QMS Requirements

Does API Q1 Require Suppliers To Be ISO 9001:2008 Certified?

Fayyaz Ahmed Asks The Following About APIQ1 : What will be viable corrective action to take if it is observed during an audit that one of their suppliers of calibration services does not have valid ISO 9001:2008 certification? Should a corrective action report (CAR) be issued because the supplier possess an invalid ISO 9001:2000 QMS certification and is not being evaluated? ATCS REPLY: Hi Fayyaz, ISO 9001, clause 7.4.1, requires the ...
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Can the API Q1 monogram be used on company letterhead?

Fayyaz Ahmed Asks, "Can a manufacturer use API Monogram on company letter head or inspection certificate issued by the organization at the time of releasing acceptable material". ATCS Reply: Fayyaz, API Q1 prohibits the use on the API monogram on letterhead or in any advertising, including websites without an express statement of fact describing the scope of the Licensee's authorization which must include the organization's API issued ...
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Does API Q1 still refer to ISO 9001:2000 as a valid standard?

Fayyaz Ahmed Asks: API Q1 requires that the organization establish control features for the purchasing process and supplier selection. But what if an approved supplier has an ISO 9001:2000 certification and has not upgraded to ISO 9001:2008? This supplier is providing calibration services to its clients. What action should be taken at this stage? REPLY: Hello Fayyaz, this is a great question. ISO 9001:2008 was issued for use during Nov. 2008. ...
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API 7K – Can Engineering Be Excluded From The Quality Manual Scope?

Question: Sammy O. asks, can design and development be excluded from the scope of our API 7K product specification license and our API Q1 QMS manual? ATCS Reply: Good question, however, according to the API's Advisory 6, dated June 10, 2011, API 7K is not listed as one of the product specifications where an exclusion can be taken from the product specification's design and development requirements. A copy of this advisory can be downloaded ...
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How to Write an ISO 9001 or ISO TS29001/API Q1 Quality Policy

First things first, there’s no difference between writing a quality policy for an ISO 9001 or an ISO TS29001/API Q1 quality management system. Next, there’s no established or preferred format for writing a quality policy. Your organization’s quality policy can be as detailed or as brief as your organization chooses to make it. However, it must reflect the purpose of the organization and set the framework for quality objectives and continual ...
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ISO 9001 Response Time Requirements

Question: Recently, a new firm began auditing our organization, and I’m noticing differences in requirements compared with our previous auditor. At the closing of an annual surveillance audit for a three-year certificate, if a nonconformance is issued at the closing meeting: • What is the expectation for response to the auditor for a minor nonconformance and a major nonconformance? • How many days are expected for the initial response for ...
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