ISO 9001:2008

Backgrounds

ISO 9000 is a family of standards related to quality management systems and designed to help organizations ensure that they meet the needs of customers and other stakeholders. The standards are published by ISO, the International Organization for Standardization, and available through National standards bodies. ISO 9000 deals with the fundamentals of quality management systems,including the eight management principles) on which the family of standards is based. ISO 9001 deals with the requirements that organizations wishing to meet the standard have to fulfill.

Contents of ISO 9001

ISO 9001:2008 Quality management systems — Requirements is a document of approximately 30 pages which is available from the national standards organization in each country. It is supplemented by two other standards, ISO 9000:2005 Quality management systems — Fundamentals and vocabulary and ISO 9004:2009 Managing for the sustained success of an organization — A quality management approach, which do not contain specific requirements and are not used directly in certification. Outline contents for ISO 9001 are as follows:

• Page iv: Foreword
• Pages v to vii: Section 0 Intro
• Pages 1 to 14: Requirements
  • Section 1: Scope
  • Section 2: Normative Reference
  • Section 3: Terms and definitions (specific to ISO 9001, not specified in ISO 9000)
  • Section 4: Quality Management System
  • Section 5: Management Responsibility
  • Section 6: Resource Management
  • Section 7: Product Realization
  • Section 8: Measurement, analysis and improvement

In effect, users need to address all sections 1 to 8, but only 4 to 8 need implementing within a QMS.

• Pages 15 to 22: Tables of Correspondence between ISO 9001 and other standards
• Page 23: Bibliography

The standard specifies six compulsory documents:

• Control of Documents (4.2.3)
• Control of Records (4.2.4)
• Internal Audits (8.2.2)
• Control of Nonconforming Product / Service (8.3)
• Corrective Action (8.5.2)
• Preventive Action (8.5.3)

In addition to these, ISO 9001:2008 requires a quality policy and Quality Manual (which may or may not include the above documents).

Summary of ISO 9001:2008 in informal language

• The quality policy is a formal statement from management, closely linked to the business and marketing plan and to customer needs.
• The quality policy is understood and followed at all levels and by all employees. Each employee works towards measurable objectives.
• The business makes decisions about the quality system based on recorded data.
• The quality system is regularly audited and evaluated for conformance and effectiveness.
• Records show how and where raw materials and products were processed to allow products and problems to be traced to the source.
• The business determines customer requirements.
• The business has created systems for communicating with customers about product information, inquiries, contracts, orders, feedback, and complaints.
• When developing new products, the business plans the stages of development, with appropriate testing at each stage. It tests and documents whether the product meets design requirements, regulatory requirements, and user needs.
• The business regularly reviews performance through internal audits and meetings. The business determines whether the quality system is working and what improvements can be made. It has a documented procedure for internal audits.
• The business deals with past problems and potential problems. It keeps records of these activities and the resulting decisions, and monitors their effectiveness.
• The business has documented procedures for dealing with actual and potential nonconformances (problems involving suppliers, customers, or internal problems).
• The business:
  1. makes sure no one uses a bad product,
  2. determines what to do with a bad product,
  3. deals with the root cause of problems, and
  4. keeps records to use as a tool to improve the system.

Certification

ISO does not itself certify organizations. Numerous certification bodies exist, which audit organizations and, upon success, issue ISO 9001 compliance certificates. Although commonly referred to as 'ISO 9000' certification, the actual standard to which an organization's quality management system can be certified is ISO 9001:2008. An ISO certificate is not a once-and-for-all award, but must be renewed at regular intervals recommended by the certification body, usually around three years.

ISO 9001:2008 basically renarrates ISO 9001:2000. The 2008 version only introduced clarifications to the existing requirements of ISO 9001:2000 and some changes intended to improve consistency with ISO 14001:2004. There were no new requirements. For example, in ISO 9001:2008, a quality management system being upgraded just needs to be checked to see if it is following the clarifications introduced in the amended version.

 sample certificate of ISO 9001:2008

Implementing ISO often gives the following advantages:

1. Creates a more efficient, effective operation
2. Increases customer satisfaction and retention
3. Reduces audits
4. Enhances marketing
5. Improves employee motivation, awareness, and morale
6. Promotes international trade
7. Increases profit
8. Reduces waste and increases productivity.
9. common tool for standardization.

When ISO 9001 is implemented in an organization:

• Well defined and documented procedures improve the consistency of output
• Quality is constantly measured
• Procedures ensure corrective action is taken whenever defects occur
• Defect rates decrease
• Defects are caught earlier and are corrected at a lower cost
• Defining procedures identifies current practices that are obsolete or inefficient
• Documented procedures are easier for new employees to follow
• Organizations retain or increase market share, increasing sales or revenues

source: wikipedia