You are on page 1of 10

Internal Laboratory - Defining the Laboratory Scope - Inspection, Test, Calibration (http://Elsmar.com/Forums/showthread.php?

t=8270) DJN 1st April 2004 03:53 AM

Internal Laboratory - Defining the Laboratory Scope - Inspection, Test, Calibration I have been asked to write the procedure on the Internal Laboratory, but am confused. The standard says that the Lab shall have a defined scope the includes its capability to perform the required inspection, test or calibration services. Question is, how do I define that scope? What evidence would I need to supply? Any help or guidance appreciated. David

JStain - 2008 Internal Lab If I understand you correctly, they want you to define what your capable of doing. Here's a link to some examples: http://www.a2la.org/#

1st April 2004 05:29 AM

This is a bit more involved, however it will give you a place to start. I've seen them as simple a a spread sheet to as complex as a Power Point Presentation.

sal881vw Hello DJN, I think something like this will fit the scope.......... This technical, QMS......whatever, defines the technique used to carry out tests, calibrations........ using standard and in house methods. You can also find valuable information by searching the web for ISO/IEC 17025 Good luck

1st April 2004 05:58 AM

DJN Thanks both. That helps greatly.

1st April 2004 06:30 AM

ralphsulser 1 Attachment(s) Dave, I have attached one of ours which be be helpful for you to see how we put it together. Hope this helps

1st April 2004 06:43 AM

bpritts David: The format provided by Ralph is absolutely on target. With regard to evidence, you need to consider: A. the written procedures (either standards or your own internal) on how to do the procedure B. Evidence of qualification. How do you determine that your internal procedures work? Could be confirming a test using a 3rd party to repeat a test as an audit check, for example. C. Most auditors also have special focus on training of those doing the testing. Have your training records up to date! Best regards, Brad

1st April 2004 11:24 PM

Hershal Quote:

2nd April 2004 09:53 AM

In Reply to Parent Post by DJN I have been asked to write the procedure on the Internal Laboratory, but am confused. The standard says that the Lab shall have a defined scope the includes its capability to perform the required inspection, test or calibration services. Question is, how do I define that scope? What evidence would I need to supply? Any help or guidance appreciated.

David David, The scope provided by Ralph is good, and for an internal lab may be sufficient. I am a bit fuzzy whether TS-16949 requires internal labs to be accredited however. Your external providers are required to be accredited to ISO/IEC 17025 so I am given to understand. If accreditation of internal labs is required, then the scope needs more work. Places to go to look at scopes for either calibration or testing include three of the accrediting bodies that offer accreditation to ISO/IEC 17025: http://www.iasonline.org http://www.a2la.org http://ts.nist.gov/htdocs/210/214/214.htm Hope this helps. Hershal

Hershal David, If you need additional help, contact me off-line. Hershal

2nd April 2004 09:54 AM

ralphsulser

2nd April 2004 10:11 AM

My understanding at this time is that Internal Labs (ours at least) does not require accrediation. However, you are correct about external labs needing it.

Ken K If your company supplies product to GM, your internal lab needs to be ISO 17025 accredited. They are currently upgrading their specs to read: 3.1 General Requirements. Testing is to be performed by a laboratory accredited or audited, by a third party organization recognized by GM, to ISO 17025/IEC Guide 25 or GM GP-10. Include a Scope of Accreditation or a Scope of Activity with the test data. Registration to QS9000 is not a substitute for lab accreditation. Since GP-10 is no longer praticed by GM, your only choice is accreditation.

14th April 2004 05:56 AM

CINDY Ken, I have not heard about these changes yet. Thanks.

14th April 2004 06:18 AM

Do you know if this also applies to the Inspection lab. Our Testing laboratory is in compliance with their new requirements, however our inspection lab is not and we are not planning to. Cindy

tomvehoski Ken, Where is this change officially documented? Is it a customer specific requirement to TS, or somewhere else? Tom

14th April 2004 07:18 AM

D.Scott Quote: In Reply to Parent Post by Ken K If your company supplies product to GM, your internal lab needs to be ISO 17025 accredited. They are currently upgrading their specs to read: 3.1 General Requirements. Testing is to be performed by a laboratory accredited or audited, by a third party organization recognized by GM, to ISO 17025/IEC Guide 25 or GM GP-10. Include a Scope of Accreditation or a Scope of Activity with the test data. Registration to QS9000 is not a substitute for lab accreditation. Since GP-10 is no longer praticed by GM, your only choice is accreditation.

14th April 2004 07:36 AM

This doesn't make much sense to me. I would like to see something official if it is available. Why would GM require accreditation for testing done in-house as a process control? Certainly, if you were sending something out for testing or if you were testing work done by others your lab would need to be accredited but where is the need for in-house testing of your own product? Is this supposed to apply to calibration as well? I don't think GM would "upgrade" their requirement to include GP-10 if GP-10 were no longer available. I don't mean to sound argumentative on this but is it possible you are quoting the existing GM requirement for "outside" testing labs? If this is in fact a mandate of GM, TS16949 is falling apart faster than it can be put into place. 7.6.3.1 Internal Laboratory - Note states - Accreditation to 17025 may be used to demonstrate supplier in-house lab conformity to this requirement but it is not mandatory (lit.). Thanks for anything further you can provide. Dave

Ken K

14th April 2004 07:56 AM

Tom, the changes are in the material specifications. The Interior Systems Group at GM made ISO17025 accreditation for internal labs mandatory if you supply them product. We found this out when GM refused test data listed in PPAP generated from our lab even though we were GP10 certified in the past. Even though Ford and DCX said at the TS16949 rollout meetings they would not require internal labs to become accredited, DCX recently superceded PS-8965 with ISO17025. My guess is accreditation will become mandatory for internal labs in the near future for both.

Howard Atkins When is a Lab a Lab? Quote: In Reply to Parent Post by CINDY Ken, I have not heard about these changes yet. Thanks.

7th May 2004 12:43 AM

Do you know if this also applies to the Inspection lab. Our Testing laboratory is in compliance with their new requirements, however our inspection lab is not and we are not planning to. Cindy The definition of Laboratory in Ts is (3.1.4) "laboratory facility for inspection, test or calibration that may include, but is not limited to, chemical, metallurgical, dimensional,physical, electrical or reliability testing" This would tend to mean to me that even in process measurements or incoming inspection are in fact laboratory processes. This seems to me to be harsh, and would require compliance to 7.6.3.1. Despite this in clause 8.2.4.1 where a layout and functional testing is required as this is not in process does this need to be performed by a defined internal lab.

Any one any input. :confused:

Montse

4th March 2005 04:25 PM

I have the same opportunity. We have a test quality area whete our pieces are analyzed, however is not located in a special area. We located it on the 2nd floor of our installation only for space reasons and maybe in the future we will move near to production floor. Auditor says that is an laboratory....we think that is like the other inspections that we have on the floor during the process... Somebody can definy or clary what means "Facility" for TS ? Facility...is a special area?... Tks in advance

Qualiman Ken K is right of course, but if you are not GM supplier you dont need accreditation of your internal Lab.

4th March 2005 11:20 PM

"NOTE: Accreditation to ISO/IEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory. (7.6.3.1) Qualiman

Hershal Quote:

5th March 2005 10:39 AM

In Reply to Parent Post by Montse I have the same opportunity. We have a test quality area whete our pieces are analyzed, however is not located in a special area. We located it on the 2nd floor of our installation only for space reasons and maybe in the future we will move near to production floor. Auditor says that is an laboratory....we think that is like the other inspections that we have on the floor during the process... Somebody can definy or clary what means "Facility" for TS ? Facility...is a special area?... Tks in advance Some questions that may help you include: What exactly is performed in this area? Is that different than what is performed on the production floor? Is there special test equipment or controlled conditions in the special area that may be different than on the production floor? If the answers indicate that there is special equipment or extra controls, then it can be considered a laboratory. For your accreditation, I recommend contacting EMA (Mexico's accrediting body) before you contact a U.S. based accrediting body. Hope this helps. Hershal

Ken K Quote: but if you are not GM supplier you dont need accreditation of your internal Lab.

7th March 2005 10:20 AM

Actually, I have a feeling that might change. Do any of you DCX suppliers remember PS-8965? (Supplier Testing Action Protocol) We used it in the very early 90's for; The purpose of this standard is to set forth the general requirements with which a testing laboratory shall comply if it is to be recognized as a technically competent source for which submissions of fabric samples and test specimen/test data folders will be considered for material source approval by the Organic Materials Engineering Department, Engineering Office, Chrysler Corporation.

It has been superceded by ISO17025 :rolleyes: In-House Laboratory Scope - Calipers, Pin Gages and Digital Indicators (http://Elsmar.com/Forums/showthread.php?t=10536) ozziegood In-House Laboratory Scope - Calipers, Pin Gages and Digital Indicators I am wondering about my in-house lab scope if I only perform calibration on calipers, pin gages and digital indicators. What would my internal lab scope need to 4th January 2005 01:56 PM

entail??

Hershal Ozziegood,

4th January 2005 02:26 PM

It appears you have adimensional lab, primarily length and diameter. I am presuming that the digital indicators are a length type instrument (like a dial indicator). The diameter part of the scope comes from the pin gages. Your measurement uncertainty (MU) will likely be different for each of the three however. Hershal

Tom W Quote:

4th January 2005 02:41 PM

In Reply to Parent Post by ozziegood I am wondering about my in-house lab scope if I only perform calibration on calipers, pin gages and digital indicators. What would my internal lab scope need to entail?? Welcome to the Cove. The type of lab scope I typically see list the following: Types of Equipment in the lab Which of that equipment requires calibration The types of tests you do in the lab The specifications that the tests are done to. I do not know anything about your situation but you might want to start with these items and fill in the blanks. Are you going for registration to a standard? If so what standard?

gaugefixer Tom; good list; the only thing I would add to it is the resolution and the measurement uncertainty of the lab equipment. Roger Quote: In Reply to Parent Post by Tom W Welcome to the Cove. The type of lab scope I typically see list the following: Types of Equipment in the lab Which of that equipment requires calibration The types of tests you do in the lab The specifications that the tests are done to.

6th January 2005 11:50 AM

I do not know anything about your situation but you might want to start with these items and fill in the blanks. Are you going for registration to a standard? If so what standard?

Marty6619 Re: In-house laboratory scope - Calipers, pin gages and digital indicators Hi, Im work in the smal PME and I need to do LAB SCOPE:mad: for a big customer. Do you have already made a form that I could copy it's rush ??? Thank you Martin In-House (Internal) Laboratory Scope Requirement (http://Elsmar.com/Forums/showthread.php?t=31101) Sean Kelley In-House (Internal) Laboratory Scope Requirement

3rd April 2012 02:28 PM

24th November 2008 08:35 AM

We have an internal lab that tests our own products only but do not provide certificates of analysis on our products to customers. We also do not have an internal Lab Scope which I find unusual but wonder is it a requirement? I was used to almost everyone having a Lab Scope and it seems appropriate but it may not be required.

Stijloor Re: Lab Scope Requirement Quote:

24th November 2008 08:41 AM

In Reply to Parent Post by Sean Kelley (Post 285321) We have an internal lab that tests our own products only but do not provide certificates of analysis on our products to customers. We also do not have an internal Lab Scope which I find unusual but wonder is it a requirement? I was used to almost everyone having a Lab Scope and it seems appropriate but it may not be required. Sean, You started this thread in the ISO/TS 16949 Forum. Is your organization ISO/TS certified or in the process implementing it? If yes, then you are required to have a scope statement for your internal lab. Stijloor.

Sean Kelley Re: Lab Scope Requirement

24th November 2008 08:44 AM

Yes we have ISO/TS 16949 certification. We also have Ford's Q1 certification. I just started here with them ~4 months ago and am taking over them QMS portion that is still considered local. We have corporate functions that manage some of the functions such as Purchasing, Management Review and others.

Stijloor Re: Lab Scope Requirement Quote:

24th November 2008 08:47 AM

In Reply to Parent Post by Sean Kelley (Post 285325) Yes we have ISO/TS 16949 certification. We also have Ford's Q1 certification. I just started here with them ~4 months ago and am taking over them QMS portion that is still considered local. We have corporate functions that manage some of the functions such as Purchasing, Management Review and others. Oops! Was that never discovered during internal and external audits????? Stijloor.

Sean Kelley Re: Lab Scope Requirement Internal audits have said it is not a requirement and therefore N/A. I am not sure about external audits or if they agreed.

24th November 2008 09:05 AM

Stijloor Re: Lab Scope Requirement Quote: In Reply to Parent Post by Sean Kelley (Post 285331) Internal audits have said it is not a requirement and therefore N/A. I am not sure about external audits or if they agreed. Sean, Show this to your folks..... Quote: 7.6.3.1 Internal laboratory

24th November 2008 09:14 AM

An organizations internal laboratory facility shall have a defined scope that includes its capability to perform the require d inspection, test or calibration services. This laboratory scope shall be included in the quality management system documentation. The laboratory shall specify and implement, as a minimum, technical requirements for * adequacy of the laboratory procedures,

* competency of the laboratory personnel, * testing of the product, * capability to perform these services correctly, traceable to the relevant process standard (such as ASTM, EN, etc.), and * review of the related records. NOTE Accreditation to ISO/IEC 17025 may be used to demonstrate the organizations in-house laboratory conformity to this requirement but is not mandatory. Emphasis mine. Hope this helps. Stijloor.

AndyN Re: Lab Scope Requirement Sean:

24th November 2008 09:26 AM

Gotta have a lab scope! Not an internal audit call, I'm afraid, they've been auditing from a point of view, not the requirements! The definition is in the front of the TS requirements. I have a copy of a lab scope which was successfully reg. by VCA

WCHorn Re: In-House (Internal) Laboratory Scope Requirement

24th November 2008 12:00 PM

Section 7.6 is titled Control of monitoring and measuring devices, (to me clearly the topic is calibration) yet TS includes testing laboratory requirements as a sub element of 7.6. Just a poke at the authors. I believe the key phrase is required testing. If you have an automotive product that does not have any testing requirements, why are you testing it? If you are testing it, then there must be requirements for that testing, either your own or the customers. In eithe r case, clearly a laboratory scope is required. Of course, your third-party auditor is the final authority. Its not a big deal and I recommend a lab scope because its a good idea. With a lab scope, you and your customers know the testing your laboratory is competent to perform. That leads me to a further question for the forum. Is it a requirement to have a calibration scope and an inspection scope, in addition to a laboratory (testing) scope?

Stijloor Re: In-House (Internal) Laboratory Scope Requirement Quote:

24th November 2008 12:05 PM

In Reply to Parent Post by WCHorn (Post 285361) Section 7.6 is titled Control of monitoring and measuring devices, (to me clearly the topic is calibration) yet TS includes testing laboratory requirements as a sub element of 7.6. Just a poke at the authors. I believe the key phrase is required testing. If you have an automotive product that does not have any testing requirements, why are you testing it? If you are testing it, then there must be requirements for that testing, either your own or the customers. In either case, clearly a laboratory scope is required. Of course, your third-party auditor is the final authority. Its not a big deal and I recommend a lab scope because its a good idea. With a lab scope, you and your customers know the testing your laboratory is competent to perform. That leads me to a further question for the forum. Is it a requirement to have a calibration scope and an inspection scope, in addition to a laboratory (testing) scope? Because calibrations and testing are typically performed in different facilities utilizing different resources, I can see that there are different scope statements. I would not see any problem in combining those into one document as long as it is clear what is included. Just a matter of determining what works best. What do my Fellow Automotive Covers think? Stijloor.

Icy Mountain Re: In-House (Internal) Laboratory Scope Requirement Quote: In Reply to Parent Post by WCHorn (Post 285361) Is it a requirement to have a calibration scope and an inspection scope, in addition to a laboratory (testing) scope?

24th November 2008 03:18 PM

It is a requirement to have a laboratory scope. If you prefer (and I suggest that you do), you can roll inspection, testing and calibration into one scope. How I answered this finding is on the first page of this thread (laboratory is highlighted). Quote: In Reply to Parent Post by Stijloor (Post 285363) I would not see any problem in combining those into one document as long as it is clear what is included. Just a matter of determining what works best. What do my Fellow Automotive Covers think? :yes:Agree. Roll it in to one if it works for you. See above link for an example of developing a laboratory scope that passed examination as an audit finding corrective action.

AndyN Re: In-House (Internal) Laboratory Scope Requirement 1 Attachment(s) Try this as an example. ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope (http://Elsmar.com/Forums/showthread.php?t=54171) Dan M ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope In our Stage 2 audit we received the following minor nonconformance:

24th November 2008 03:34 PM

23rd April 2012 09:44 PM

The process to ensure that the internal laboratory scope is defined is not fully effective. The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records. The Laboratory scope did not capture requirements for competency of personnel or review of related records. Our laboratory scope document consists of a following matrix that includes: Test Description | Instrument(s) | Test Method (i.e. ASTM#) Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position. I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks!

Stijloor Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope A Quick Bump! Can someone help Dan? Thank you very much!! Stijloor.

24th April 2012 02:28 AM

qusys Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope Quote: In Reply to Parent Post by Dan M (Post 479076) In our Stage 2 audit we received the following minor nonconformance:

24th April 2012 04:12 AM

The process to ensure that the internal laboratory scope is defined is not fully effective. The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records. The Laboratory scope did not capture requirements for competency of personnel or review of related records. Our laboratory scope document consists of a following matrix that includes: Test Description | Instrument(s) | Test Method (i.e. ASTM#) Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education,

experience, skills, and training necessary for the position. I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks! Hi, the requirement of ISO TS related to the " review of the records" for internal labs is related to the whole internal lab mgmt and not only for the training. In the scope of the lab you shall specify how you are proceeding for the " related records review". For example, you can set periodical meeting where you examine the KPI of the activity or the major issue of the activity and fixing solutions. Besides you can examine the chance of changing procedure or the introduction of new method as well as the needs of new training for your personnel, in brief a sort of mgmt review for the lab based upon the technical requirements of the 7.6.3.1 clause. Hope this helps:bigwave:

AndyN Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope Quote: In Reply to Parent Post by Dan M (Post 479076) In our Stage 2 audit we received the following minor nonconformance:

24th April 2012 06:23 AM

The process to ensure that the internal laboratory scope is defined is not fully effective. The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records. The Laboratory scope did not capture requirements for competency of personnel or review of related records. Our laboratory scope document consists of a following matrix that includes: Test Description | Instrument(s) | Test Method (i.e. ASTM#) Can I address "competency of laboratory personnel" by linking to our HR Job Description for a Laboratory Technician? It defines the minimum education, experience, skills, and training necessary for the position. I am at a total loss for how to address "review of related records." Can anyone provide some examples? Many thanks! Dan - the auditor is wrong! I don't have the requirement open in front of me, but I faced a similar issue about lab scope not being complete. Nowhere in the description (definition in the standard) does it even suggest that competencies need to be defined within the scope and, quite frankly, your auditor is smoking something bad if they even imagine that's where you'd list them! And what do they mean about review of records? Which records? Where (clause) is it in ISO/TS 16949? Frankly an 'effective' scope is BS, anyways! So you know they are making it up! I used examples of lab scopes from ISO/IEC 17025 accredited labs, found on the internet as an example. Competencies could be in your JD's. This is another case of us not being the right place to help you address what the auditor hasn't properly communicated to you (or us, for that matter). Please, call your CB, ask for their technical people and get them to explain what the auditor is asking for. If they refer you back to the auditor, tell them "No thanks, he left without telling us when he had an opportunity, if YOU don't know what they wrote, it's YOUR problem and I'm rejecting the NC"...:mg:

Dan M Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope Quote:

2nd May 2012 03:31 PM

In Reply to Parent Post by AndyN (Post 479122) Dan - the auditor is wrong! I don't have the requirement open in front of me, but I faced a similar issue about lab scope not being complete. Nowhere in the description (definition in the standard) does it even suggest that competencies need to be defined within the scope and, quite frankly, your auditor is smoking something bad if they even imagine that's where you'd list them! And what do they mean about review of records? Which records? Where (clause) is it in ISO/TS 16949? Frankly an 'effective' scope is BS, anyways! So you know they are making it up! I used examples of lab scopes from ISO/IEC 17025 accredited labs, found on the internet as an example. Competencies could be in your JD's. This is another case of us not being the right place to help you address what the auditor hasn't properly communicated to you (or us, for that matter). Please, call your CB, ask for their technical people and get them to explain what the auditor is asking for. If they refer you back to the auditor, tell them "No thanks, he left without telling us when he had an opportunity, if YOU don't know what they wrote, it's YOUR problem and I'm rejecting the NC"...:mg: As you can tell I have been very busy the past several weeks and hadn't a chance to follow-up to your post. I was busy coordinating our responses to the CB's corrective action requests. Due to lack of time, we capitulated and accepted the corrective action request. I added a statement to the Laboratory Scope that points toward the JD's. For "review of related records" I added the statement "laboratory personnel participate in statistical studies to analyze variation in test results. Related record are reviewed to verified that the laboratory technician is competent in performing the test."

morteza Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope

3rd May 2012 08:16 AM

Hi Dan I agree with Andy. The auditor is wrong. According to ISO/TS clause 3.1.5 the lab scope contains: - A list of tests . - A list of equipment - A list of methods So it is not necessary to include requirements for competency of personnel. For your case, refer to job description document can be acceptable. But please pay attention that Job Description for a Laboratory Technician is a general competency list. Maybe you need special skills for a special test which is not stated in job description document. I recommend you to provide an independent table stating competency needed for each test or a group of tests.

AndyN Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope Quote:

3rd May 2012 09:32 AM

In Reply to Parent Post by Dan M (Post 480194) As you can tell I have been very busy the past several weeks and hadn't a chance to follow-up to your post. I was busy coordinating our responses to the CB's corrective action requests. Due to lack of time, we capitulated and accepted the corrective action request. I added a statement to the Laboratory Scope that points toward the JD's. For "review of related records" I added the statement "laboratory personnel participate in statistical studies to analyze variation in test results. Related record are reviewed to verified that the laboratory technician is competent in performing the test." Oh, Dan, Dan! I fear all you have done is re-inforced that this auditor is (in their mind) correct in recording such an NC! So, the next TS audit he does, he's going to go to them, write the same thing and they'll do the same...and so on. I'd still suggest that you remove it, contact your CB operations people and tell them that, in review, you realize it isn't a requirement and, that you'd prefer not to have the auditor back. We need, in our industry, for clients to hold the CB community to a high standard! Management will never support management systems implementation, when certification drags it through the dirt like this.

qusys Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope Quote:

3rd May 2012 10:17 AM

In Reply to Parent Post by morteza (Post 480286) Hi Dan I agree with Andy. The auditor is wrong. According to ISO/TS clause 3.1.5 the lab scope contains: - A list of tests . - A list of equipment - A list of methods So it is not necessary to include requirements for competency of personnel. For your case, refer to job description document can be acceptable. But please pay attention that Job Description for a Laboratory Technician is a general competency list. Maybe you need special skills for a special test which is not stated in job description document. I recommend you to provide an independent table stating competency needed for each test or a group of tests. Hi, I do not think that the auditor was completely wrong in the essence of the NC . He wrote citing the original poster : "The TS 16949-2009 specification requires that 'The laboratory shall specify and implement, as a minimum, technical requirements for ... competency of laboratory personnel... review of related records. The Laboratory scope did not capture requirements for competency of personnel or review of related records" I am assuming that he was redundant in writing " The Lab scope did not capture........" , because the lab scope does not requires this, but if he did not find how the internal lab meets " the requirement for lab personnel competence" and " lab related records review" somewhere ( in the documentation of the lab , in some database or in other evidences), he was right in raising the NC. This is a requirement related to the 7.6.3.1 clause of ISO TS.:bigwave:

rickmcq Re: ISO/TS 16949 Stage 2 Audit Nonconformance Against 7.6.3.1 Laboratory Scope Quote:

3rd May 2012 02:25 PM

In Reply to Parent Post by Dan M (Post 480194) For "review of related records" I added the statement "laboratory personnel participate in statistical studies to analyze variation in test results. Related record are reviewed to verified that the laboratory technician is competent in performing the test." May I ask how you arrived at that response? TS says " The lab shall specify and implement, as a minimum, technical requirements for...... review of related records". I don't have a clue what that means. Rick

10