Does anyone have a checklist to prepare for ISO 13485, Stage I audit?

Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Leader
Admin
#4
Hello SGquality,

Your registrar should be willing to describe to you what to expect during the certification process. Some even publish the certification process information. I find that published audit checklists usually just repeat the clauses in the standard. But a Stage 1 audit is meant to confirm you will pass the certification audit by having the processes in place and functioning. You are not yet certified, so there is no such thing as a nonconformance. The auditor will list areas of concern. It is common to expect to see that a round of internal audits have been done, and a management review as well. If there is something missing that would prevent certification (such as no internal audits done) the registrar will likely put the process on pause for you to complete the areas of major concern, if any, then a follow up review would be done to confirm your readiness before scheduling the certification audit.

Please contact your registrar's Customer Service. They should provide you with information of what to expect.

Disclaimer: I contract audit for DQS.
 
Thread starter Similar threads Forum Replies Date
A Does anyone have a checklist of API Spec 650 13th Edition? Oil and Gas Industry Standards and Regulations 0
J Does anyone have an excel IATF 16949 Internal Audit checklist I could use? IATF 16949 - Automotive Quality Systems Standard 7
W Does anyone have an API Q2 checklist for internal auditing? Oil and Gas Industry Standards and Regulations 1
A Does anyone have a SW (LIMS) Vendor Audit Checklist? Other ISO and International Standards and European Regulations 5
Ajit Basrur Does anyone have a Cleanroom audit checklist? ISO 13485:2016 - Medical Device Quality Management Systems 12
D What are APQP Deliverables? Does anyone have a Checklist of APQP Deliverables APQP and PPAP 4
S Does anyone have a layered audit checklist they can share? General Auditing Discussions 2
S A-2 Design Information Checklist - Does anyone have the A-2 checklist in Word format? Design and Development of Products and Processes 3
K Layered Audit Checklist - Does anyone have an example? Document Control Systems, Procedures, Forms and Templates 4
M Does anyone have a checklist for auditing to the ISO 9001:1994 standards? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
G Does anyone know about tobacco-free nicotine pouches? US Food and Drug Administration (FDA) 0
R Does anyone use iQMS for their ISO based document control? Manufacturing and Related Processes 1
Q Does anyone know what this call out means? Manufacturing and Related Processes 3
H Does anyone has feedback on a notified body for small companies? EU Medical Device Regulations 3
N Does anyone use SGS for ISO 13485 / CE certification Registrars and Notified Bodies 0
U Does *anyone* know a lab that will test to EN 455-4 Medical Gloves shelf life determination? EU Medical Device Regulations 1
N Does anyone have experience of GB/T 34986-2017? China Medical Device Regulations 1
Z Does anyone have experience with EN ISO 17664 ? IEC 62366 - Medical Device Usability Engineering 9
F Does anyone have an ESD quality/cooler talk to share? Training - Internal, External, Online and Distance Learning 4
P Does anyone have a API Q1 Documentation Package? Quality Management System (QMS) Manuals 1
C Document Control Stamps - Does anyone still stamp their documents? Document Control Systems, Procedures, Forms and Templates 24
MDD_QNA QR Code Standard ISO/IEC 15417:2007 - Does anyone use it? Other Medical Device Related Standards 3
GreatNate Metrotom - Does anyone have any exposure to the Zeiss Metrotom 800 or 1500? Manufacturing and Related Processes 0
M Honda Audits - Does anyone have any experience with the QAV audit? General Auditing Discussions 4
Q Does anyone have experience implementing a QMS without ISO certification? Quality Manager and Management Related Issues 2
J Does anyone here use ISOXpress/IMSXpress QMS software? Software Quality Assurance 11
K Does anyone have a copy of a GM 5 Phase Problem solving form Problem Solving, Root Cause Fault and Failure Analysis 1
M Does anyone have a good verification and validation plan template? ISO 13485:2016 - Medical Device Quality Management Systems 8
B Does anyone charge for annual layouts? APQP and PPAP 8
N Does anyone know a registrar that offers both ISO 9001 and ISO 17020? Registrars and Notified Bodies 6
W Does anyone have any experience with the Easy Metric System? General Measurement Device and Calibration Topics 2
J Does anyone have a good APQP template that meets IATF requirements? APQP and PPAP 3
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
C Does anyone have an AS9100:2015 audit schedule template? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
R Does anyone have example test report of defibrillator IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
G Definition Parallel Loop - Does anyone know what the term Parallel loop means? Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 2
B Does Anyone utilize MS Outlook Read Receipts ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
L Does anyone know what is going on in DQS? Registrars and Notified Bodies 1
P Scope Document - Does anyone happen to have an Example Scope Document (4.3)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
A Does anyone have a comparison between ISO 9001:2015 and ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 2
D Does anyone have a list of the IATF "Shalls" they would be willing to share? IATF 16949 - Automotive Quality Systems Standard 4
S Plant within a Plant - Does anyone currently manage their facility this way? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
E Does anyone have experience implementing a Tiered QMS? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 3
J Does anyone have an example Authority Listing SOP example? Misc. Quality Assurance and Business Systems Related Topics 3
S Does anyone know what a healthcare GDSN data pool actually looks like? Hospitals, Clinics & other Health Care Providers 2
R Does anyone have any experience on change control? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
ScottK Does anyone have experience with how MDD unanounced audits of suppliers are going? EU Medical Device Regulations 21
A Does anyone have experience providing a summary of Pre-IDE discussions in the 510k US Food and Drug Administration (FDA) 1
S Does anyone use the Boeing STP0565 and STP0637 specs? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
M Does anyone have a breakup of Establishments based on Device Classes ? Other US Medical Device Regulations 1

Similar threads

Top Bottom