One Supplier Audit Checklist to cover ISO 9001:2008 and 13485:2003

T

theva

Involved In Discussions
#1
#1
Dear Covers,

I need an advise whether should we combine ISO 9001:2008 and 13485:2003 clauses or requirements under 1 supplier audit checklist. If it is combined how would be the justifications or scores given to the respectives suppliers. This checklist is applicable only for those suppliers who are common part producers.

Rgds/Theva
 
GAGEpack - Gage & Calibration Management
Elsmar Forum Sponsor
Roberticus

Roberticus

ASQ CQE
#2
#2
I was brought into my Company's Quality dept. in order to help with the transition from ISO9001 to ISO13485. My Management declined to seek 9001 AND 13485 simultaneously as a largely redundant measure. In other words, the requirements of 13485 are seen as equal to or greater than 9001 (except that continual improvement is nominally changed to QMS 'maintenance', and customer satisfaction is similarly changed to 'feedback') Therefore, wouldn't a thorough vetting to an ISO13485 checklist ensure an adequate system in terms of 9001???
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
S AS9100 Supplier Audit Checklist example AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
C Supplier Audit - Looking for a quality audit checklist General Auditing Discussions 3
G ISO 22442 Supplier Audit Checklist - Medical devices utilizing animal tissues General Auditing Discussions 0
P IATF checklist for External Supplier Audit IATF 16949 - Automotive Quality Systems Standard 9
F Tips, Guidelines and Checklist to conduct Audit of Supplier & Subcontractor Document Control Systems, Procedures, Forms and Templates 5
T I'm seeking ISO 13485:2003 Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 1
R Supplier Audit Checklist wanted Customer Complaints 2
K Global Supplier Audit Checklist wanted General Auditing Discussions 3
J Powder Paint Supplier Audit Questions Checklist General Auditing Discussions 3
F Plating Supplier Audit Checklist Supplier Quality Assurance and other Supplier Issues 15
Z SMT and Sheet Metal Supplier Process Audit Checklist Supplier Quality Assurance and other Supplier Issues 5
G Supplier audit of ETO Sterilization Lab - Need a checklist or advice Supplier Quality Assurance and other Supplier Issues 3
E Supplier audit checklists for special processes - Plating Process audit Checklist Process Audits and Layered Process Audits 2
CarolX Supplier Audit checklist for special processes Supplier Quality Assurance and other Supplier Issues 3
D Critical Supplier will not allow us to audit Plant floor US Food and Drug Administration (FDA) 12
GStough Audit Nonconformances (?) for Suppliers Not Registered to ISO and No Supplier Quality Agreement Exists General Auditing Discussions 24
G Audit & Agreements for "Test Laboratory" Supplier? US Medical Device Regulations 4
D Re-labeler - audit the supplier EU Medical Device Regulations 2
D Question and advice for a supplier self audit questionnaire ISO 13485:2016 - Medical Device Quality Management Systems 6
D Special IATF audit of sub-supplier IATF 16949 - Automotive Quality Systems Standard 18
D Supplier audit Medical Device and FDA Regulations and Standards News 2
K New supplier audit as per V3.1 by French Automotive OEM General Auditing Discussions 2
M Supplier Audit Report - Template for second party audit wanted Lean in Manufacturing and Service Industries 1
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
shimonv Rigid rules for handling supplier audit findings ISO 13485:2016 - Medical Device Quality Management Systems 11
Q Supplier audit question cataloque VDA Standards - Germany's Automotive Standards 0
Genofear Customer wants to audit our supplier audits - seems inappropriate General Auditing Discussions 16
A Agenda for 8D audit on Supplier's side - Auditing Corrective Actions General Auditing Discussions 5
A Supplier Audit Results - when do you prepare? General Auditing Discussions 10
H 8.4.2.4.1 Supplier Audit - Supplier with IATF certified loss IATF 16949 - Automotive Quality Systems Standard 4
S Supplier Audit Assessment / Evaluation Forms IATF 16949 - Automotive Quality Systems Standard 1
Pmarszal Supplier Auditing Services (Audit Needed?) General Auditing Discussions 4
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
GStough Have You Had to Write a NC Against a Quality Manual in a Supplier Audit? General Auditing Discussions 12
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
K Audit a sole supplier? Supplier Quality Assurance and other Supplier Issues 9
R Vertical Supplier Audit Plan Supplier Quality Assurance and other Supplier Issues 4
A Supplier Audit Request - Made be laugh ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
C Performing an ISO 9001 based Supplier Audit - Multiple Supplier Facilities Supplier Quality Assurance and other Supplier Issues 4
G Supplier Significant Environmental Aspects - Audit Finding ISO 14001:2015 Specific Discussions 21
GStough Template for Supplier Notification of Audit Supplier Quality Assurance and other Supplier Issues 5
M Supplier Audit Form for Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 2
L Sourcing Audit Schedule for Supplier Audits IATF 16949 - Automotive Quality Systems Standard 3
S Supplier Audits - What to Audit when a Supplier is not Certified Supplier Quality Assurance and other Supplier Issues 11
Q Supplier Audit Corrective Action Request Responses Supplier Quality Assurance and other Supplier Issues 4
R Can our Supplier's Quality Mgr. conduct Supplier Audit on behalf of manufacturer? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
C Going Rate for Performing a Supplier Audit? Consultants and Consulting 1
T Contacting the Supplier's CB vs a Supplier Audit - Nonconformance Problems AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
E Do I need to audit the supplier supplying mop heads for our Clean Room ? ISO 13485:2016 - Medical Device Quality Management Systems 8
Marc Definition ASAS-P - Alliance Supplier Audit Standard - P for Production Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0

Similar threads

Top Bottom