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What is ISO?


- 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

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
- 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
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

- 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
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
- 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.
- 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
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
Mutually Beneficial Supplier Relationship
- establish relationship with suppliers to enhance the abiliy of both organization to
create value.