Overview of iso 9001
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The ISO is the world's largest developer of international standards and has 162 member countries. ISO standards like ISO 9001 provide requirements for quality management systems to help organizations ensure their products and services meet customer and regulatory requirements. ISO 9001 certification requires an organization to establish processes covering key business areas, monitor effectiveness, and facilitate continual improvement.
Overview of iso 9001
- 2. 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
- 3. standard for a general quality-management system. maintained by ISO administered by accreditation and certification bodies.
- 4. 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
- 5. 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)
- 7. • 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.
- 8. 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.
- 9. The rules are updated as the requirements change over the time. Some of the requirements in ISO 9001:2008 include:
- 10. 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
- 12. ISO 9001 is for quality management Quality 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.
- 13. Quality management also means what the organization does to enhance customer satisfaction and achieve continual improvement of its performance.
- 14. ISO9000 quality models is instantiated as Organization quality process Organization Quality manuals For assessment Is used to develop Project 1 Quality plan Project 2 Quality plan supports Project 3 Quality plan Project quality management
- 15. 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.
- 16. 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.
- 17. 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
- 18. International, expert consensus on state-ofthe-art practices for quality and environmental management Common language for dealing with customers and suppliers worldwide Increase efficiency and effectiveness Model for continual improvement
- 19. 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
- 20. Sustainable business Unifying base for industry sectors Qualify suppliers for global supply chains Technical support for regulations
- 21. 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.
- 22. 1. General This International Standard specifies requirements for a quality management 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 a) product intended for , or required by, a customer b) any intended output resulting from the product realization processes Note 2 Statutory and regulatory requirements can be expressed as legal requirements 22
- 23. 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. 23
- 24. • 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.
- 25. • 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.
- 26. 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