SBS - The Best Value in QMS software

Upgrading from ISO 9001:2015 to IATF 16949:2016 - Anyone have a gap analysis tool?

Cats Clause

Starting to get Involved
#1
Hi

Has anyone have a gap analysis tool showing the "add on's" required to transition from the latest 9001 to the latest 16949?

thanks! :)
 
Elsmar Forum Sponsor

howste

Thaumaturge
Super Moderator
#2
The IATF 16949:2016 standard itself only shows the additional requirements. It seems that it would be pretty easy to do it just with the standard.
 
Thread starter Similar threads Forum Replies Date
N Template for a Quality Plan upgrading to ISO 13485 from ISO 9001 ISO 13485:2016 - Medical Device Quality Management Systems 2
Q ISO 9001:1994 Upgrading to ISO 9001:2000 or ISO 9001:2008? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T Upgrading of QMS from ISO 9001 to ISO 13485 - Quality Manual Revision ISO 13485:2016 - Medical Device Quality Management Systems 5
W Questions about upgrading from ISO 9001 to ISO 13485 or do I have both? ISO 13485:2016 - Medical Device Quality Management Systems 13
H Upgrading ISO 9001 to TS 16949 - Plastic injection molding company IATF 16949 - Automotive Quality Systems Standard 13
G Upgrading: ISO 9001:2000 to TS 16949 IATF 16949 - Automotive Quality Systems Standard 3
Marc Upgrading to ISO 9001:2000 - Changing Documentation Document Control Systems, Procedures, Forms and Templates 4
N Upgrading ISO 13485:2003 QMS to FDA 21 CFR 820 Compliance ISO 13485:2016 - Medical Device Quality Management Systems 1
N Upgrading to ISO 9000:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R QS Shop upgrading to ISO 9K2K QS-9000 - American Automotive Manufacturers Standard 1
Marc Your opinion on upgrading to Xenforo 2.2 Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 5
shrutisancheti Upgrading medical device at healthcare establishments (user facility) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
V Upgrading Systems from CFR 211 to CFR 820 (drug+device combination) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 7
T Reduced Audit days when UPGRADING from AS9100 to TS16949 - Is it possible? IATF 16949 - Automotive Quality Systems Standard 2
C Upgrading an old Supermicrometer General Measurement Device and Calibration Topics 3
R QMS System Upgrading - Should the HSE and Finance functions be included? Quality Manager and Management Related Issues 15
T Upgrading to AS9120A - Configuration Management AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
R Upgrading to TS 16949 - A Management Overview and Kickoff Document IATF 16949 - Automotive Quality Systems Standard 5
J Upgrading an existing Management System into a full-fledge QMS? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
J Upgrading ISO9001 to ISO13485 - Relationship of ISO9001 to ISO13485? Registrars and Notified Bodies 7
Claes Gefvenberg Upgrading the Windows OS PC? After Work and Weekend Discussion Topics 29
A Upgrading from ISO9001:2000 to AS9120 - Difficulties? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 17
B Upgrading our QS-9000 system to TS 16949 - Where do I start? IATF 16949 - Automotive Quality Systems Standard 6
M Criteria for Auditor Selection and upgrading their auditing skills General Auditing Discussions 6
T Are registrars taking a harder line on upgrading QS-9000 certs to TS 16949? Registrars and Notified Bodies 10
L Upgrading to TS 16949 from QS-9000 IATF 16949 - Automotive Quality Systems Standard 7
R 'Upgrading' to TS 16949:2002 from QS-9000 IATF 16949 - Automotive Quality Systems Standard 2
C Procedures - New Revision or Original Issue - Upgrading to ISO9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 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