QUESTION:
From: An Inquiry From ASQ 's Ask the Experts Program
Sent: June 7, 2012
To: ATCS - Ask the Expert
Subject: ISO 9001:2008 QMS Requirements – Record Availability
During a recent second party audit, the customer's Auditor asked to be provided with specific records for review. This request was made near the end of a one day audit with less than an hour remaining in the audit. The requested records were associated with parts ...
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risk management
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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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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Corrective & Preventive Actions Explained
A standard requirement for every ISO 9001 and ISO TS29001/APIQ1 quality management system is to have documented procedures for corrective and preventive actions.
Explanation: A corrective action is “REACTIVE” and a Preventive action is “PROACTIVE”. Any action taken to prevent the reoccurrence of a nonconforming condition will always be a corrective action, not a preventive action. This is because the action taken addresses a nonconforming ...
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Supply Chain Management & Quality Audits, Part 4
Supplier Management and Quality Audits has been the primary focus of our past discussions presented in parts 1, 2 and 3. The key points covered in each of these parts are as following.
Supplier Chain Management & Quality Audits, Part 1:
The importance of conducting supplier quality audits
Which suppliers should be audited
The potential impact that poor supplier performance can have on customer satisfaction.
The Purchaser’s duty ...
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Supply Chain Management & Quality Audits, Part 2
The effectiveness of your organization’s supplier quality program hinges on one key item; that is selecting experienced and trained Auditors. Assigning inexperienced or untrained personnel to conduct an audit will sabotage the audit before it begins. If your organization is willing to invest the resources required to conduct supplier quality audits, then it should ensure that a plan is in place to identify the persons best suited to conduct the ...
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