Tasked to change ISO 9001:2008 to ISO 9001:2015

P

PeggyLHS

#1
Good morning all,

I am new in my current company. At the moment, I have been given a task to change ISO 9001:2008 to ISO 9001:2015. Nobody in the company know how to start.

Any guidance for me where I can start the transition? What I have to do at first?

Thank you
Regards
Peggy
 
Elsmar Forum Sponsor
B

BoardGuy

#4
Good news is that you do not have to adopt the numbering systems of ISO 9001:2015 or any it terminology found within the Standard. I would start by going to the ISO TC/176/SC2 Home Page using this link: http://isotc.iso.org/livelink/livelink/open/tc176SC2public

My analysis is there is more hype than fact about 2015 and for the most part your current system will need need to be revised to address new requirements such as, Context of The Organization, Risk Base Thinking and Organizational Knowledge. Use the “ISO 9001:2008 and ISO/DIS 9001 Correlation Matrices” found on the TC 176 Home Page as a starting point.
 
Thread starter Similar threads Forum Replies Date
D Tasked to set up a Safety Program Occupational Health & Safety Management Standards 10
B Non Quality Engineer tasked with ISO certification.... Help needed.. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
J Tasked with revamping our Website using Dreamweaver 8 After Work and Weekend Discussion Topics 7
C Tasked with gaining AS9100 certification AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R ISO9001 / AS9100 Small Aerospace company - Tasked to get company certified AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Tasked with Raising Quality Awareness - Metrics to apply - Identification wrist bands Quality Tools, Improvement and Analysis 4
L Tasked to perform a gap analysis between APQP and ISO 9001:2000 requirements APQP and PPAP 1
Z Auditor's committment - How many clients are one auditor tasked to serve Miscellaneous Environmental Standards and EMS Related Discussions 1
N API Q1, Management of Change & Document Change Request Oil and Gas Industry Standards and Regulations 1
adir88 Substantial Change to QMS (Annex IX, Chapter I) EU Medical Device Regulations 0
A Eudamed actor registrations if you change AR for MDR product EU Medical Device Regulations 0
C Change Management Process ISO 14971 - Medical Device Risk Management 8
S ISO13485:2016 7.3.9 design and development change ISO 13485:2016 - Medical Device Quality Management Systems 3
N Change Control for processes & products Manufacturing and Related Processes 6
Q Change Control Numbering system Document Control Systems, Procedures, Forms and Templates 6
D Laboratories listed in the Declaration of Conformity change Canada Medical Device Regulations 1
M Change control on Tracking Sheet ISO 13485:2016 - Medical Device Quality Management Systems 11
D EU MDR - Change of device name (legacy device) EU Medical Device Regulations 4
L Change Log in (controlled) Forms? (ISO 9001:2015) Document Control Systems, Procedures, Forms and Templates 6
H Control of Change i.e. process and WI IATF 16949 - Automotive Quality Systems Standard 9
dgrainger Informational MHRA's Software and AI as a Medical Device Change Programme UK Medical Device Regulations 0
K Is implementing Electronic Signatures a Significant Change to the QMS? ISO 13485:2016 - Medical Device Quality Management Systems 10
A Management of change procedure for ISO 45001 Occupational Health & Safety Management Standards 5
N Cleanroom Classification Change Other Medical Device Related Standards 7
D Engineering Change order vs. Change Control ISO 13485:2016 - Medical Device Quality Management Systems 3
Watchcat Change Request Documents - What's Typical These Days? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 14
NDesouza Management of Change (MOC) Manufacturing and Related Processes 11
H Customer Specific Change in a SaaS SAMD IEC 62304 - Medical Device Software Life Cycle Processes 1
D GAMP CAT 5 Change Control Qualification and Validation (including 21 CFR Part 11) 9
lanley liao Questions regarding the change of critical suppliers and key personnel Oil and Gas Industry Standards and Regulations 5
I What revalidation is necessary if we change parts in a WFI loop ? Qualification and Validation (including 21 CFR Part 11) 1
Y Exporting data to the cloud is a "Significant Change"? EU Medical Device Regulations 5
A Design Change/ECO Related Question 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Reseller Request to Change UPC on Medical Device via Re-labeling Medical Device and FDA Regulations and Standards News 5
S Change management with FAA Federal Aviation Administration (FAA) Standards and Requirements 0
R Revalidation under VDmax25 following material change ISO 13485:2016 - Medical Device Quality Management Systems 2
D Change to labelling - does it require a new 510(k)? US Food and Drug Administration (FDA) 5
A How can we change a device trade name in 510(k) summary? US Food and Drug Administration (FDA) 0
L Change Notification Requirements for class 1 devices Medical Device and FDA Regulations and Standards News 1
R CB/Auditor Requiring a change in scope ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
Ed Panek Notified Body Substantial Change MDD EU Medical Device Regulations 1
A Purchasing Controls on Change Management of Literature/Labeling ISO 13485:2016 - Medical Device Quality Management Systems 3
A For software change - New Channel of interoperability CE Marking (Conformité Européene) / CB Scheme 5
JoCam IEC 60601-1 and 60601-1-2 retest after PCBA change IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
N ISO 13485 7.3.9 Change control in medical device software ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 13485 procedure change and reflect to legacy manufacture items ISO 13485:2016 - Medical Device Quality Management Systems 2
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
D Reports under change management | ISO 13485:2016 & ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Time change via change of Time Zone Qualification and Validation (including 21 CFR Part 11) 3
T IEC 60601-1-8:2020 Is it necessary to change the alarm melody? IEC 60601 - Medical Electrical Equipment Safety Standards Series 5

Similar threads

Top Bottom