20200126-ISO 9001:2015-Eng.Dima Ayesh

Section 10 - Improvement 2008 – Clause 8.5

Section 10 - Improvement 10.1 General • QMS must continually 10.2 Nonconformity and improve corrective action • nonconformities must be 10.3 Continual improvement identified and reacted to 2008 – Clause 8.5 • corrective action must be considered Continual improvement remains a core focus of the QMS.

Section 10 – Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • opportunities for improvement must be determined • action must be taken to meet customer requirements and enhance customer satisfaction: ▫ improve products and service ▫ correcting, preventing or reducing undesired effects ▫ improve performance and effectiveness of the QMS. 2008 – Clause 8.5.1

Section 10 - Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • nonconformities (including complaints) must be reacted to and applicable action taken • root cause analysis must be considered based on its significance • effectiveness of corrective action must be reviewed • change QMS if required • evidence of action taken from nonconformities must be documented • evidence of results of corrective action must be documented. 2008 – Clauses 8.3 & 8.5.2

Section 10 – Improvement 10.1 General 10.2 Nonconformity and corrective action 10.3 Continual improvement • organisations must continually improve the suitability, adequacy and effectiveness of the QMS • must consider results of analysis and evaluation, and outputs from management review. 2008 – Clause 8.5.1

Annex A – Clarification  information on new structure, terminology and concepts. 2008 – No equivalent clause

Annex B – Other (informative)  other international standards on quality management and quality management systems developed by ISO/TC 176. 2008 – No equivalent clause

Summary of Changes  better format and ease for integration  increased emphasis of achieving value  enhanced leadership requirements  risk based thinking  documentation requirements  interested parties.

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