Overview of iso 9001

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Project topic-ISO 9001

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Transcript of Overview of iso 9001

Page 1: Overview of iso 9001

Project topic-ISO 9001

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Who is the ISO? International Organization for Standardization is the world's

largest developer of International Standards ISO is a network of the national standards institutes of 162

countries, one member per country ISO is a non-governmental organization that forms a bridge

between the public and private sectors◦ Many of its member institutes are part of the governmental

structure of their countries, or are mandated by their government

◦ Other members have their roots uniquely in the private sector, having been set up by national partnerships of industry associations

This enables ISO to reach a consensus on solutions that meet both the requirements of business and the broader needs of society

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 standard for a general quality-management system.

 maintained by ISO

  administered by accreditation and certification bodies.

What is ISO 9001?

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ISO 9001 is the standard that gives the requirements for a quality management system

ISO 9001:2008 is the latest, improved version

It is the only standard in the ISO 9000 family that can be used for certification

There are 16 other standards in the family that can help an organization on specific aspects such as performance improvement, auditing, training

The ISO 9000 family

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What is in the ISO 9000 Family ISO 9000-1 is a general guideline which gives background

information about the family of standards ISO 9001, ISO 9002, and ISO 9003 are standards in the

family, containing requirements on a supplier ISO 9002 and ISO 9003 are subsets of ISO 9001

◦ ISO 9002 applies when there is no design◦ ISO 9003 applies when there is neither design nor production

ISO 9004 is a comprehensive guideline to the use of the ISO 9000 standards

For software development, ISO 9001 is the standard to use ISO 9000-3 is a guideline on how to use ISO 9001 for

software development ISO 9004-2 is a guideline for the application of ISO 9001 to

the supply of services (including computer centers and other suppliers of data services)

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Overview of ISO 9001

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When was this effort initiated?

• As opposed to ISO 9000 which was introduced in 1987, ISO 9001,ISO 9002, and ISO 9003 were all combined in year 2000 and called ISO 9001:2000.

• ISO 9001 was updated in 2008 and is known as ISO 9001:2008. The changes are considered minor. Companies that seek ISO 9001:2008 certification will be evaluated by the process of examining a sample of their product(s) ,  processes and functions to see if they are compliant.

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ISO 9001 and ISO 14001 are among ISO's most well known standards ever.

They are implemented by more than a million organizations in some 175 countries.

ISO 9001 helps organizations to implement quality management.

Facts about ISO 9001

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The rules are updated as the requirements change over the time.  Some of the requirements in ISO 9001:2008 include:

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a set of procedures that cover all key processes in the business

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

facilitating continual improvement

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The ISO Survey

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ISO 9001 is for quality managementQuality refers to all those features of a

product (or service) which are required by the customer

Quality management means what the organization does to ensure that its products or services satisfy the customer's quality requirements

and comply with any regulations applicable to those products or services.

Quality Management

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Quality management also means what the organization does to enhance customer satisfaction

and achieve continual improvement of its performance.

Quality Management (contd)

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ISO9000quality models

OrganizationQuality manuals

Project 1Quality plan

Project 2Quality plan

Project 3Quality plan

Organizationquality process

Project qualitymanagement

is instantiated as

Is used to develop

For assessment

supports

ISO 9000 and Quality Management

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Generic standards

ISO 9001 and ISO 14001 are generic standards.

Generic means that the same standards can be applied:

to any organization, large or small, whatever its product or service,

in any sector of activity, and

whether it is a business enterprise, a public administration, or a government department.

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Generic standards (cont.)

Generic also signifies that no matter what the organization's scope of

activity

if it wants to establish a quality management system, ISO 9001 gives the essential features

or if it wants to establish an environmental management system, ISO 14001 gives the essential features.

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Processes, not products ISO 9001 concern the way an organization

goes about its work◦ Its not a product standard◦ Its not a service standard◦ It’s a process standard

It can be used by product manufacturers and service providers.

Processes affect final products or services. ISO 9001 gives the requirements for what the

organization must do to manage processes affecting quality of its products and services

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International, expert consensus on state-of-the-art practices for quality and environmental management

Common language for dealing with customers and suppliers worldwide

Increase efficiency and effectiveness

Model for continual improvement

Benefits of ISO 9001

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Model for satisfying customers and other stakeholders

Build quality into products and services from design onwards

Address environmental concerns of customers and public, and comply with government regulations

Integrate with global economy

Benefits of ISO 9001 (contd)

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Sustainable business

Unifying base for industry sectors

Qualify suppliers for global supply chains

Technical support for regulations

Benefits of ISO 9001 (contd)

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What are the main/unique features of this approach?

The main features of the ISO9000 family of standards are:

• The ISO9000 family of standards constitute a quality management system and form an effective management tool.

• It is a top-down management system that defines responsibility and activates the organization.

• WHAT is a requirement, but HOW is a decision taken by the organization. It respects the autonomy of the organization and is a tool that allows the organization to individual expression.

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1. GeneralThis International Standard specifies requirements for a

qualitymanagement system where an organisation a) needs to demonstrate its ability to consistently provide

product that meets customer and applicable statutory and regulatory requirements, and

b) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.

Note 1 In this International Standard, the term “product” only applies to

c) product intended for , or required by, a customerd) any intended output resulting from the product realization processesNote 2 Statutory and regulatory requirements can be expressed as

legal requirements

Scope

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All requirement of this international Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided. Where any requirement(s) of this International Standard can not be applied due to the nature of an organization and its product, this can be considered for exclusion.

Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.

2. Application

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What relationship, similarities,or differences does this have with other approaches?

• The ISO 9000/9001 is unique in the sense that it focuses mainly on quality management and is sometimes required by purchasers in order sell their products focusing on many principles that have financial benefits to a company.

• The ISO 9000/9001 standard separates itself from other standards such as the ISO 12207 and ISO 15504 such that these standards focus on structures, modularity/flexibility and independent activities of a software process.

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What is our opinion of this approach?

• The ISO 9000/9001 approach is certainly an industry fail-safe management system for most companies to use. The primary reason for this is because is becoming almost a necessary to sell software products.

• The ISO 9000/9001 has also been a proven quality

management tool over the year and as stated previously, used be many different companies.

• Comparatively to the other standards, ISO 9000/9001 is one of

the most robust quality management tools. Companies would greatly benefit from financially over the long term.

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A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered." Certification to an ISO 9001standards does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied

Our views

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Thank you