In the coming future, having a firm working knowledge of risk management will become an important asset for an Auditor. Unfortunately, those that don't ungraded their skills in this area will begin to find themselves at a disadvantage when compared to other fellow quality professionals. For this reason, every Auditor should consider improving their knowledge and skills on the subject of risk management.
During February 2015, I attended a 5-day ...
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API Q2
ISO 9001:2008 vs. ISO 9001:2015, Receiving Inspection
Question:
Referring to ISO 9001:2008 clause 7.4.3, Verification of Purchased Product; since we are only a trading company that receives a limited amount of purchased items at our site, please advise if this requirement is applicable to our organization. Thank You, Razif
Reply:
Hello Razif,Thanks for contacting us. Regarding ISO 9001:2008, clause 7.4.3, verification of purchased product requirements, it’s important to remember the primary purpose ...
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Tools for Auditing ISO 9001: 2015, Risk Based Thinking
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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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, 9th edition – Risks, Contingency Plans and MOC
QUESTION:
From: Darcy K.
Sent: May 10, 2014
To: ATCS - QBlog, Ask The Experts
Subject: API Q1, 9th edition, Risks, Contingency Plans and MOC
In regard to MOC Process, in your opinion, would it be effective to tie this into corrective and preventative actions? Any corrective or preventative actions that require changes to the QMS also require MOC, and risk assessment as well and furthermore, tying in any contingency plans that require QMS ...
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