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  • Documentation requirements for production process

    Which documents are required for production dept for iso as well as daily activity?

  • Example of statutory and regulatory requirements for products

    Can you give me an example of statutory requirement and regulatory requirement related to quality of a product?

  • Documentatio audit

    Is that the audit is done on the mandatory documents only or on the whole?

  • Defining context of the organization

    how to formulate context of the organization, for cement industry?

  • Requirements of the clause 8.3.2 in ISO 9001

    What is the actual requirement for the documentation from 8.3.2.j? Does it include the rest of the letter section in 8.3.2? Does it mean somehow showing that the requirements from 8.2.3 have been incorporated into the design output?

  • Competence requirements for auditors and management representative

    What is the difference in the extent of knowledge/competence between Internal auditors and Management representative/Project manager?

  • Integrating ISO 9001, ISO 14001 and ISO 45001

    What I would like to know: what are and how to write the procedures of the integrated management system slon the standards ISO 9001: 2015 and ISO 14001: 2015 and ISO 45001?

  • Scope and Quality Objectives

    We are part of the big organization (our HR, IT, Finance and Marketing) are part of a shared service i.e. they reports to the HQ but they located locally in our facility. My question is, should they be a part our ISO scope? My gut feeling tells me yes since they are impacting customer service. If yes, do Shared Services create their own quality objectives based on their immediate leaders from HQ that is also aligned with our Quality Objectives. Also, how would we required them to do their quality objectives, should our top management discuss this to their bosses in HQ? Note, the HQ and our facility supports different quality policy.

  • Risks and opportunities and SWOT

    Do we need to determine risks for 4.1 and 4.2. If so, when a SWOT analysis is performed; my understanding is Strength and weakness for internal context represents Opportunity and risks. While Opportunity and threats as the name indicates represent the same for external context. Can you clarify on this please?

  • Role of quality department and management representative

    I would like you to elaborate on what are the common processes as per standard which would be Quality Assurance departments’ responsibility? Further, What are the roles of the Quality Manager?
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