ch-4 iso(quality management systems)

8/12/2019 Ch-4 ISO(Quality Management Systems)

1/76

4-1 Excel BooksTotalQualityManagement Text and Cases G Nagalingappa, Manjunath V S

Copyright 2010, G Nagalingappa, Manjunath V S

Quality Management SystemsCH-4

Quality Circles

Is a small group employees in the same

work area or doing a similar type of work

who voluntarily meet regularly for about anhour every week to identify, analyze and

resolve work-related problems, leading to

improvement in their total performance

and enrichment of their work life.


2/76




Features of QCSmall group of employees

Belong to same work area

Voluntary participation

Meet regularly every week

Identify analyze and resolve work related problems

They contribute to better performanceThey aim at enrichment of work life


3/76




What QCs are not

Are not just for quality problems

Not substitute for task forces, product committees,

joint plant councils & quality assurance groups.

Do not change the existing structure of the

organization

Not means for the management to unload all their

problemsNot a forum for grievances

Are not a panacea for all ills of an organization


4/76




QC BenefitsTeam sprit development

Change in the attitudeSelf development


5/76




Chapter

4 QualityManagement Systems


6/76




Introduction

A QMS can be defined as "A set of co-ordinated activities to direct and control

an organisation in order to continually improve the effectiveness and

efficiency of its performance."


7/764-7 Excel BooksTotalQualityManagement Text and Cases G Nagalingappa, Manjunath V S



Cont.

The Benefits of a QMS

1. The customers' requirements confidence in the ability of the

organisation to deliver the desired product and service consistently

meeting their needs and expectations.

2. The organisation's requirements both internally and externally, and at

an optimum cost with efficient use of the available resources

materials, human, technology and information.





Cont.

QMS

Organizations

Business

Progress

Time

QMS and Business Growth





A good QMS will Set direction & meet customers expectation. Improve process control

Reduce wastage Lower costs

Increase market share

Facilitate training Involve staff

Raise morale





Different ISO Standards

ISO 9001:2008 gives the requirements for quality

management systems.

Certification to the standard is used in global supply

chains to provide assurance about suppliers' ability tosatisfy quality requirements and to enhance customer

satisfaction in supplier-customer relationships.

ISO 14001:2004, which gives the requirements for

environmental management systems, retains its global

relevance for organizations wishing to operate in an

environmentally sustainable manner.






ISO/TS 16949:2009 gives the requirements for

the application of ISO 9001:2008 by suppliers

in the automotive sector.

ISO 13485:2003 gives quality management

requirements for the medical device sector for

regulatory purposes.






ISO/IEC 27001:2005 gives the requirements

for information security management systems.

ISO 22000:2005 gives the requirements for

food safety management systems.

ISO 50001:2011 gives the requirements for

energy management systems.


13/76




What is ISO 9000?

The International Organization for Standardization (ISO) was founded

in 1946 in Geneva, Switzerland.

The objective of this organization is to promote the development of

international standards to facilitate free exchange of goods and

services across the globe.

ISO 9000 defines quality system standards.


14/76




ISO 9000 objectives: Achieve, maintain & seek to continuously improveproduct quality & after sales services in relationship

to requirements.

Improve the quality of operations to continuously

meet customers stakeholders' stated & impliedneeds.

Provide confidence to internal & other stakeholders

that quality requirements are being achieved in thedelivered products.

Provide confidence that quality system

requirements are fulfilled.


15/76




Benefits of ISO 9000 Certification

1. Achievement of international standard quality

2. Higher productivity

3. Increased customer satisfaction

4. Higher profitability

5. Higher employee morale

6. Reduction in customer complaints

7. Increased market share

8. Acceptability of the product in other countries, leading to increasedexport sales

9. Improved corporate image of the organization

10. Reduced need for inspection


16/76




Cont.

ISO 9000: 2000 Series of Standards

ISO 9000: 2000 standards focus on developing, documenting and

implementing procedures to ensure consistency of operations and

performance in production and service delivery processes.

ISO 9000: 2000 consists of three series of standards:

1. ISO 9000: 2000Quality Management Systems (QMS): fundamental &

vocabulary discuss fundamental concepts to QMS & provides terminology

used in other standards.

2. ISO 9001: 2000Quality Management Systems (QMS): standard used

for registration by documenting conformity of the QMS to customer,

regulatory & organization requirements.

C


17/76




3. I SO 9004: 2000Quality Management

Systems (QMS): guidelines for performanceimprovements provide guidelines that an

organization can use to establish a QMS

focused on improving performance.

Note: ISO 9000 standards revised in 2008,

known as ISO 9000:2008.

CH 4


18/76




Cont.

ISO 9000: 2000 Quality Management Principles

1. Principle of customer focus

2. Principle of Leadership

3. Principle of involvement of people

4. Principle of process approach

5. Principle of systems approach to management

6. Principle of continuous improvement

7. Principle of factual approach to decision-making

8. Principle of mutually beneficial supplier relationship

CH 4


19/76




Principle of customer focus: organization

should understand clear present & futurecustomer needs, & strive continuously for

exceeding the customer expectation.

Principle of leadership: most important part ofquality management. Create an internal

environment in which employees can perform

& involve fully in the process of achievingorganization quality goals.

CH 4


20/76




Principle of involvement of people: HR are key components of

the organization & success of an organization depends on its

employee involvement in quality management efforts.

Employees full involvement helps organization in achieving

its objective.

Principle of process approach: ISO 9000 calls for process

approach as good process automatically leads to good output.

Hence organization must focus on better and standard process

which can prevent defects rather than focusing corrective

actions.

CH 4


21/76




Principle of systems approach to management: organizations are

made of interrelated components in the form of various

functional groups & department with coordinated efforts.

Hence identifying understanding, & managing interrelated

process as s system contributes to the organizationseffectiveness & efficiency.

Principle of continuous improvement: organizations should focus

continuous improvement of existing products, services &

process. Continuous improvements of organizations overall

performance should be the permanent of the organization.

CH 4


22/76




Principle of realistic approach to decision-making: Data is the

most important for any decision-making. Hence collection of

reliable data is very important & effective decisions are made

on the analysis of accurate data.

Principle of mutually beneficial supplier relationship: Quality

products & services depends on quality of the inputs hence

suppliers are the key for getting best quality inputs. An

organization are interdependent and mutually beneficial

relationship enhances the ability of both to created value.

CH 4


23/76




Cont.

ISO 9001 Requirements

1. Scope

2. Normative Reference

3. Terms and Definitions

4. Quality Management Systems (QMS)

5. Management Responsibilities

6. Resource Management

7. Product realization

8. Measurement, analysis and improvement

CH 4


24/76




1.Scope: the organization to demonstrate its ability to

provide a product that meets customer & regulatoryrequirements & achieve customer satisfaction.

2.Normative Reference: ISO 9000: 2000 QMS-

Fundamental & Vocabulary are normative reference

that provide applicable concepts & definition.

3.Terms & Definition: for the purposes of this

standard the terms & definitions given in ISO:2000

apply. In addition, the supply chain is defined as:Supplier-------Organization-------Customer

CH 4


25/76




4.Quality Management System (i) General Requirements: the organization shall establish,

document, implement & maintain QMS & continually improveits effectiveness.

(a) identify needed process such as management activities,

provision for resource, product realization & measurement.

(b) Determine their sequence & interaction.(c) Determine criteria & methods for effective operation &

control of these process.

(d) Ensure the availability of resources & information necessary

to support & monitor these processes.(e) Monitor, Measure, & analyze these process.

(f) Implement actions to achieve planned results & continuous

improvement of theses processes.

CH 4


26/76




4.Quality Management System (ii) Documentation: includes quality policy,

quality manual, documented procedures,operation & Control of processes etc.

Quality manual shall be established & maintained &

it must contain interactions among QMS processes. All the records must be established & maintained to

provide evidence of conformity.

Records must be legible, readily identifiable &

retrievable.

CH 4


27/76




5. Management Responsibilities

(i) Management Commitment

(ii) Customer focus

(iii) Quality Policy

(iv) Planning

(v) Responsibility, authority, & Communication

(vi) Management Review

Q li M SCH 4


28/76




6. Resource Management

I. Provision of resources

II. Human Resources

III. Infrastructure

IV.Work environment

Q lit M t S tCH 4


29/76




7. Product realizationi. Planning of product realization

ii. Customer related processes

iii. Design & development

iv. Purchasing

v. Production & Service provision

vi. Control of monitoring & measuring devices


30/76

Q lit M t S tCH-4


31/76




Cont.

Implementation

The process of im plement in g ISO 9000 depends on :

Step 1:Top Management Commitment

Step 2:Establish Implementation Team

Step 3:Start ISO 9000 Awareness Programmes

Step 4:Provide Training

Step 5:Conduct Initial Status Survey

Step 6:Create a Documented Implementation Plan

Step 7:Develop Quality Management System Documentation

Q lit M t S tCH-4


32/76




Step 8:Document Control

Step 9:Implementation

Step 10:Internal Quality Audit

Step 11:Management Review

Step 12:Pre-assessment Audit

Step 13:Certification and Registration

Step 14:Continual Improvement



33/76




Step 1:Top Management Commitment

Communicating the importance of customer as well as statutory &

regulatory requirements. Defining quality policy & making this known to every employees.

Ensuring that quality objectives are established at all levels and functions

Ensuring the availability of resources required for the development &

implementation of the QMS.

Appointing a management representative (MR) to coordinate QMS

activities

Conducting management review.

The management should also consider action such as1. Leading the organization by example,

2. Participating in improvement projects.

3. Creating an environment that encourages the involvement of people.



34/76




Step 2:Establish Implementation Team

Establish team & appoint a management

representative (MR).

MR is coordinator to plan and oversee

implementation. Team should contain, all functional

department: Marketing, design &

development, planning, production,quality control etc.,



35/76




Step 3:Start ISO 9000 Awareness Programmes

Arrange the awareness programme about, the QMS , the advantage it offers to

employees, customers & the organization.

The awareness programme should emphasize the benefits that organization expects

to realize through its ISO 9000 quality management system.

The programme should also stress the higher levels of participation & self-direction

that quality management system renders to employees.

The programme could be conducted by implementation team or by experts hired toeducate all levels of employees.



36/76



Quality Management SystemsCH 4

Step 4:Provide Training

The training should cover the basic concepts of QMS &

standards & overall impact on the strategic goals of

the organization, the changed processes, likely work

culture implication s of the system.

Training is also necessary for writing the quality

manual, procedures, work instruction, auditingprinciples, techniques of laboratory management,

calibration, testing procedures, etc,



37/76




Step 5:Conduct Initial Status Survey

Ascertain and establish the following

What is the present operation/process? What already exists?

Analyze the relevant sections of the quality standards-ISO

9001:2000:

What is actually required?

If necessary, supplement and change operational arrangement

in accordance with the standard, develop documents and

records and describe operations/processes.

What is desired operation/process?



38/76




Step 6:Create a Documented Implementation Plan

The implementation plan should through & specific

1. Quality documentation to be developed

2. Objective of the system

3. Pertinent ISO 9001: 20000 section

4. Person or team responsible

5. Approval required

6. Training required

7. Resources required

8. Estimated completion date



39/76




Step 7:Develop Quality Management System Documentation

Documentation of the QMS includes

1. Documented statements of a quality policy & quality objectives.

2. A quality manual

3. Documented procedures & records required by the standard ISO 90001:

2000,

4. Documents needed by the organization to ensure the effective planning,

operation and control of its processes.



40/76




Step 8:Document Control

Should include

1. approval for adequacy by authorized person before issue,

2. Review, updating & re-approval of documents by authorized person

3. Identification of changes and of the revision status of documents

4. Availability of relevant versions of documents at points of use

5. Identification and control of documents of external origin

6. Assurance of legibility and identifability of documents, and prevention of

unintended use obsolete documents.



41/76




Step 9:Implementation

QMS being documented as documentation is developed.

In smaller companies the QMS can be implemented all at once throughout.

The implementation progress should be monitored to ensure that the QMS

is effective & conforms the to the quality.

The activities include internal quality audit, formal corrective action and

management review.



42/76




Step 10:Internal Quality Audit

Check regularly internal quality audits to verify the installed QMS.

1. Conforms to the planned arrangements, to the requirements of the

ISO:2000 & to the QMS requirements established by theorganization.

2. Is effectively implemented & maintained.

3. Internal audits should be planned and performed as part of an

ongoing strategy.



43/76



Quality Management Systems

Step 11:Management ReviewThe management review include information on:

1. Results of audits

2. Customer feedback

3. Process performance and product conformity

4. Status of preventive and corrective actions

5. Follow-up actions from previous management reviews

6. Changes that could affect the QMS and

7. Recommendations for improvements.



44/76




Step 12:Pre-assessment Audit If no nonconformance exists normally time to apply for the

certification

A pre-assessment audit should be arranged with an

independent and qualified auditors.

The pre-assessment audit would provide a degree of

confidence for formally going ahead with an application forcertification.



45/76




Step 13:Certification and Registration Once QMS has been operation for few months & stabilized.

The formal application for certification could be made to

selected certification agency.

If the documents conform to the requirements of the quality

standard , then on-site audit is carried out.

If certification bodies find the system to be working

satisfactory, it awards the organization a certificates for period

of 3-years.

During this 3-year period, it will carry out surveillance audits

to ensure that the system is continuing to operate satisfactorily.



46/76




Step 14:Continual Improvement

organization should continually seek to improve the

effectiveness & suitability of the QMS through the

use of:

1. Quality policy

2. Quality objective3. Audit results

4. Analysis of data

5. Corrective & preventive actions

6. Management review

ISO 9004:2000 provides a methodology for continual

improvement.



47/76



Q y g y

ISO 9001:2008 Standard

The ISO 9000 standard contains requirements

affecting virtually all aspects of any company.

Because ISO 9000 is designed for any

company of any size and in any industry, the

requirements are rather broad and hard to read.



48/76



Q y g y

ISO 9001:2008 Standard

The ISO 9001:2008 requirements fal l into th e fol low ing sect ions :

Section 1: Quality Management System

Section 2: Management Responsibility

Section 3:Resource Management

Section 4: Product Realization

Section 5:Measurement, Analysis and Improvement



49/76



y g y

Section 1: Quality Management SystemISO 9001: 2008 standards outlines the necessary steps to

implement the ISO 9001 QMS:

1. Identify the process needed for the QMS.

2. Determine the sequence & interaction of these processes.

3. Determine how these process are effectively operated and

controlled.

4. Ensure all information is available to support the operation &

monitoring of these processes.

5. Measure, monitor & analyze these processes, & implement

action necessary to correct the process and achieve continual

improvement.



50/76



y g y

Section 2: Management Responsibility

Top management commitment to quality is important.

Requires a quality policy, objective, reinforces the

involvement of top management with customer requirement.

Top management has to establish responsibilities & authorities

within the company, including Management Representative.



51/76



y g y

Section 3:Resource Management

Determine the requirements, provide in timely

manner, resources needed to implement and

improve the processes of QMS and address

customer satisfaction.

Including employee training as well as for the

physical facilities and work enviornment



52/76



y g y

Section 4: Product Realization

Defined as that sequence of processes and sub-processesrequired to achieve the product.

This section also contains various requirements for the design of

products and for the planning of processes, projects and

services.

Quality Management SystemsCH-4S i 5 M A l i d I


53/76



Section 5:Measurement, Analysis and ImprovementMeasurement & monitoring activities include

internal audits and monitoring of customerperception as to whether the company has

fulfilled customer requirements.

All these activities must be defined, planned andimplemented. Measuring and monitoring

allows the company to manage by fact, not by

guess.



54/76



What is ISO 9001 Certification?

ISO 9001 certification is also known as ISO 9001 registration, ISO 9000

registration, ISO 9001:2008 certification or ISO 9001:2008 registration.

All of these refer to an independent certification body attesting that a

company's ISO 9001 quality management system meets all

requirements of the ISO 9001 2008 standard.



55/76



What are the changes in ISO 9000:2008

ISO 9000: 2008 only introduces clarifications to the existing

requirements of ISO 9000:2000.

Reasons for limited changes are A key factor in the

development of ISO 9001:2008 was to limit the impact of

changes on users.

Changes & Benefits are:

Easier to use

Clearer language

Easier to translate into the other languages Better compatibility with the environmental

management standard ISO 14001:2004.



56/76



Problems Related to ISO 9000

Problem 1:Management Attitude and Purpose

Problem 2:Implementation by Consultants

Problem 3:ISO 9000 Management Representative without Power

Problem 4: Insufficient Resources

Problem 5: Lack of Improvement

Problem 6: Making it Complicated



57/76



Problem 1:Management Attitude and Purpose

Goal should be clear defined

Not for customer requirement

Not for attracting the business



58/76



Problem 2:Implementation by Consultants

Consultants promise to write quality manual, qualityprocedures and other documents & provide training.

Consultant is unfamiliar with the business, the company & its

culture resulting system does not fit the company.

For fees tires to set an overly complicated & complicated

quality system.

Consultant is not flexible.



59/76



Problem 3:ISO 9000 Management Representative without Power

MR who is desperately trying to improve

company while top management pays mere lip

service to ISO 9001.



60/76



Problem 4: Insufficient Resources

MR should be trained

Management allocation enough time

Financial resources

Availability of documents


P bl 5 L k f I


61/76



Problem 5: Lack of Improvement

Common misconception that an QMS needs to

be implemented, certified & thats it.

System must constantly evolve as the company

changes, as the market conditions change & as

technologies improve.


P bl 6 M ki i C li d


62/76



Problem 6: Making it Complicated

Processes System

Unfair practices

Overly bureaucratic



63/76



ISO 14000

ISO 14000 is environmental management system, to

protect environment and to prevent pollution while

taking into account the economic needs of thesociety.

The standard based on the principles of continuous

improvement in environmental performance of a

company.



64/76



Benefits of EMS

1. Assuring customers about environmental commitment of the organization

2. Maintaining good public image and relations

3. Increased brand image and market share

4. Competitive advantage

5. Conservation of scarce resources

6. More exports

7. No legal harassments

8. Increased compliance to statutory requirements

9. Protection to human health

10. Cost effectiveness.



65/76



Cont.

Requirements of ISO 14001

In order to effectively implement and benefit from an ISO 14001 EMS, it is

important to have an understanding of the standard's requirements.

Policies

ISO 14001 requires that the organization have a policy statement to drive theEMS.

Planning

Environmental Aspects

Legal and Other Requirements

Objectives and Targets


P li i


66/76



Policies

A policy statement to drive the EMS.

May be short, one page or less documents &

simply affirm the commitments.

for example: we are committed to prevention

of pollution.

The policy must be clearly endorsed by top

management and be available to the public &

employees.


67/76



68/76



Cont.

Implementation and Operation

Environmental Management Programmes (EMP)

Structure and Responsibility

Training Awareness and Competence

Communications

EMS Documentation

Document Control

Operations Control

Emergency Planning and Response



69/76



Checking and Corrective Action

Monitoring and Measurement

Non-conformance, Corrective, and Preventive Action

Records

EMS Audit



70/76



Cont.

Integrating ISO 14000 and ISO 9000

Implementing ISO 14000 requires huge efforts and it can consume a lot

of time an organization.

But organizations which have successfully implemented ISO 9000

previously may find it easy and this is due to the fact that manyrequirements for ISO 14000 would have already in place.



71/76



Relationship with Health and Safety

ISO 14000 is an environmental management system which aims at

improving environmental management system and it results in improved

work environment.

Improved work environment will always result increased health and

safety to the employees.



72/76



The Capability Maturity Model (CMM) The original Capability Maturity Model (CMM) was developed at

the Software Engineering Institute (SEI) at Carnegie MellonUniversity to support improvements in the reliability of software

development organizations, i.e., their ability to develop quality

software on time and within budget.

It was designed to help developers to select process-improvement

strategies by determining their current process maturity andidentifying the most critical issues to improving their software

quality and process.

The CMM includes a number of key concepts: maturity levels, key

process areas, key practices and common features.

CMM is a software process maturity model. This model attempts to

quantify a software organisations capability to consistently and

predictably produce high-quality software products.



73/76



The Capability Maturity Model (CMM)

CMM is a development model created after study of data

collected from organizations that contracted with the U.S.

Department of Defense, who funded the research. The term

"maturity" relates to the degree of formality and optimization

of processes, from ad hoc practices, to formally defined steps,to managed result metrics, to active optimization of the

processes.

The model's aim is to improve existing

software-development processes, but it canalso be applied to other processes.



74/76



There are five levels defined along the continuum of the model

and, according to the SEI: "Predictability, effectiveness, and

control of an organization's software processes are believed toimprove as the organization moves up these five levels.



75/76



1. Initial (disorganized, ad hoc, individual heroics) - the starting

point for use of a new or undocumented repeat process.

2. Repeatable - the process is at least documented sufficiently

such that repeating the same steps may be attempted.

3. Defined - the process is defined/confirmed as a standard

business process, and decomposed to levels 0, 1 and 2 (the lastbeing Work Instructions).

4. Managed - the process is quantitatively managed in

accordance with agreed-upon metrics.

5. Optimizing - process management includes deliberate processoptimization/improvement.


76/76