QUALITY MANAGEMENT SYSTEMS

&
STANDARDS
Management Systems
What the organization does to manage its processes, or activities in order
that
• its products or services meet the organization’s objectives, such as
• satisfying the customer's quality requirements,
• complying to regulations, or
• meeting environmental objectives
• to be really efficient and effective, the organization can manage its way of doing
things by systemizing it.
• everyone is clear about who is responsible for doing what, when, how, why and
where.
• management system standards provide the organization with an international,
state-of-the-art model to follow.
 What is a Quality Management System?
 Policies
 Processes
 Procedures

Required for planning and executing business

processes to meet customer requirements

• ISO 9001:2008 is an example

Quality Standard
A document that provides requirements, specifications, guidelines or
characteristics that can be used consistently to ensure that materials,
products, processes and services are fit for their purpose.
• Provide world-class specifications for products / services
• Guidance for implementing a quality system for the first time.
• Used for assessing the quality system already in place.
• Creating quality assurance requirements
• Breaking down barriers to international trade and open up global
markets
• Conformity to Standards helps reassure consumers that products are
safe, efficient and good for the environment.
Generic Standard
Set by national and international quality certification bodies
Applicable to any organization, producing any product or service, in any
sector of activity.
whether it is a business enterprise, a public administration, or a
government department

Industry Related Standard

Standards specific to a particular industry e.g. Defence, Aerospace,
Nuclear industry
CMM by Software Engineering Institute, Carnegie Mellon University
ISO 9001 and ISO 14001
• ISO 9001 & ISO 14001 are ISO's most well known standards ever.
• Implemented by > a million organizations in some 175 countries.
• ISO 9001 helps organizations to implement a quality management
system and gives the essential features
• ISO 14001 helps organizations to implement environmental
management system and gives the essential features.
• Both ISO 9001 & and ISO 14001 standards are not product or service
standards.
• They are process standards.
• ISO 9001 gives the requirements for what the organization must do to
manage processes affecting quality of its products and services.

• ISO 14001 gives the requirements for what the organization must do
to manage processes affecting the impact of its activities on the
environment.
 International Organization for Standardization

ISO was founded in 1946 in Geneva, Switzerland

'International Organization for Standardization'
would have different acronyms in different languages (IOS in English, OIN in
French for Organisation Internationale de Normalisation).
ISO is an independent, non-governmental membership organization and the
world’s largest developer of voluntary international standards
Comprises of 163 member countries, 3368 technical bodies to take care of
standard development.
Published over 19,500 International Standards covering almost all aspects of
technology and manufacturing.
 International Organization for Standardization
• ISO Series ….. set of international standards on quality management and Quality
assurance that are critical to international business
• Requires firms to document every thing they do that affects the quality of goods and
services.
• Document every step (incoming raw materials, product design, in-process monitoring
and so forth) to be able to identify those areas that are causing quality problems and
correct them.
• When an organization feels that its quality system is good enough, it may ask for
assessment.
• The audit begins with a review of the company's quality manual. The audit team
checks to see that the documented quality system meets the requirement of ISO 9000
and that the organization is practicing what is documented.
• When the registrar is satisfied with the recommendation of the audit team, it issues a
registration document to the company.
 ISO Standards Development
ISO does not decide when to develop a new standard. ISO responds to a
request from industry / stakeholders such as consumer groups or an industry
sector who communicates the need for a standard to its national member
who then contacts ISO.
Standards developed by groups of experts who are part of larger groups
called technical committees. These experts negotiate all aspects of the
standard, including its scope, key definitions and content.
The technical committees are made up of experts from the relevant industry,
but also from consumer associations, academia, NGOs and government.
Developing ISO standards is a consensus-based approach and comments
from stakeholders are taken into account.
ISO 9001 Requirements : 4. Quality Management System
4.1 General requirements : Organization shall establish, document,
implement and maintain a QMS and continually improve its effectiveness.
(a) determine the processes needed for QMS, their application sequence and
interaction of the processes
(b) determine criteria throughout the organization
(c) determine methods for effective operation and control of these processes
(d) ensure availability of resources & information necessary to support / monitor
these processes
(e) monitor, measure and analyse these processes,
(f) implement actions to achieve planned results and continual improvement of
these processes. Outsourced processes that affect the quality of the product
shall be identified and included in the system
ISO 9001 Requirements : 4. Quality Management System
4.2 Documentation
4.2.1 General Documentation shall include
(a) Quality policy and Quality objectives
(b) Quality manual
(c) required documented procedures and records
(d) documents to ensure effective planning, operation, and control of processes
Extent of the documentation will depend on the organization's size and type of activities; the
complexity of the processes and their interactions; and the competency of the employees.

4.2.2 Quality Manual: Shall be established and maintained that includes

• the scope of the QMS with details and justification for any exclusions
• the documented procedures or reference to them
• a description of the interaction among the QMS processes.
ISO 9001 Requirements : 4. Quality Management System
4.2.3 Control of Documents: Documents required by the QMS shall be controlled & a
procedure shall be in place to define the controls needed to :--
(a) identify the current revision status
(b) ensure that current versions are available at the point of use
(c) ensure that documents are legible and readily identified
(d) prompt removal of obsolete documents
4.2.4 Control of Records :
• Records provide evidence of effective operation of QMS.
• A documented procedure for the identification, storage, protection, retrieval,
retention and disposition of the records.
• Records can be used to document traceability and to provide evidence of verification,
preventive action, and corrective action.
 ISO 9001 Requirements : 5. Management Responsibility

5.1 Management Commitment : Top management shall provide evidence of its

commitment to the development, implementation, and continual improvement of the
QMS by

(a) communicating the need to meet customer, legal, and regulatory requirements
(b) establishing a quality policy
(c) ensuring that quality objectives are established
(d) conducting management reviews
(e) ensuring the availability of resources.
 ISO 9001 Requirements : 5. Management Responsibility
5.2 Customer Focus

5.3 Quality Policy : The quality policy gives the overall intention and direction of
the organization related to quality.
(a) is appropriate to the organization's purpose or mission
(b) includes a commitment to comply with requirements and continually improve the
effectiveness of the QMS
(c) provides a framework for establishing and reviewing the quality objectives
(d) is communicated and understood within the organization
(e) is reviewed for continuing stability.
 ISO 9001 Requirements : 5. Management Responsibility
5.4 Planning
5.4.1 Quality Objectives
established at relevant functions and levels within the organization and include
product requirements.
Measurable and consistent with the quality policy.
Ensure that customer expectations are met
For example, finishing department scrap will be reduced from 5.0% to 4.3% and the first line
supervisor is the person responsible.

5.4.2 Quality Management System Planning Top management shall ensure that the
planning of the QMS is accomplished in order to meet the requirements of the QMS
 ISO 9001 Requirements : 5. Management Responsibility
5.5 Responsibility, Authority & Communication
5.5.1 Responsibility & Authority ….. Are defined and communicated within the
organization. Responsibilities can be defined in job descriptions, procedures, and work
instructions. Authorities and interrelationships can be defined in an organization chart.
5.5.2 Management Representative ….. Top management shall appoint a member of
organization's manager who shall have the responsibility and authority to ensure :--

(a) Processes for the QMS system are established, implemented, maintained
(b) Reports to top management on the performance of the QMS
(c) Any need for improvement
(c) Promoting awareness of customer requirements throughout the organization.
 ISO 9001 Requirements : 5. Management Responsibility
5.5 Responsibility, Authority & Communication
5.5.3. Internal Communication …..

Top management shall ensure that appropriate communication channels are

established within the organization and that communication takes place
regarding the QMS.

• Management workplace briefing

• Recognition of achievement
• Bulletin boards
• e-mails and in-house news brochures.
 ISO 9001 Requirements : 5. Management Responsibility
5.6 MANAGEMENT REVIEW
5.6.1. General ……… review the QMS at planned intervals to ensure its continuing
suitability, adequacy & effectiveness. It shall include assessing opportunities for
improvement, need for changes to the QMS including the quality policy and quality
objectives. Records from the review shall be maintained.
5.6.2. Review Input …….

(a) results of audits

(b) customer feedback
(c) process performance and product conformity
(d) status of corrective and preventative performance
(e) follow-up actions from previous management reviews
(f) changes that could affect the QMS
(g) recommendations for improvement.
 ISO 9001 Requirements : 5. Management Responsibility
5.6 MANAGEMENT REVIEW

5.6.3 Review Output ……. any decisions and actions related to

(a) improvement of the effectiveness of the QMS and its processes

(b) improvement of the product related to customer requirements
(c) resource needs.

Top management can use the outputs as inputs to improvement opportunities.

 ISO 9001 Requirements : 6. Resource Management
6.1. Provision of Resources ………
(a) to implement and maintain the QMS and continually improve its effectiveness
(b) to enhance customer satisfaction by meeting customer requirements.

6.2. Human Resources

6.2.1 General …. Personnel performing work that affects conformity to product
requirements shall be competent on the basis of appropriate education, training, skills,
and experience.
6.2.2. Competence, Training, and Awareness
• Current competence
• Provide training or take other actions to achieve the necessary competence
• Evaluate the effectiveness of the actions taken
• Ensure personnel are aware of the relevance and importance of their
activities and how they contribute to the achievement of the quality objectives
• Maintain appropriate records of education, training skills, and experience
 ISO 9001 Requirements : 6. Resource Management
6.3. Infrastructure ………
• Buildings, workplace associated utilities
• Process equipment (both hardware and software)
• Supporting Services (such as transport, communication or information systems).

6.4 Work Environment ….. conditions under which work is performed including
physical, environmental and other factors (such as noise, temperature, humidity, lighting
and weather).

The organization shall determine and manage the work environment needed to achieve
conformity to product requirements.

Creation of a suitable work environment can have a positive influence on employee

motivation, satisfaction, and performance.
 ISO 9001 Requirements : 7. Product Realization
7.1 Planning of Product Realization … the organization shall determine the following,
as appropriate:

(a) quality objectives and requirements for the product

(a) establish processes and documents, and to provide resources specific to the product

(b) required verification, validation, monitoring, measurement inspection, and test

activities specific to the product and the criteria for product acceptance

(c) records needed to provide evidence that the realization processes and resulting
product or service meet requirements
 ISO 9001 Requirements : 7. Product Realization
7.2 Customer Related Processes

7.2.1 Determination of Requirements Related to the Product …..

(a) requirements specified by the customer, including requirements for

delivery and post-delivery activities
(b) requirements not stated by the customer but necessary for specified or
intended use, where known
(c) statutory and regulatory requirements applicable to the product
(d) any additional requirements considered necessary by the organization.
 ISO 9001 Requirements : 7. Product Realization
7.2 Customer Related Processes
7.2.2 Review of Requirements Related to the Product …… conducted prior to the
organization's commitment to supply product to the customer
(a) product requirements are defined
(b) Contract / order requirements differing from those previously expressed are resolved
(c) the organization has the ability to meet the defined requirements.

7.2.3 Customer Communication ….. The organization shall determine and implement
effective arrangement for communicating with customers in relation to

(a) product information

(b) inquiries, contracts, or order handling, including amendments
(c) customer feedback, including customer complaints.
 ISO 9001 Requirements : 7. Product Realization
7.3 Design & development
7.3.1 Design and Development Planning. The organization shall determine
(a) Design and development stages

(b) Verification & validation appropriate to each design & development stage

(c) the responsibilities and authorities for design and development.

(d) Manage the interfaces between different groups involved in design and
development to ensure effective communication and clear assignment of
responsibility.
 ISO 9001 Requirements : 7. Product Realization
7.3 Design & development

7.3.2 Design and Development Inputs Inputs relating to product requirements

shall be determined and records maintained. These shall include

(a) functional and performance requirements

(b) applicable statutory and regulatory requirements
(c) where applicable, information derived from previous similar designs,
(d) other requirements essential for design and development.

The inputs shall be reviewed for adequacy. Requirements shall be complete,

unambiguous and not in conflict with each other.
 ISO 9001 Requirements : 7. Product Realization
7.3 Design & development

7.3.3 Design and Development Outputs The outputs of design and development
shall be in a form suitable for verification against the design and development input and
shall be approved prior to release.

Design and development outputs shall

(a) meet the input requirements for design and development
(b) provide appropriate information for purchasing, production, and service provision
(c) contain or reference product acceptance criteria
(d) specify characteristics of the product that are essential for its safe and proper use.
 ISO 9001 Requirements : 7. Product Realization
7.3 Design & development

7.3.4 Design and Development Review At suitable stages, systematic reviews of

design and development shall be performed in accordance with planned arrangements

(a) evaluate adequacy of results of design and development to meet requirements

(b) identify any problems and propose necessary actions.
(c) Participants in such reviews shall include representatives of functions concerned with
the design and development stage(s) being reviewed.

Risk assessment such as FMEA, reliability prediction, and simulation techniques can be
undertaken to determine potential failures in products or processes.
 ISO 9001 Requirements : 7. Product Realization
7.3 Design & development

7.3.5 Design and Development Verification

7.3.6 Design and Development Validation

7.3.7 Control of Design and Development Changes

 ISO 9001 Requirements : 7. Product Realization
7.4 PURCHASING

7.4.1 Purchasing Process

Purchased product conforms to specified purchase requirements.
Evaluate and select suppliers based on their ability to supply product in accordance with
the organization's requirements
Criteria for selection, evaluation, and re-evaluation shall be established.

7.4.2 Purchasing Information Purchasing information shall describe the product to be

purchased, including :--
(a) requirements for approval of product, procedures, processes, and equipment
(b) requirements for qualification of personnel
(c) QMS requirements.

7.4.3 Verification of Purchased Product

 ISO 9001 Requirements : 7. Product Realization
7.5 PRODUCTION AND SERVICE PROVISION
7.5.1 Control of Production and Service Provision
7.5.2 Validation of Processes for Production and Service Provision
7.5.3 Identification and Traceability
7.5.4 Customer Property
7.5.5 Preservation of Product
• Specifying characteristics of the product
• Availability of work instructions
• Approval for and use of suitable equipment
• Approval of and qualification of personnel
• Use of specific methods and procedures
• Requirements for records
• Defined criteria for review and approval of the processes
• Availability and use of monitoring and measuring equipment
• Implementation of monitoring and measurement
• Implementation of product release, delivery, and post-delivery activities.
 ISO 9001 Requirements : 7. Product Realization

7.6 CONTROL OF MONITORING AND MEASURING EQUIPMENT

• Determine the monitoring and measurement to be undertaken

• Monitoring and measuring equipment needed to provide evidence of
conformity of product to determined requirements.
• Establish processes to ensure that monitoring and measurement can be
carried out
• Establish processes to ensure that monitoring and measurement are carried
out in a manner that is consistent with the monitoring and measurement
requirements.
 ISO 9001 Requirements : 8. Measurement, Analysis & Improvement
8.1 General ……. Plan and implement the monitoring, measurement, analysis, and
improvement processes to demonstrate conformity to product requirements
8.2 Monitoring and Measurement
8.2.1 Customer Satisfaction ..… customer satisfaction surveys, customer data on
delivered product quality, user opinion surveys, lost business analysis, compliments,
warranty claims and dealer reports
8.2.2 Internal Audit
8.2.3 Monitoring and Measurement of Processes
8.2.4 Monitoring and Measurement of Product and Service
8.3 Control of nonconforming product
ISO 9001 Requirements : 8. Measurement, Analysis & Improvement
8.4 ANALYSIS OF DATA

8.5 IMPROVEMENT

8.5.1 Continual Improvement

8.5.2 Corrective Action
8.5.3 Preventive Action
Ten Steps to ISO Registration
10. Registration!

9. Final assessment by registrar

8. Take corrective actions

7. Pre-assessment by registrar

6. Submit quality manual for approval

5. Perform self-analysis audit

4. Select a third-party registrar and apply

3. Develop and implement the quality system

2. Select the appropriate standard

1. Set the registrationISO

objective
9000
 Quality Awards

Baldrige Award

Deming Prize
MALCOLM BALDRIGE NATIONAL QUALITY AWARD

Named after Malcolm Baldrige

Created by Public Law 100-107, signed on August 20, 1987

First introduced in 1988

Award are made annually to U.S. companies that excel in

quality management and quality achievement.
OBJECTIVES/GOALS
To help companies improve quality and productivity

To recognize achievements

To establish guidelines and criteria

To provide guidance to other organization

 Malcolm Baldrige National Quality Award

1 Leadership (120 points)

2 Strategic Planning (85 points)
3 Customer and Market Focus (85 points)
4 Measurement, Analysis & Knowledge Management (90 points)
5. Human Resource Development and Management (85 points)
6 Process Management (85 points)
7 Business Results (450 points)

TOTAL = 1000
 1. Leadership (120 pts.)

Addresses Senior Leaders’ Roles, Governance, and Citizenship

1.1 Organizational Leadership (70 pts.)

1.2 Social Responsibility (50 pts.)
 2. Strategic Planning (85 pts.)

Addresses Strategic and Action Planning and Deployment of Plans

2.1 Strategy Development (40 pts.)

2.2 Strategy Deployment (45 pts.)

 3. Customer and Market Focus (85 pts.)

How an Organization Seeks Knowledge, Satisfaction & Customer Loyalty

3.1 Customer and Market Knowledge (40 pts.)

3.2 Customer Relationships and Satisfaction (45 pts.)

4. Measurement, Analysis & Knowledge Management (90 pts.)

Analysis and Management of Data,Information, and Knowledge Assets

4.1 Measurement and Analysis of Organizational Performance (45 pts.)

4.2 Information and Knowledge Management (45 pts.)

 5. Human Resource Focus (85 pts.)
Addresses Key Human Resource Practices

5.1 Work Systems (35 pts.)

5.2 Employee Learning and Motivation (25 pts.)

5.3 Employee Well-Being and Satisfaction (25 pts.)

 6. Process Management (85 pts.)

Addresses Key Work Processes and Process Management

6.1 Value Creation Processes (50 pts.)

6.2 Support Processes (35 pts.)

 7. Business Results (450 pts.)
Addresses Progress on Results—Including Levels, Trends, and
Comparative Data
7.1 Customer-Focused Results (75 pts.)
7.2 Product and Service Results (75 pts.)
7.3 Financial and Market Results (75 pts.)
7.4 Human Resource Results (75 pts.)
7.5 Organizational Effectiveness Results (75 pts.)
7.6 Governance and Social Responsibility Results (75 pts.)
 The Deming Prize

• Honoring W. Edwards Deming

• Japan’s highly coveted award
• Main focus on statistical quality control Deming
Prize
 Purpose
To recognize those who excelled in quality control and as a way of
driving quality control.

It was also established to thank Dr. Deming for his accomplishments

and impact in the Japanese industry.

Bring out competition in companies to try to receive the award and as

well and improving quality.
 Deming Prize Concentrates on :

• Purpose • Planning for future

• Organization and • Education and training
operations • Quality assurance
• Collection and use of • Quality effects
information
• Standardization
• Analysis
• Control
 Categories of the Deming prize
The Deming Prize for Individuals
The Deming Distinguished Service
Award for Dissemination and
Promotion (Overseas)
The Deming Application Prize
For individuals or groups
For outstanding contributions to the study of TQM or
statistical methods used for TQM, or those who have made
outstanding contributions in the dissemination of TQM
For individuals whose primary activities are outside Japan
Given to individuals who have made outstanding
contributions in the dissemination and promotion of TQM.
Examination will be carried out every 3-5 years.
For organizations such as companies, institutes, divisions of
organizations, operational business units and headquarters
office (organization, hereafter)
An annual award presented to a company that has achieved
distinctive performance improvements through the
application of Companywide Quality Control (CWQC)
 Comparison of the Deming Prize and Baldrige Award
Topic Baldrige Award Deming Prize
Consideration less concerned concern for productivity, delivery,
safety, and environment
Information heavily concerned less concerned
Management
Winners Maximum of two per All firms meeting standard
category
Scope U.S. firms only Firms for any country
Applications $2500 and 75 pages packet 1000 pages and one year working
with consultant from the union of
Japanese Scientist & Engineers
Grading time six months one year
First Award 1987 1951
Sponsor National Institutes Standards Union of Japanese Scientists and
and Technology Engineers
THANK YOU