LEADERS OF CHANGE - Leadership begins at the top. Although ISO 9001:2015, sub-clause 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 needed to champion the effectiveness of the QMS remains with top management. The responsibilities to provide direction and to ensure the effectiveness of the QMS stay ...
Read More
QMS Basics
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 told us that we could not monogram valves if they had been disassembled and reassembled. These are new valves, so why is this even a concern, especially since the valves were ...
Read More
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 need for organizations to identify risk as associated with QMSs, environmental management systems, and occupational health and safety management. ISO 19011:2011 also ...
Read More
Certified Enterprise Risk Manager
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 ...
Read More
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 ...
Read More
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 ...
Read More