- ISO stands for INTERNATIONAL STANDARD ORGANIZATION
- An international agency for standardization of system and its certification. - Represents a network of national standard organisations with 164 National members out of the 206 total countries in the world - Worlds largest developer of standards of various types - It promotes: -Worldwide proprietary - Industrial - Commercial standards - Founded on February 23, 1947 - Headquarted in Geneva, Switzerland - 3 Official Languages of the ISO -English -French -Russian
ISO 9001 - Series of international quality standards that serves as a guidance to suppliers and purchasers about the requirement of quality system - Objectives: - achieve, maintain, and improve product quality - improve quality of operations to continually meet customers and stakeholders needs - provide confidence to management, employees, customers, and stakeholders that quality requirements are fulfilled
Why use ISO 9001?
- It helps the organization to: - Identify current process problems - Establish improvement objectives - Search for solutions - Evaluate solutions - Implement solutions using improvement tools - Measure, verify, and evaluate results - Solution implementation
ISO 2000 - A quality system standards adopted in 1987 by International Organization for Standardization; revised in 1994 and 2000 - Technical specifications and criteria to be used as rules, guideines, or definitions of characteristics to ensure that materials, products, processes, and services are fit for their purpose Creation of ISO 9001:2000
The ISO 9000 series is a collection of good management practices related to
quality systems and composed of generic and specific standards. Its intention is to help organizations meet and increase customer satisfaction and achieve continual improvement. Quality can be defined as the degree to which a set of inherent characteristics fulfils requirements. In the case of clinical laboratories, many of these requirements are specified by customers. These requirements are specified by customers and organizations must be able to achieve them. Thats the reason ISO 9001, being a standard focused on customers satisfaction, is applicable to our clinical lab context.
ISO 9001 is part of this series and is the standard applicable for certifying quality management systems. The 1994 version of the standard was originally divided in three guidelines:
- ISO 9001- Model for Quality Assurance in Design, Development, Production,
Installation and Services - ISO 9002- Quality systems- Model for Quality Assurance in Production, Installation and Services - ISO 9003- Quality systems- Model for Quality Assurance in Final Inspection and Test
According to the scope of certification, the organization could decide which
standard should be implemented. However, at the same time ISO 9001 was adopted by many companies worldwide, it also received many criticisms: it was too bureaucratic, too operational, departments-focused, without a systemic approach. The concept of quality assurance stated by the ISO 9001:1994 in fact made it distant from management and closer to operational control. Thats the reason the standard was revised in the year 2000 and what many people still dont know is that its new version- the ISO 9001:2000 is totally focused on business and quality management.
IS0 9001:2000
- Titled as Quality Management System
- It presents requirements to the implementation of quality management systems. - Its main objective is to achieve customer satisfaction by meeting their needs and also by providing services /products and developing continual improvement. - A company level certification based on a standard developed and published by the ISO - Gives guidelines on how to implement and maintain a quality management system Fundamental Requirements to be ISO Certified: QMS (Quality Management System) - It is the general requirement. - It ensures a long term strategy with respect to quality management. - It also provides framework for ensuring quality in every sphere of activity in the organization. - It is a continuous process improvement. - It is all about the evaluation and analysis of customer requirements to achieve products and services acceptable to the customer. Management Responsibility - The top management conducts management reviews at regular interval of time. The management determines the requirement and expectations of customer and take appropriate measures to satisfy the customers. Resource Management - The organization should determine and provide resources required to implement, maintain and improve the Quality Management System. Product Realization - It demands for planning and developing processes for product realization.
Principles of ISO 9001:2000
Customer-focused organization - the organization should understand the current and future needs of the customers and exceed their expectations. Leadership - the organization should establish a unity of purpose and direction creating an internal environment where people can contribute to achieve the organizations results. Involvement of People - these people are the employees. Full involvement of employees enables their abilities to be used for organizations benefit. Process Approach - it is a systematic identification and management of processes employed within an organization and the interactions amon these processes in order to obtain desired results. Systemic Approach - It is all about managing a system of interrelated processes to contribute to efficiency. It is about integrating and aligning processes to lead to better results. Continual Improvement - it is the permanent objective of the organization to lead the overall performance of the organization. Factual Approach to Decision Making - effective decisions are based on the logical analysis of reliable data and information. Mutually Beneficial Supplier Relationship - establish relationship with suppliers to enhance the abiliy of both organization to create value.
