Background: This question was received from an attendee during a recent Exemplar Global RTP, API Q1 Certification Workshop.
Question: Does API Q1, 9th edition specify any wait time for an organization to maintain between the completion of an internal audit and conducting a management review?
Response: No. API Q1 9th edition, section 6.5 states that an organization must conduct a Management review at least every 12 months. API Q1 does not ...
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API Q1
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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API 6D Monogram, Requirements, Timing, and Costs
An API 6D monogram can add value and provide customers with the assurance the product has met applicable industry requirements. The first steps toward obtaining a monogram license should include understanding the certification and monogram license requirements, estimating resource needs, costs, and a timeline for completing the monogram license process. This information and more are discussed in the API Q1 & API 6D Certification Workshop ...
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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 ...
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API Q1 & API 6A Cost for Certification and Product Monogram
QUESTION:Hi Eugene, Excellent question and one that’s frequently asked. To accurately estimate the cost to obtain API Q1 certification and API 6A product monogram license, the following items should be considered:
The first step should include contacting an API Sales Representative to identify:
1. The cost of application fees for API Q1 certification and a Product monogram license.
2. The cost of conducting required stage 1 and stage 2 audits for ...
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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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