“Shall Be Determined” in 9001


Many of the Quality Management Systems requirements in the ISO 9001: 2015 manual include the verbiage “shall be determined.”  I need to be sure that I understand exactly what this means in this context.  For example, “4.4  QMS and its processes 4.4.1 a)  The inputs required and the outputs expected of the QMS processes are determined.”   Does this mean that there should be process or work instruction written describing this?  Does it mean that there should be documentation showing the development of this information?


Thank you for your question.  It might be useful to look at the definition of the word determine.  According to the Oxford Dictionary:  Determine means to “Ascertain or establish exactly be research or calculation”, Merriam Webster has a similar definition:  “to find out about or come to a conclusion about by investigation, reasoning, or calculation.

Now to your question.  There does not need to be a procedure about how things are determined.  The output, or the determination itself, will serve as evidence that you did it.  But determine things in an honest way.  You and your CB auditor will assess the reasonableness of your determinations based on the context of your organization.  For example, if you are a hospital, and you “determine” that surgeons do not need to wash their hands, you should be subject to a nonconformance for getting that wrong.    In your example, taken from clause 4.4, the best way to do this is to create a flowchart(s) showing a series of process steps and their interactions.  The arrows in and out of each box along with explanatory text, will demonstrate that you have determined the inputs and outputs of each process step.

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

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

Approved Supplier List 17025 or 9001?


Every once and while our company will need to find a rare or hard to find item on the web. Due to the rarity of the item we sometimes need to look at sites that are not a typical supplier. So how would you go about approving a supplier such as Amazon or EBay since they are more like a distributor then a supplier and utilize a large pool of other retailers/sellers?


I think ISO 17025 is not the correct citing; ISO 9001-2015 Section 8.4. would be a better fit.

Approving a distributor is meaningless whether the distributor is Amazon or EBay.  The requirement is under Section 8.4.1 of ISO 9001-2015.  Consider that the supplier is the manufacturer of the item (product) being bought on the web.  The user needs to approve the use of that item – not the supplier. 

The last paragraph under Section 8.4.1 reads, in part: The organization shall determine and apply criteria of the evaluation, selection, and monitoring of performance, and re-evaluation of external providers, based on their ability to provide processes or products and services in according with requirements.  This means that the organization determines the requirements, documents those requirements, and follows the establish requirements.  The requirements here, I suggest, are to approve the supplier based on the supplied item meeting the organization’s needs – specifications.

For example, Home Depot or Lowes is a distributor (source) of a hex-nut that is infrequently used.  The hex-nut has a specification, thread size, length, etc.  The requirement then would be that an inspection of the hex-nut confirms it meets the predetermined requirements. This is all documented.

James Werner

Posted in ISO 17025 - Testing and Calibration Laboratories, ISO 9001 - Quality Management Systems, Other | Tagged

Z1.4 Sample Size


I am trying to determine the sampling size using my ANSI/ASQ Z1.4 table and I wanted to get some clarification. If I am using Table II A and my Sample Size Code letter is D, what would be my sample size? If it falls on an arrow does it mean that I have to change to the next sample size based on where the arrow points?


From Charlie Cianfrani:

If you are using Z1.4, your sample size is selected based on your lot size.  You would pick the AQL you need based on the risk you are willing to take for the process average of percent defective.  It is important to understand what you are doing when using sampling plans, what they are and the protection you are trying to ensure. Thus, the important step is to determine the AQL. Then you select the sample size to provide the level of protection you are striving to ensure. It is more important to understand the theory behind the tables than to mechanically use the tables.

From Fred Schenkelberg:

Use the sample size where the arrow points. In the 2008 and 2013 versions it explains this in section 9.4, “When no sampling plan is available for a given combination of AQL and code letter, the tables direct the user to a different letter. The sample size to be used is given by the new code letter, not by the original letter.”

From Steven Walfish:

The standard sample size for Code Letter D from IIA is a sample size of 8.  But depending on your AQL, a sample size of 8 would be inappropriate, so the standard has arrows to delineate alternative sample sizes to reach the target AQL.  So, you sample size and accept/reject values are changed.  For example, at an AQL of 0.25, you would move down to a sample size of 50, with an accept/reject of 0/1.  If the lot size is less than 50, you would need to do 100% inspection.  In other words, there is no sampling plan that can give an AQL of 0.25 without a minimum sample size of 50.

From James Werner:

Yes.  When using Z1.4 two items need to be known, lot size and the AQL (Acceptance Quality Limit).  You use Table I – Sample size code letters to determine the Sample size code letter based on the Lot or batch size.  In the question below that was determined to be “D”.  Next step is to use Table II-A to find the sample size related to the sample size code letter – D and the AQL.  On Table II-A go across the table’s row for letter D until it intersect the given AQL column heading.  If an arrow is in that intersection point, follow the arrow then go back to the sample size code letter column to find the actual sample size (if a up/down arrow is in there then you choose).

Example 1.  Code letter is D (as in the question below).  Let’s say the AQL is 0.25.  Starting at code letter D, move across that row until you intersect at the AQL 0.25 column.  There’s a down arrow this row/column intersection.  Follow the arrow downward until the “Ac Re” reads ” 0 1″.  Staying on this row go back to the Sample size code letter column and find Code Letter H and Sample size = 50.  This means for the lot size with code letter D and with an AQL of 0.25 the sample size = 50 and accept the entire lot if no nonconformances were found else reject the entire lot if 1 or more nonconformance were found in the sample.

Example 2.  Let’s say the Sample size code letter was determine from Table I to be “F”.  Looking at Table II-A; If the AQL = 0.65, then the sample size would be 20 and the lot would be accepted zero nonconformance.  But if the AQL = 0.15 then the sample size would be 80.

ASQ/ANSI Z1.4 is available for purchase in PDF as well as hard copy.

Posted in Other, Sampling, Z1.4 & Z1.9 - Sampling | Tagged , , , | 1 Comment

Audit Timeline


What is the ASQ recommended time frame between an auditee receiving a final audit plan and the audit commencing at the auditee’s site?


From Charlie Cianfrani:

ASQ does not have a recommendation!

From George Hummel:

This is not an ASQ requirement.  A CB generally sends an audit schedule/plan three weeks before the audit.

From Jim Werner:

Typically, the final audit plan has been agreed to by both the auditor and the auditee and it includes the date(s) the audit is to take place. This means that the audit plan includes the audit schedule in one document.  There are many books written, with examples, on this topic.  The ASQ Audit Division is a good source.

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Is Certification Revocable?


If a company is ISO 9001: 2015 certified, is it revocable?


From Jim Werner:

A company can indeed have its certification revoked.  Being certified means the company has established a qualify management system that meets the requirements of ISO9001:2015.  The failure of the company to continue to meet those requirements can result in de-certification.

From George Hummel:

Most CBs will revoke a certificate if the client does not answer an audit non-conformance.  Their contract may define other instances.  The questioner should review his or her organization’s contract.

From Charles Cianfrani:

Certified companies receive surveillance audits periodically. If the company fails to maintain compliance with ISO 9001:2015 requirements, eventually (after a series of intermediary steps related to resolution of nonconformity have been unsatisfactorily pursued) their certification can be voided.

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Transition to ISO 9001: 2015


We are in the process of reviewing our policies and procedures to be compliant with the ISO 9001: 2015 standard. When converting from ISO 9001: 2008 to ISO 9001: 2015, how should the version control be handled? Should we start at 0 again or move on to the next number?


I would recommend that the site does not re-number the revisions to zero.  The revision number should be used only for new procedures.

John G. Surak, PhD
Surak and Associates
Clemson, SC
A member of Stratecon International Consultants

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

Cleanrooms, Classes, and Control Charts


My question has to do with cleanroom monitoring, specifically particle counts. Using ISO 14644-1: 1999, (we are still transitioning to the new standard).
We have 27 test sites in our cleanroom. Our Particle Counter takes 10 readings per minute and averages those readings into one value. This is the number we record at each of the 27 test sites. Since an ISO Class 8 Cleanroom can have no more than 3,520,000 particles greater than 0.5 micron in size per cubic meter, for the room, do you add all 27 results and compare to the acceptance criteria? Do you average all 27 results and compare to the acceptance criteria? or as long as each individual result is below the acceptance criteria we are in compliance? what makes me think you add all results together is that the acceptance criteria states: ISO Class 8 Cleanroom can have no more than 3,520,000 particles greater than 0.5 micron in size per cubic meter, for the room. Your input would be greatly appreciated!

The way for analyzing these data is very straightforward. Considering you have continuous data, the most appropriate way for accomplishing this is by using a control chart. Use the 27 readings for constructing the averages needed for a control chart. Identify control limits and respond to special cause variation only. You will know that you are in compliance as long as your control charts remain under control. If you ever find any points out of control, you may want to quarantine the product processed during that time and conduct the appropriate corrective actions. As your regular housekeeping, keep the cleanroom certification current. The same for the particle counter system calibration.

If you are new to control charts, the easiest/simplest reference I have ever found is Understanding Variation – The Key to Managing Chaos by Donald J. Wheeler.

Based on your data performance, you may also be able to identify areas within your cleanroom that perform better than class 8 (7 or better). Knowing where those areas are may be handy.



Posted in Other, Quality Tools | Tagged ,