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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