ISO 9001 Requirements

ISO 9001 is also known as quality Management System Standard. This standard is very popular and worldwide more than one million companies have adopted ISO 9001 Certificate. Many of new business owners do not know what are the requirements for ISO 9001 . This blog post will help them to know what are the minimum documentation requirements for ISO 9001:2015  Certification.:

MANDATORY DOCUMENTS:

  • scope of QMS
  • Process operation related documentation
  • Quality Policy
  • Quality Objectives

OPTIONAL DOCUMENTS:

  • Organization charts
  • Process maps, process flow charts and/or process descriptions
  • Procedures
  • Work and/or test instructions
  • Specifications
  • Documents containing internal communications
  • Production schedules
  • Approved supplier lists
  • Test and inspection plans
  • Quality plans
  • Quality manuals
  • Strategic plans
  • Forms

ISO 9001 Standard

ISO 9001 Basic idea

ISO 9001 is the most popular standard around the world. During the  second world war the Geneva based organization ISO was established to provide unique quality system for different kinds of industries around the world. It was influenced by British Standards Institute (BSI). Specially ISO 9001 standard conception  was influenced by  British standard BS 5750. BS 5750 was a British standard to control factory product i.e arms and ammunition production based factory. Very often bomb explosion incidents were happened during the second world war in Britain.

The British government saw the causes of it was arms defect. So, they introduced BS5750 standard for arm supplying companies to maintain a quality. It is also heard that BS5750 was influenced by American Military standard MIL-Q-9858.

Later based on this standard ISO 9000 Standard was established by ISO. It was requested by British government for introducing a standard which is applicable for nonmilitary industries too. In response to British request finally in 1987.  ISO has introduced a Quality management system standard ISO 9000. Before ISO 9000 Series BSI(British standard Institute) has certified many companies since 1978. Its first standard was FM 00001. the company name was The Trmac Ltd.

At the same year in 1987 another standard ISO 9002:1987 was also introduced by ISO. It was based on quality assurance in production, installation, and servicing On the other hand the ISO 9000:1987 was based on quality assurance in design, development, production, installation, and servicing The another standard ISO 9003:1987 was also introduced by ISO and it was based on quality assurance in final inspection and test covered only the final inspection of finished product. The differences of these three standards are 9000 is related with new products, 9002 does not cover the creation of new products and 9003 has no concern how the product is made. So, the objective of the three version of iso 9000 series was different.

Later these 9000 standards were revised and published in 1994. Without final inspection of product preventive action process was introduced to quality assurance. Some evidences like quality manual, SOP was made by company as a evidence of their quality assurance commitment.

Later revising all of those three standards 9001,9002,9003, and their two versions 1987, 1994 it was introduced as ISO 9001:2000. Design and development has been considered optional in this standard. Monitoring and Optimization options have been included rather final inspection of product.

In this version 2000 of iso 9001 involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Improving effectiveness of quality was done by introducing numerical measurement of effectiveness of task and activities in different processes inside the organization.

Some of the key features of this 2000 version of 9001 are: a) approved documents by top management b) correct and latest version of documents at the point of use c) keeping records of activities to meet the requirements d) Introducing  SOP for record.

In 2008 the standard was revised again and it is known as ISO 9001:2008. No major changes came in this version comparing with the ISO 9001:2000. However some changes intended to improve consistency with ISO 14001. This version was partially influenced by ISO 9000:2005, 19011, 10000 etc.

Remarkable changes are coming in ISO 9001: 2015 version. However  it will take few years more to come into the organization for  implementation. Until then ISO 9001:2008 will be continued. Massive improvement can be achieved from the QMS standard. So worldwide the most popular standard is ISO 9001

Related article what is iso certificate

ISO 9001

ISO 9001 Basic idea

After second world war the Geneva based organization ISO was established to provide unique quality system for different kinds of industries around the world. It was influenced by British standard BS 5750. BS 5750 was a British standard to control factory product i.e arms and

ammunition production based factory. Very often bomb explosion incidents were happened during the second world war in Britain.The British government saw the causes of it was arms defect. So, they introduced BS5750 standard for arm supplying companies to maintain a quality. It is also heard that BS5750 was influenced by American Military standard MIL-Q-9858.

Later based on this standard ISO 900 Standard was established by ISO. It was requested by British government for introducing a standard which is applicable for nonmilitary industries too. In response to British request finally in 1987.  ISO has introduced a Quality management system standard ISO 9000. Before ISO 9000 Series BSI(British standard Institute) has certified many companies since 1978. Its first standard was FM 00001. the company name was The Trmac Ltd.

At the same year in 1987 another standard ISO 9002:1987 was also introduced by ISO. It was based on quality assurance in production, installation, and servicing On the other hand the ISO 9000:1987 was based on quality assurance in design, development, production, installation, and servicing The another standard ISO 9003:1987 was also introduced by ISO and it was based on quality assurance in final inspection and test covered only the final inspection of finished product. The differences of these three standards are 9000 is related with new products, 9002 does not cover the creation of new products and 9003 has no concern how the product is made. So, the objective of the three version of iso 9000 series was different.

Later these 9000 standards were revised and published in 1994. Without final inspection of product preventive action process was introduced to quality assurance. Some evidences like quality manual, SOP was made by company as a evidence of their quality assurance commitment.

Later revising all of those three standards 9001,9002,9003, and their two versions 1987,1994 it was introduced as ISO 9001:2000. Design and development has been considered optional in this standard. Monitoring and Optimization options have been included rather final inspection of product.

In this version 2000 of iso 9001 involvement by upper executives in order to integrate quality into the business system and avoid delegation of quality functions to junior administrators. Improving effectiveness of quality was done by introducing numerical measurement of effectiveness of task and activities in different processes inside the organization.

Some of the key features of this 2000 version of 9001 are: a) approved documents by top management b) correct and latest version of documents at the point of use c) keeping records of activities to meet the requirements d) Introducing  SOP for record.

In 2008 the standard was revised again and it is known as ISO 9001:2008. No major changes came in this version comparing with the ISO 9001:2000. However some changes intended to improve consistency with ISO 14001. This version was partially influenced by ISO 9000:2005, 19011, 10000 etc.

Remarkable changes are coming in ISO 9001: 2015 version. However  it will take few years more to come into the organization for  implementation. Until then ISO 9001:2008 will be continued.