ISO 9000 - QUALITY MANAGEMENT

The ISO 9000 Series is a set of international standards for quality management and quality assurance. The standards were developed to help companies effectively document the elements they need to maintain an efficient quality system. They are not specific to any one industry.

ISO 9000 can help a company satisfy its customers, meet regulatory requirements, and achieve continual improvement. But it’s a first step, many quality professionals will tell you, the base level of a quality system, not a complete guarantee of quality.

ISO 9000 Facts

• Applies to any organization regardless of size or industry
• Implemented by more than one million organizations in over 170 countries
• Includes ISO 9000:2005 (definitions), ISO 9001:2008 (requirements) and ISO 9004:2009(continuous improvement)
• ISO 9001:2008 is the only standard in the ISO 9000 series to which organizations can certify
  

History

• Originally published in 1987 by the International Organization for Standardization (ISO), a specialized international agency for standardization composed of the national standards bodies of more than 160 countries
• Underwent major revision in 2000
• Next revision is underway, with anticipated publication in 2015

There are many standards in the ISO 9000 family, including:

• ISO 9001:2008 - sets out the requirements of a quality management system
• ISO 9000:2005 - covers the basic concepts and language
• ISO 9004:2009 - focuses on how to make a quality management system more efficient and effective
• ISO 19011:2011 - sets out guidance on internal and external audits of quality management systems.

 so let take one example of ISO9OOO, ISO 9001:2008

ISO 9001:2008 sets out the criteria for a quality management system and is the only standard in the family that can be certified to (although this is not a requirement). It can be used by any organization, large or small, regardless of its field of activity. In fact ISO 9001:2008 is implemented by over one million companies and organizations in over 170 countries.

Quality Management Principles

The standard is based on a number of quality management principles including a strong customer focus, the motivation and implication of top management, the process approach and continual improvement. These principles are explained in more detail in the pdf Quality Management Principles. Using ISO 9001:2008 helps ensure that customers get consistent, good quality products and services, which in turn brings many business benefits.

Audits

Checking that the system works is a vital part of ISO 9001:2008. An organization must perform internal audits to check how its quality management system is working. An organization may decide to invite an independent certification body to verify that it is in conformity to the standard, but there is no requirement for this. Alternatively, it might invite its clients to audit the quality system for themselves. Read more about certification to management system standards.

Preview ISO 9001:2008

You can preview the freely available sections of ISO 9001:2008 on ISO's Online Browsing Platform.
To purchase this standard please visit the ISO Store.

ISO 9001 Revision

ISO 9001 Quality Management Systems is under review and an updated version is expected by the end of 2015. All ISO standards are reviewed every 5 years to make sure they remain as helpful and relevant.

Documents required by ISO 9001:2008

1) Quality Manual

2) Six Quality Procedures

3) Quality Policy

4) Quality Objectives

5) Process Flowchart

6) Work Instructions

The best ISO 9001 documentation combines the Quality Manual and the Quality Procedures into a single, user-friendly document.

Who needs Training in ISO 9001?

All Employees:
Overview/Introduction to ISO 9001

Management:
Executive Overview of ISO 9001

ISO 9001 Management Rep:
Intensive Training in ISO 9001 Requirements

Internal ISO 9001 Auditor(s):
Intensive Training in ISO 9001 Requirements and Auditing Methods

Are ISO 9001 Forms Required?

ISO 9001:2008 does not require any specific forms but good forms and checklists will make compliance with ISO 9001:2008 much easier. The best ISO 9001 forms and checklists will:

1) save time by requiring only necessary data without duplications;

2) help employees follow procedures without the need to look up separate instructions;

3) increase productivity by combining several ISO 9001 requirements in one efficient form;

4) meet the record-keeping requirements of ISO 9001:2008.

The ISO 9001 forms and checklists presented on this website provide all of these advantages.

ISO 9001 Software

Many companies think that they will need to purchase specific ISO 9001 software, for example, for document control, corrective action or for internal ISO 9001 audits. While there are many software solutions available that help with some aspects of ISO 9001, it isnot necessary to use any such software.

Most small and mid-size companies will only need the features and functionality already included with their existing word processing and computer network software. Even a simple paper-based system may work just fine for smaller companies! Note that none of our ISO 9001 products require that you purchase any specific ISO 9001 software.