SBS - The best value in QMS software

Several questions about TS 16949 including associated ISO 9001 certificate

Sidney Vianna

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
#11
AndyN said:
I can confirm that my CB (NQA, USA) will issue an ISO 9001 certificate, following an ISO/TS 16949 audit, wit no extra time being required for the audit an no extra cost for the certificate(s)
Click to expand...
Even if the ISO 9001 certificate includes non-automotive product lines?
 
Elsmar Forum Sponsor
V

vanputten

#13
#13
"You get 1 certificate which is good for both. If you are TS 16949 registered, you are ISO 9001 registered with the additional TS requirements."


I don't mean to hammer Marc any more nut I need to add my experience. My registrar requires that we explicitly state that we want our TS 16949 audit to include ISO 9001. This has to be satated on the Audit Plan. We have to pay extra money for the certificate. Wget a TS certificate AND an ISO 9001 certificate. One certificate is never good for both 16949 and 9001 as far as I know. Every organization must be registered to both standards. The registration are maintained by different oversight bodies (TS = IATF, 9001 = NOT IATF but national accrediation boards such as ANAB).

An onsite audit may fulfill the requirements for TS or 9001 registration but getting the certificate is a totally different process between TS and 9001.

Sidney can clarify or correct where my posting is incorrect.
 
Howard Atkins

Howard Atkins

Forum Administrator
Staff member
Admin
#14
#14
If the scope is the same then there is no need to add audit time, this was in the 2nd edition rules FAQ. The rules were not changed.
If your registrar charges for issuing the certificate then he charges.
The audit report for IAFT can be used as is for ANAB.
This is a CB service issue. Companies I work with routinely give the ISO 9001 certificate for FREE.

If you do not sell to non automotive customers then you have absoultly no need for ISO 9001, I also have customers that do not require ISO 9001 certificates.
 
V

vanputten

#15
#15
Wow. I must have had a chemical imbalance when I wrote my posting. I used incorrect wording to be sure. So I will try again. Also, I can't believe I used the word "never" as I am a fan of things being relative and dependent on the situation.

1. I referred to Sidney for clarification because I knew he was in the discussion and I knew he was an employee of a certification body. I meant no disregard to anyone else that can clarify as Howard did.

2. I mentioned that our certification body charges only as a side note. As was pointed out, some cb's charge and some do not.

3. I wanted to pont out that some cb's require the auditee to specifically clarify that they are interested in an ISO 9001 cert in addition to the TS 16949 cert. I would not assume that all cb's will provide an ISO 9001 cert, when requested, after a TS audit. My cb will not provide an ISO 9001 cert if the auidt plan and audit report do not specificy that ISO 9001 was part of the scope of the audit. An ISO 9001 cert is not automatic for us and may not be for other organizations. And I do not understnd why this is because TS 16949 inlcudes all of 9001, as we know. I beleive my cb's requirement is related to my main point, that a single audit report will have to go to 2 different Accreditaiton Boides, if you want both a TS 16949 and an ISO 9001 certificate.

4. Items 3 and 4 are my main point. It is my understanding that the IATF does not approve organizations for ISO 9001 registration, only TS 16949 registration (or is it certification?). And I believe the national accreditaiton bodies that approve ISO 9001 registration, cannot approve TS 16949 registrsation. ANAM cannot approve our TS registration and the IATF cannot approve our ISO 9001 registration.

5. Whether or not a specific organzation should get both or just one registration was not supposed to be part of my posting. The answer to this question is definitely.... it depends.

6. Another side note, we have over 7,500 direct customers. Some of them insist that we provide an ISO 9001 certificate and will not accept a TS 16949 certificate. I beleive this is rooted in a lack of awareness of TS 16949.

7. The requirement of audit time is something I was not referring to and is something I am not competent about in any way.

Anyway, I was trying to point out that "if you are TS 16949 registered, you are ISO 9001 registered with the additional TS requirements" is not exactly correct.

Thank you,

Dirk
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
E FIRST Kiss - I's your first kiss and several questions might come to mind Funny Stuff - Jokes and Humour 1
A AS9100 procedures and format - Several questions AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 12
A Several sections of traditional 510(K) have the same or similar requirement of content. US Food and Drug Administration (FDA) 4
M Informational Several US FDA draft guidances, including some specific device guidances for the Safety and Performance Based Pathway Medical Device and FDA Regulations and Standards News 0
MDD_QNA How to deal with FDA after not reporting anything for several years Other US Medical Device Regulations 14
M Informational Several revised or updates USFDA guidance - 9/9/2019 Medical Device and FDA Regulations and Standards News 12
L What to do if a Corrective Action requires several extensions Nonconformance and Corrective Action 7
qualprod Write down same nonconformity in several processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M Informational TGA – Several proposed changes to classification to better align with the EU MDR Medical Device and FDA Regulations and Standards News 0
J Referencing Medical Device in FDA records - Package contains several other components Other Medical Device Regulations World-Wide 1
Q Several Nonconformances with same Root Cause with just one CA ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
MDD_QNA Several CE Marks on a Repaired Class IIa Medical Device EU Medical Device Regulations 9
M UDI (Unique Device Identification) for Convenience Kits with several options Other US Medical Device Regulations 3
F Can be several measurement in a repl considered as nested factor in Minitab analysis Using Minitab Software 14
M Need several examples of procedures Document Control Systems, Procedures, Forms and Templates 5
T ISO 9001 for a Holding Company which owns several Food Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R Auditing to several standards simultaneously Internal Auditing 3
Q One Procedure Containing Several Processes Document Control Systems, Procedures, Forms and Templates 5
D Distribution of a Kit composed of Piece Parts from several Manufacturers EU Medical Device Regulations 3
Q Several Processes in One Procedure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
bio_subbu EU publishes several new & Revised MEDDEV guidance documents (FEB 2012) EU Medical Device Regulations 0
R Involvement of several Departments in Contract Review Process Contract Review Process 12
M I came across this site with several analyzing tools (Excel) Statistical Analysis Tools, Techniques and SPC 4
hogheavenfarm Need better Job Tracking Method - Fabricated in several departments at once Manufacturing and Related Processes 5
A Auditing Checklist for MDD 93/42/EEU that will cross reference several regulations EU Medical Device Regulations 9
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Manufacturing and Related Processes 1
C Equivalence Studies - Validation Activities for several Identical Pieces of Equipment Qualification and Validation (including 21 CFR Part 11) 2
L How to Avoid Missed Welds - Job shop and weld several small quantity jobs Manufacturing and Related Processes 11
J0anne Link to find 502 (f)(1) which is quoted several times in 21 CFR 820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
Q One procedure or several? For "Developing Engineering" ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Control of Documents in several languages and Document Linking ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
V Corporate TS 16949 system or not? Several production locations world wide IATF 16949 - Automotive Quality Systems Standard 4
V PPAP for one material but for several customers APQP and PPAP 1
K One site reporting to several business owners ? How to structure? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S DOE (Design of Experiment) with Several Output Variables Quality Tools, Improvement and Analysis 4
Z Combining Several Systems into One - ISO9001 + ISO14001 + OHSAS18001 (etc) IATF 16949 - Automotive Quality Systems Standard 10
A Lead time reduction project on several processes Lean in Manufacturing and Service Industries 6
Antonio Vieira Quality Manager in Several Organizations at the Same Time Career and Occupation Discussions 10
G Texts for Several Disciplines - Seeking Recommendations Lean in Manufacturing and Service Industries 2
D Can several trainees share one answer sheet? Training - Internal, External, Online and Distance Learning 10
Icy Mountain Audit Scheduling for TS16949 - Audit split up by several 'working days' General Auditing Discussions 7
P t-test or ANOVA to compare variance of several samples series Statistical Analysis Tools, Techniques and SPC 12
W Can we make one quality manual based on several standards Quality Management System (QMS) Manuals 13
P ISO14001 Certification - What happens if we have several minor audit findings Miscellaneous Environmental Standards and EMS Related Discussions 2
S MSA (measurement systems analysis) on several CMM's - Correlation issue Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
Tim Folkerts Is Cpk a good measure of capability? There are several shortcomings of Cpk Capability, Accuracy and Stability - Processes, Machines, etc. 31
L Seeking: Medical Device SOP Templates for several topics Document Control Systems, Procedures, Forms and Templates 6
N 7.2.3 Customer Communication - Several late orders that didn?t have any notes Document Control Systems, Procedures, Forms and Templates 7
RoxaneB Several Key Indicators a Company Should Consider Using Misc. Quality Assurance and Business Systems Related Topics 40
S The theories and practices of Deming, Juran, Kaizen and several others Philosophy, Gurus, Innovation and Evolution 3

Similar threads

Top Bottom