Inquiry:
Question received via ASQ's Ask the Experts Blog, Published 10/21/2015
In addressing clause 4 of ISO 9001:2015 regarding organization context and interested parties, what type of tool (spreadsheet,diagram,flowchart,etc), would you recommend to use to simplify the practice and to give a proper understanding for auditors? I understand that risk evaluation (ISO 9001:2015) should be accomplished not only at a high level of establishing and ...
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QMS Requirements
API Q2 Risk Assessment, Contingency Planning & MOC
Inquiry: Where can examples of how to implement API Q2 requirements for risk assessments, contingency planning and management of change be found? Suggestions are appreciated.
Maxwell
Reply: Hello Maxwell, ISO 31000 can provide some general guidance regarding risk management terminologies and methods. However, to fully understand what is actually required to meet API Q2 requirements for risk assessment, contingency planning and management of ...
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API Q1, Risk Management, Contingency Planning & MOC
In the event of changes that affect the QMS or organizational structure, does API Q1 require a corrective/preventive action to be initiated to document the MOC action?
Inquiry:
Hi Bill,
Firstly, going through the different queries on this site has been very helpful and greatly appreciated, that being said, I have still been in the grey about the whole MOC process. I know that a change in the QMS or organization structure will initiate an MOC ...
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API Q1 Risk Assessment Conformance
QUESTION:
From: Fayyaz Ahmed
Sent: Feb. 10, 2015
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 5.3, Risk Assessment and Management
Fayyez Ahmed asks the following about API Q1:
An organization started its transition from API Q1 8th to API Q1 9th edition during September 2013. They still had not performed risk assessment between June -Nov 2013. This organization was audited by the API during Jan 2014. However, API Auditor did not ...
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API Q1, Documentation Requirements
QUESTION:
From: Jamil K.
Sent: Dec. 11, 2014
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 4.4.1, sub. e., Documentation Requirements - General
Jamil K. asks the following about APIQ1:
API Q1, 9th Edition, requires an organization to identify legal and other applicable requirements to which it claims compliance. Please provide any insight as to what kind of items should be considered. We manufacture manifolds, valves, chokes and ...
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API Q1, Risk Assessment Requirement
QUESTION:
From: Yusri
Sent: Aug. 12, 2014
To: Q-Blog, Ask the Experts
Subject: API Q1, clause 5.3, Risk Assessment Requirements
Yusri asks the following questions about API Q1:
API Q1, requires the organization to maintain a documented procedure for risk assessment and management. What parameters need to be considered for determining risk and their impact on delivery and quality of product? Should the risk assessment be performed before ...
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