SBS - The best value in QMS software

21CFR820 vs. ISO 9000:2000 - Cross Reference Matrix Attached

RCW

Quite Involved in Discussions
#1
Somebody help me!

I am updating my quality manual from ISO 9000:1994 to ISO 9000:2000 HOWEVER.....in addition I need to add in references to 21CFR820.:bonk:

Comparing 21CFR820 to ISO9000:1994 isn't too bad but it looks a lot messier comparing it to ISO9000:2000. Does anybody out there have a handy-dandy cross-reference between 21CFR820 and ISO9000:2000? Also does anybody have a quick reference on the additional requirements for 21CFR820 that aren't covered in ISO9000:2000?

I was planning to put a cross reference in the index of my quality manual.

Also I read somewhere that 21CFR820 was in the process of being updated to align with ISO9000:2000 (or was that a whole new ISO medical spec?).

Any help would be appreciated!
 
Elsmar Forum Sponsor
A

Alf Gulford

#2
Hi, RCW-

The last I heard, the FDA has declared that they will harmonize with ISO 13485:200x instead of ISO 9001:2000. If you're medical device you need to order a copy of that. All that's out is the Committee Draft right now, but the word on the 'street' is that the final version isn't expected to change much.

I've got a matrix with ISO 9001:1994, ISO/CD 13485:200x and FDA 21 CFR, part 820 that I created for my next Quality Manual. If I can figure out how to do so, I'll be glad to share it with you (but no guarantees of accuracy, caveat emptor). I didn't have much luck recently with Avatars but I'll take a shot at this in the next day or so.

Alf
 
A

Alf Gulford

#3
RCW-
Here's the matrix I was talking about. Again, probably only useful if you're medical device and selling in Europe and/or Canada. You can also check other threads in this category and find more info on ISO 13485.

Alf
 

Attachments

Last edited by a moderator:
A

Alf Gulford

#5
My pleasure, Bubba.

If it's worth anything to anyone, I found a 4 way matrix I made that also includes 9001:2000. My problem is that I did it several months ago (before we made the decision to go with 13485) and can't remember if I final proofed it or not. I do remember that trying to match everything perfectly was a miserable task and I wouldn't want anyone to bet their job on the result.

Alf
 

Attachments

RCW

Quite Involved in Discussions
#6
A hearty thumbs-up!

Thanks Alf!

That 4-way matrix looks like exactly what I need. I will double check the cross-references you gave but that table definitely puts a big dent into what I need to get done.

Thanks again!:D
 
Thread starter Similar threads Forum Replies Date
M Differing interpretations in ISO 17025 and 21CFR820.72(b)(2) ISO 17025 related Discussions 5
S Packaging and Label Change Requirements - ISO 13485/FDA 21CFR820 ISO 13485:2016 - Medical Device Quality Management Systems 3
V Implementing Dock-to-Stock when regulated by ISO 13485 and 21CFR820 ISO 13485:2016 - Medical Device Quality Management Systems 12
J ISO 13485, Canadian MDR and FDA 21CFR820 Comparison Matrix ISO 13485:2016 - Medical Device Quality Management Systems 14
M 21 CFR 820 vs 21CFR820 vs 21 CFR Part 820 Document Control Systems, Procedures, Forms and Templates 3
J 21CFR820 requirements for Foreign Exporter? US Food and Drug Administration (FDA) 4
F Distribution Records required by FDA - 21CFR820.160 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
Q When does the FDA deem something "where appropriate"? 21CFR820.30(g) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 11
Q 21CFR820 as it was in 1993 or 1997? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
S Is a Dynamic Controlled Form acceptable per 21CFR820 Document Control Systems, Procedures, Forms and Templates 3
M 21CFR820.120 Device Labeling Requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
sagai Preventive Action vs. Corrective Action as defined by 21CFR820 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
J Correlation matrix between HSA TS-01 and 21CFR820 or ISO13485 Other Medical Device Regulations World-Wide 1
M FDA 21CFR820, ISO13485 and AS9100 co-existence? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
N Requirements to Comply With FDA 21CFR820 For Invitro Diagnostic Device 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 8
S 21CFR820-820.50 Purchasing controls - Using Non-Approved Suppliers 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 10
A FDA Quality Audits 21cfr820.22 - Audits by the head of the company not allowed ISO 13485:2016 - Medical Device Quality Management Systems 1
Le Chiffre Online training available for ISO/IEC 17021-1: Requirements for bodies providing audit and certification of management systems Training - Internal, External, Online and Distance Learning 3
B ISO 6508 and portable hardness measurement instruments General Measurement Device and Calibration Topics 0
M Scope for ISO 13485 Certification of a Translation Service Provider ISO 13485:2016 - Medical Device Quality Management Systems 2
S Knee Implant (Femoral -Cobalt chrome)-Sub chronic toxicity test (ISO 10993-11)choice of root Medical Device and FDA Regulations and Standards News 2
Sidney Vianna Release of ISO 10013:2021, Quality management systems – Guidance for documented information Other ISO and International Standards and European Regulations 0
K Integrating ISO 9001:2015 with ISO 17025:2017 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q ISO 13485 7.5.6 Validation - Off the shelf Software ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Certification for Resin Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 4
R Remote Audits for ISO 9001 (or any other standard) General Auditing Discussions 29
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 and compliance of electronic signature ISO 13485:2016 - Medical Device Quality Management Systems 5
T ISO 13485 - Assembly instructions written vs. online ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485:2016 internal audit checklist Medical Device and FDA Regulations and Standards News 5
D ISO 17021 Certificate Registrars and Notified Bodies 1
X ISO 17025 certification for Laboratory for online gambling products ISO 17025 related Discussions 3
C ISO 19227 Validation Cost Other Medical Device Related Standards 2
N 93/42/EEC certification without ISO 13485 EU Medical Device Regulations 3
T Relationship between ISO 9001 and ISO – IEC BS EN 870079- 34 2020 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M How Specific in an ISO 13485:2016 Scope for a Contract Manufacturer ISO 13485:2016 - Medical Device Quality Management Systems 9
A ISO 13485 for Class 1 Medical Device ISO 13485:2016 - Medical Device Quality Management Systems 7
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
qualprod Business Continuity Planning in ISO 9001? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
C Sampling - ISO 16269-6 vs ISO 2859 Other ISO and International Standards and European Regulations 0
Brizilla Employee Data Privacy Policy - ISO 9001:2015 requirement(s)? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R ISO 17025 - ISO Guides 33 & 80 ISO 17025 related Discussions 1
0 ISO 13485:2016 Chapter 8 Integration of the subsections ISO 13485:2016 - Medical Device Quality Management Systems 1
S ISO 9001:2015 Internal Auditing Internal Auditing 8
Q Process: Knowledge Section 7.1.6 of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
N ISO 27001 for Jumb Burger - Risk Assessment sheet IEC 27001 - Information Security Management Systems (ISMS) 10
H What ISO certification is for an IT department? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
M Change in Constitution / Ownership of firm -------ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 1
P ISO 9001 certification with zero customers? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11

Similar threads

Top Bottom