Sales Group Using Contract Manufacturer, Contract Designer for ISO 13485 Products

H

Here I Am

#1
What portions of 13485 and the quality system in general must be followed by a company that is utilizing a contract manufacturer for manufacturing and distribution and has a contract engineering firm that has conducted all design and development for the products. Is Section 7 applicable if the engineering and contract manufacturing contractors are doing the work?

Essentially, the company is a sales group that wants to hold the CE mark as well. Management Review is conducted and the company is involved in the design review as well.

Thanks,

Here I Am
 
Elsmar Forum Sponsor

DannyK

Trusted Information Resource
#2
As a consultant, I have dealt with several "virtual manufacturers." The easiest way to deal with this situation is to outsource it to a certified ISO 13485 company. The registrar will probably want to visit the contract maniufacturer and enjgineering firm to ensure that the controls meet the ISO 13485 requirements.


Also, as part of the internal audit process, you should be auditing these key suppliers.

Your QMS cannot exclude the manufacturing or engineering clauses.

Danny
 
A

AG Kumar

#3
Danny has clarified it very well.

Clauses 7.1 & 7.2 can not be excluded. Though you outsourced your design, you can not exlude it, since design input and design review might involve your organization necessarily. All your outsourced processes/vendors are to be evaluated and approved in accordance with clause 7.4. Clauses 7.5 and 7.6 - though your organization doesn't involve in manufacturing, but the device master record will be provided by you, you need to play monitoring & control role of 7.5 and 7.6. In my opinion, you shall not exclude anything from clause 7.0

AG Kumar
 
H

Here I Am

#4
I understand that you can not omit Section 7. But how much can you write into your quality system and your SOPs besides that we are involved with the review and approval of design and that all vendors including contract enginnerring and manufacturing vendors are audited and monitored in accordance with the vendor management SOP?

I am having difficulty writing some of the SOPs considering the company is essentially approving design and doing distribution activies. How much information needs to be present for things such as purchasing controls since the company is only purchasing services, handling and storage since contractors are doing those activies?

Thanks for the responses.
 

burovoy

Starting to get Involved
#5
What portions of 13485 and the quality system in general must be followed by a company that is utilizing a contract manufacturer for manufacturing and distribution and has a contract engineering firm that has conducted all design and development for the products. Is Section 7 applicable if the engineering and contract manufacturing contractors are doing the work?

Essentially, the company is a sales group that wants to hold the CE mark as well. Management Review is conducted and the company is involved in the design review as well.
In addition to previous responses, your contract(s) with your engineering and manufacturing contractors must reflect your responsibilities and the responsibilitites of your subs under section 7. Look here for possible solutions:
 

Attachments

Thread starter Similar threads Forum Replies Date
G Quality Group Salaries as Percent of Sales (as part of the Cost of Quality) Misc. Quality Assurance and Business Systems Related Topics 8
H MD Technical Documentation and SALES possibility EU Medical Device Regulations 0
B Free Sales Certificate for Non Medical Devices Other Medical Device Related Standards 2
B Countries with no need for FSC (Free sales certificate) Other Medical Device Regulations World-Wide 0
G Free Sales certificates for Medical Devices - List of countries EU Medical Device Regulations 4
M Covid Free Statements for Implants and sales reps. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Should volume of sales be factored into risk probability assessments? ISO 14971 - Medical Device Risk Management 33
qualprod On Time Delivery KPI for sales? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
M Identical Sales Package in Different Countries Pharmaceuticals (21 CFR Part 210, 21 CFR Part 211 and related Regulations) 0
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
Farley.0 QMS Sales Goals & Quality Objectives Manufacturing and Related Processes 22
I Sales Documents in scope for ISO-9001:2015? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
C Are we required to obtain a Certificate of Free Sales for export to China? Other Medical Device Regulations World-Wide 6
S Handling Cost of Sales requests for Customer Quality Manager and Management Related Issues 2
A ISO 9001:2015 Implementation for Marketing and Sales Companies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Customer Corrective Action requests and Sales Employees Promises AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
G 7.3 Design and Development in a Sales and Service Organisation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S Sales Department Internal Audit Internal Auditing 24
S ISO9001:2008 for Sales Office ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Y Local Agent and Sales Rights in countries like Brazil and Russia Other Medical Device Regulations World-Wide 2
Q Which ISO/TS 16949 clauses are applicable to auditing Quoting and Sales? IATF 16949 - Automotive Quality Systems Standard 19
M Manufacture and Sales of GHS Labels and Pictograms Occupational Health & Safety Management Standards 1
Ajit Basrur China breaks world record for car sales in 2013 ! World News 1
S Auditing Sales and Marketing Processes and Technical Support Canada Medical Device Regulations 2
J Setting Quality Objectives for Service, Repair and Sales ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K Supplier or outsourced? Medical Device installation, sales, training Other ISO and International Standards and European Regulations 7
I International Sales Legal/Regulatory Gray Area? CE Marking (Conformité Européene) / CB Scheme 3
E Marketing and Sales involvement in 8.2.1 Customer Satisfaction ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
E Validation of SAP Purchase Order and Sales Order modules Software Quality Assurance 7
B Performance Evaluation for my boutique's Sales Staff Benchmarking 7
C Implementing ISO 9001:2008 in a small Sales and Service company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
N When your Owner is the Sales Guy... Quality Manager and Management Related Issues 6
E List of Sales Procedures required for ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Y ISO 9001 Registration - Different Manufacturing and Sales Locations ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
B Control and Traceability of Sign-ups for Sales of a Product Career and Occupation Discussions 9
F How to manage Intermediary Sales Agents ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M SFDA Legal Agent and After Sales Agent in China - Differences? China Medical Device Regulations 3
V Query on TS 16949:2009 Certification for a Tool and Die Sales & Service office IATF 16949 - Automotive Quality Systems Standard 3
sagai Renewal of Canada Manufacturer Licence if there is no Sales (Only Support) Canada Medical Device Regulations 5
sagai Renewal of US Manufacturer Licence if there are no Sales (Only Support Activities) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
P Certificate of Free Sales (CFS) - Need to attach to each lot of exported product? Other Medical Device Regulations World-Wide 2
N Customer Service/Inside Sales Will Not Leave Us (Quality Assurance) Alone! Document Control Systems, Procedures, Forms and Templates 3
M Improving Purchases and Sales Sheets Manufacturing and Related Processes 1
B Sales vs. Quality vs. Manufacturing - Interactions and Responsibilities Quality Manager and Management Related Issues 13
Q Sales, different products/path to client, should be pictured each in Process Maps? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
K Sales Department KPI's (Key Performance Indicators) template and suggestions Misc. Quality Assurance and Business Systems Related Topics 1
Q Process Maps: Sales, different products, more boxes - Critique my map? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S Value Stream Mapping (VSM) in After Sales Customer Support Service Department Lean in Manufacturing and Service Industries 4
D Are we required to obtain ISO-13485 to act as a Sales Channel for Medical Devices ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom