Over-view of ISO 9001 and ISO 14001

Presented By:Gautam Shreyas Pallavi Linu Luxica vaibhav Somiya Payal

The International Organization for Standardization

Widely known as ISO, is an international standard-setting body composed of representatives from various national standards organizations. Founded on February 23, 1947, the organization promulgates worldwide proprietary, industrial, and commercial standards. It has its headquarters in Geneva, Switzerland.

ISO 9000 In Brief

The ISO 9000 family of standards are related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies while meeting statutory and regulatory requirements. ISO 9000 deals with the fundamentals of quality management systems, including the eight management principles) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.

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

The quality policy is 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. Each employee works towards measurable objectives. The business makes decisions about the quality system based on recorded data. The quality system is regularly audited and evaluated for conformance and effectiveness. Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.

ISO 9001:2008 (cont.)

The business determines customer requirements. The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints. When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs. The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.

ISO 9001:2008 (cont.)

The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness. The business has documented procedures for dealing with actual and potential non conformances (problems involving suppliers, customers, or internal problems). The business: omakes sure no one uses a bad product, odetermines what to do with a bad product, odeals with the root cause of problems, and okeeps records to use as a tool to improve the system.

Advantages
It is widely acknowledged that proper quality management improves business, often having a positive effect on investment, market share, sales growth, sales margins, competitive advantage, and avoidance of litigation. The quality principles in ISO 9000:2000 are also sound, according to Wade and also to Barnes, who says that "ISO 9000 guidelines provide a comprehensive model for quality management systems that can make any company competitive." Implementing ISO often gives the following advantages: Creates a more efficient, effective operation Increases customer satisfaction and retention Reduces audits Enhances marketing Improves employee motivation, awareness, and morale Promotes international trade Increases profit Reduces waste and increases productivity Common tool for standardization.

Criticisms of ISO
A common criticism of ISO 9000 and 9001 is the amount of money, time, and paperwork required for registration. ISO 9001 promotes specification, control, and procedures rather than understanding and improvement. reliance on the specifications of ISO 9001 does not guarantee a successful quality system. The standard is seen as especially prone to failure when a company is interested in certification before quality.

while "quality has a positive effect on return on investment, market share, sales growth, better sales margins and competitive advantage," that "taking a quality approach is unrelated to ISO 9000 registration. In fact, ISO itself advises that ISO 9001 can be implemented without certification, simply for the quality benefits that can be achieved.

Quality Management System

A quality management system (QMS) can be expressed as the organizational structure, procedures, processes and resources needed to implement quality management. Early systems emphasized predictable outcomes of an industrial product production line, using simple statistics and random sampling. By the 20th century, labor inputs were typically the most costly inputs in most industrialized societies, so focus shifted to team cooperation and dynamics, especially the early signaling of problems via a continuous improvement cycle. In the 21st century, QMS has tended to converge with sustainability and transparency initiatives, as both investor and customer satisfaction and perceived quality is increasingly tied to these factors. Of all QMS regimes the ISO 9000 and ISO 14000 series are probably the most widely implemented worldwide

Elements of a Quality Management System

Organizational structure Responsibilities Methods Data Management Processes - including purchasing Resources - including natural resources and human capital Customer Satisfaction Continuous Improvement Product Quality Maintenance Sustainability-including efficient resource use and responsible environmental operations Transparency and independent audit

ISO 14000
ISO 14000 is a family of standards related to environmental management that exists to help organizations (a) minimize how their operations (processes etc.) negatively affect the environment (i.e. cause adverse changes to air, water, or land); (b) comply with applicable laws, regulations, and other environmentally oriented requirements, and (c) continually improve in the above.
As of 2010, ISO 14001 is now used by at least 223149 organizations in 159 countries and economies.

What is EMS? (Environment Management System)

A continual cycle of Planning, Implementing, Reviewing, and Improving the processes and action actions that an organization undertakes to meet its environmental obligations. Continual Improvement: Enhancing your EMS to better your overall Environmental Performance

QMS & EMS

QMS Quality Policy Adequate Resources Responsibilities & Authorities Training System Documentation Process Control Document Control System Audits Management Review EMS Environment Policy Adequate Resources Responsibilities & Authorities Training System Documentation Operational Control Document Control System Audits Management Review

EMS
An effective EMS is built on TQM concepts. Most EMS models [Including ISO 14000] are built on the PLAN, DO, ACT, CHECK [PDCA] cycle. Applying ISO 14000 and to initiate and sustain EMS effort, top management must communicate to all employees the importance of :
Making the environment an organizational priority [Thinking of an effective environmental management as fundamental to the organizations survival] Integrating Environmental Management throughout the Organization.[thinking about the environment as part of product/service and process development and delivery among other activities]

Flexible & Simple

An effective EMS is dynamic enough to allow organization to adapt to a quickly changing environment . Compatibility with organization culture. Employee awareness & Involvement.

Key Elements of EMSISO 14001

ISO 14001 is widely accepted international standard for EMS that focuses on continual improvement. Companies may be asked to demonstrate conformance with ISO 14001 as a condition of doing business in some markets & The standard is consistent with the key elements found in many EMS models, including the European Unions eco management and audit scheme. ISO 14001 Is the standard that gives the requirements for an environmental management system. ISO 14001:2004 Is the latest, improved version. It is the only standard in the ISO 14000 family that can be used for certification. The ISO 14000 family includes 21 other standards that can help an organization specific aspects such as auditing, environmental labelling, life cycle analysis

Key Elements of EMSISO 14000A snapshot

Environmental Policy Environmental AspectsIdentify Products, Activities / services attributing to environment Legal and other requirements. Objectives & Targets Environmental Management ProgramPlan Actions necessary to achieve above objectives. Structure and Responsibility.

Key Elements of EMSISO 14000A snapshot

Training, Awareness and competence. EMS documentation Document Control Operational Control Emergency preparedness & Response Monitoring & Measurement NC & Corrective and Preventive actions Records EMS audit Management Review.

Prevention of Pollution Hierarchy

Source Reduction In- Process Recycling Other Recycling Treatment & Recovery Control Mechanism

Typical Example of EMS policy

We will comply with the environmental laws & regulations and will strive to secure fundamental reforms that will improve our environmental effectiveness and reduce our cost of compliance. We will consider environmental factors and the acquisition and use and disposal cost when making Planning, Purchasing, and operating Decisions.

Typical Example of EMS policy

We will monitor Environmental Performance through regular evaluation. Manage Land Water, wild Life and forest recourses in environmentally sensitive manner. Use energy efficiently throughout our operations and support the efficient use of coal, wood, & electricity. Reuse and recycle whenever and wherever possible. Use Environmentally preferred materials. Clean up residual pollution from past operations in cost effective manner.

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. 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 system means what the organization does to manage its processes, or activities in order that its products or services meet the organizations 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.

Management systems (cont.)

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. 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

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

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 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 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 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 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 Survey

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.

The ISO Survey (cont.)

The ISO Survey (cont.)

The worldwide total of ISO 14001 certificates at the end of 2007 was 154 572. This was an increase of 21 % over 2006 when the total was 128 211. Certificates had been issued in 148 countries compared to 140 the year before.

Benefits of ISO 9001 and ISO 14001

International, expert consensus on state-of-theart practices for quality and environmental management. Common language for dealing with customers and suppliers worldwide in B2B. Increase efficiency and effectiveness. Model for continual improvement. Model for satisfying customers and other stakeholders.

Benefits of ISO 9001 and ISO 14001 (cont.)

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. Regional integration Facilitate rise of services

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 Transfer of good practice to developing countries Tools for new economic players

References
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

Wikipedia
www.wikipedia.org

R E S O U R C E S

Thank you