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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? -
Is addressing risks and opportunities one time activity?
IS addressing risk and opportunities a one time process which is to be done only once while establishing the QMS? -
Defining quality objective
I need to add one more quality objective. How I should refer to our time response after quality issue has been raised by customer? -
Risks and opportunities in ISO 9001
9001:2015, section 6.1, Actions to address risks and opportunities; the risks and opportunities of internal and external issues that affect you to achieve the intended result(s) of the quality management system. Is it about programmatic risk? Not System Safety Risk via Safety Management System (SMS). What is the context of opportunity?