SBS - The best value in QMS software

Rules for Achieving IATF Recognition: 4th edition for ISO/TS 16949

#31
Well, it looks like the Cossacks beat me to it.

Everyone who is registered to ISO/TS16949:2009 needs to read the document that rjkozak posted very carefully. Also, you should get a copy of Automotive Certification Scheme for ISO/TS 16949, Rules for Achieving and Maintaining IATF Recognition, Fourth Edition.

Most especially, items 1 and 2 in the 4th Edition Top Impacts and What They Mean to Your Organization that rjkozak posted.
4th Edition Top Impacts and What They Mean to Your Organization said:
1) Existing site extensions will need to transition into single certified sites between April 1, 2014 and April 1, 2015 according to the process described in the IATF Certification Body Communiqu? #2013-006 (available from the IATF website). This adds significant audit days to convert a site extension to a site , contact your CB for specifics.
As has been discussed previously, this is a huge hassle and makes for Byzantine interpretation of what goes where. Expect that registration bodies will take full advantage of this. If you are not prepared for this change when they show up, you are going to end up with a terminated audit, a cancelled cert and expensive followup audit and more frequent surveillance$$$$$$$$$$$$
4th Edition Top Impacts and What They Mean to Your Organization said:
2) Clause 1.0 Eligibility- Manufacturing sites where production and/or service parts are manufactured and supplied to Automotive customers are eligible for TS certification. The term ?subscribing customer? has been removed and eligible quality management systems must support all automotive customers (requiring TS or not). Expect additional workload to suppliers ; for review of supplier quality manuals , control plans, FMEA?s , MSA, and other core tools that may have not been required with term TS subscribing customer.
THIS IS HUGE AND EVERYONE IS MISSING THIS BECAUSE IT IS NOT PLAIN. Here's what this means: The registration bodes are going to require a full application of the Core Tools to every single product that you ship to any customer that builds something on wheels. Bus manufacturers, ambulance manufacturers, scooter manufacturers, you name it.

We have sectioned off our products that do not ship to TS "subscribers" for years. No FMEA for that product? No problem, not required. No MSA for that 8-32VDC input USB charging port? It doesn't matter, we only ship it to an ambulance manufacturer that doesn't even require ISO9001.

Alas, no more. They're going to want to see objective evidence for the application of the Core Tools to every product that ships to anyone in the new, loosely defined, "automotive" market. Whether the customer requests it or not. When you don't have it when they show up, you are going to end up with a terminated audit, a cancelled cert, an expensive followup re-cert audit and more frequent surveillance$$$$$$$$$$$$

There is no way that a company like mine could accomplish this across our entire product catalog in six months. I suspect a change to ISO9001-registered-TS16949-compliant-but-not-registered in our future.

I don't mind applying the Core Tools when the customer requests, the customer pays for the time and effort of doing all the work and generating all the documents, AND, MOST IMPORTANTLY, there's a reason for it. Can anyone here really defend the need to generate a full PPAP, with the 19 points of light documentation package, for a $25 dual port USB charger?

This whole thing is worse than the Frank-Dodd Act and even less efficacious.
 
Elsmar Forum Sponsor
#32
Having thought about this for 24 hours: I wonder if a statement from a couple of dozen of my top "automotive" customers to the effect that "Full PPAP and core tools application is not required unless specifically requested, in writing, as part of the Purchase Order requirements for [Supplier] product," would be enough to stop this madness.

Certification body representatives feel free to chime in here.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#33
I am not sure why they changed the concept of CB auditors focusing on subscribing customers:
The term “subscribing customer” has been removed and eligible quality management systems must support all automotive customers (requiring TS or not).
In my opinion, this is a HUGE mistake. CB Auditors should FOCUS the audit sample on issues, product lines, contracts, etc. related to customers that have invoked TS-16949 certification. They are the reason behind the registrants seeking certification. In my mind, it makes NO SENSE whatsoever to dilute the audit efforts looking at processes, products, etc for customers that don't value/require the certificate.

Even in the ISO 9001, AS9100, etc certification world... I would hope that ISO 17021 would adopt the concept of subscribing customers. I am surprised with this IATF change of direction.

Having thought about this for 24 hours: I wonder if a statement from a couple of dozen of my top "automotive" customers to the effect that "Full PPAP and core tools application is not required unless specifically requested, in writing, as part of the Purchase Order requirements for [Supplier] product," would be enough to stop this madness.

Certification body representatives feel free to chime in here.
I don't think this whole thing was well thought out. PPAP requires the customer support to review the submission, in my understanding. What's a supplier to do when they submit a PPAP to a customer that did not request one and will provide no feedback?

As for your question if CB's could disregard a requirement from a QMS standard if the registrant's customers are on the record stating that they don't require compliance to that specific requirement could turn into a potential loophole and bureaucratic nightmare to track who wants PPAP or not... Personally, if a customer provides blanket waivers for specific requirements, as a CB auditor, I would not insist on adherence to the requirement for that customer/product line, as it would not add any value to any interested party.

Oh what a tangled web we weave....
 
Last edited:
#34
As for your question if CB's could disregard a requirement from a QMS standard if the registrant's customers are on the record stating that they don't require compliance to that specific requirement could turn into a potential loophole and bureaucratic nightmare to track who wants PPAP or not...
But that's the point, up until April 1, my CB wasn't applying TS requirements to any customers other than the single entity that required us to get certified.

I have customers that require a PSW; they don't invoke PPAP, they just want a PSW. They really don't know why and don't have anyone to review a full PPAP anyway. I include "PPAP documentation limited to this PSW" in the comment section on the PSW. They sign.

I have several customers that request PSW's like they request Certificates of Conformance. They simply will not sign them and return them. "They're just like Certificates of Conformance," they say, "We're not signing them and returning a copy!" I print these emails and put them with the PSWCoC, just to satisfy third party auditors.
:frust::bonk::truce:
 
R

Reg Morrison

#36
The IATF document now leaves no room for ambiguity: consultants can NOT BE physically present at the site, during a CB audit.

Will anyone sue the IATF for restriction of trade? What about the constitutional amendment of freedom to assemble? Unchecked powers surely corrupts....:mad:
 
#37
The IATF document now leaves no room for ambiguity: consultants can NOT BE physically present at the site, during a CB audit.
I have a gentleman that does all of my auditing, with the exception of auditing the audit process. This takes him approximately 5 days per year. I audit the audit process.

He also fills the Quality Manager role at another small company. This takes him about 20 days per year.

In both cases, he is listed as a Contract Employee. He is most certainly not a consultant. Never let a third party auditor define terms for you.
 

Helmut Jilling

Auditor / Consultant
#38
I have a gentleman that does all of my auditing, with the exception of auditing the audit process. This takes him approximately 5 days per year. I audit the audit process.

He also fills the Quality Manager role at another small company. This takes him about 20 days per year.

In both cases, he is listed as a Contract Employee. He is most certainly not a consultant. Never let a third party auditor define terms for you.
I partially agree with you, doing the audits should be a nonissue. Not so sure about the second example....would have to look further... The contract employee issue may not be an issue...how they pay the guy should be immaterial.... But, they would have to demonstrate how 20 days a year makes him a meaningful "member of management." The intent is not a title, but a meaningful position with authority and responsibility. A part time contract employee? ...maybe.... 20 days a year....would really have to look into that.....
 
R

Reg Morrison

#39
I partially agree with you, doing the audits should be a nonissue. Not so sure about the second example....would have to look further... The contract employee issue may not be an issue...how they pay the guy should be immaterial.... But, they would have to demonstrate how 20 days a year makes him a meaningful "member of management." The intent is not a title, but a meaningful position with authority and responsibility. A part time contract employee? ...maybe.... 20 days a year....would really have to look into that.....
??? Not sure what you are talking about. Nobody mentioned the guy as the management rep for Icy's organization.

Are you confused?
 

Helmut Jilling

Auditor / Consultant
#40
??? Not sure what you are talking about. Nobody mentioned the guy as the management rep for Icy's organization.

Are you confused?
Fair point..I thought Icy inferred that from his comment...but it is possible I inferred something not intended. The same question could be implied however, a Quality "MANAGER" who only works 20 days a year? I would definitely follow it as an audit trail...
 
Thread starter Similar threads Forum Replies Date
Crimpshrine13 Rules of achieving and maintaining IATF recognition - Determining audit days IATF 16949 - Automotive Quality Systems Standard 2
J Rules for Achieving IATF Recognition 3rd Edition FAQ?s - Certification Decision 5.12 IATF 16949 - Automotive Quality Systems Standard 2
M Rules for achieving IATF (International Automotive Task Force) recognition IATF 16949 - Automotive Quality Systems Standard 1
J Certification Scheme for ISO/TS 16949:2002 - Rules for achieving IATF Recognition IATF 16949 - Automotive Quality Systems Standard 4
P IATF Information - Rules for Achieving IATF Recognition - TS 16949 3rd Edition ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 23
C Help with Rules for achieving IATF recognition IATF 16949 - Automotive Quality Systems Standard 7
A Rules for Achieving IATF Recognition - A Second Edition for ISO/TS 16949:2002 ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 10
S IATF Certification Rules - "Rules for Achieving IATF Recognition" 2nd edition soon? ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 14
M Rules for achieving for ISO/TS 16949:2002 Certification (Registration) IATF 16949 - Automotive Quality Systems Standard 7
O Release of Sanctioned Interpretations (SIs) related to Rules 5th Edition and Sanctioned Interpretations related to IATF 16949:2016 IATF 16949 - Automotive Quality Systems Standard 0
G IATF Rules for COVID 5th revision - Re-certification audit timing IATF 16949 - Automotive Quality Systems Standard 3
T IATF Rules for sharing production space with another company IATF 16949 - Automotive Quality Systems Standard 10
M Indian Medical Device Rules - Manufacturing and Wholesale Lic. Required? Other Medical Device Regulations World-Wide 12
S Is QMS like a set of rules and regulations that a company follows? ISO 13485:2016 - Medical Device Quality Management Systems 10
D Rules for Paper Forms outside of an eQMS - 3 Questions (ISO 13485) Document Control Systems, Procedures, Forms and Templates 9
S Drugs and Cosmetics Rules - India Other Medical Device Regulations World-Wide 0
G Do HIPAA Rules Apply to a 3rd Party Logistics Shipper? Other US Medical Device Regulations 2
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
K EU MDR Rule 11 - Does the 'Risk logic' used in Rule 11 conflict with that used in the other rules? EU Medical Device Regulations 2
N Is there a standard / rules pertaining to eating in medical device manufacturing area? Manufacturing and Related Processes 5
M Informational TGA – Advertising health products: Rules about safety claims in advertising Medical Device and FDA Regulations and Standards News 0
D Volkswagen Complaints Management Rules Customer and Company Specific Requirements 0
M Informational US FSA – Surgical staples – Guidance and proposed rules Medical Device and FDA Regulations and Standards News 0
M Informational MDCG 2019-2 Guidance on application of UDI rules to device-part of products referred to in Article 1(8), 1(9) and 1(10) of Regulation 745/2017 Medical Device and FDA Regulations and Standards News 0
M Medical Device News EU – MDCG 2019-1 MDCG guiding principles for issuing entities rules on Basic UDI-DI Medical Device and FDA Regulations and Standards News 0
M Why have IATF rules required the CBs to audit remote supporting functions at first? IATF 16949 - Automotive Quality Systems Standard 11
T Informational Family or Baseline PFMEA Rules FMEA and Control Plans 22
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
M Medical Device News FDA Withdrawals Two Proposed Rules Other US Medical Device Regulations 0
R How to keep track of all FDA rules and regulations for medical device companies 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C What are rules to notify customers if IATF cert is put on hold? IATF 16949 - Automotive Quality Systems Standard 2
L What are the rules on significance of digits in numbers in IEC/ISO standards? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5
J Rules associated with introducing new QMS processes IATF 16949 - Automotive Quality Systems Standard 1
R IATF 16949 certification rules IATF 16949 - Automotive Quality Systems Standard 5
K Rules or guidelines for quoting FDA announcements and such? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
M INDIA - GSR 78 (E) - New Medical Device Rules - 2017 Other Medical Device Regulations World-Wide 6
L Hypothesis Testing + Thumb Rules Inspection, Prints (Drawings), Testing, Sampling and Related Topics 1
L Percentage Thumb Rules for Quality Costs Misc. Quality Assurance and Business Systems Related Topics 1
A EASA Easy Access Rules for Continuing Airworthiness - June 2017 EASA and JAA Aviation Standards and Requirements 0
Sidney Vianna IATF 16949 Areas of Impact - Rules 5th Edition Document (February 2017) IATF 16949 - Automotive Quality Systems Standard 0
Uriel Alejandro Including "Internal Rules" as Controlled Documents in a QMS Document Control Systems, Procedures, Forms and Templates 7
Marc Rules for Posting in the Paid Consulting, Training and Services Forum Paid Consulting, Training and Services 3
M I am looking for the text of the copyright 'rules' for AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
F Rules to respect when changing from Certification Body ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
Anerol C IATF or ISO TS 16949 rules about Scope of QMS IATF 16949 - Automotive Quality Systems Standard 7
Ajit Basrur New Medical Device and IVD Registration Rules - Pakistan Other Medical Device Regulations World-Wide 5
A PUWER (Provision and Use of Work Equipment Regulations) and old machines (UK rules) Occupational Health & Safety Management Standards 4
M Translating and Rotating Rules when programming or measuring with a CMM Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
M Are there specific rules regarding ISO 13485 and R&D? ISO 13485:2016 - Medical Device Quality Management Systems 4
Mikey324 Questionable Audit Findings after Rules 4th Edition Release IATF 16949 - Automotive Quality Systems Standard 4

Similar threads

Top Bottom