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 ...
Read More
API Q2
PECB, ISO 9001 Lead Auditor Certification Training
A 5-day ISO 9001 Lead Auditor certification training course will be held from Aug. 01 to 05, 2022, and from Oct. 24 to 28, 2022. This instructor-led virtual course will enable participants to develop the necessary competence to perform a quality management system (QMS) audit utilizing recognized audit principles, procedures, and techniques. This course combines the requirements of ISO 17021-1, ISO 19011 guidelines, and other established auditing ...
Read More
Market Slowdown: Can We Postpone Our API Q1 Surveillance Audit?
QUESTION:
From: Fayyez, Sept. 11, 2018
Dear Sir,
We are a certified API Q1 & ISO 9001 API QR registered organization. Our surveillance audits are scheduled to be conducted on an annual basis. We have maintained all quality management system requirements very well with all records available. But due to the present market slowdown, we might not have any production or manufacturing activities in progress during the time of the surveillance ...
Read More
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 ...
Read More
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 ...
Read More
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 ...
Read More