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API Q1 Management Review & Internal Audit Timing

Background: This question was received from an attendee during a recent Exemplar Global RTP, API Q1 Certification Workshop. Question: Does API Q1 specify any maximum for the number of days or months between when a Management review meeting is held and the Internal audit is performed? Response: No. API Q1 requires a full system QMS Internal Audit and Management review be conducted at least every 12 months. API Q1 does not prescribe any ...
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ISO 9001:2008 vs. 2015, Receiving Insp.

Question: Referring to ISO 9001:2008 clause 7.4.3, Verification of Purchased Product; since we are only a trading company that recieves a limited amount of purchased items at our site, please advise if this requirement is applicable to our organization. Thank You, Razif Reply: Hello Razif, Thanks for contacting us. Regarding ISO 9001:2008, clause 7.4.3, verification of purchased product requirements; it’s important to remember the primary ...
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Tools for Auditing ISO 9001: 2015, Risk Based Thinking

Inquiry: Question received via ASQ's Ask the Experts Blog, Published 10/21/2015 In addressing clause 4 of ISO 9001:2015 regarding organization context and interested parties, what type of tool (spreadsheet,diagram,flowchart,etc), would you recommend to use to simplify the practice and to give a proper understanding for auditors? I understand that risk evaluation (ISO 9001:2015) should be accomplished not only at a high level of establishing ...
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When Will ISO 9001:2015 Certifications Start To Be Issued?

Inquiry: Our company currently holds dual certifications to API Q1 and ISO 9001:2008 that are not set to expire until November 2017. When making the transition to ISO 9001:2015 and re-certifying in November 2017, will we be able to do dual certifications or will we have to do API Q1 separate from ISO 9001:2015? Thanks! Brian Reply: Hello Brian, in response to your inquiry, the timing for transitioning your existing QMS from ISO 9001:2008 ...
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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 ...
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API Q1, Risk Assessment Requirement

QUESTION: From: Yusri Sent: Aug. 12, 2014 To: Q-Blog, Ask the Experts Subject: API Q1, clause 5.3, Risk Assessment Requirements Yusri asks the following questions about API Q1: API Q1, requires the organization to maintain a documented procedure for risk assessment and management. What parameters need to be considered for determining risk and their impact on delivery and quality of product? Should the risk assessment be performed before ...
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API Q1, 9th Edition – Critical Supplier

QUESTION: From: Joe St. J., Sent: May 1, 2014 To: ATCS - QBlog, Ask The Experts Subject: API Q1, 9th Edition, Critical Suppliers Joe St. J, asks the following about APIQ1: Hello, Our company remains in the process of transitioning to API Q1, 9th edition. While reading sections 5.6.1.2 and 5.6.1.3, one of our suppliers we purchased materials from for our final product that some of his products we deem as "critical" for our final product ...
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API Q1, 9th Edition – Verification of Proprietary Product vs. Receiving Inspection

Muhammad I. asked the following question: API Q1, 9th edition, clause 5.6.1.2, Section b) and Sub-section iii) requires the organization to verify that supplied product conform to stated requirements when limited by proprietary, legal and/or contractual arrangements. How is this requirement different from - API Q1, 9th edition, clause 5.6.3, which states that “The organization shall ensure and provide evidence that purchased product and ...
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API Q1, 9th Ed., Quality Policy vs. Objectives

QUESTION: From: T.S. , Tercel Oilfield Sent: Jan. 20, 2014 To: ATCS - QBlog, Ask The Experts Subject: API Q1, 9th Ed., Quality policy and Objectives Am I correct in saying that Objectives should establish the highest overall expectation and direction of the Top Management and that S.M.A.R.T. Goals should then established by the different departments and personnel that are in support of achievement of the Objective? For instance, each ...
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