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Showing posts with the label iso 9001 2015 good practices

Organizational structure in ISO 9001:2015 Quality manual

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Does ISO 9001:2015 require Quality Manual to contain brief information of the Organization?  The structure of documented information as per ISO 9001: 2015 (cl 7.5.1) does not contain requirements to have a Quality Manual, as was the case with the ISO 9001: 2008 documentation structure. Thus, Quality manual is not a mandatory QMS document . The existence of Quality Manual is a decision of the organization in accordance with good practices . This is attributable to: Feasibility of QMS operation description in general and linking the processes to solve organization's management tasks; Training objectives; Audit objectives;  Acquaintance of interested parties, including customers, with the QMS.  If the organization makes a decision to have a Quality Manual , then: The organizational structure should be given in section 5.3 of the document.  It is advisable to provide brief information about the organization to the auditors and interested parties. Thi...

What did ISO 9001:2015 teach you?

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What are the new things - which you ignored about your Quality Management System - did/does the new edition of ISO 9001:2015 teach you? Our experience in consulting the transition of the organizations to the new version of ISO 9001:2015 showed that the main « new things that were previously ignored » are the following four . 1. System-level analysis of internal and external context of the Organization.     1.1 Gathering information and analysis of the Context components in the following processes : ‘Management review’, ‘Marketing’, ‘Control of personnel’, ‘Design and development or products and (or) services’, ‘Production and service provision’, ‘Control of documented information’.    1.2 Distribution of information about the context internally in the Organization within the framework of control of organizational knowledge and documented information    1.3 Use of information about the context in QMS processes when planning and making manageme...