ISO 9001 (Quality Management System)

ISO 9000 is a series of standards for Quality Management System. While ISO 9001 is meant for certification purpose, ISO 9000 and ISO 9004 provide vocabulary and guidelines respectively. The latest revision of the standard has taken place in September 2015. The ISO 9001 (Version 2000) replaced the older version (1994 version) of ISO 9001, ISO 9002 and ISO 9003. Now, the 5th edition of the standard (ISO 9001:2015) replaces ISO 9001:2008.

ISO 9001:2015 is based on the new seven principles of quality management, and is modelled on ‘process approach’. It advocates the P-D-C-A (Plan-Do-Check-Act) cycle for continual improvement and customer satisfaction. ISO 9001:2015 certification is for quality management system, and NOT a product certification scheme.

With practical implementation, ISO 9001 benefits any type of business and organization including public sector and non-profit organization. It provides a better visibility of how a business or organization operates by placing appropriate emphasis on aspects such as customer satisfaction, continuous improvement etc. ISO 9001 also helps a business or organization to reach a new height of success by promoting work efficiency practices which can lead to less waste, more productivity and therefore potential cost savings.

Other benefits of ISO 9001 registration are:

• Clarity in definition of authorities and responsibilities
• Enhanced corporate image and market positioning
• Better records and documentation in case of litigation
• Use of recognized mark (of certifying agency) on stationary and advertisement
• Reduction in the need for multiple second party assessments
• Better traceability to root causes of quality problems
• Rectification of errors at the earliest stage
• Reduced repetition of errors

In ISO 9001:2015 there are only a few required documents – or “documented information that must be maintained:

• Scope of the management system
• Quality Policy
• Quality Objectives

plus information that is necessary to support operation of your processes. Typical examples would be procedures, inspection and test plans, forms, checklists, work instructions.

To support the implementation of the ISO 9001:2015 Quality Management System, records – or documented information including but not limited to the following must be retained:

• Review of requirements for products and services
• Design and development: inputs, reviews, controls, verification, outputs, validation, change control.
• Supplier evaluation
• Unique identification – (e.g. serial / batch number) if traceability is required
• Customer property – lost, damaged or found unsuitable for use and communication to the owner
• Change control – reviews, actions, authorisations
• Criteria and authorisation for release of products and services for delivery to the customer
• Calibration of monitoring and measuring equipment
• Training records
• Nonconformities
• Corrective Actions and results
• Monitoring and measurement activities
• Audit findings and actions
• Management reviews