API Q1 & ISO 9001, CA Effectiveness

QUESTION: From: Muhammad I. Sent: Thursday, Feb. 28, 2013 To: ATCS Q-Blog Subject: How to Determine Effectiveness of Corrective Action Taken When dealing with a nonconforming situation, how can we ensure that API Q1 requirements for corrective actions have been adequately addressed?  Also, how can we determine that the corrective action taken was effective?  What evidence will be required to prove what we claim? RESPONSE: From: ATCS –Q-Blog, Ask the Experts Sent: Thursday, Feb. 28, 2013 Dear Muhammad, Thank you for contacting ATCS’s Ask the Experts.  With regard to your question, ISO 9001, clause 8.5.2 and API Q1 require that (more…)

Does ISO 9001 allow the Plant Manager to be Management Representative?

QUESTION: From: Mike G. Sent: Feb. 27, 2013 To: Q-Blog, Ask the Experts Subject: Does ISO 9001 allow the Plant Manager to be Management Representative? While conducting an internal audit at one of our branch facilities, I became concerned about the fact that the Plant Manager had recently appointed himself as the Management Representative. This is a small facility that has less than ten (10) employees.  But to me, this seems like a conflict of interest since he’ll be reporting to himself as the management representative. Should an audit finding be issued for nonconformance with ISO 9001:2008, clause 5.5.2 requirements?  (more…)

ISO 9001 vs. API Q1 Requirements, What are The Differences?

QUESTION: From: Saudi Mechanical Industries Sent: Jan. 23, 2013 To: ATCS – Ask the Expert Subject: ISO 9001:2008 & API Q1 Requirements Inquiry: What are the major differences between API Q1 and ISO 9001:2008?   RESPONSE: From: Bill Aston, ATCS –Q-Blog, Ask the Expert Sent: Jan. 23, 2013 To: Saudi Mechanical Industries Thank you for submitting your question to Aston Technical Consulting Services’.  Please click this link http://tinyurl.com/9001vsAPIQ1 to review our response to a very similar question asked during Sept. 2011.  This posted question and answer can also be found on the Q-Blog achieve. Feel free to contact me if (more…)

API Q1, Clause 8.4, Measurement, Analysis & Improvement

QUESTION: From: Valser Oil and Gas Sent: Sept. 20, 2012 To: ATCS – Ask the Expert Subject: ISO TS29001/API Q1, Clause 8.4, Measurement, Analysis and Improvement Valser Oil and Gas asks the following about ISO TS29001/APIQ1 : API Q1, clause 8.4, identifies four areas that must be monitored for improvement.  These areas include customer satisfaction, product conformity, process trends and supplier performance.  Should internal audit results be used?  I would appreciate it if you would describe these 4 areas and the type of information needed. Thank you.   RESPONSE: From: Bill Aston, ATCS –Q-Blog, Ask the Expert Sent: Sept. 20, (more…)

Can ISO 9001 Certification Be A Supplier Requirement?

QUESTION: From: ASQ Ask the Experts Sent: Jan. 18, 2013 To: ATCS – ASQ Ask the Experts Subject: Can ISO 9001 Certification Be A Supplier Requirement? Our company has bought another company in Canada and we are outsourcing to them. They are not ISO 9001:2008 certified.  Do we have the legal right to require them to get certification since we are? RESPONSE: From: Bill Aston, ATCS –Q-Blog, Ask the Expert Sent: Jan. 18, 2013 To: ASQ Ask the Experts Thank you for contacting us.  With regard to your question, there is no requirement in ISO 9001 that requires any organization (more…)

ISO 9001 & API Q1 Management Rep Requirements

QUESTION: From: An inquiry from a recent Q-Blog visitor- Bud Sent: Jan. 17, 2013 To: ATCS – Ask the Expert Subject: ISO 9001:2008, Clause 5.5.2, Management Rep Appointment We are a small company that employs less than 20 people. Our Quality Manager, who was also our ISO 9001 QMS management representative recently resigned. As a result, our company’s President has appointed himself as the QMS management representative. Does ISO 9001, clause 5.5.2, allow a company’s President to be the QMS management representative or is this a conflict? RESPONSE: From: Bill Aston, ATCS –Q-Blog, Ask the Expert Sent: Jan. 17, 2013 (more…)

ISO 9001:2008 Record Availability Requirements

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 produced 6-8 months earlier.  I do not think it is reasonable for the Auditor to expect 1-2 hour turn around on documents that are filed (more…)

Does CMMI, Level 3 Conformance Ensure ISO 9001 Certification?

The following question has been asked: “Does a software company need to conform with or be capable of meeting CMMI level 3 guidelines in order to become ISO 9001:2008 certified?” Our company is working toward obtaining ISO 9001:2008 and CMMI certifications. I have studied ISO 9001 and mapped sections to CMMI goals and practices. It appears that some sections of ISO 9001:2008 map to CMMI Level 3 process areas and practices e.g., section 5.6.1 relates basically to organizational process areas; section 7.2.1 is relative to Requirements Development which is a level 3 process area. A large part of section 7.3 (more…)

ISO 9001, Clause 5.3, Quality Policy Requirements

E. Chukwu has asked the following question. To ensure conformance with ISO 9001:2008 requirements, what are the important areas to be addressed when writing a quality policy for a company involved in shipping agency, husbanding and protective agency business? Answer: Thank you for contacting ATCS. With regard to your question, ISO 9001:2008, clause 5.3 has two primary points that must be included in every organizations quality policy. 1. The first primary point includes providing a commitment to comply with requirements. This includes customer, statutory, regulatory and internal requirements. 2. The second point includes providing a commitment to continually improve the (more…)

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 14001 and OHSAS 18001. The only exceptions are those organizations licensed under the API monogram program (i.e., API 7-1, API 5CT or other product (more…)

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 unintended use. To determine any potential consequences of nonconforming products that may have been shipped to the customer, the organization must assess if the function or performance of the product or (more…)

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 organization to establish criteria for the selection, evaluation and re-evaluation of suppliers. ISO 9001:2008 does not prescribe the use of any specific methods. Therefore, it may or may not (more…)