CHAPTER 8 :Quality Standards

ContentsContents

• Commonly applied in industries and management:

ISO 9000ISO 9000ISO 14000

ISOISO

• ISO is a name used for the International Organization for Standardization

• The ISO was formed in 1947 in Geneva, SwitzerlandSwitzerland

ISO 9000ISO 9000

• ISO 9000 is an international quality standard for goods and services.

• Aim of ISO;– Historically: To ensure that the product or – Historically: To ensure that the product or

services provided by registered organizations are consistently fit for their intended purposes.

– New aim: To enable organizations to better serve their customers and be more competitive

• ISO 9000 does not set any specifications for quality. • Rather, it sets broad requirements for the insurance

of quality and for management’s involvement.• More on prevention rather than inspection and

ISO 9000ISO 9000

• More on prevention rather than inspection and rework.

• ISO 9000 is about standardizing the approach organizations everywhere take to managing and improving the processes that ultimately result in their product and services.

Benefits That Registered Organizations Can Enjoy from ISO 9000

• Wider Customer Acceptance of products and services.

• Improved effectiveness and reliability of its process.process.

• Improved Quality of products and services.• Improved Organizational performance and

competitiveness.

• ISO 9000 is a European Standard• The organization has two stated objectives:

1. To promote development of standardization to facilitate international

ISO 9000ISO 9000

1. To promote development of standardization to facilitate international exchange of goods and services.

2. To promote cooperation in intellectual, scientific, technological, and economic activity.

What are the parts of ISO 9000?What are the parts of ISO 9000?

• ISO 9000 is composed of 5 different, but related parts:

ISO 9000ISO 9001ISO 9002ISO 9002ISO 9003ISO 9004

• ISO 9000 and 9004 are only guidelines, • ISO 9001, 9002, and 9003 are the categories in

which a company may apply for certification

ISO 9000, Quality management systems Fundamentals and vocabulary.

• Covers the basics of what quality management systems are

• Contains the core language of the ISO 9000 series of standards.

• A guidance document, not used for certification • A guidance document, not used for certification purposes, but important reference document to understand terms and vocabulary related to quality management systems.

• In the year 2005, revised ISO 9000:2005 standard has been published, so it is now advised to refer to ISO 9000:2005.

ISO 9001:2008ISO 9001:2008

• Published on November 14th 2008• new version of ISO 9001 (ISO 9001:2008), the

world's most widely used quality management system standard.

• The changes are small and fairly insignificant • The changes are small and fairly insignificant • Few changes being required to most organizations

management systems. • This is the first change that has been made since the

2000 version was published.

• Model for Quality Assurance in design/Development, Production, Installation, and Servicing”

• This is the category for companies which are involved in manufacturing or the creation and delivery of a service.

ISO 9001:2008 ISO 9001:2008 Quality management systems Quality management systems —— RequirementsRequirements

service.• A formal statement from management, closely linked

to the business and marketing plan and to customer needs.

• The quality policy is understood and followed at all levels and by all employees.

What ISO9001 What ISO9001 requires from companies? requires from companies? –– a summarya summary

• Decisions about the quality system are made based on recorded data

• The system is regularly audited and evaluated for conformance and effectiveness

• Records should show how and where raw materials • Records should show how and where raw materials and products were processed, to allow products and problems to be traced to the source

• Review performance through internal audits and meetings

• Need documented procedures for dealing with actual and potential nonconformances

ISO 9001:2008ISO 9001:2008

Some of the requirements in ISO 9001 (one of the standard is ISO 9000) are;• A set of procedures that cover all key processes in

the business; • Monitoring processes to ensure they are effective; • Monitoring processes to ensure they are effective; • Keeping adequate records; • Checking output for defects, with appropriate and

corrective action where necessary; • Regularly reviewing individual processes and the

quality system itself for effectiveness; and • Facilitating continual improvement

• Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being appliedbusiness processes are being applied

• ISO 9002: “Quality Systems – Model for Quality Assurance in Production and Installation”

• Companies who perform many functions,

ISO 9002ISO 9002

• Companies who perform many functions, with the exception of design and development, may apply to this category

• ISO 9003: “Quality Systems – Model for Quality Assurance in Final Inspection and Test”

• This category is useful for outside of the

ISO 9003ISO 9003

• This category is useful for outside of the manufacturing sector, such as in distributors

• ISO 9003 is being used less and may be dropped in the future

• E.g – distributors, warehouses

• ISO 9004: “Quality Management and Quality System Elements – Guidelines”

• Used in order to help interpret the categories

ISO 9004ISO 9004

• Used in order to help interpret the categories included in ISO 9000 certification

ISO 9004:2000 Quality management systemsISO 9004:2000 Quality management systemsGuidelines for performance improvementsGuidelines for performance improvements

• Covers continual improvement. • Advice on what do to enhance a mature

system. system.

Comparative Scope of ISO 9000 and Total Comparative Scope of ISO 9000 and Total Quality ManagementQuality Management

• Total Quality Management is the organization wide management of quality. Management consists of planning, organizing, directing, control, and assurance.

• TWO principal quality initiatives are;› ISO9000› Total Quality Management› Total Quality Management

• There are some relationship between these two.› ISO 9000 and TQM are not interchangeable (not same).› ISO 9000 is compatible and is a subset of TQM› ISO 9000 is frequently implemented in a non-TQM

environment› ISO 9000 may be redundant in a mature TQM environment.› ISO 9000 and TQM are not in competition.

Total Quality Management Characteristics Total Quality Management Characteristics Compared with ISO 9000Compared with ISO 9000

Characteristics of TQM ISO 9000:2000 TQMCustomer Focus (Internal and External) ! !Obsession with Quality !Scientific approach to problem solving ! !Long-term commitment partial !Long-term commitment partial !Teamwork !Continual Process and Product Improvement

! !

Education and Training Intensive ! !Freedom through Control !Unity of Purpose ! !Employee involvement and empowerment partial !

• The primary difference between ISO9000: 2000 and TQM is in the degree to which the total organization is involved.– TQM requires the involvement of all

functions and levels of the organization.

Compatibility of ISO 9000 and Total Compatibility of ISO 9000 and Total Quality Quality

• ISO 9000 is compatible with and can be viewed as a subset of TQM.

• Organizations that already apply TQM in a mature level can find it easy to implement ISO 9000. ISO 9000.

• Because TQM has its top-management commitment, documented processes and procedures, continuous improvement, obsession with quality etc.

• This means, TQM requires everything required by ISO 9000.

• No international certification for TQM.• So, even a mature TQM organization may

find it necessary to seek ISO 9000 to satisfy demands of its customers.demands of its customers.

• On the other hand, traditional organization that is registered under ISO 9000 may find it needs the larger TQM to stay competitive.

Movement from ISO 9000 to TQM Movement from ISO 9000 to TQM and vice versaand vice versa

• An organization that has its process documented and under control, such as a company involved in TQM, should find it relatively easy to prepare for ISO 9000relatively easy to prepare for ISO 9000

• Company that already have ISO 9000 can have an advance start towards TQM.

Pollution COST!

ISO14000 - introduction

• Most managers will try to avoid pollution – can cost the company a fine for infringing environmental legislation.

• Better managers - doing only just enough to

ISO 14000ISO 14000

• Better managers - doing only just enough to keep the company out of trouble is a rather weak and reactive approach

• The ISO 14000 standards are practical tools for the manager who is not satisfied with mere compliance with legislation – which may be perceived as a cost of doing business.

ISO 14000ISO 14000

• For the proactive manager with the vision to understand that implementing a strategic approach can bring return on investment in environment-related measures.

• A standard for environmental management systems

• The aim - to reduce the environmental to reduce the environmental footprint (effects) footprint (effects) of a business and to

ISO 14000ISO 14000

footprint (effects) footprint (effects) of a business and to decrease the pollution and waste decrease the pollution and waste a business produces

• Also to help organizations minimize how their operations negatively affect the environment

ISO 14000ISO 14000

• Applicable to all types of organization, large or small, whether in the private or public sectors.

• Benefits:– reduced cost of waste management– savings in consumption of energy and materials– savings in consumption of energy and materials– lower distribution costs– improved corporate image among regulators,

customers and the public– outline for continual improvement of

environmental performance.

In briefIn brief

ISO 9000 family ISO 14000 family

•The ISO 9000 family addresses "Quality management".

•This means what the organization does to fulfill:

•The ISO 14000 family addresses "Environmental management".

•This means what the organization does to fulfill:• the customer's quality requirements, • applicable regulatory requirements, • enhance customer satisfaction, • achieve continual improvement of its performance in pursuit of these objectives.

•This means what the organization does to:

• minimize harmful effects on the environment caused by its activities, and to• achieve continual improvement of its environmental performance.

Additional infoAdditional info

• SIRIM QAS International is Malaysia’s leading certification, inspection and testing body.

MS ISO 9001:2008

• MS 1900 : 2005 - Quality management systems - Requirements from Islamic perspectives

Malaysian Standard

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