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Skip Navigation LinksISO 9001:2015 Products / ISO 9001:2015 Actions to address risks and opportunities in QMS processes – Methodical Manual

ISO 9001:2015 Actions to address risks and opportunities in QMS processes – Methodology

mm61 risks New
This Methodology 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 into QMS processes’;
 - ‘Evaluation of the effectiveness of actions to address risks and opportunities. Monitoring and analysis of risk management framework’;
 - ‘Achieving improvement’.
>>Level 2 - the process
Document 2 – This Methodology - MM 6.1-01-01 ‘Actions to address risks and opportunities in QMS processes’
The proposed Methodology provides details for the implementation of the second sub-process ‘Integration and implementation of actions to address risks and opportunities into QMS processes’ and is aimed at organizing of risk management activities in each process of the QMS in compliance with ISO 9001:2015 cl.4.4.1.f requirements.
  •  .ZIP archive contains 3 files
  • Type of delivery: Instant download
  • $149.00
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What is included in the package?
Preview
PDF
The Methodology MM 6.1-01-01 Actions to address risks and opportunities in QMS processes
MS Word, 13 pages
Preview
PNG
Form MM 6.1-01-01-01 Quality Risk Register
MS Word, 1 page, fully editable, easy to use table format
Preview
PDF
Annex 2 to ММ 6.1-01-01: Examples of Risk wording and Risk reduction activities
PDF, 8 pages, easy to use table format
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