SBS - The Best Value in QMS software

Joint ISO TS 29001 and ISO 9001 Certification - One or two certificates?

M

Matrix45

#1
If an organisation already holds ISO 9001:2008 certification then transition to ISO 29001 can happen. Relevant audits will be carried out to upgrade their quality management certification but will this be one certificate (ISO TS 29001 is 9001 in its entirety with additional supplimentary requirements) or will both certificates (ISO 29001 & 9001) still need to apply?
 
Elsmar Forum Sponsor

Sidney Vianna

Post Responsibly
Staff member
Admin
#2
Re: ISO 29001 Certification

Assuming that you have a properly accredited ISO 9001 certificate, you will have to end up with two certificates because, to the best of my knowledge, no accreditation scheme exists for the ISO TS 29001 standard. Thus all certificates issued against that Technical Specificaction are not accredited.
 

John Broomfield

Staff member
Super Moderator
#4
If an organisation already holds ISO 9001:2008 certification then transition to ISO 29001 can happen. Relevant audits will be carried out to upgrade their quality management certification but will this be one certificate (ISO TS 29001 is 9001 in its entirety with additional supplimentary requirements) or will both certificates (ISO 29001 & 9001) still need to apply?
Matrix,

What benefit to you expect from making sure your organization's management system conforms to ISO/TS 29001?

Is it to keep a current customer happy or to prequalify for work with new clients?

Many thanks,

John
 
M

Matrix45

#5
John.
Because the oil and gas industry requires to be regulated in the UK, I feel it is important that they work to ISO 29001. However because of low interest and costs , ISO 29001 is not accredited. It used to be linked to API Q1, but because intellectual property ownership, the linkage is now broken. Whilst some organisations may conform to the standard, internal audit plans do not and do not cover the supplementary requirements of ISO 29001 - there are continuos issues concerning these required supplementary requirements. Some clients require ISO 29001 but generally it would be to ensure that we meet the requirements of the standard. Hope this answers your question?
 

John Broomfield

Staff member
Super Moderator
#6
John.
Because the oil and gas industry requires to be regulated in the UK, I feel it is important that they work to ISO 29001. However because of low interest and costs , ISO 29001 is not accredited. It used to be linked to API Q1, but because intellectual property ownership, the linkage is now broken. Whilst some organisations may conform to the standard, internal audit plans do not and do not cover the supplementary requirements of ISO 29001 - there are continuos issues concerning these required supplementary requirements. Some clients require ISO 29001 but generally it would be to ensure that we meet the requirements of the standard. Hope this answers your question?
Matrix,

Thanks. Do the additional requirements in the TS provide benefits to your organization and your clients?

Or are they a waste of time?

If they do provide benefits, then quietly conforming to the tech spec as well as ISO 9001 might be a good idea.

ohn
 
Thread starter Similar threads Forum Replies Date
B Integrated management system - ISO 9001 and ISO 14001 - Is possible to have a joint certificate covering both standards? ISO 14001:2015 Specific Discussions 6
S Acquisitions and Joint Ventures (Business Development Department) and ISO 13485 EU Medical Device Regulations 3
S ISO 9001, ISO 17020 and ISO 3834 Joint (Integrated) QMS ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
Sidney Vianna Joint IAF-ISO Communique' - Expected Outcomes of Accredited Certification ASQ, ANAB, UKAS, IAF, IRCA, Exemplar Global and Related Organizations 5
Sidney Vianna ISO TC's 176 & 207 & other Stakeholders Joint Vision ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
K Joint approval between OEM and Manufacturer on Design Documents ISO 13485:2016 - Medical Device Quality Management Systems 4
M Informational EU – October 2019 update – State-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 2
M Informational EU – State-of-play of joint assessments of Notified Bodies in the medical device sector – June 2019 Medical Device and FDA Regulations and Standards News 0
M Informational EU – Update on state-of-play of joint assessments of Notified Bodies in the medical device sector Medical Device and FDA Regulations and Standards News 1
M Medical Device News Joint Action On Market Surveillance Of Medical Devices (JAMS) Releases Progress Update EU Medical Device Regulations 0
M Medical Device News State-of-play of joint assessments of Notified Bodies in the medical device sector EU Medical Device Regulations 0
S 1st AHWP-RAPS Joint Conference @ KL, Malaysia 2-3 Dec 2013 Other Medical Device Regulations World-Wide 2
P Selling Joint Implants without a Validated Process Manufacturing and Related Processes 8
T Packaging Box Mix Joint - Corrective Action help Manufacturing and Related Processes 9
Ronen E Australia and New Zealand joint scheme for Regulation of Therapeutic Goods Other Medical Device Regulations World-Wide 0
C Analyzing Attribute Data - Mechanical Pull Testing of Joint Statistical Analysis Tools, Techniques and SPC 15
Marc Joint Aviation Authorities (JAA) - Disbanded in 2009 EASA and JAA Aviation Standards and Requirements 0
B Partial Joint (Hip Prosthesis) Replacement Class inquiry EU Medical Device Regulations 3
E 510k Submission Samples - Class II Medical Device - Knee Joint Prosthesis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Ron Rompen Alternatives to welding two pieces of aluminum extrusion together at a miter joint Manufacturing and Related Processes 2
Ajit Basrur U.S. ? China Joint Commission on Commerce and Trade (JCCT) - Fact Sheet ISO 13485:2016 - Medical Device Quality Management Systems 2
A Ring Joint Gasket Defect Types and their Consequences Various Other Specifications, Standards, and related Requirements 13
D Industry Standard for Brazed Joint Integrity - Customer Specification Various Other Specifications, Standards, and related Requirements 1
J Gage R&R - Operators scanning in defect codes - PCB w/various solder joint defects Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
C Relationship - Break over (click type) torque wrench and short term joint relaxation General Measurement Device and Calibration Topics 4
P JAR's - Joint Aviation Requirements Various Other Specifications, Standards, and related Requirements 4
C Sanctioned Interpretation - Merger / Joint Venture Miscellaneous Environmental Standards and EMS Related Discussions 19
Marc Input - Joint Auditing Standard General Auditing Discussions 3
D Question on Documented Calibration versus ISO 17025 Accredited Calibration ISO 13485:2016 - Medical Device Quality Management Systems 0
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 7
pbojsen ISO 13485 Requirements versus FDA product classification and GMP exemptions - Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
D "certified" in ISO 19011, as well as IATF required? IATF 16949 - Automotive Quality Systems Standard 4
S ISO/IEC 15408 - Is this is Certifiable Standard? Other ISO and International Standards and European Regulations 2
D Lead time to schedule an ISO 13485 audit Auditing Quality and Environmental Management Systems 2
T Do we need an SOP for ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
K ISO 9001 Auditing in a Healthcare setting Auditing Quality and Environmental Management Systems 15
S Does anyone have a checklist to prepare for ISO 13485, Stage I audit? ISO 13485:2016 - Medical Device Quality Management Systems 1
H QMS ISO 13485:2016 - ISO14971 IEC60304 etc ISO 13485:2016 - Medical Device Quality Management Systems 2
Y How can i integrate ISO 13845 into ISO 27001? ISO 13485:2016 - Medical Device Quality Management Systems 4
vickyva ISO 14155:2020 CIP CIR templates Other Medical Device Related Standards 0
C ISO 9001:2015 8.3.2. h) Design and Development Planning - What is required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
B Employee Handbook in ISO 9001:2015 Section 7 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
B Operational Procedures for ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 7
Q ISO 9001/IATF 16949 Audit Finding Question - Document Retention IATF 16949 - Automotive Quality Systems Standard 10
D ISO 14971 applicability in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 7
G Trying to get a financially reasonable ISO Certification Body Registrars and Notified Bodies 8
L ISO 45001:2018 - Clause 5.4: Consultation and Participation of Workers Process Maps, Process Mapping and Turtle Diagrams 1
E ISO 13485 in Clinical Trial conduct: Applicable or No ISO 13485:2016 - Medical Device Quality Management Systems 2
G ISO 13485 Certification - Can we get the ISO 13485 certification prior to shipment of the device? ISO 13485:2016 - Medical Device Quality Management Systems 6
Richard Regalado Informational ISO/IEC DIS 27001:2021, to be published soon. IEC 27001 - Information Security Management Systems (ISMS) 0

Similar threads

Top Bottom