ISO TS 22163 - New Rail Industry Standard

Paul Simpson

Trusted Information Resource
#1
My search came up with zero results. Anyone involved in or interested in the new draft international standard for the rail industry - ISO TS 22163?

It is established to take over from the IRIS certification scheme developed and managed by UNIFE for rail industry suppliers.

My web search indicates it is due out in May 2017.

Any commentary appreciated! :cool:
 
Elsmar Forum Sponsor
#3
A bit more from the sales pitch on Linked-In - "... continues to be supported by the "IRIS Audit Tool" that is based on the new IRIS Assessment Sheet, composed by around 870 mandatory requirements, which are grouped into about 300 questions, as well as new KO-requirements (plus additional optional requirements),
requires the appraisal of the customer focus performance level,
requires introduction of turtle diagrams and applies the methodology of Process Effectiveness Assessment Reviews (PEAR) for some mandatory processes,..."


Needless to say, the various industries 'splitting off' to create their own standards tells me that they do not believe 9001:2015 is 'good enough' even though they claim it is the 'basis' of their systems. A quick read shows that these systems often contradict the spirit of 9001 on almost every level.
We have no intention of signing on, ever.
 

Nadaabo

Starting to get Involved
#4
Hey Paul,
From what I understand, [FONT=&quot]ISO/TS 22163 is now out and it is the new requirement for the rail sector and is the evolution of the IRIS rev 02. It includes ISO9001:2015 requirements plus the rail specific requirements.
[/FONT] I have a link, but the system will not let me post it. Go to the IRIS-rail org website and click on information. it explains all this in detail.


I hope this helps :)
 
J

Jinko

#6
Hello all,

First time posting here and seeking some clarification.

There has been much speculation regarding compulsory use of turtle diagrams for compliance to the new TS 22163 standard.

We have a well established and well performing IRIS compliant QMS so don't see the benefit in spending a lot of time developing diagramatical representations of already established systems.

I have read the TS standard a few times, when I had trouble sleeping ......., and can find no reference to their use. Am I missing something?

Thanks.
J
 
J

Jinko

#8
Sorry but if an auditor tried to pick me up for a line in a newsletter I think we may have a problem.

I can't see any reference to turtle diagrams (or PEAR) in TS 22163.

Specific questions relating to turtle diagrams may be in the revised audit tool ( I haven't checked that yet) which may then result in 'Defined' / 'Qualified' / 'Optimised' ranking.
 
P

Priss80

#10
Can any of you to share the ISO/TS 22163:2017 standard? I need this urgently and lack of time to purchase at the moment.

Thanks
 
Thread starter Similar threads Forum Replies Date
J RAMS and LCC assessment per ISO/TS 22163 Other ISO and International Standards and European Regulations 0
A ISO/TS 22163 Item 5.2.4 Safety policy - Example wanted Other ISO and International Standards and European Regulations 2
K ISO 13485 Design Requirement with respect to "component" manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 3
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
rob3027 ISO 13485 justification for design and development exclusion for medical packaging ISO 13485:2016 - Medical Device Quality Management Systems 18
A Help understanding what it takes to implement a QMS that is ISO 13485 compliant ISO 13485:2016 - Medical Device Quality Management Systems 1
R ISO 17025 Lead Assessor Training ISO 17025 related Discussions 0
H Active Implantable Medical Devices - ISO 14708 and EN 45502 Other Medical Device Related Standards 0
L ISO 10993-18 vs ISO 18562-4 Other Medical Device Regulations World-Wide 4
J Iso 9001 Clause 7.1 - Advice needed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 21
D ISO 14001 Finding - Missing Safety Data Sheets ISO 14001:2015 Specific Discussions 2
J ISO 17025 Calibration Other Medical Device Related Standards 2
FuzzyD ISO 13485:2016 Customer Assessment OFI ISO 13485:2016 - Medical Device Quality Management Systems 2
K Applicable ISO 9001 clauses for Human Resources? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Clinical Trial using Prototype devices (EU MDR & ISO 14155) EU Medical Device Regulations 4
I IEC 60812 or ISO 14971 for PFMEA? What should we use? ISO 14971 - Medical Device Risk Management 3
I ISO 9000 Where to Start ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 81
M ISO 13485 consultants and auditors with design oriented focus ISO 13485:2016 - Medical Device Quality Management Systems 7
D ISO 9001:2015 Internal Audit Check Sheet ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
H Does ISO state in anyway that we MUST keep physical first piece parts? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B ISO cl. 5.3 - Ensuring that the integrity of the QMS is maintained ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
A ISO 9001- any advise please with transitioning from a paper based system to eQMS and multi site scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L ISO 20417 crucial changes Other Medical Device Related Standards 1
R ISO 27001 Mandatory Policies , Procedures and Records IEC 27001 - Information Security Management Systems (ISMS) 0
R Use of historical version of ISO standards CE Marking (Conformité Européene) / CB Scheme 3
I QMS and ISO 9001 Misc. Quality Assurance and Business Systems Related Topics 11
E ISO 17025 Key Performance Indicators (KPIs) ISO 17025 related Discussions 5
A ISO 9001:2015 8.5.6 and 7.5.3 Document Control Questions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
J ISO 9001:2015 Clause 8.2.3 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
LabCat Internal SOP for a validated (ISO) method? ISO 17025 related Discussions 2
L Confusion about ISO 14644 Other Medical Device Related Standards 2
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
S Brexit ISO 13485:2016 + Corrigendum - What does a UKCA DoC require? EU Medical Device Regulations 2
M Is complete testing required as per ISO 10993 for materials used in orthopedic implants or is literature review route possible Other Medical Device Related Standards 3
Aliken Recommendation for the ISO 13485 certification company ISO 13485:2016 - Medical Device Quality Management Systems 7
ISO-tired ISO 13485: file structure overview ISO 13485:2016 - Medical Device Quality Management Systems 11
J ISO 10993-1:2018 Format to Perform Risk Management Process US Food and Drug Administration (FDA) 1
B ISO 9001:2015 Registered Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C ISO Cert and Parent Company is not Certified ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
B Is 14971 Annex C checklist now in ISO/TR 24971 required to complete prior to 510k filing? ISO 14971 - Medical Device Risk Management 3
Q ISO Training Providers to fix careless workers? Training - Internal, External, Online and Distance Learning 19
M PROBLEM IN SCOPE OF ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 6
S ISO 13485 signing of Procedures etc. ISO 13485:2016 - Medical Device Quality Management Systems 10
N ISO 13485 Scope Reduction Other ISO and International Standards and European Regulations 2
Sidney Vianna ISO 37301 - Compliance management systems – Requirements with guidance for use Other ISO and International Standards and European Regulations 2
S ISO 3497 Metallic Coatings Other ISO and International Standards and European Regulations 1
R Basic Lab Practices - related to ISO 17025 testing labs ISO 17025 related Discussions 1
JDJohnson Micrometer & Caliper Calibration (ISO-9001) General Measurement Device and Calibration Topics 26
M Can veterinary implants be ISO 13485 certified? ISO 13485:2016 - Medical Device Quality Management Systems 23
D Audit Report details when ISO 13485:2016 and cGMP 21 CFR 820 are applicable ISO 13485:2016 - Medical Device Quality Management Systems 6

Similar threads

Top Bottom