ISO 9000

PRESENTED BY

VARUN DEV

IK

M PHARM(1ST YEAR) NCP

STANDARDS
Standards ensure desirable characteristics of products and services such as quality, environmental friendliness, safety, reliability, efficiency and interchangeability at an economical cost. Standards ensure that products we use meets our requirements.

ISO
ISO is the international standardization organization. ISO name borrowed from Greek word ISOS meaning equal ISO began its operation on 23rd February 1947. ISO is world federation situated in Geneva, Switzerland with 178 countries as members. ISO is the largest and most comprehensive worldwide, non-governmental forum.

Founding members consists 14 industrialized countries from Europe, U.S and British commonwealth. General secretariat in Geneva coordinating ISO operations worldwide. Actual standards preparation is done by ISO technical committees.

ISO WAY OF WORKING

OBJECTIVES OF ISO
To be a client oriented organization that is maximum customer satisfaction. To be a technology oriented organization that should be aware of new technologies & training process To be quality conscious organization To be a learning and a adaptive organization has continuous training To be an innovative organization that has innovative methods, technology, client service & team management is adopted

ISO 9000 REGISTRARION PROCESS

1.

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Application accepted Review documentation and issue report Pre-assessment visit site, assess documentation & implementation. Registration audit assess implementation & effectiveness of quality system Registration decision review audit for registration approval. Surveillance periodic survey of quality system.

ISO 9000 :FAMILY OF STANDARDS

ISO 9000, 9001, 9002, 9003, 9004 were issued in 1987. The accreditation agency reviews registrars finding and if satisfied permits the registrar to issue certificate of registration. Reviews the standards every five years

ISO 9000 STANDARDS

ISO 9000:2005 Fundamentals and vocabulary ISO 9001:2008 Quality management system requirements ISO 9004:2009 Guidelines for performance improvement based upon the quality management principles ISO 19011:2002- Audit of management systems.

ISO 9001:2008
Used for establishment of quality management system Five sections that specify activities:

I.

Overall requirements of QMS and documentation II. Management responsibility, focus, policy, planning and objectives. III. Recourse management and allocation IV. Product realization and process management V. Measurement, monitoring analysis and improvement

ISO 9004

Managing for sustained success of organization. Guidance of continual improvement of an organizations overall performance, efficiency on broader prospective. Extends benefits to those interested or affected by standards in organization.

ELEMENTS OF ISO 9004

Managing for the sustained success Strategy and policy Recourse management Process management

Monitoring, measurement and improvement

Improvement, innovation and learning

ISO 19011:2002

Covers the area of auditing of quality management systems and environmental management systems. It provides guidance on the audit programs. ISO 19011 provides an overview of how an audit programe should operate and how management system audits should take place.

SUB COMMITTEES

ISO 1001- quality management- customer satisfaction- guidelines for codes of conduct for organizations. ISO 1002- guidelines for complaints handling ISO 1003- guidelines for dispute resolution external to the organization

QUALITY MANAGEMENT SYSTEM

Eight QMS principle have been emphasized. Defined in ISO 9000:2005 Eight principles:

Customer focus Leadership Involvement of people Process approach System approach to management Continual improvement Factual approach to decision making Mutually beneficial supplier relationships

IMPLEMENTING ISO 9000 STANDARDS

Gap analysis Objectives Documented policy Evaluation of quality policy Documentation of quality system manual, quality system procedures, process procedures, supporting documents Identify boundaries of the management system Implementation Auditing

BENEFITS OF QMS
Consistent quality of products, services etc. Focus especially on customer requirements Status of organization enhanced Regular monitoring and assessment ensure improvement Cost effective and systematic organization approach

BENEFITS OF ISO 9000

Streamlined operations Effective management of documents and records Competitive advantage Encourages internal communication

Continuous improvement
Enhanced customer satisfaction

PROBLEMS WITH CERTIFICATION

Costs Time Level

- application & maintenance

- application & maintenance of internal expertise commitment of registration

Executive Selection

INTRODUCTION
ISO 14000 was developed by the ISO technical committee ISO/TC207, environmental management committee ISO/TC 207 was established in 1993, as a response to complex challenge of sustainable development articulated at the 1992 United Nations Conference on Environment and Development in Rio de Janeiro. ISO 14000 series of standards were created in 1996. Includes over 100 contries

ISO 14000 SERIES

Organization evaluation:

Environmental management system- ISO 14001, 14004, 14005 Environmental auditing- ISO 14015, 19011 Environmental performance evaluation- ISO 14031, 14032
o

Products, services and processes

Environmental labeling- ISO 14020, 14021, 14024, 140254 Life cycle assessment- ISO 14040, 14044, 14047, 14048, 14049 Green house gases- ISO 14064-1, 2, 3; ISO 14065, 14066

Environmental management supporting tools

ISO 14044, 14044, 14047, 14048, 14049

STANDARDS ISO 14001: Guidance for use. environmental aspect of organizations process and services ISO 14004: Additional guidance on principles, systems and supporting techniques. ISO 14005: Guidance for staged implementation of EMS. ISO 14031: Guidance for environmental performance evaluation. ISO 14015: Environmental assessment sites and organization. ISO 19011: Guidelines on quality and environmental auditing.

ISO 14020: General principles of different approaches to environmental labels and declarations. ISO 14064 parts 1, 2 and 3: International greenhouse gas (GHG) accounting and verification standards. ISO 14065: Complements ISO 14064 by specifying requirements to accredit or recognize green house gas validation or verification. ISO 14063: Environmental communication guidelines and examples, helps companies to make the important link to external stakeholders. ISO Guide 64: provides guidance for addressing environmental aspects in product standards.

PRINCIPLE ELEMENTS OF ISO 14001

Environmental policy Planning

Implementation and operation

Checking Management review

ENVIRONMENTAL POLICY

Top management commitment and environment policy Policy includes : rationale for company to become green and overall intentions regarding environmental issues. Unique to an organization. Policy communicated to all members of organization

PLANNING

Organizations interaction with environment is identified Legal and other requirements determined Environmental targets and objectives are defined Responsibilities assigned

IMPLEMENTATION AND OPERATION

Takes most time and effort Roles and responsibilities of personnel are defined, documented and communicated to all. Competence, training and awareness- all personnel responsible should be trained Communication- procedure for communication internal and external are well defined Documentation- EMS must be documented for audit purposes Operation control Emergency preparedness and response

CHECKING
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Monitoring of equipments Register to record additional information

Specification to deal with non-compliance

MANAGEMENT REVIEW
Audits determine the capability of the EMS to achieve the organizations environmental objective and targets. Periodic assessments must be on regular basis Review addresses changes needed Review helps to ensure:a. Meet third party expectations b. New business operations c. Changes in technologies d. Improve environmental performance

COMMUNICATION DIRECTIONS
Communicating environment aspects to stakeholders on continuous basis Providing periodic information with environmental report:
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ii.
iii. iv. v.

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vii. viii.

Environment policy Environment strategy Description of EMS component Policy regarding environmental aspects Listing of all inputs and outputs Assessment of compliance with environmental regulations Evaluation of environmental performance Audit report findings

BENEFITS
Certification act as guidance to reach objectives Enables to implement efficient equipment and workable EMS system Demonstrate efforts of an organizations towards the functioning of EMS Consumer receives product of high quality Helps cost cutting policy Protects resources, limits emissions and risk minimization is possible.

THANK
YOU