Implementation Guideline for Clause 10 of ISO 9001 2015 Standard

This clause of ISO 9001 2015 standard serves purpose of ACT of PDCA cycle.

Clause 10 – Improvement

Clause 10.1 – General

This clause of ISO 9001 2015 standard requires that organization shall take appropriate actions on identified opportunities for improvements for improvement in

  • products and services
  • Reducing non conformities
  • Improving performance and effectiveness of Quality Management system.

In similar terms, organization shall improve products, processes and effectiveness of Quality management system. Product shall be gradually improved to meet and exceed customer expectations and to remain in market competition.

 

Clause 10.2 – Non conformity and corrective action

This clause of ISO 9001 2015 standard requires that organization shall take corrective actions whenever any non conformity occurs. The non conformity may include product non conformity and process  non conformity both.  Entire procedure for dealing with non conformity will include

  • Taking immediate action to deal for resolution of non conformity
  • Dealing with consequences of non conformity
  • Determine cause / causes / root cause of non conformity
  • Take corrective action to prevent such non conformity occuring again
  • Take corrective action at other places where similar non conformity may occur first time.
  • Review effectiveness of corrective action taken
  • Update Risk based on non conformity occured
  • Update SOPs for integration of new action in the process

 

Clause 10.3 – Continual improvement

This clause of ISO 9001 2015 standard requires that organization shall continually improve suitability, adequacy and effectiveness of quality management system. Organization shall use DATA analysis methods & Management review output for making this improvement.

 

Organizations looking to implement ISO 9001 2015 quality management system , looking to upgrade existing ISO 9001 2008 quality system to ISO 9001 2015 version, looking to know changes made in ISO 9001 2015 version against ISO 9001 2008 version may contact us.

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