A Quality Management System (QMS) auditor plays a critical role in confirming that an organization's processes, products, and services meet stated quality and product requirements. The auditor's competence is a vital element of the auditing process. While some organizations believe that conducting more frequent audits can improve the quality of their QMS, it's been shown that improving the auditor's competency is more effective.Auditor ...
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risk management
Internal Audits as a Tool for Improvement
Background: This question was received from a person that recently completed an Exemplar Global RTP, API Q1 Certification Workshop.
Question: If any concerns regarding improvement are identified while conducting an internal audit, should the Auditor issue a preventive action ?
ATCS Comment: It's important to remember a Preventive Action Request (PAR) is always proactive. It's an action taken to prevent the occurrence of a nonconforming ...
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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 think the standard is clear enough. As a comment, I think subclause 9.3.2.c5. is redundant. Your feedback will be appreciated.
REPLY:
From: ATCS, Ask the Experts, April 24, 2017
Hello ...
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Leaders of Change
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 ...
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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 need for organizations to identify risk as associated with QMSs, environmental management systems, and occupational health and safety management. ISO 19011:2011 also ...
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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 ...
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