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

Posted on March 13, 2012 by Bill

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 include insuring that a supplier has a documented quality management system such as ISO 9001:2008 or a currently certified QMS.

API Q1, supplemental requirement, 7.4.1.2, sub clause d, lists verifying that a supplier’s quality management system conforms with an international standard/technical specification such as ISO 9001, ISO TS29001/API Q1, ISO 17025 or others, as one (1) of four (4) potential methods for selection, evaluation and re-evaluation of suppliers. Another potential method of selection could be grandfathering, provided that criteria is established for grandfathering suppliers.

Consider this, an organization may select to keep a supplier with an expired ISO 9001:2000 certification on their approved supplier list based upon that supplier’s past performance, inspection of delivered items or inspection of product at the supplier’s facility. Any or all of these methods are acceptable and within the requirements of ISO 9001:2008 and ISO TS29001/API Q1. Provided that the organization has records of their supplier selection, evaluation and re-evaluation, no corrective action would be warranted. I hope this helps.

Best regards,
Bill Aston, Managing Director
Aston Technical Consulting Services
Kingwood, TX 77339

Can the API Q1 monogram be used on company letterhead?

Posted on March 13, 2012 by Bill

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 license number.  Please review API Q1, Annex A, section A.3.5 for specific wording.

API Q1, Annex A, section A.3.3, provides specific requirements for applying the API monogram on equipment that meets API Q1 requirements.  Please note that applicable product specifications such as API 7-1, API 5CT and API 6A and/or others should be consulted to determine specific product marking requirements.  I hope this helps.

Best regards,

Bill Aston, Managing Director
Aston Technical Consulting Services
Kingwood Texas, 77339

 

Does API Q1 still refer to ISO 9001:2000 as a valid standard?

Posted on March 12, 2012 by Bill

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. ISO 9001:2000 certifications remained valid for 24 months after this issuance date.  The current version of API Q1, addendum 1, June 2010, specifically references ISO 9001:2008, since ISO 9001:2000 is no longer a valid standard.

Also, please note that ISO 9001:2008 is intended for quality management systems. Consider using or referring to ISO 10012 or ISO 17025 which are applicable to suppliers of calibration services. I hope this helps!

Best regards,
Bill

API 7K – Can Engineering Be Excluded From The Quality Manual Scope?

Posted on March 6, 2012 by Bill

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 at www.api.org.  Also, note that even those product specifications that are eligible for an exclusion, still must provide justification to be reviewed and approved by the API.  Please review API Advisory 5 for complete information.  I hope this helps.
Bill Aston
ATCS, Managing Director,
Kingwood, TX 77339

How to Write an ISO 9001 or ISO TS29001/API Q1 Quality Policy

Posted on January 28, 2012 by Bill

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 improvement of the quality management system.

It’s also important for the quality policy to state the organization’s commitment to its customers, stake holders and to comply with customer, industry (regulatory) and any applicable local, state or federal (statutory) requirements.

Ensure your organization’s quality policy includes reference to the following two key statements:
1. Top management’s commitment to meet requirements.
2. Top management’s commitment to continually improve the effectiveness of the quality management system.

The following is an example of an ISO 9001 or ISO TS29001/API Q1 quality policy.
“ACME Widget Company is committed to providing its customers with products and services that will meet or exceed their expectations for quality, on-time deliveries and value.
Our top management is committed to complying with requirements and continually improving the effectiveness of the quality management system.”
Remember, the bottom line is to write a quality policy that actually describes your organization’s purpose and top management’s commitment to meet requirements and continually improve the effectiveness of the quality management system.
I hope this helps!

ISO 9001 Response Time Requirements

Posted on January 16, 2012 by Bill

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 each?
• How many times during the next 12 months should we expect the auditor to revisit the site to verify corrective action for each?
Deborah M.
Grand Rapids, MI

Answer: Clause 8.2 of ISO 9001:2008, internal audits, does not specify or prescribe any time limits. Clause 8.2.2 only requires the management for the responsible area—the process owner—to take corrective action without undue delay. With regard to audit follow-up visits, this depends strictly on the registrar or other auditing body. Some auditing bodies will follow up on closed corrective action reports during their next scheduled surveillance audit. This allows enough time for the organization to evaluate the effectiveness of the corrective action taken.
In most cases, the Auditee is required to complete the correction action report identifying the root cause and the corrective actions taken to prevent a recurrence. This information is assessed by the auditing body to confirm that a root cause was identified and that the action taken matches the root cause. This is normally done in the form of a desk review. Due to the costs involved and other logistics, it’s rare for any auditing body to want to come out to verify each corrective action taken. This is usually something for the internal audit staff to perform as part of its audit activities.
I hope this helps.
Bill
Bill Aston
Managing Director
Aston Technical Consulting Services
Kingwood, TX

API Q1 Versus ISO TS29001 QMS Certification

Posted on January 12, 2012 by Bill

Question:  Robert Meyer asks the following about APIQ1.
As this standard was developed by API and basically covers the requirements ISO 9001 and ISO TS 29001, is the API the only company that can provided certification?  Can this certification be obtained from another certification body or registrar?  Thanks for your kind answer.

Answer:  Hello Robert,  Thanks for contacting us. The API is the only registrar that can provide APIQ1 QMS certification which authorizes the application of the APIQ1 Monogram.  The APIQ1 and ISO TS29001 standards are identical, with exception of Annex A which is specific to the APIQ1 monogram and not included as a part of the ISO TS29001 standard.  ISO TS29001 QMS certification can be obtained from other registrars, not just the API.

I hope this helps.

Best regards,

Bill

An International Standard or format for API Q1 Management Reviews?

Posted on October 24, 2011 by Bill

QUESTION:

Fayyaz asks the following about APIQ1 :
Dear Sir
Kindly let me know that is there any INTERNATIONAL STANDARD or guideline for conducting API Q1 management reviews effectively on standard forms, records or patterns.

REPLY:

Hello Fayyaz,

There is no international standard or required format reporting or documenting management reviews.  Each organization must make their own decision as to the format that will work best for them.

As long as all input items as defined in clause 5.6.2 are presented or discussed and that the output items as defined in clause 5.6.3 are document, that all that’s required to show evidence of conformance.

A best practice is to prepare an agenda that shows all management review input items discussed as well as review of the quality policy and objectives.  The output items, which include action items or management decisions made regarding resources must be documented.

If a meeting is used to conduct the management review, consider documenting all information in the form of meeting minutes, along with names of all meeting attendees.

I hope this helps.

Best regards,

Bill Aston

Managing Director, ATCS

ISO 9001, ISO TS29001 and ISO TS2900/APIQ1 QM Systems

Posted on September 26, 2011 by Bill

Knowing and understanding the fundamental requirements of quality management systems used by an organization, or being considered by an organization, can improve the opportunities for success, minimize useless costs, and mitigate confusion or misunderstanding.

Let’s discuss ISO 9001, TS 29001 and API Q1.  Although these QMS standards are interrelated, there are key differences that should be understood for their successful implementation.

ISO 9001:2008:  This is a generic QMS that can be implemented by any organization of any size that provides a service or product.  This standard is not product, source or industry specific.

ISO TS29001:2010:  This QMS is based upon the requirements of ISO 9001.  However, this standard includes the addition of numerous “supplemental requirements”.  These supplemental requirements identify and enhance requirements for documented procedure control features and records of conformity.  This standard is specific to suppliers of equipment, materials and services for the oil and gas industry.

ISO TS29001:2007/APIQ12008 (Addendum 1, 2010):  This standard is identical to ISO TS29001:2010.  However, it includes specific requirements for applying the API monogram to product or equipment.  This is an essential standard for API Q1 certification and API product specification licensing.  It is important to note that ISO TS 29001 does not include API monogram requirements.

Visit www.ISO.org for more details.

API speaks at ASQ, EED, Conference in Las Vegas, NV

Posted on August 21, 2011 by Bill

Bill Aston, Chairman for ASQ, Energy & Environmental Division’s Oil & Gas Committee, announces and encourages all interested quality professionals to attend the ASQ, EED’s 38th conference.

This conference will be held in Las Vegas, NV from Sept. 26 to Sept. 28, 2011.  A presentation related to ISO TS29001/API Q1 and ISO 9001 will be provided by the API.  Other quality related presentations will be conducted by speakers from the ASQ, EED, Nuclear and Environmental committees.  For additional information contact ASQ, EED at www.ASQ.org or Bill Aston at www.astontechconsult.com.