"Purchasing Controls" for Stand-alone Software

K

keldez

Involved In Discussions
#1
#1
Hello all,
First off thanks to everyone that has made Elsmar possible. It has been a life saver for me. It's a shame to see it go.

On to my question.. I'm currently developing the our Purchasing Controls (from 820.50) procedure supporting our single product, which is a Class 2 stand-alone software. As I comb through the requirements and even some articles related to the matter, I'm finding the scope of what applies to be almost non-applicable. If someone could give me a sanity check I would appreciate it.
- Purchases from suppliers: There are none, unless one would make the argument to start tracking purchases of computer hardware and software (very mainstream) used to develop the product.
- Evaluation of the suppliers: Requires application of the "Purchases from suppliers"
- Purchasing Data: I haven't determined any significant equipment/components that support the production of the product of product itself. The one exception is the User Manual, which is controlled, distributed electronically to the third party label for our product.
- Receiving Inspection (outside the scope of Purchasing but aligns with the theme): As the theme suggests, there are no "unit" based or tangible product supporting the DMR that appear to require inspection.

I've never been in this situation of such little to no application, so it doesn't feel right. Is there anyone else out there in a similar situation, or can enlighten me on maybe where I've missed something. Thank you!
 
Paper to QMS ad
Elsmar Forum Sponsor
Y

yodon

Staff member
Super Moderator
#2
#2
I'll toss out a few thoughts...

If your only purchase is computer equipment (you're not purchasing services for software integration, you're not purchasing cloud storage services, etc.) then you still want to have assurance that the equipment you buy is reliable (as can be expected) and legitimate. For example, if you buy from Fred's Oil, Lube, and PC services because they are extremely cheap, you may not get quality equipment (and may be loaded with bootleg OS, etc.). You DO have expectations for the supplier (probably a business whose primary purpose is computer equipment / electronics, offers some kind of quality of product, etc.). Only needs to establish your requirements and show that the selected supplier(s) meet them.

In terms of receiving inspection, just a review of the spec sheet to ensure you got what you ordered would be reasonable. If you ordered a system with a 500Gb hard drive and received one with only 125Gb, you wouldn't accept it probably.

Doesn't need to be a big deal, but does need to be a deal.
 
K

keldez

Involved In Discussions
#3
#3
Thank you for your thoughts.
I have gone back and forth on taking a similar approach. I feel somewhat like I'm trying to fill empty space just to fill it. I understand the importance of having the appropriate computer equipment to product.
Maybe I could take the approach of some sort of "inventory matrix" based on how vital it is or associated risk of the equipment to the product to ensure the equipment and software is accounted for and legitimate.
I'm a little hesitant to go down the rabbit hole of adding, for example, Dell and Microsoft as suppliers.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
D Do purchasing controls apply to non-medical parts? ISO 13485:2016 - Medical Device Quality Management Systems 5
V Purchasing Controls - Prerequisites for Batch Release or even before Purchase Order 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 3
E ISO 9001-2008 Purchasing controls ? Issuing POs Without Specific Approvals Quality Manager and Management Related Issues 8
M Supplier Audit Form for Purchasing Controls ISO 13485:2016 - Medical Device Quality Management Systems 2
M Distributor and 21 CFR Part 820.50 Purchasing Controls 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
M QSR Purchasing Controls governing evaluation and use of consultants ISO 13485:2016 - Medical Device Quality Management Systems 1
L Purchasing procedure and workload ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
W Non-Conformance from recent Audit carried out on Purchasing AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
Q Purchasing requirements for Toll Manufacturers Manufacturing and Related Processes 1
R Do Brands Matter When Purchasing Bore Gauge? General Measurement Device and Calibration Topics 2
J COC (Certificate of Conformity) when NOT purchasing medical devices direct from the Manufacturer Other Medical Device Related Standards 2
R ISO 13485 purchasing QMS and ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 8
A Purchasing - Internal Audit Questions Internal Auditing 8
M Case study - If the restaurant (ISO 9001:2015 certified) was run by 2 persons covering cooking and purchasing processes (Mother and Father) supported ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
D Use of non-ISO 9001 Supplier - Purchasing through a distributor IATF 16949 - Automotive Quality Systems Standard 7
M AS9100d Controlling External Provided Processes (purchasing 8.4) - The customer want us to use supplier X AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
S Purchasing for Design and Development Organization ISO 13485:2016 - Medical Device Quality Management Systems 3
Q AS 9100 C and D Purchasing requirements difference AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 2
Q Risks and opportunities that could be associated with the purchasing department ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R DFARS Compliance - Purchasing Aluminum Alloy 7075 -T73511 per AMS-QQ-A-200/11 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 4
N ISO 17025 Clause 4.6 Purchasing Services & Supplies (Compliance) ISO 17025 related Discussions 3
L ANVISA RDC 16 - purchasing records Other Medical Device Regulations World-Wide 2
H Cause analysis for an Audit Finding - Purchasing Procedure Content ISO 13485:2016 - Medical Device Quality Management Systems 9
D Can we exclude purchasing and supplier evaluation - ISO9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
S Difference between 7.4.1 & 7.4.3 - Purchasing Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9100 7.4 "Purchasing of a Service" - Stress and Design Analysis AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
A Question on Purchasing clause 7.4.1 of ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
A 7.4 Purchasing Question - My company only provides services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
W ISO 9001 Clause 7.4.2 Purchasing Information for Retail Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
L AS9100 - 7.4.2d Purchasing - Specification revision for raw material needed? AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 3
P Purchasing Process Out of Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
H Methods to Ensure that we are Purchasing what we've Designed Benchmarking 16
T Purchasing SPC Software for Automotive Company Statistical Analysis Tools, Techniques and SPC 9
P Supplier Scorecard for ISO 9001 - Help me review the draft from my purchasing team ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
V Satisfying AS9100 7.4.2 Purchasing Requirements AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 10
quality1 Exclusion to Purchasing - AS9100 Clauses 7.4.1 & 7.4.2 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
S Do I have to audit 7.4 Purchasing ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
D AS9100 Tooling Purchasing Process Manufacturing and Related Processes 5
T Purchasing a Digital Multimeter Calibration and Metrology Software and Hardware 3
B Bill of Material Content to meet Purchasing Requirements Manufacturing and Related Processes 2
W ISO 9001:2008 Purchasing Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T ISO 9001 Clause 7.4.1 Purchasing Process (Supplier Approval) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
A Purchasing Performance KPI (Key Performance Indicators) Benchmarking 4
K Purchasing a Portable CMM to Measure a 14' Cylinder that's 5' Tall Calibration and Metrology Software and Hardware 3
C Purchasing Department Internal Audit HELP! Internal Auditing 12
T Employee not following Purchasing Process Other Medical Device Related Standards 27
Q AS9100 Clause 7.4.1 Purchasing Process and Approved Supplier List Records AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 37
A Purchasing Verification & Supplier Selection ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R ISO 9001:1987 or 1994 - Wording of Purchasing in section 6.0 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
Similar threads
Top Bottom