Introduction

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. The rules are updated, as the requirements motivate changes over time. Some of the requirements in ISO 9001:2008 (which is one of the standards in the ISO 9000 family) include:

• a set of procedures that cover all key processes in the business
• monitoring processes to ensure they are effective
• keeping adequate records
• checking output for defects, with appropriate and corrective action where necessary
• regularly reviewing individual processes and the quality system itself for effectiveness
• facilitating continual improvement

A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered". Certification to an ISO 9001 standard does not guarantee any quality of end products and services; rather, it certifies that formalized business processes are being applied.

It is a simple format of Quality Model that addresses small, medium, or large organization, whether in manufacturing, software, services, profit or non-profit whatever. It emphasizes on evaluation and improvement of effectiveness of Quality Management System based on objective measures; not just on compliance to standards.

A Brief History

• 1968AQAP-Allied Quality Assurance Publication Military standards
• 1972BS4891- A Guide to QA - British Standards Institute
• 1974BS5179 - Guide to Operation & Evaluation of QA Systems
• 1979BS5750 - Quality Systems
• 1987ISO 9000 series (EN 29000 series, IS 14000 series)
• 1994ISO 9001 upgraded
• 2000Intermediate upgrade
• 2008Latest upgrade

Process Approach

ISO 9001 – Quality Management Principles

• Customer focus
• Process approach
• System approach
• Continual improvement
• Leadership approach
• Mutually beneficial supplier relationships
• Involvement of people
• Factual approach

ISO 9000:2000 Standards

ISO 9001:2000 Clauses

1. Scope

1.1 General

1.2 Application

2. Normative reference

3. Terms and definitions

4. Quality management system

A system must have an aim. A system must create something of value, in other words, results. Management of system requires knowledge of interrelationships between all components within the system and of the people that work in it (W Edwards Deming)

4.1 General requirements

Establish, document, implement and maintain a quality management system and continually improve its effectiveness

• Identify processes needed for Quality Management System
• Determine the sequence and interaction of these processes
• Ensure availability of resources and information necessary to support the operation and monitoring of these processes
• Implement actions necessary to achieve planned results and continual improvement of these processes

4.2 Documentation requirements

5 Management responsibility

Attention to quality can becomes organization’s mind set only if all of its managers – indeed all of its people – live it (Tom Peters)

5.1 Management commitment

Top management shall provide evidence of its commitment to development and implementation of quality management system and continually improving its effectiveness by

• Communicating to the organization the importance of meeting customer as well as statutory & regulatory requirements
• Establishing the quality policy
• Ensuring that quality objectives are established
• Conducting management reviews
• Ensuring availability of resources

5.2 Customer focus

5.3 Quality policy

5.4 Planning

5.5 Responsibility, authority and communication

5.6 Management review

6 Resource management

Only the orchestra playing a joint score makes music (Peter Drucker).

Resource management is the key business process in any organization. In practice, resource management is a collection of related processes, which are often departmentally oriented. Resources are:

• Financial
• Physical
• Human

A management system is a dynamic process that will not function without such resources. That is why resource management becomes important.

There are two types of resource requirements: those needed to set up and develop the organization and those needed to execute a particular contract or order. This clause (6.1) addresses the former, while the latter are addressed in clause 7.1.

6.1 Provision of resources

6.2 Human resources

6.3 Infrastructure

6.4 Work environment

7 Product realization

Quality must be built in to each design and each process. It cannot be created through inspection (Kaoru Ishikawa)

7.1 Planning of product realization

7.2 Customer-related processes

7.3 Design and development

7.4 Purchasing

7.5 Production and service provision

7.6 Control of monitoring and measuring devicesv

8 Measurement, analysis and improvement

There can be no improvement where there are no standards. Every standard, every specification, and every measurement cries out for constant revision and upgrading (Masaaki Imai)

8.1 General

8.2 Monitoring and measurement

8.3 Control of nonconforming product

8.4 Analysis of data

8.5 Improvement

Points to remember

• Always have to remember the PDCA cycle in our tasks
• Focus on what the process intends to achieve in the larger context of business goals and customer objectives
• Have data on performance of key processes – effective application of processes is what matters, not just compliance to ISO 9001 standards
• Only data will provide inputs to measurement of process effectiveness, leading to continual process improvement.