iso 9001

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www.iso.org International Organization for Standardization www.iso.org International Organization for Standardization

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Overview of ISO 9001 By Vikas B. Senjaliya First year M.pharm (Quality Assurance) Shree Devi college of pharmacy 22-08-2011

ISO 9001 in brief: 

ISO 9001 in brief 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. ISO 14001 helps organizations to implement environmental management .

Need for 9000: 

Need for 9000 To the quality terms and definitions used by industrialized nations and terms to demonstrate a supplier’s capability of controlling it’s process.

Quality management : 

Quality management 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.

Quality management (cont.): 

Quality management (cont.) Quality management also means what the organization does to enhance customer satisfaction , and achieve continual improvement of its performance.

Principles of ISO 9000:2000: 

Principles of ISO 9000:2000 1. Focus on your customers. It must understand customer needs. It must meet customer requirement. It must exceed customer expectations. 2. Provide leadership Leaders must establish a unity of purpose & set the direction the organization should take. Leaders must create an environment that encourages people to achieve the organization’s objectives. 3. Involve your people It must encourage the involvement of people at all levels. It must help people to develop & use their abilities.

Principles (cont.): 

Principles (cont.) 4. Use a process approach It must use a process approach to manage activities & related resources. 5. Take a systems approach It must identify interrelated process & treat as a system. It must use a systems approach to manage their interrelated processes. 6. Encourage continual improvement It must take a permanent commitment to continually improve their overall performance.

Principles (cont.): 

Principles (cont.) 7. Get the facts before you decide It must base decisions on the analysis of factual information & data. 8. Work with suppliers It must maintain a mutually beneficial relationship with their suppliers.

Generic standards : 

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.

Generic standards (cont.): 

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.

Management systems : 

Management systems Management system means 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

Management systems : 

Management systems To be really efficient and effective, the organization can manage its way of doing things by systemizing it. Nothing important is left out. 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.

Management systems (cont.): 

Management systems (cont.) Large organizations, or ones with complicated processes, could not function well without management systems. Companies in such fields as aerospace, automobiles, defence, or health care devices have been operating management systems for years. The ISO 9001 and ISO 14001 management system standards now make these successful practices available for all organizations .

Processes, not products : 

Processes, not products Both ISO 9001 and ISO 14001 concern the way an organization goes about its work . They are not product standards. They are not service standards. They are process standards. They can be used by product manufacturers and service providers .

Processes, not products (cont.): 

Processes, not products (cont.) 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.

Certification and registration: 

Certification and registration Certification is known in some countries as registration . It means that an independent, external body has audited an organization's management system and verified that it conforms to the requirements specified in the standard (ISO 9001 or ISO 14001). ISO does not carry out certification and does not issue or approve certificates,

Accreditation: 

Accreditation Accreditation is like certification of the certification body. It means the formal approval by a specialized body - an accreditation body - that a certification body is competent to carry out ISO 9001:2008 or ISO 14001:2004 certification in specified business sectors. Certificates issued by accredited certification bodies - and known as accredited certificates - may be perceived on the market as having increased credibility. ISO does not carry out or approve accreditations.

Certification not a requirement: 

Certification not a requirement Certification is not a requirement of ISO 9001 or ISO 14001. The organization can implement and benefit from an ISO 9001 or ISO 14001 system without having it certified. The organization can implement them for the internal benefits without spending money on a certification programme.

Certification is a business decision: 

Certification is a business decision Certification is a decision to be taken for business reasons : if it is a contractual, regulatory, or market requirement, If it meets customer preferences it is part of a risk management programme, or if it will motivate staff by setting a clear goal.

ISO does not certify: 

ISO does not certify ISO does not carry out ISO 9001 or ISO 14001 certification . ISO does not issue certificates. ISO does not accredit, approve or control the certification bodies. ISO develops standards and guides to encourage good practice in accreditation and certification.

The ISO 9000 family: 

The ISO 9000 family 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 Survey : 

The ISO Survey

The ISO Survey (cont.): 

The ISO Survey (cont.) The worldwide total of certificates to ISO 9001:2001 at the end of 2007 was 951 486. This was increase of 6 % over 2006 when the total was 896 929 certificates. Certificates had been issued in 175 countries compared to 170 the previous year.

Benefits of ISO 9001 and ISO 14001: 

Benefits of ISO 9001 and ISO 14001 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 and ISO 14001 (cont.): 

Benefits of ISO 9001 and ISO 14001 (cont.) 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 and ISO 14001 (cont.): 

Benefits of ISO 9001 and ISO 14001 (cont.) Sustainable business Unifying base for industry sectors Qualify suppliers for global supply chains Technical support for regulations

Benefits of ISO 9001 and ISO 14001 (cont.): 

Benefits of ISO 9001 and ISO 14001 (cont.) Transfer of good practice to developing countries Tools for new economic players Regional integration Facilitate rise of services

More information: 

More information ISO 9000/ISO 14000 section on ISO Web site : www.iso.org ISO Management Systems magazine www.iso.org/ims IMS Alerts free electronic newsletter www.iso.org/imsalerts

Resources: 

Resources

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