INTERNATIONAL STANDARDIZATION ORGANIZATION || ISO 9000 || ISO14000 || benefits || elements || steps for registration

 

 INTERNATIONAL STANDARD ORGANIZATION (ISO)

¨   OVERVIEW OF ISO

¨   AIMS OR ISO

¨   PRINCIPLES OF ISO

¨   ISO 9000

¨   BENEFITS

¨   ELEMETNS

¨   STEPS FOR REGISTRATION PROCESS

¨   ISO 14000

¨   BENEFITS

¨   DIFFERENT BETWEEN ISO 9000 & 14000

 

OVERVIEW OF ISO

  • ISO is a name used for the international organization for standardization
  • It is derived from the Greek word “isos” that means equal. 
  • From the 25 members who met to initiate this process, ISO has grown to a huge network of more than 160 member countries who represent their nation's standards organizations. 
  • The 150 headquarters is located in Geneva, Switzerland. 
  • The ISO is considered the world's largest organization involved with developing voluntary international standards. 
  • In this role, the ISO helps to facilitate global trade by creating common standards across countries. 
  • Over the years since it began functioning, ISO has set more than 20,000 standards in different areas right from manufacturing and agriculture to food safety and healthcare.

 AIM OF ISO

  • The International Standards created by ISO are meant to guarantee the quality, dependability, and safety of goods and services. 
  • They serve as strategic instruments for business, cutting down on waste and errors while boosting output. 
  • They support free and fair international trade, level the playing field for emerging nations, and support companies in expanding into new markets.
  • The ISO does not provide any certificates for organizations that want to accredit their quality systems. 
  • On the other hand, there are accredited organizations and registered institutions that are qualified to carry out the certification on behalf of ISO. 
  • If an organization satisfies the certification requirements, an ISO certificate for the standards to which it adheres is granted, and the certificate is good for three years.

Principles

  • Customer-focus
  • Leadership
  • Engagement of people
  • Process approach
  • Continual improvement
  • Evidence-based decision making
  • Relationship management

Customer focus:

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Leadership:

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment better.

Engagement of people:

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organizations benefit.

Process approach:

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Improvement:

Improvement of the organizations overall performance should be a permanent objective of the organization.

Evidence-based decision making:

Effective decisions are based on the analysis of data and information.

Relationship management:

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

ISO 9000

  • The ISO 9000 family is probably the best known of ISO standards. 
  • It is the set of International Standards that lays down the framework for a quality management system. 
  • The purpose of these is to guide organizations with the tools required to make sure that their services or products meet quality requirements and drive the process of continued quality improvement. 
  • These standards are universal and may be applied to organizations in any industry and of any size.
  • ISO 9000 standards were published first in 1987. 
  • Major revisions were made in 2000 and later in 2008. 
  • The most recent versions are the ones published in 2015.

Some of the important standards in this family include:

  • ISO 9000: Explains fundamental quality concepts and provides guidelines for the selection and application of each standard.
  • ISO 9001: Model for quality assurance in design, development, production, installation and servicing.
  • ISO 9002: Model for quality assurance in the production and installation of manufacturing systems.
  • ISO 9003: Quality assurance in final inspection and testing.
  • ISO 9004: Guidelines for the applications of standards in quality management and quality systems.
  • ISO 9000 :2015: Basic concepts and vocabulary (definitions)
  • ISO 9001: 2015: Requirements of a quality management system
  • ISO 9004: 2018: Continuous improvement of quality management systems
  • ISO 19011: 2011: Guidelines for internal and external audits of quality management systems.

Criteria to get ISO 9001

  • It must meet its own requirements.
  • It must meet regulatory and statutory requirements.
  • It must meet customer requirements.
  • It must document its performance.

Benefits of ISO 9001

  • Increases marketability
  • Reduced operational expenses
  • Better management control
  • Increased customer satisfaction
  • Improved internal communication
  • Reduction of product-liability risks.
  • Improved health, safety and reduction of waste

Elements of ISO 9000

  • Management responsibility
  • Quality system
  • Contract review
  • Design control
  • Document and data control
  • Purchasing
  • Control of customer-supplied product
  • Product identification and traceability
  • Process control
  • Inspection and testing
  • Control of inspection, measuring and test equipment
  • Inspection and test status
  • Control of non-conforming material
  • Corrective and preventive action
  • Handling, storage, packaging, preservation and delivery
  • Control of quality records
  • Internal quality audits 
  • Training
  • Servicing
  • Statistical techniques

Steps for registration of ISO




ISO 14000

  • ISO 14000 family comprises the international standards, technical reports and guides for environmental management by organizations. 
  • They specify the requirements necessary to set up an environmental management policy, plan and implement environmental objectives, determine the impact of products or services on the environment and conducting corrective actions and management review. 
  • By working towards ISO 14000 certification, organizations can reduce the negative impact of their processes on the environment (air, land or water). 

Some of the important standards in this family include:

  • ISO 14001: Set criteria for EMS
  • ISO 14010: Standards about auditing
  • ISO 14004: 2016: Environmental management systems general guidelines on implementation.
  • ISO 14006: 2011: Environmental management systems - guidelines to incorporate eco-design.
  • ISO 14031: 2013: Environmental Management - environmental performance evaluation guidelines.
  • ISO 14064: 2006: Greenhouse gases standards.
  • ISO 14020: 2000: Environmental Labels and Declarations- general principles.

Aim of ISO 14000

  • The ISO 14000 standards were developed as industries recognized the need for standardization in the area of environmental management. 
  • They aim at ensuring organizations promote environmental management systems that are effective.
  • The first standard, for environmental management system was the BS 7750 that was published in 1992. 
  • In 1996, ISO published the ISO 14000 family of standards, which was subsequently revised in 2004 and the latest version available is of 2015. 
  • ISO 14001 is the standard to which organizations can get certified.

Benefits of ISO 14000

  • It helps meet legal obligations towards environmental protection.
  • Resources are used more efficiently.
  • Waste is reduced.
  • Environmental impacts get measured.
  • Customer and stakeholder trust increases.
  • Environmental obligations are managed the right way.

Different in ISO 9000 & ISO 14000

  • ISO 9000 is an international standard for the development of quality management systems that any organization can adopt.
  • ISO 14000 is an international standard for environmental management systems that any organization can also adopt potentially.

Comments

Popular posts from this blog

NEW ERA OF DRUG PRODUCT: OPPORTUNITIES AND CHALLENGES

QbD || QUALITY BY DESIGN TOOLS || advantages of qbd

Organization and Personnel in quality assurance || Bpharma || Mpharma