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Showing posts with the label iso 9001 2015 procedures

ISO 9001:2015 Control of Monitoring and Measuring Resources

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The execution of  ISO 9001:2015 ‘ Control of Monitoring and Measuring Resources ’ process includes definition of the requirements, ensuring availability and maintenance of the three components of monitoring and measuring resources: measuring equipment (ME); monitoring and measuring methodologies; personnel conducting monitoring and measuring. The diagram of ‘ Control of Monitoring and Measuring Resources ’ process is shown below: ISO 9001:2015 ‘Control of Monitoring and Measuring Resources’ Quality System Procedure requirements apply to the activities of metrology department; owners of quality management system(QMS) processes, where the monitoring and measuring is carried out, including ‘Production and service provision’ process;  responsible for monitoring and measuring in QMS processes;  ‘Design and development’ process production engineers.  Download the complementary description of ‘ Control of Monitoring and Measuring Resources ’ process i...

Actions to address risks and opportunities in QMS processes Methodical Manual

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This Methodical Manual summarizes 15 years of field risk management experience at the workplace. For the organization, the regulatory framework for actions to address risks and opportunities in the Quality Management System (QMS) consists of: ISO 9001:2015 cl.6.1 requirements - relevant to the entire QMS , ISO 9001:2015 cl.4.4.1.f requirements - relevant to the process , ISO 31000 Guidelines - relevant to the entire QMS . Based on the good industrial practice, it is advisable to carry out actions to address risks and opportunities on two levels and, therefore, describe them in two documents. >>Level 1 - the entire QMS Document 1 - QSP 6.1-01 ‘Actions to address risks and opportunities’ Describes risk management process, including four sub-processes:  - ‘Planning of actions to address risks and opportunities. Project of risk management framework’;  - ‘Integration and implementation of actions to address risks and opportunities in...

You can manage only what you measure: Monitoring and measuring resources in ISO 9001:2015

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  Question : We are doing internal audit ( Gap analysis ) for ISO 9001:2015 C ertification (transition from 2008 to 2015 version) . What P rocesses and S ystems should we have in place to ensure that Monitoring and Measuring Resources (cl.7.1.5) is covered by our Management system ? Section 7.1.5 Monitoring and measuring resource s The organization shall determine and provide the resources needed to ensure valid and reliable results when monitoring or measuring is used to verify the conformity of products and services to requirements. The organization shall ensure that the resources provided: a) are suitable for the specific type of monitoring and measurement activities being undertaken; b) are maintained to ensure their continuing fitness for their purpose. The organization shall retain appropriate documented information as evidence of fitness for purpose of the monitoring and measurement resources. Answer : 1. It is ...