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Quality Management Standards

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THE ISO 9000 FAMILY

ISO 9000: 2005• Identifies the fundamentals and vocabulary for Quality Management

Systems (QMS)

ISO 9001:2008• Specifies requirements for a QMS where capability to provide product

that meets customer and regulatory requirements needs to be demonstrated

ISO 9004:2009• Provides guidance on QMS that contributes to the satisfaction of

customers and other interested parties

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ISO 9000 : 2008

Eight quality management principles1. Customer focus2. Leadership3. Involvement of people4. Process approach5. System approach to management6. Continual improvement7. Factual approach to decision making8. Mutually beneficial supplier relationships

ISO 9001:2008CONTINUAL IMPROVEMENT OF THE QUALITY

MANAGEMENT SYSTEM

CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM

Measurement, analysis and improvement

Measurement, analysis and improvement

ProductProductInput Output

Management responsibility

Resource management

Resource management

Clause 5

Clause 6 Clause 8

Clause 7

Requirements

Product

realization

Satisfaction

Value adding activitiesInformation flow

Customers

Customers

5

Inputs

With What?(Materials / Equipment)

How Many?(Measurement /

Controls)

How?(Methods/

Procedures)

WHO?Special Skills? / Competence?

Outputs

Process Linkages

Objectives

and Targets

Business Process

Source: AIAG ISO/TS 16949:2002 Implementation Guide

PROCESS REQUIREMENTS

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SCOPE OF STANDARD

1. Scope General

Application

2. Normative reference

3. Terms and definitione.g., Supplier Organization Customer

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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

4.1 General requirements Document, implement, maintain and continually improve Identify and determine sequence and interaction of processes Determine criteria and methods needed Ensure availability of resources Monitor, measure and analyze processes Implement actions to achieve planned results

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QUALITY MANAGEMENT SYSTEM REQUIREMENTS

4.2 Documentation requirements Management system documentation Quality Manual Control of documents Control of records

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MANAGEMENT RESPONSIBILITY

5.1 Management commitment

5.2 Customer focus

5.3 Quality policy

Must be documented Must be used for setting objectives

5.4 Planning

Document objectives- Must be Measurable

Quality management system planning

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MANAGEMENT RESPONSIBILITY

5.5 Responsibility, authority and communication Responsibility and authority Management representative Internal communication

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MANAGEMENT RESPONSIBILITY

5.6 Management Review General Review input Review output

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RESOURCE MANAGEMENT

6.1 Provision of resources

6.2 Human resources General Competence, awareness and training

6.3 Infrastructure

6.4 Work environment

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PRODUCT REALIZATION

7.1 Planning of product realization

7.2 Customer-related processes Determination of requirements related to

the product

Review of requirements related to the product

Customer communication

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PRODUCT REALIZATION

7.3 Design and development Planning, inputs, outputs, systematic

reviews, verification and validation, control of changes

7.4 Purchasing Supplier evaluation and selection Relevant purchasing information Verification of purchased product

- receiving, source

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PRODUCT REALIZATION

7.5 Production and service provision Controlled conditions including product

characteristics, work instructions (as necessary), suitable equipment, monitoring and measuring devices, monitoring and measurement, and release, delivery and post- delivery activities

Validation of processes when no other method Identification and traceability of product and

it’s status Care of customer property Preservation of product

Includes constituent parts

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PRODUCT REALIZATION

7.6 Control of monitoring and measuring devices Calibrated or verified where necessary Adjusted and re-adjusted as necessary Identified to enable calibration status Safeguarded from invalid adjustment Protected from damage and deterioration

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MEASUREMENT, ANALYSIS, AND IMPROVEMENT

8.1 General8.2 Monitoring and measurement

Customer satisfaction Internal audit Monitoring and measurement of processes Monitoring and measurement of product

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MEASUREMENT, ANALYSIS, AND IMPROVEMENT

8.3 Control of nonconforming product8.4 Analysis of data8.5 Improvement

Continual improvement Corrective action Preventive action

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ISO 9001:2008

A Structured

Approach to Quality Manageme

nt

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Documented Systems

Diaco Inc. asahi515874@comcast.net 505 780-3185 21

QUALITY SYSTEMDOCUMENTATION STRUCTURE

1st LevelQuality Manual2nd Level

Procedures

3rd LevelWork Instructions

Machine instructions Computer inputs Detailed work

instructions4th Level

Technical Data International standards Computer operating

manuals Detailed product

specifications

Policy and ObjectivesWhat the company wishes to achieve

How the company implements its policy Structured to reflect process flow of events

Detailed instructions How to completea job or task

TQM

• TOTAL QUALITY MANAGEMENT

Total quality management is a systemic approach to productivity improvement using qualitative and quantitative methods and involving all stakeholders to continuously improve the quality of all products and services.

TQM

TQM

• IS THE SET OF MANAGEMENT PROCESSES AND SYSTEMS THAT CREATE DELIGHTED CUSTOMERS THROUGH EMPOWERED EMPLOYEES, LEADING TO HIGHER REVENUES & LOWER COST

THE JURAN INSTITUTE, Inc.

TQM

• It is the process of individual & organizational development the purpose of which is to increase the level of satisfaction of all the stakeholders

PIKE, R J BARNES

WHY TQM?

B/C IT IS FOR BENEFIT OF ALL STAKEHOLDERS

• INTERNAL SATKEHOLDER

• EXTERNAL STAKEHOLDER

COMPONENTS OF TQM

1. PRICE REDUCTION

2. CUSTOMER SATISFACTION

3. INVOLVEMENT OF EVERYONE

4. CONTINUOUS QUALITY IMPROVEMENT

5. LEADERSHIP

PRICE REDUCTION

• COST AN ESSENTIAL ELEMENT OF TQM

• CROSBY PHILOSPHY QUALITY IS FREE QLTY IS THE RIGHT OF CUSTOMER

Who determines quality?

THE CUSTOMER

If the customer does not perceive you as offering quality service you are not.

INVOLVEMENT OF EVERYONE

CONTINUOUS IMPROVEMENT

• Improve each and everyday - Do not focus on problems, focus on improvements.

• IF YOU’RE NOT PART OF THE SOLUTION, YOU’RE PART OF THE PROBLEM.

CONTINUOUS IMPROVEMENT

• Customers are not interested in excuses, they’re interested in results.

• Be proactive - because if you don’t someone else will.

• Ishikawa Says The organization which does not make a change in the 06 months is a dead organizations

LEADERSHIP

• NO EFFORT FOR QUALITY IMPROVEMENT CAN SUCCEED WITHOUT COMMITMENT OF TOP MANAGEMENT

LEADERSHIP

A NATION WITHOUT LEADERSHIP IS THE HERD OF SWINE

EINSTEIN