Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820?

Q

QSEngineer20850

Registered
#1
#1
Does anyone have a good spreadsheet or check list that compares ISO and 21CFR820? Something that would cover the ISO clause in one column the 820 reference in another and then space for notes and links to my documents? Any help would be useful. Thanks!
 
somashekar

somashekar

Staff member
Super Moderator
#2
#2
QSEngineer20850 said:
Does anyone have a good spreadsheet or check list that compares ISO and 21CFR820? Something that would cover the ISO clause in one column the 820 reference in another and then space for notes and links to my documents? Any help would be useful. Thanks!
Click to expand...
I did some search for you.....and you still have to do your bit on it. Hope the attachments are helpful.
Thanks .....
 

Attachments

S

snoopy2017

#3
#3
ISO 13485 and QSR are very similar. However, it's my experience that the QSR has additional requirements that are clearly spelled out in the regulations. But they have the same QMS processes (e.g design control, CAPA which falls under measurement and analysis ). I would start with ISO as a baseline and do a gap analysis with QSR. Complete your SOPs based on ISO and incorporate the additional FDA elements. There are also some terminology differences. For example, DHF and DMR are FDA terms. In ISO 13485:2016, what is known as the medical device file is similar to the DMR (and there has been a debate about the distinction between DMR and MDF; just search around on Elsmar). Also, both QSR and ISO 2016 are risk-based. I hope this makes sense.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
R Controlling Quick Reaction Checklists Document Control Systems, Procedures, Forms and Templates 1
R How to SHOW the importance of checklists, through some team gaming or play? Training - Internal, External, Online and Distance Learning 37
D Internal audit forms or checklists for a medical/veterinary laboratory General Auditing Discussions 5
N ISO 9001: 2015 - Example standards policies, procedures, acknowledgements and checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
R AS9100D Internal Audit Process Checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO9001:2015 and ISO14001:2015 Readiness/Self Evaluation Checklists wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M I need Audit Checklists for nearly all Car suppliers Customer and Company Specific Requirements 8
M Are auditing checklists required for Internal Audits? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
C Are these Final Inspection Process Checklists required? Document Control Systems, Procedures, Forms and Templates 10
D National Highways Sector Schemes Checklists wanted Quality Manager and Management Related Issues 4
H ISO 9001 Document Control Requirements - Design and Development Department Checklists Document Control Systems, Procedures, Forms and Templates 3
S Innovation in ER (Essential Requirements) Checklists EU Medical Device Regulations 6
D "Simplified" AS9100 and ISO 9001 Internal Audit Checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 43
P Effectiveness of CAPDo Approach / Checklists IATF 16949 - Automotive Quality Systems Standard 7
R Special Process Checklists for Plating, Phosphate Coating, Welding and NDT AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
Marc iPhone "App" for Checklists - What Checklist would you want? Quality Assurance and Compliance Software Tools and Solutions 13
michellemmm Software Product Development Quality Assurance (PDQA) Audit Checklists Software Quality Assurance 12
M Should Internal Audit Checklists be Controlled Documents? Document Control Systems, Procedures, Forms and Templates 9
O Human Resource (Employee) Assessment - Procedures, forms, checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Software Quality Audit - Internal Audit Checklists Software Quality Assurance 6
J Internal Audit schedule & Process Audit Checklists Internal Auditing 3
B GM's QSB - Requirement, Checklists needed - Checklist used by GM to assess & sample Customer and Company Specific Requirements 9
V Effectiveness of detailing all the steps of its flowchart in checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
A ISO 17020 vs. ISO 9001 standards integrated checklists required? Other ISO and International Standards and European Regulations 15
V Reference Number required in Internal Audit Checklists ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Customs-Trade Partnership Against Terrorism (C-TPAT) - Checklists/Guidance Customer and Company Specific Requirements 11
R Is QA responsible for supplying a cleaning matrix schedule and checklists? Manufacturing and Related Processes 4
T Internal audit checklists related to the software development process Internal Auditing 3
D The Internal Audit Plan, Checklists and Repercussions Internal Auditing 18
T New standard 'impact assessment' - Essential Requirement/Principles Checklists ISO 13485:2016 - Medical Device Quality Management Systems 3
Z Electronic APQP checklists in electronic form wanted APQP and PPAP 3
E Supplier audit checklists for special processes - Plating Process audit Checklist Process Audits and Layered Process Audits 2
D AIAG's APQP Package Checklists: What is Required? APQP and PPAP 2
D Question about ISO 9001 Registrar Audit Checklist - No more checklists? General Auditing Discussions 9
C ISO 9001 Audit - Bank Branch - Checklists & Guidelines General Auditing Discussions 6
Gman2 ISO 9001 Internal Audit Checklists and Process Audits Process Audits and Layered Process Audits 31
C Audit Checklists: Quality Management System - Manufacturing Process - Product IATF 16949 - Automotive Quality Systems Standard 6
J Generic or Specific Checklists for Internal Audits Internal Auditing 15
M APQP Checklists - A5 (Floor Plan Checklist) - A7 (PFMEA checklist) APQP and PPAP 2
L Internal Audit Plans and Checklists Internal Auditing 6
K Design Review Checklists Design and Development of Products and Processes 1
M Internal Audit Checklists - Using the standard itself replace any checklist Internal Auditing 8
B Our QS9000 audit team has been using checklists to perform internal audits Internal Auditing 37
J APQP Checklists - Process Flow Chart Checklist, PFMEA Checklist, Floor Plan Checklist APQP and PPAP 11
F ISO 17025:2017 Clause 7.7 Ensuring the validity of results - Threshold ISO 17025 related Discussions 9
U ISO 17025:2017 Clause 7.7 Ensuring the Validity of Calibration Results ISO 17025 related Discussions 6
E AS9120B 8.4.2a Ensuring external providers remain within control of the QMS AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
H On choosing touchscreen displays and ensuring IEC 60601 compliance IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
M Complying with AS9100 D Section 8.4.3 m. Ensuring that persons are Aware of... AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 22
A Ensuring Tooling Use Tracking and Traceability AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1

Similar threads

Top Bottom