Definition Factored Products - Will have another contractor manufacture material for us

G

George Rivas

#1
#1
We are trying to get our overseas facility ISO certified. They will have another contractor manufacture material for us. How would we address this issue. Is this a subcontractor implementation?
 
Paper to QMS ad
Elsmar Forum Sponsor
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#2
#2
Yes - if another company is manufacturing something for you they are a supplier (subcontractor) to you.
 
S

Sam

#3
#3
The registrar, BVQINA publishes an excellent article on "factored" products. Provides guidance for the 'Who, What , Where , When & Why"
 
Marc

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
#4
Re: Factored products

Can someone define 'factored products' for me? Excuse my ignorance.
 
A

Al Rosen

Holed-up in a Hotel in South Florida
Staff member
Super Moderator
#5
#5
Re: Factored products

Marc said:
Can someone define 'factored products' for me? Excuse my ignorance.
Click to expand...
I believe they are products produced by a subcontractor or third party.
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
K Multiple function device products EU Medical Device Regulations 0
Inggo28 Products Potentially Infected by Covid - 19 Human Factors and Ergonomics in Engineering 1
C Combination Products - Distributor of the device? EU Medical Device Regulations 7
A Can a US manufacturer put export only products on a CFG? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
D Question regarding ECO process, specifically for Life Science products and defining form fit and function ISO 13485:2016 - Medical Device Quality Management Systems 1
R DFMEA/PFMEA mitigation of high severity (9-10) in low volume products IATF 16949 - Automotive Quality Systems Standard 1
shimonv FDA News FDA guidance on Multiple Function Device Products (8/2020) Other US Medical Device Regulations 1
K Biocompatibility Testing - Multile products of different sizes and shapes US Food and Drug Administration (FDA) 2
S ISO 45001 and outsourcing the transporation of products Occupational Health & Safety Management Standards 3
R IVDR CE Mark for Class A products - Declaration of Conformity CE Marking (Conformité Européene) / CB Scheme 2
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
BeaBea Interesting Discussion Where Does Marketing/ Advertisement of Products fit in to ISO 9001? Process Maps, Process Mapping and Turtle Diagrams 39
J Iterative design and production for custom made products ISO 13485:2016 - Medical Device Quality Management Systems 3
Q Old products new class - Dental Devices - Choosing tests EU Medical Device Regulations 2
J Design file for pre-existing products - Inputs and Outputs ISO 13485:2016 - Medical Device Quality Management Systems 5
P Do I need to get registered or have German entity to sell IVD products in Germany? CE Marking (Conformité Européene) / CB Scheme 2
R Reduced sampling plan for sterial products APQP and PPAP 0
D Cleanroom Cleaning Products and Storage Other Medical Device and Orthopedic Related Topics 18
J Raw material certificates - CC - Safety products - Sheet metal stamping IATF 16949 - Automotive Quality Systems Standard 1
M Validation of two nearly identical products Other Medical Device Regulations World-Wide 5
B Unit of Use DI (Device Identifier) - Products using the same device US Food and Drug Administration (FDA) 0
G Class IIa medical products - PMS report and PSUR EU Medical Device Regulations 6
Z 510(k) usage - Company has 2 physically similar products Medical Device and FDA Regulations and Standards News 2
T API Q1 - Will I be able to maintain Q1 if I have products that fall under 6A Oil and Gas Industry Standards and Regulations 5
A VDmax25 and cGMP requirements for "research use only" products Other Medical Device Related Standards 1
B QMS question in regards to multiple medical devices/products and N/A activities Other Medical Device Related Standards 12
H Re-labelling in IVDD - Re-label two products and package them as one CE Marking (Conformité Européene) / CB Scheme 5
V IATF 16949 8.4.1 Control of externally provided processes, products and services - Should the CB be on our Approved Supplier List? IATF 16949 - Automotive Quality Systems Standard 10
S Similar scope medical products connected by WIFI US Food and Drug Administration (FDA) 2
F Calibrating Gagemaker Products General Measurement Device and Calibration Topics 1
C AS9100D -8.5.1j - Accountability For All Products Tiny Parts AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
M NANDO codes of products - These are not the GMDN codes, correct? EU Medical Device Regulations 4
M Informational TGA – Current status of breast implant products in Australia Medical Device and FDA Regulations and Standards News 0
shimonv Recall - Is there a European regulation for recalls of products EU Medical Device Regulations 3
M Informational EU – New designated Notified Body under the MDR – TÜV Rheinland LGA Products GmbH Medical Device and FDA Regulations and Standards News 0
A Design and development of products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Clause 8.2.2 Determining the requirements for products and services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
Marc Goldsmiths University will take beef products off the menu starting in September 2019 Sustainability, Green Initiatives and Ecology 19
T Product Labeling - Modified the name of one of our products EU Medical Device Regulations 5
J MDR Annex VIII, Rule 6 Classification - Implication for lower risk CV products? CE Marking (Conformité Européene) / CB Scheme 3
M Informational US FDA Final guidance – Postmarketing Safety Reporting for Combination Products Medical Device and FDA Regulations and Standards News 0
M Informational TGA – Advertising health products: Rules about safety claims in advertising Medical Device and FDA Regulations and Standards News 0
M Informational BSI – ISO 13485 and products with May 2020 deadline for MDR certification Medical Device and FDA Regulations and Standards News 0
M Informational Medicines and Healthcare Products Regulatory Agency Annual Report and Accounts 2018 to 2019 Medical Device and FDA Regulations and Standards News 0
J US Manufacturer of Export Only Exempt Products applying for CFG 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
S GMDN Code for Chitosan Products CE Marking (Conformité Européene) / CB Scheme 1
DuncanGibbons Why is 8.4 post-delivery activities before 8.6 release of products and services in AS9100D? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
O Validation approach for a Photostability Chamber (used for fluid therapy and injectable drug products) Qualification and Validation (including 21 CFR Part 11) 1
M Informational EMA – Consultation on draft guideline on quality requirements for medical devices in combination products Medical Device and FDA Regulations and Standards News 0

Similar threads

Top Bottom