Can a soon-to-be ISO 17025 certified charge its own fees as a company separate from its parent company?

Question:

We are in the process of getting our new laboratory ISO 17025 certified. At this moment, our lab is a part of a parent organization. However, it has been requested that the lab should have its own name and with the ability to charge fees, etc. My question is would that be possible without establishing the lab as its own company (LLC, division, etc.)? If we charge fees, would we be considered a third party lab in relation to our parent company with our own, HR, admins, IT, etc separate from the parent company?

Answer:

The ISO/IEC 17025 accreditation (not certification) process allows for captive laboratory under a parent organization to accredited. ISO/IEC 17025:2005 Clause 4.1.4 states:

If the laboratory is part of an organization performing activities other than testing and/or calibration, the responsibilities of key personnel in the organization that have an involvement or influence on the testing and/or calibration activities of the laboratory shall be defined in order to identify potential conflicts of interest.

 NOTE 1 Where a laboratory is part of a larger organization, the organizational arrangements should be such that departments having conflicting interests, such as production, commercial marketing or financing do not adversely influence the laboratory’s compliance with the requirements of this International Standard.

 NOTE 2 If the laboratory wishes to be recognized as a third-party laboratory, it should be able to demonstrate that it is impartial and that it and its personnel are free from any undue commercial, financial and other pressures which might influence their technical judgement. The third-party testing or calibration laboratory should not engage in any activities that may endanger the trust in its independence of judgement and integrity in relation to its testing or calibration activities.”

 

There is no requirement that the “laboratory should have its own name and have ability to charge fees”. It is up to the laboratory to organize in a manner that it sees fit as long potential conflicts with the parent organization are identified. Notes 1 and 2 provide more guidance for this Clause. Nor is there a requirement that it have its own IT, HR and other departments as long as those arrangements are identified and any potential conflict of interest resolved to the Accrediting Body’s interest.

 

Dilip A. Shah ASQ Fellow, ASQ-CQE, CQA, CCT, 
President, E = mc3 Solutions,

Technical Director, Sapphire Proficiency Testing Services

Chair, ASQ Measurement Quality Division (2016, 2012-2013, 2007, 2004-2005)

Past Member of the A2LA Board of Directors (2006-2014)           
Tel: 330-328-4400 
Fax: 1-888-226-9533 
E-mail: emc3solu@aol.com

Posted in Other

Conducting an internal audit before a third-party audit

Question

Shouldn’t a company audit its own processes and procedures to ensure compliance before a third-party audit is scheduled?

Answer

Thanks for contacting ASQ’s Ask the Experts Program.  In response to your inquiry, yes, it would be a good idea for the organization to conduct an internal audit before a third party audit is performed, especially if no previous internal audit has been completed.  It’s important to remember that the primary purpose of conducting an internal audit is to assess the continued implementation and effectiveness of the quality management system and its processes.  Not conducting internal audits on a scheduled basis could jeopardize the organization’s ability to maintain its ISO 9001 certification as well as increase the probability of the occurrence of nonconformances and customer complaints.  An internal audit process is an indispensable tool required for the assessment of the QMS, its processes as well as to identify opportunities for improvement.

 

I hope this helps.

Best regards,

Bill

 

Bill Aston, Managing Director

Aston Technical Consulting Services, LLC

Office: (281) 359-2827

Website: www.astontechconsult.com

Posted in Other

Receiving a signed audit report post-audit

Question

Is it acceptable for an auditor to submit an UNSIGNED audit report in Word version? I’m QA director at a pharmaceutical CRO. We were recently audited by one of our clients. They refuse to provide a signed audit report because they say it is not their policy to do so. This seems wrong to me on many levels. Is this acceptable?

Answer

Thank you for submitting this question to ASQ’s Ask the Experts Program.

I’m not aware of any requirement that states that the auditor must sign the audit report. In situations, where an audit organization is involved, the audit organization’s management or representative signs the audit report cover letter. The name of the lead or principal auditor, as well as the names of all audit team members, should be included in the audit report. The actual audit report may or may not include a signature sign-off from the auditor or audit team members.

If an audit organization is not involved, then it would be the responsibility of the lead or principal auditor to sign the cover letter or audit report to approve its content. As you’re aware, the audit report serves as a record to document the audit results. For this reason, the signature of the auditor or audit organization is essential since it confirms the content of the audit report. This sign-off may appear on the cover letter or the report.

If your organization requires sign-off on the audit report in addition to the cover letter, then this requirement should be identified and agreed upon by all parties prior to conducting the audit. In the future, if no audit organization is involved, consider requiring independent auditors to provide copies of their qualifications and auditor certifications (ASQ CQA, Exemplar Global, IRCA, PECB or other) before the start of the audit. Aforementioned could minimize a recurrence of this or a similar concern.

I hope this helps.

Best regards,

Bill

 

Bill Aston, Managing Director

Aston Technical Consulting Services, LLC

Coldspring, TX 77331

Website: www.astontechconsult.com

Posted in Other | 1 Comment

Audit Versus Inspection?

Question

Would you please tell me what the differences between audit and inspection are?

Answer

This is a great question.   We can start with the definitions of inspection and audit per the new ISO 9000:2015 standard.  Inspection is “Determination of conformity to specified requirements”  (3.11.7)  and Audit is “systematic, independent and documented process for obtaining objective evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled”  (3.13.1).    Without parsing the words to much, the difference is one of scale:  Inspection is most often associated with inspecting a product or a service to make sure it is right, and an audit is most often associated with a higher-level review of the system that is designed to produce and inspect the product or service.    An audit of a manufacturing process wouldn’t just inspect the product, it would ensure (at a system level) that required inspections had already been performed on the product.  I have often made the differentiation in the following way… “An inspection is down in the grass, but to do an audit, you have to climb a tree.”  The reflects the difference in purpose and perspective for an audit.   Other authors, such as Arter, Sayle, and Russell refer to inspections as ‘backward looking’, that is, what was actually done to provide a product or service, while audits are ‘forward looking’.   Audits ensure that proper management controls are in place to ensure product quality into the future.   Instead of inspecting quality in (to a product produced in the past), an audit evaluates how well a quality system will predict and prevent quality problems (in the future).   My three favourite references are Quality Audits for Improved Performance by Dennis Arter, Management Audits, by Allan Sayle, and the ASQ Auditing Handbook, edited by JP Russell.

Thanks very much,

Denis J. Devos, P.Eng
A Fellow of the American Society for Quality
Devos Associates Inc.
(519) 476-8951
www.DevosAssociates.com

Posted in Auditing, Other | Tagged | 1 Comment

Transitioning to ISO 9001: 2015

Question

ISO 2015 has a 3 year implementation period. I recertified in 2014 and need to recertify in 2017. At this point I have a little under one year to transition instead of the 3 years identified. What alternatives are there that I might take advantage of so I have a longer transition period? My 3rd party registrar has been no help.

Answer

I would suggest that this individual approach their registrar/auditor and reason with them. I have heard of 3rd party auditors who are willing to help organizations with their transitions in numerous ways, including finding a comfortable way to transition without losing investment made in the current standard.

Second, the requirement to transition over to the new standard is not demanding that people wait until their current certificate runs out.  This company can begin a gradual transition right away. Stretching it over a couple years gives a company plenty of time to ‘learn’ and transition. Therefore, 2017 would be a possible time for a smooth change over to the new standard.

Registrars are our helpers; not some strangers lurking in the dark. They should be approachable and willing to help.

Also ASQ, as well as other sources, offer various forms of transition training and information.  The new standard can seem a bit intimidating at first glance but once thoroughly examined, it is actually more simple in several areas.

Atychiphobia – a persistent fear of failure can lead us to see stumbling blocks ahead of us. You can turn those stumbling blocks into stepping stones with some support from your registrar and a positive attitude.

Bud Salsbury, CQT, CQI
Quality Assurance Manager
Takco Manufacturing

For more information about ISO 9001: 2015, please visit our Learn About Quality page or view these articles about transitioning to ISO 9001: 2015.

Posted in ISO 9001 - Quality Management Systems, Other | Tagged , ,

Switching Rules

Question 

We are planning to implement ANSI/ASQ Z1.4-2003(R2013) sampling inspection plan with our Finish products which are currently 100% inspected by QC Inspectors.  I read  about the importance of the switching rules  on a continuing stream of lots and have the following  questions:
1.Is it acceptable to select a specific plan (tightened, normal or reduced ) and use it without the switching rules?
2.Are there any exceptions which allow us to use a specific plan without applying  the switching rules?

Answer

  1. You can use any plan without using the switching rules but it does run the risk of not meeting the alpha risk in the end. These plans were developed to be used as documented. A normal plan is generally used and the switching rules come in when the clearance number has been obtained.  Some processes may never switch.  If you choose a plan that is tightened or reduced to start with, you potentially will either spend too much on inspection (tightened) or risk having bad product go to the customer (reduced).  It is a business decision for you to make if your customer is not demanding it.  The switching rules are there to protect the producer when the product is running very well or it has problems.
  2. If your customer is not requiring a particular plan, you can use what you want. It is a business decision, no reason for any exceptions.

I hope this helps.

Jim Bossert
Sr Performance Improvement Specialist
JPS Hospital
ASQ Fellow, CQE, CQA, CMQ/OE, CSSBB, CSSMBB
Fort Worth, TX

Posted in Other, Z1.4 & Z1.9 - Sampling

ISO 9001:2015 Documented Information Requirements

Question

I am trying to ascertain if I need to write a Quality Manual to comply with ISO 9001:2015. I see some clauses require ‘documented information’. Do I just address those or the entire document?

Answer

Thank you for the question.

To begin with, the new ISO 9001:2015 Standard does not present a requirement for a Quality Manual. Those requirements are now part of Clause 4.3 and 4.4 of the new standard. That information “shall” be maintained as documented information.

You would be wise to 1] Acquire a copy of the 9001:2015 standard if you haven’t already done so. 2] Check in ASQ.org for information explaining the new terminology related to the standard. 3] Consider pursuing the services of a quality consultant for thorough guidance.

Respectfully,

Bud Salsbury
ASQ Senior Member, CQT, CQI
Takco Manufacturing
Phillips, WI
STEAK@PCTCNET.NET

Posted in ISO 9001 - Quality Management Systems, Other | Tagged ,