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 Sterilization Protocol Change in Validation Process and further impacts ISO 13485:2016 - Medical Device Quality Management Systems 1
M Label change - 510(k) Medical Device and FDA Regulations and Standards News 5
M EMS change management ISO 14001:2015 Specific Discussions 2
E Document Change Request forms (or no forms)? ISO 13485:2016 - Medical Device Quality Management Systems 3
J Significant change related to design and intended use EU Medical Device Regulations 2
J Need Change Control Yes/No Decision Tree Template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Cleaning process center change ISO 13485:2016 - Medical Device Quality Management Systems 4
U NOC - What is considered a "design change" EU Medical Device Regulations 5
qualprod What do CB´s change when doing a partial moving ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Y Algo change significancy Medical Information Technology, Medical Software and Health Informatics 3
Revision36 Engineering Change Order Industry Standards Other Medical Device and Orthopedic Related Topics 4
Z Iterative development and FDA change requests IEC 62304 - Medical Device Software Life Cycle Processes 12
D ECO (Engineering Change Order) process questions ISO 13485:2016 - Medical Device Quality Management Systems 7
R Medical Device - Change manufacturing plant Design and Development of Products and Processes 6
Tagin Template or Checklist for Process Change Document Control Systems, Procedures, Forms and Templates 5
R Do we need issue ECN (Engineering Change Notice) towards updated Material Specification? Design and Development of Products and Processes 2
A What does this line from MDCG 2020-3 (MDR art. 120 substantial change) mean to you? EU Medical Device Regulations 4
M Change management procedure when 7.3 is not applicable ISO 13485:2016 - Medical Device Quality Management Systems 5
D Change Approval Requirements - Does every change need formal customer approval? Design and Development of Products and Processes 17
Q Change the shape of the raw material FAI AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
D Engineering Change Order (ECO) metrics to track ISO 13485:2016 - Medical Device Quality Management Systems 6
P Notified Body Approval of Change EU Medical Device Regulations 2
F Change to Formulation due to Reach (China Medical Device Regulations) China Medical Device Regulations 0
E Change in control plan - Do I have to do sampling? IATF 16949 - Automotive Quality Systems Standard 1
S Forced ServiceNow validation - No change in our current user and functional requirements IT (Information Technology) Service Management 6
M Address change for a company with CE/ISO13485 EU Medical Device Regulations 2
G Need to change KPI we called NC parts (maximum 3%.) to FTQ (first time quality) IATF 16949 - Automotive Quality Systems Standard 4
J FDA notification of address change US Food and Drug Administration (FDA) 2
D Class 3 Device - Change of supplier of material Canada Medical Device Regulations 6
D List A IVD - Change to material supplier EU Medical Device Regulations 3
R Change Management vs Opportunity for Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Is There a Revision History or Change Log for Canadian Regulations? Canada Medical Device Regulations 3
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
S Requirement to Conduct New Shelf-life Testing? (re-do testing for design change) EU Medical Device Regulations 3
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
J Sub-supplier change from manual to automated process - same specs - Report to FDA? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
S Special 510(K) - Labeling change from Rx to OTC Other US Medical Device Regulations 11
A Document Change Notice vs complete System re-write Manufacturing and Related Processes 4
S MDR Delay - MDD design Change? (before new MDR DOA) EU Medical Device Regulations 8
Jane's Like-for-like critical raw material change qualification - type of testing/ number of lots required ISO 13485:2016 - Medical Device Quality Management Systems 4
R Change Notification - Registrar vs Notified body ISO 13485:2016 - Medical Device Quality Management Systems 1
Marc Insects and Climate Change - 2020 World News 0

Similar threads

Top Bottom