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Showing posts with the label actions to address risks and opportunities

Which ISO 9001 revision applies during transition from 2008 to 2015 versions

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When a company is transitioning from the 2008 version of ISO 9001 to the 2015, which version must the company comply with? For example : A company has an existing ISO 9001:2008 certification. From now, to when a 2015 based certification will be obtained (in several months’ time, after an audit) - does the company have to comply with ... the 2008 version? the 2015 version? or both ?! There are two deadlines when transitioning to the new version of ISO 9001:2015: 1) September 2018 – 3 years since ISO 9001:2015 was released. During this time, ISO 9001:2008 QMS certification is valid. 2) Organization’s recertification date (closest certification audit). A date that comes first is considered to be the deadline. Before the deadline, the organization should: Train the personnel on the new version of ISO 9001; Design and implement the missing processes; Adopt new documented information structure (by the decision of the Organization); Develop the missing documented in...

'Actions to Address risks and opportunities' QSP has been updated

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We listen to our customers' feedback and continuously improve our products. ISO 9001:2015 QSP 6.1-01 Actions to Address risks and opportunities has been recently updated. We have added 8 quality system forms relevant to the procedure: QSF 6.1-01-01 Risk management plan QSF 6.1-01-0 2 Risk criteria QSF 6.1-01-03 Risk List QSF 6.1-01-04 Risk treatment plan { .PNG preview } QSF 6.1-01-05 Risk Owner to Process Owner and to Risk Manager Report on the results of monitoring and review of risk management process, including improvement proposals.{ .PNG preview } QSF 6.1-01-06 Risk Manager to Quality Manager Current Report on the results of addressing risks and opportunities in QMS Processes. QSF 6.1-01-07 Risk Manager to Company Management information report on the productivity of the ‘Actions to address risks and opportunities’ Process QSF 6.1-01-08 Risk Manager to Company Management annu...

Employees' Awareness (ISO 9001:2015 Cl. 7.3)

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The organization shall ensure that relevant persons doing work under the organization’s control are aware of: c) their contribution to the effectiveness of the quality management system, including the benefits of improved performance; ISO 9001:2015 Cl.7.3.c I am looking for ideas on how to implement the requirements referenced above.  How do you communicate to your employees that their efforts contribute to the success of the company in a way that everyone will understand? A good practice is to form quality objectives at the subdivision level based on the principle of expanding the strategy and policy chain: The quality objectives of the subdivision consists of two components: 1) Subdivision objectives to implement Annual organization development program; 2) Objectives to develop and improve subdivision activities. In this case, the analysis of subdivision quality objectives fulfillment means the analysis of the subdivision employees’...

Risk definition in ISO 9001:2015 and ISO 31000

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What is the Difference in Risk definition between ISO 9001:2015 and ISO 31000? The key difference of ISO 31000:2009 is that the Standard defines the requirements for Risk management as a System . Risk management system (as per ISO 31000) and Quality management system (as per ISO 9001:2015) can be seen as Integrated enterprise management systems (as well as ISO 14001, 45001, 27001, 11462, SA 8000 and others) . P-D-C-A Cycle in Risk management system per ISO 31000:2009 is defined as follows: P lan - Planning actions to address risks and opportunities. P roject of risk management framework. D o - Integration and implementation actions to address risks and opportunities into QMS processes. C ontrol - Evaluation of the effectiveness of actions to address risks and opportunities. Monitoring and analysis of risk management framework . A ct - Achieving improvement. The key idea of ISO 9001:2015 is risk management provision in each QMS process – as per cl.4.4....