to ISO 9000
ISO : International Organization for Standardization
ISO 9000 : International Quality Management System Standard
: Applies to Quality Management System and not to the Products
: They are generic and not specific to any Industry
• These are developed to effectively document the quality elements to be implemented in order to maintain an efficient quality system in company.
• Do not specify the technology to be used for implementing quality system elements.
• They tell what you ought to consider doing when you manage your organization, not how precisely you should do.
QMS-ISO9001:2008
What is Standard ?
A Written document detailing minimum features, specifications and requirement of product. These are required to
(a) Prescribe the minimum requirements for Quality(b) Ensure safety of operations both for workmen and users(c ) Promote interchangeability of the product.(d) Achieve variation reduction
ISO 9000
QMS Manual
PROCEDURE
FORMS RECORDS
WORK INSTRUCTION
ISO Requirements
QMS-ISO9001:2008
CUSTOMER
CUSTOMER
Management responsibility
Resourcemanagement
Measurement, analysis,improvement
ProductProductrealisation
Quality Management SystemContinual Improvement
Requirements
Satisfaction
InputOutput
The QMS Model
QMS-ISO9001:2008
Plan: establish the objectives and processes necessary to deliver results in accordance with customer requirements and the organization's policies
Do: implement the processes
Check: monitor and measure processes and product against policies, objectives and requirements for the product and report the results
Act: take actions to continually improve process performance;"
PDCA Cycle
The Deming Cycle
QMS-ISO9001:2008
Process
ProcessProcessActivitiesActivities
++ResourcesResources
InputInput OutputOutput
ControlsControls(e.g.procedure)(e.g.procedure)
An activity using resources and managed in order to enable the transformation of input into outputs can beconsidered as process.
ISO 9000:2000 clause 3.4.1 defines a "Process" as:"Set of interrelated or interacting activities which transforms inputs into outputs”
QMS-ISO9001:2008
Process ApproachThe application of a system of processes within organization, together with the identification and interactions of these processes and their management can be referred to as the “Process Approach”
Processes - understand interactions
ProcessProcessAA
ProcessProcessDD
ProcessProcessBB
ProcessProcessCC
InputInputOutputOutputControlsControls
QMS-ISO9001:2008
Why Process Approach
If processes are right Product/Service is supposed to be ‘right’
A desired result is achieved more efficiently when activities and related resources are managed as a process.
Knowledge is input to Process and not output
From Process
Person Dependent
to
Process Driven Organization
QMS-ISO9001:2008
Process Integration
Process Dimensions
Proof of Process Performed
Process Verification
Process Validation
Process Monitoring
Process Owner
Process Measurement
QMS-ISO9001:2008
Process Performance
•Skill and Knowledge to Perform the Process•What is to be done (Procedure)•How it is to be done (Work Instruction)
This is irrespective of Technology and Technicality of process, irrespective of infrastructure used, tools used.
•Effectiveness of Process•Efficiency of Process
Institutionalization of Processes
Person is incidental to Organization
Tools & Technology also should be incidental to Organization
QMS-ISO9001:2008
Effectiveness
“producing or capable of producing desired effect”
“extent to which planned activities are realized and planned results are achieved”
Efficiency
“Acting or Producing effectively with a minimum of waste, expense, or unnecessary effort”
“Exhibiting high ratio of output to input”
“relationship between the result achieved and the resources used”
Effectiveness and Efficiency
QMS-ISO9001:2008
Better Product Quality
• Cost Effectiveness
• Transparency in operations
• System dependent rather than person dependent
Advantages to Employees
• Simple Standard Instruction
• Less blaming & finger pointing
• Pride
• Training to newcomers becomes easy
• Enhance confidence of customer
• Demonstrates company is committed to Quality
•Less stress at work
•Better work environment
Advantages to Company
QMS-ISO9001:2008
QMS Plan-Do-Check-Act Implementation Model
QMS-ISO9001:2008
•Apex Manual
• Policy and Objectives
•Mandatory Process Documentation
•Business Process Documentation (What is to done)
•Procedure Documentation (How it is to be Done)
•Record Formats / Templates (Proof of Process Performed)
•Training – Awareness, Internal Audit and MR
•Implementation
•Internal Audit
•Management Review
•Invite Certification Body for Initial Audit
•Surveillance Audit
•Re-Certification Audit
QMS Certification Process
QMS-ISO9001:2008
SHANTIKRUPAESTATES PVT LTD
Icons Who Trusted us
Hashmukh Shah Group
Government AgenciesUGC-AICTE-INFLIBNET-AMC
Government CorporationsGSFC-GIIC-GAIC-GIDC
GHB
Gujarat Housing
Board
QMS-ISO9001:2008
Think TechknowlogicallyMSWH-new Generation ERP
Technology
KnowledgeLogic ownership
SolutionTechniqueTechknowlogical
Quality Seekers are
Too BUSY
to be SAD
Too POSITIVE to be DOUBTFUL
Too OPTIMISTIC to be FEARFUL
Too DETERMINED to be DEFEATED
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