QMS awareness 12th may 2015
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Awareness on Quality Management SystemISO 9001: 2008 @ SCH June 2014By Maheswran N.
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• Definition of Quality & Evolution of QMS• Evolution of ISO 9001 Standard• Key Drivers for QMS• PDCA cycle of ISO 9001 • 8 Quality Management Principles• Benefits of ISO 9001• Process Approach• Overview of Clauses / Elements of ISO 9001: 2008• Implementation & Certification Process• Pitfalls in Implementation
AGENDA & LEARNING OBJECTIVES
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Definition of Quality & Evolution of QMS
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Evolution of QMS & Definition of Quality
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5 R’s in Health Care Quality
CARE
PERSON
PLACETIME
PRICE 5 R’S RIGHT
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6 Dimensions of Health Care Quality - STEPEE
Safe
Timely
Equitable
Patient Centric
Effective
Efficient
QUALITY IN HEALTHCARE
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QUALITY
Quality is the Degree to which health services for individuals and populations increase the likelihood of desired health outcomes and are consistent with current professional knowledge
Institute of Medicine (IOM)
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WHAT IS MANAGEMENT SYSTEM
Management is all about
Dealing or Controlling
Management as a Noun : refers to a Group of Managers.
Management as a Process : refers to the Functions i.e. Planning, Organising, Directing, Controlling, etc.
Management as a Discipline
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WHAT WE MANAGE
SYSTEMS
Man (Woman)Method
Machine Money
Material
Mother Nature
(Market)
6 M’s
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HENCE WHAT IS MANAGEMENT SYSTEM A management system is the
framework of processes and procedures used to ensure that an organisation can fulfill all tasks required to achieve its policy & objectives.[
A management system is the framework of processes and procedures used to ensure that an organisation can fulfill all tasks required to achieve its policy & objectives.
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WHY DO WE REQUIRE PROCESS / PROCEDURE……. Product/
Service Process: A set of interrelated or
interacting activities which transforms inputs into output
Input Activity Output
Procedure: Specified way to carry out an activity or a process
: Result of Process
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Policy & ObjectivePolicy: Overall intentions and direction of an organization related to quality as formally expressed by top management•- Appropriate to the organization•- Commitment to comply with requirements•- Commitment to continually improve•- Framework for establishing and reviewing quality objectives•- Communicated and understood•- Reviewed for continuing suitability
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At relevant function and levels- Measurable- Consistent with the quality policy
Objective: something sought, or aimed for, related to ... e.g. Quality, Environment, Health & Safety
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WHAT IS ISO
ISO stands for
International Organisation for Standardisation
ISO is the world’s largest developer of voluntary ISO Publications. Founded in the year 1947, and since then have published more than 19000 ISO Publications. Today there are members from 164 countries and about 150 people work full time for the Central Secretariat in Geneva, Switzerland.
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WHAT is the objective of the ISO Body
Develop Worldwide standards,
Improve International communication and collaboration,
Eliminate the differences e.g. vocabulary that promote
international trade.
ISO standards are used by exporters and importers in both
government and industry.
ISO’s means EQUAL in Greek- hence the Acronym ISO and not IOS
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KEY DRIVERS OF A MANAGEMENT SYSTEM
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KEY DRIVERS FOR any MSS
•INTERNAL OR EXTERNAL TO THE ORGANISATION
•LEGAL & REGULATORY•IMPROVEMENT•PREVENTION OF SOMETHING CRITICAL THAT ALIGNS WITH THE SCOPE OF THAT MANAGEMENT STANDARD
Manage-ment System Standa
rd
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KEY DRIVERS FOR EACH OF THE MGMT SYS.
• INTERNAL OR EXTERNAL TO THE ORGANISATION
• LEGAL & REGULATORY• IMPROVEMENT• PREVENTION OF SOMETHING CRITICAL THAT ALIGNS WITH THE SCOPE OF THAT MANAGEMENT STANDARD
MSS
•Customer Satisfaction•Statutory & Regulatory Requirement
•Continual Improvement•Prevention of Non conforming product
QMS
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BASIS OF ANY MSS
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Bases on any Management System
Based on the Deming Cycle-
PDCA Cycle
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PLAN & DOPlan: Establish the objectives and processes necessary to deliver results in accordance with the expected output (the target or goals). Do: Implement the plan, execute the process, make the product.
Check: Study the actual results and compare against the expected results (targets or goals from the "PLAN") to ascertain any differences. Look for deviation in implementation from the plan and also look for the appropriateness and completeness of the plan to enable the execution, i.e. Collect data for charting and analysis in the following "ACT" steps.
Act: Collect data for charting and analysis, request corrective actions on significant differences between actual and planned results.
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PRINCIPLES ON WHICH THE ISO 9001: 2008 STANDARD IS
BASED
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QMS IS BASED ON 8 QMP’s
Management
Mutually Beneficial Supplier
Relationships
Customer Focus
Leadership
Involvement of People
Process Approach
System Approach
Factual Approach to
Decision making
Continual Improvement
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• Customer focus - You depend on your customers, therefore should understand current and future customer needs, meet their requirements and strive to exceed customer expectations.
• Leadership - Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the objectives.
• Involvement of people - People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.
• Process approach - A desired result is achieved more effectively when activities and related resources are managed as a process.
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• System approach to management - Identifying, understanding and managing interrelated processes as a system contributes to the organization’s effectiveness and efficiency in achieving its objectives.
• Continual improvement - of the organization’s overall performance should be a permanent objective of that organization.
• Factual approach to decision making - Effective decisions are based on the analysis of data and information.
• Mutually beneficial supplier relationships - An organization and its suppliers are interdependent and this relationship enhances the ability of both to create value.
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Process Approach
• What is a “Process”?– Any activity that receives input and converts them to
outputs can be considered as a process
• What is “Process Approach”?– The systematic identification and management of the
processes employed within an organisation and particularly the interaction between such processes is referred as the “Process Approach”. ( ISO 9000:2005 )
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Resources:PeopleFacilities/EquipmentMaterialMethods
• Schematic Representation of a Process
ProcessInput Output
Results:ProductsServicesPerformance
Process Approach - Concept
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With what?Resources
OutputsTo whom/where
What results?Performanceindicators
InputsFrom whom/ where
How done?Methods/Documentation
With Who?Personnel
Process(specific valueadded activities)
Process Auditing “Turtle Diagram”
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QMS Process Model
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Continual improvement of the quality management system
Customer Customer
Requirements
Satisfaction
Management responsibility
ResourceManagement
Measurement,analysis andimprovement
Productrealization Product
outputinput
QUALITY MANAGEMENT PROCESS MODEL
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QUALITY MANAGEMENT PROCESS MODEL
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Benefits of QMS
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QMS IMPLEMENTATION / CERTIFICATION BENEFITS
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Objective & Benefits of Quality Management Systems• To ensure the effective planning, operation and control of the
organisation’s processes. • Communicates the same message to many people simultaneously• Saves time – methods and processes do not need to be re-invented
each time• Can be used as a training aid to induct people into new roles or
activities• Documenting processes can help to ensure there are no gaps, and
that the interfaces have been properly considered• Record and reminder of what has been agreed.• Acts as a reference so that people can work independently• Help to ensure consistency of output• Provides a mechanism to communicate and implement changes.
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Overview of the ISO 9001Elements / Clauses
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CLAUSES / ELEMENTS of ISO 9001: 2008
• 1.0 SCOPE:• 4 C’s / Conformity, Consistency,
Continual Improvement, Customer Satisfaction
• 1.2 Application• 2.0 Normative Reference• 3.0 Terms & Definitions
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Scope: 4 C’s
• Conformity• Consistency• Continual Improvement• Customer Satisfaction
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4.1 GENERAL REQUIREMENTS
• Identify the processes• Determine sequence and interaction• Determine criteria and methods for effective control• Ensure availability of resources and information• Monitor, measure and analyse processes• Implement actions for continual improvement
4.2 DOCUMENTATION REQUIREMENTS 4.2.2 Quality Manual
4.2.3 Document Control4.2.4 Records Control
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TYPICAL DOCUMENTATION STRUCTURE6 procedures- on 1. Document Control2. Record Control 3. Internal Audits 4. Control of Non-- conforming Products, 5. Corrective Action 6. Preventive Action
RECORDS OF 1. Training Records2. Input / Customer enquiry / Order Review, 3. Design & Development Records 4. Supplier, selection, evaluation, re-
evaluation & Purchase Order 5. Validation of process, 6. Calibration, 7. Internal Audits,8. Monitoring & Measuring , 9. Non conformance, 10. Internal Audits results, 11. Management Review Records, 12. NC in Customer property 13. Traceability14. Corrective and15. Preventive Action
Policy & Quality Manual- Scope,
Interaction of Processes,
Procedures -
Activity Level Work Instructions, Job Descriptions, Quality Checklists,
Monitoring and Measurement checks, Formats etc
Records
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5.1 MANAGEMENT COMMITMENT
5.2 CUSTOMER FOCUS
5.3 QUALITY POLICY
5.4 PLANNING
5.5 RESPONSIBILITY, AUTHORITY & COMMUNICATION
5.6 MANAGEMENT REVIEW
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5.1 MANAGEMENT COMMITMENT
Top management - commitment to the QMS by:• Communicating the importance of meeting customer &
regulatory requirements• Establishing the quality policy• Establish quality objectives• Conduct management reviews• Availability of resources
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5.3 QUALITY POLICY
Overall intentions and direction of an organization related to quality as formally expressed by top management–Appropriate to the organization–Commitment to comply with requirements–Commitment to continually improve–Framework for establishing and reviewing
quality objectives–Communicated and understood–Reviewed for continuing suitability
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5.4 PLANNING
5.4.1 Quality objectives: something sought or aimed for related to quality
At relevant function and levels– Measurable– Consistent with the quality policy
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Objective a Key Component- for driving Management Systems
QMP
Quality as reqd
Resources
On time delivery
OBJECTIVE: Reduce Customer Complaint
Very soon I hope ! ???
When will we Know whether we have improved
Target: 20%
Time Sep 2014
Responsibility
Response
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OBJECTIVES- SMART
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6 Resource management
6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment
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ISO 9001 - REQUIREMENTS
7 Product realization (Permissible exclusions)
7.1 Planning of product realization7.2 Customer-related processes7.3 Design and development7.4 Purchasing7.5 Production and service provision7.6 Control of monitoring and measuring
devices
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ISO 9001 - REQUIREMENTS
8 Measurement, analysis and improvement
8.1 General8.2 Monitoring and measurement8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement
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Correction- Remedial Action , Corrective Action and Preventive Action
CORRECTION- Action to eliminate a detected nonconformity
CORRECTIVE ACTION - Action to eliminate the cause of detected NC
PREVENTIVE ACTION- Action to eliminate the cause of potential NC
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Prevent Unintended Usage- further damage CORRECTION
Prevent Recurrence - CORRECTIVE ACTION
Prevent Occurance - PREVENTIVE ACTION
For actual Nonconformance For potential Nonconformance
Root Cause Analysis is a MUST
8.3 8.5.2 8.5.3
Correction- Remedial Action , Corrective Action and Preventive Action
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Pitfalls in QMS Implementation
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Failure to involve everyone in the process
Failure to transfer knowledge across the organisation
Not setting an adequate time goal
Not actively using the system created
Pitfalls
Failure to monitor progress and enforce deadlines
Lack of Top Management commitment
I
K
G
I
M
C
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Certification Hierarchy & Implementation Process
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Overall IMS Implementation Stages- Certification Audit Stages
Stage I Audit By CB- .IMS Documentation Review and Reports of Internal audits and Mgmt. Review- Adequacy Audit
Stage II- By CB Compliance Audit
Take necessary actions based on the Stage I reports
Within 5 working days
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You never know what a unhappy customer is capable of--
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Looking Forward for your Cooperation & Engagement