Q-Blog

July 18, 2012

API Q1 Audit Frequency for Multiple Sites

QUESTION: If multiple sites are on the same API Q1 Certification, are all sites audited on an annual basis? I know with ISO 9001 they sample audit the facilities, meaning some are audited one year and others the next year. Question asked by J. Psencik REPLY: Thanks for contacting ATCS. With regard to your question, the API performs annual full system audits at facilities that are registered under API Spec Q1, ISO 9001, ISO TS29001, ISO ...
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July 17, 2012

What Does ISO 9001 Require, If An Obsolete Standard Has Been Used?

QUESTION: If an organization uses an outdated standard and later replaces it with latest revision after product has been shipped, what could be the adverse impact of products delivered to customers, if any? What action should be taken? Question submitted by F. Ahmed REPLY: Thanks for contacting us. With regard to your question; ISO 9001:2008, clause 4.2.3, sub. g, requires outdated (obsolete) documents to be identified to prevent their ...
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March 13, 2012

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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March 13, 2012

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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March 12, 2012

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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March 6, 2012

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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