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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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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ISO 9001 Audit Deferral – Force Majeure Event
Can An Audit Be Deferred Due To A Force Majeure Event?
The following inquiry was received from ASQ Ask the Experts on Apr. 10, 2015:
If a Force Majeure event (major storm, flood or other natural event) effects the company during the time that the annual Surveillance Audit was to be done, can the Surveillance Audit be postponed until after the conclusion of the Force Majeure period without losing ISO 9001 certification? Will the impact be 1.) ...
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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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Determining Acceptance Criteria for Metal Defects
We have some metals and we would like to know which standard to buy to determine appropriate acceptance criteria for different metals “defects” for example, rust, halo effect, etc.
Monica P. - August 24, 2009
Dear Ms. Monica P,
Without knowing any of the specifics about your company’s product such as material type, design requirements or the product’s intended end use, I can only make a general recommendation that your company purchase a copy ...
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