Category Archives: QMS Basics

ISO 9001:2015 & Determining External & Internal Issues

QUESTION: From: Adolpho P., April, 21, 2017 – My question is regarding ISO 9001:2015 requirements for reporting external and internal issues as a part of the management review process.  Which subjects should be analyzed as the inputs, subclause 9.3.2.b?  I don’t … Continue reading

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Estimating the cost for API Q1 certification & API 6A Monogram License

QUESTION: From: Eugene P., March 6, 2017 – During the past months, we have received several inquiries asking if our company was API Q1 certified or if we had an API 6A monogram.  How much does it cost to get API … Continue reading

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Are Exclusions to ISO 9001:2015, Permitted?

Inquiry:  Our organization provides mobile crane rental services. We recently received a request from a client to deliver a crane to their site location. This was the extent of the services provided to the client.  Can we exclude ISO 9001:2015, subclause 8.3 requirements … Continue reading

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Leaders of Change

LEADERS OF CHANGE – Leadership begins at the top. Although ISO 9001:2015, subclause 5.3 requires C-level or top management to assign relevant persons to ensure quality management system (QMS) requirements are communicated and understood, the responsibility to provide the leadership … Continue reading

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API 6A Monogram Restricts Remanufactured Equipment

Inquiry:  My question is regarding application of the API monogram. Our company is an API 6A licensee. We manufacture valves and other related equipment at our facilities here in the USA and overseas.  During a recent re-certification audit, the Auditor … Continue reading

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Risk Based Thinking

Using the process approach and RBT are hot topics for organizations implementing ISO 9001 for the first time and others transitioning to its revised requirements. There’s nothing new about RBT. In fact, ISO 19011:2011—Guidelines for auditing management systems highlighted the … Continue reading

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Certified Enterprise Risk Manager

A firm working knowledge of risk management has become an essential part of being an effective 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 … Continue reading

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ISO 9001:2008 vs. 2015, Receiving Insp.

Question: Referring to ISO 9001:2008 clause 7.4.3, Verification of Purchased Product; since we are only a trading company that recieves a limited amount of purchased items at our site, please advise if this requirement is applicable to our organization. Thank … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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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 … Continue reading

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