Multiple Quality Standards - AS9100 and ISO13485/9001 Cross Reference Matrix

Q

quality1

#1
#1
Hi all,

I am tasked to implement AS9100 and ISO13485/9001 for two facilities. We currently have AS in one facility. Anyone have a comparison matrix of these standards they can share? Thank you for your help.
 
Download Free White Paper
Elsmar Forum Sponsor
K

kuyakut

Involved In Discussions
#2
#2
Re: Multiple Quality Standards

quality1 said:
Hi all,

I am tasked to implement AS9100 and ISO13485/9001 for two facilities. We currently have AS in one facility. Anyone have a comparison matrix of these standards they can share? Thank you for your help.
Click to expand...
I've downloaded this file from Elsmars 6 months back when we are also trying to get AS9100 certification. Hope it helps..
 

Attachments

Q

quality1

#3
#3
Re: Multiple Quality Standards

Thank you, I am looking for a recent version of a matrix to include AS9100 Rev C, 9001:2008 and 13485 if possible.
 
D

dgriffith

Quite Involved in Discussions
#4
#4
Re: Multiple Quality Standards

quality1 said:
Thank you, I am looking for a recent version of a matrix to include AS9100 Rev C, 9001:2008 and 13485 if possible.
Click to expand...
If it helps, AS9100C incorporates all of ISO9001. The additional requirements text is in bold.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
F Flexible Quality Management System (Multiple Standards) ISO 13485:2016 - Medical Device Quality Management Systems 8
F Format of a Quality Manual with Multiple Standards ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
G Quality System Overview - Monthly System Performance - Multiple Locations Quality Manager and Management Related Issues 8
C Integrating Multiple Company Policies such Quality and an Environmental Policy ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Quality System for Multiple Facilities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 5
R Computing Supplier Quality with multiple UOM Quality Tools, Improvement and Analysis 3
D Quality Software - Multiple Use - CMM Data, Inspection Sheets, etc Quality Assurance and Compliance Software Tools and Solutions 4
N QMS (Quality Management System) Software for multiple intercontinental locations Quality Assurance and Compliance Software Tools and Solutions 7
E Whether Egypt allows the appointment of multiple AR? Other Medical Device Regulations World-Wide 0
K Sample size calculation for the medical device with multiple indications. e.g. suture US Food and Drug Administration (FDA) 3
S Gagetrak upload of multiple gauges Calibration and Metrology Software and Hardware 0
P Registrar Cancelled ISO 13485 Auditors multiple times? Registrars and Notified Bodies 1
E Performing a GRR when you get multiple readings over time per part. Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5
S Control plan - Multiple batches Manufacturing and Related Processes 2
S Setting AQL Levels with Multiple Suppliers Supplier Quality Assurance and other Supplier Issues 3
I Distinguishing multiple importers with symbols EU Medical Device Regulations 0
D Multiple amendments at same license Canada Medical Device Regulations 1
F Multiple Intended Use Statements US Food and Drug Administration (FDA) 1
P IMDS Multiple parts RoHS, REACH, ELV, IMDS and Restricted Substances 2
E How to isolate multiple APPLIED PARTS IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
J Can you have one Core Process (PEAR) with multiple plants? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
M Multiple time zones in the Audit Trail Qualification and Validation (including 21 CFR Part 11) 7
C Multiple Part Numbers, IMDS RoHS, REACH, ELV, IMDS and Restricted Substances 2
D Control chart selection of multiple batches review Statistical Analysis Tools, Techniques and SPC 6
M Reference to an archived template in multiple SOPs ISO 13485:2016 - Medical Device Quality Management Systems 2
Z GRR for multiple automated metrology tools Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 1
K COPLANARITY: Composite profile tolerance on multiple surfaces- what does" lower dimensional reference frame tolerance" control? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 11
L 1 product multiple factories EU Medical Device Regulations 0
C Custom Injection Molding - Multiple Cavities and Subgrouping Capability, Accuracy and Stability - Processes, Machines, etc. 4
A One-factor and multiple-response Minitab optimization Using Minitab Software 2
I Multiple Indications in SaMD Other US Medical Device Regulations 8
K Multiple importers EU Medical Device Regulations 2
S Instructions for use multiple manufacturing locations ISO 13485:2016 - Medical Device Quality Management Systems 0
S Defibrillator Protection applicability When using Multiple applied parts IEC 60601 - Medical Electrical Equipment Safety Standards Series 0
V Software as medical device (SaMD) replicated for multiple clients through APIs IEC 62304 - Medical Device Software Life Cycle Processes 5
C Multiple owners for one listed device Medical Device and FDA Regulations and Standards News 1
A CE-IVD Technical File with Multiple IFUs EU Medical Device Regulations 5
K One CE Mark holder - multiple manufacturing sites EU Medical Device Regulations 3
K Multiple function device products EU Medical Device Regulations 0
O Are power distribution units Multiple Socket Outlets (MSOs)? IEC 60601 - Medical Electrical Equipment Safety Standards Series 1
Ron Rompen MSA on automated measurement system - Multiple Step Vision System Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
C Contract Review with Multiple Line items ISO 13485:2016 - Medical Device Quality Management Systems 7
I Cannot Export multiple sections from Excel to PDF without losing pagination Excel .xls Spreadsheet Templates and Tools 23
Q Legal Manufacturing Address Change – multiple registrations at same address 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
Proud Liberal Power Query to combine multiple tables of unequal number of columns Statistical Analysis Tools, Techniques and SPC 1
D Reduction of software class based on multiple external risk controls IEC 62304 - Medical Device Software Life Cycle Processes 5
G Gauge R&R on multiple dimensions using 3D measurement system Capability, Accuracy and Stability - Processes, Machines, etc. 6
S Samples for GR&R - Can we get the 10 samples from multiple models Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 5

Similar threads

Top Bottom