Gap analysis to demonstrate that we comply to CAN3-Z299.3-85

CalRich

Involved In Discussions
#11
Thanks for the links!
The comany I work for is very small (7people) and is not registered at all. I have to create a Manual in order for us to become approved for a neuclear company.
My boss HAS mentioned about us going ISO, and I agree that this has been a valuable lesson for me.
Anyway nothing left to do but correct a billion typos.
Thanks again

Yikes... we had almost the same thing...a request for a GAP analysis based on CSA Z299.3. By looking at this thread, it seems it is an obsolete standard. We're already ISO 9001 and have many product approvals. A customer sent an on-site audit checklist for us to "fill out"... but now we've got to provide them with evidence. It doesn't seem very aligned with 9001 requirements (even the older revisions). It seems to mandate a procedure that explains how we do calibration.
 
Elsmar Forum Sponsor

CalRich

Involved In Discussions
#13
Well we managed to saisfy the nuclear fplks. Now we are going for 17025!

Ahhh 17025, a much more noble effort. I wish you luck with that.

I looked at the CSA website, where they boast that Z299 was the document that was used a model for the development of ISO 9001. And they say that due to demand, they still publish the Z299 standard. But their Learning Centre has only ISO 9001-related training, nothing for Z299.
 
S

SAJ328

#16
I need to do a gap analysis between ISO9K and Z299, could you please forward me some info on the Z299 requirements. Seem odd, but we are currently ISO9K, but want to get Z299. Any help would be greatly appreciated.
 
S

SAJ328

#18
I tried, but since I'm a NOOB, my PM is not yet available until I reach 5 posts, please email me at ( i can't even put the email address down), Please send me an email. Thanks.
 

Marc

Hunkered Down for the Duration with a Mask on...
Staff member
Admin
#19
I tried, but since I'm a NOOB, my PM is not yet available until I reach 5 posts.
I'll check the settings, but the PM system should be available to you. There is no 5 post minimum to use it. There is a TOS 'rule' where you cannot put email addresses in posts unless you are recruiting a job applicant, so that's not an issue.

Try the PM system again and let me know what the screen says if you get an error screen.
 
M

moiraknows

#20
I need to do a gap analysis between ISO9K and Z299, could you please forward me some info on the Z299 requirements. Seem odd, but we are currently ISO9K, but want to get Z299. Any help would be greatly appreciated.
Well fellow Canuck. It seems that we may be at a stale-mate. I sent you a PM with my email address.
 
Thread starter Similar threads Forum Replies Date
V ISO 10360-5: 2020 Gap analysis and Action plan Excel .xls Spreadsheet Templates and Tools 1
JoCam MDR Gap Analysis - Consultant fees EU Medical Device Regulations 10
M MDSAP and 13485:2016 gap analysis Quality Management System (QMS) Manuals 1
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 8
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
J Looking for a EU MDR Gap Analysis template EU Medical Device Regulations 6
B Has anyone done an IEC 60601-1 gap analysis to IEC 60335? Medical Device and FDA Regulations and Standards News 4
M 10993-11 vs 2006 gap analysis Other Medical Device Related Standards 2
Nicole Desouza AS 9100 Rev D Gap Analysis AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
R AS9100 REV D gap analysis matrix AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M MDR Medical devices Gap analysis ISO 13485:2016 - Medical Device Quality Management Systems 2
L UDI Requirments Gap Analysis - EU MDR vs FDA CFR EU Medical Device Regulations 8
J ISO 9001:2015 Excel Gap Analysis wanted ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
E ISO TC 34 and ISO 22000:2018 Gap Analysis and the principles of Codex Alimentarius Food Safety - ISO 22000, HACCP (21 CFR 120) 1
shimonv Checklist for MDD to MDR gap analysis EU Medical Device Regulations 23
Q GAP Analysis between IATF 16949 and VDA 6.3 wanted VDA Standards - Germany's Automotive Standards 4
P ISO 14001 - Looking for a Gap Analysis Template ISO 14001:2015 Specific Discussions 3
S Gap Analysis MDR req/MEDDEV 2.7.1 rev 4 EU Medical Device Regulations 3
V How do I get a rough MDD to MDR gap analysis by clauses Other Medical Device Related Standards 5
C Annex II EU MDR gap analysis EU Medical Device Regulations 7
P ISO 14155 GAP analysis Other Medical Device Related Standards 3
T IEC 60601 3.1 edition Gap Analysis wanted IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J PCI PIN compliance and Gap analysis IEC 27001 - Information Security Management Systems (ISMS) 0
B Gap analysis of new start-up company technical documentation CE Marking (Conformité Européene) / CB Scheme 1
S ISO 9001:2015 Gap Analysis - In-House or 3rd Party? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S TGA regulations and ISO 13485:2016 gap analysis MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 2
B NEED HSE-MS Gap Analysis between 2 existing Management Systems Occupational Health & Safety Management Standards 0
F New to RA: FDA Regulation Checklist/Gap Analysis 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
C Upgrading from ISO 9001:2015 to IATF 16949:2016 - Anyone have a gap analysis tool? IATF 16949 - Automotive Quality Systems Standard 2
K AS9100 Rev. D Transition - Internal Audits & Gap Analysis Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
Icy Mountain ISO9001:2015 & IATF 16949:2016 Gap Analysis Tool IATF 16949 - Automotive Quality Systems Standard 7
L Medical Device Electrical Safety Standards - Gap Analysis of Latest Revisions Other ISO and International Standards and European Regulations 2
E Gap Analysis between MEDDEV 2.7/1 rev.4 vs. rev.3 wanted EU Medical Device Regulations 3
M ISO/TS16949 to IATF 16949:2016 Gap Analysis Questions IATF 16949 - Automotive Quality Systems Standard 2
T TS16949 - What extras over the ISO 9001:2008? Gap Analysis IATF 16949 - Automotive Quality Systems Standard 5
A AS9100C to D - Has anyone done a gap analysis? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
P ISO 13485:2016 Gap Analysis with Changes Identified ISO 13485:2016 - Medical Device Quality Management Systems 26
E Gap Analysis for VDA 6.3:2010 and ISO/TS16949:2009 VDA Standards - Germany's Automotive Standards 5
S OHSAS 18001 Gap Analysis Template wanted Occupational Health & Safety Management Standards 5
F Gap Analysis Matrix for AS9100 Rev C to TS16949:2009 IATF 16949 - Automotive Quality Systems Standard 1
G Does anyone have a ISO 13485 Gap Analysis form they'd be willing to share? Quality Manager and Management Related Issues 3
K ISO 9001:2015 GAP Analysis ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
M I am looking for a Gap Analysis for TS16949 IATF 16949 - Automotive Quality Systems Standard 1
D Gap Analysis for ISO 18113-1 thru -5 (ISO 18113:2009 to ISO 18113:2012) Other ISO and International Standards and European Regulations 1
4 Initial Environmental Review and Gap Analysis, difference? Miscellaneous Environmental Standards and EMS Related Discussions 8
D Gap Analysis Checklist for ISO 13485:2003 2012 ISO 13485:2016 - Medical Device Quality Management Systems 13
K ISO 9001 vs AS9100 Gap Analysis on Delivery Performance and Document Control AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
B Macro Process Mapping (pre-GAP analysis) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Essential Gap Analysis Checklist Components for ISO Certification ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
G AS9100 Gap Analysis Report form or template wanted AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7

Similar threads

Top Bottom