How to combine ISO 9001:2015 and ISO 29001:2010 into a single QMS

R

Rabab

#1
Hi All,
Currently my organization management system is certified ISO 9001:2008 and ISO 29001: 2010.

Given the new requirements of ISO 9001:2015 , how I'm going to have one management system that reflects both ISO 9001: 2015 and ISO 29001:2010?

Appreciate your usual support.
Rabab
 
Elsmar Forum Sponsor

yodon

Staff member
Super Moderator
#2
I don't know ISO 29001 but I'm in a similar boat with ISO 13485 & 9001. In general, there will need to be more focus on risks (not just product risk) throughout so generally this should be a good thing (complementary - 13485 doesn't prohibit risk based thinking outside of product concerns).

Similarly, while the documentation requirements in 9001 somewhat evaporate, I still need them for 13485 so I'll keep my documents. 9001 won't prohibit using documents.

I expect you'll get better response if your question is more focused on a particular aspect.
 
R

Rabab

#3
Hi Jodon,
Many thanks for your reply.
you are right I should have a specific item to discuss.
ISO 29001 defines the quality management system for product and service supply organizations for the petroleum, petrochemical and natural gas industries.
it contains original ISO 9001:2008 text unaltered and specific supplemental requirements are added.

so as for the quality manual supplemental requirement I have to fulfill ISO9001:2008 requirement to get the certificate of ISO 29001 which is not required in ISO 9001:2015 as far as I understand.:frust:


 

John Broomfield

Staff member
Super Moderator
#4
Hi All,
Currently my organization management system is certified ISO 9001:2008 and ISO 29001: 2010.

Given the new requirements of ISO 9001:2015 , how I'm going to have one management system that reflects both ISO 9001: 2015 and ISO 29001:2010?

Appreciate your usual support.
Rabab
Rahab,

Your organization's process-based management can easily be changed to conform also to ISO 29001.

Simply identify the processes and controls separately specified by 29001 but missing from your management system. Then invest in making the missing processes and controls a reality.

Naturally, you'll document the procedures to effectively plan, operate, control and monitor these processes according to their importance to the success of your organization.

And you'll do this in consultation with top management (for the investment) and with the process owners (for their knowledge of their assigned processes).

You may then choose to describe your organization's management system, and how it delivers quality assurance, in a brief handout/webpage which top management could issue/use with their briefing on their management system to existing staff and incoming employees.

John
 
Thread starter Similar threads Forum Replies Date
M Combine ISO 9001 and AS9100 into a single Quality Manual and System? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
T Could we combine ISO 13485 and ISO 9001:2008? ISO 13485:2016 - Medical Device Quality Management Systems 8
A ISO 14001 and ISO 9001 combined? Talk within ISO to combine these two specs ISO 14001:2015 Specific Discussions 12
N Combine ISO 9002 and ISO 14001 - Could you please give me some suggestions? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
CPhelan Internal audit - Combine similar nonconformities in one or keep separate? Internal Auditing 6
D Doing both a top-down and a bottom-up risk assessment - How to combine ISO 14971 - Medical Device Risk Management 6
B Could I combine IQ, OQ and PQ for Minitab Software Validation ? Software Quality Assurance 3
Q Is there a way that I can combine two PMCF studies into one? EU Medical Device Regulations 4
P May I combine the Process Audit and Product Audit into Delphi's LSR? Customer and Company Specific Requirements 3
J Can I combine Recalls, Advisory notices, and Vigilance systems into one procedure? ISO 13485:2016 - Medical Device Quality Management Systems 2
A Can I combine some procedures together and pick some clauses to audit Internal Auditing 4
M How to combine the Importance Performance Matrix and the KANO Model? Benchmarking 8
C Separate Certification - Can I combine documents for ISO14001, OHSAS18001 & AS4801? Miscellaneous Environmental Standards and EMS Related Discussions 3
S Registration - Want to combine one marketing company as remote location IATF 16949 - Automotive Quality Systems Standard 3
C Uncertainty + Error...How do I combine them to recalculate TUR Measurement Uncertainty (MU) 5
B How do you combine Quality Management and Environmental Management? Quality Management System (QMS) Manuals 3
O Capability Studies: Can I combine Attribute Data and Variables Data Capability, Accuracy and Stability - Processes, Machines, etc. 2
F Organizational Charts - OK to combine Quality and Production? Quality Manager and Management Related Issues 12
M Charting Bi, Tri or More Modal Distributions to combine results from two machines Capability, Accuracy and Stability - Processes, Machines, etc. 5
C I'd like to combine corrective and preventive action into a POLICY document Nonconformance and Corrective Action 7
Q Integrated Management System - ISO9001, ISO14001, 18001 - Combine annual objectives? Other ISO and International Standards and European Regulations 17
J Combine two division manuals into one (No Procedures change) Quality Management System (QMS) Manuals 5
C Quality Policy - Combine it with our statement of 'Purpose, Values and Mission'? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A ISO 11607-1: 2019 main changes Other Medical Device Related Standards 2
G National Structural Steel Specification 7th Edition - Do I now have to be audited against ISO 3843-3 as well as ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 0
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6

Similar threads

Top Bottom