Outsourced Processes Control (Finished Medical Device Delivery, Storage)

Ronen E

Problem Solver
Staff member
Moderator
#11
In general, ISO 13485 is quite self-explanatory, and you can also take a look at ISO/TR 14969 (guidance for implementing ISO 13485). Last, there have been a lot of threads at Elsmar discussing various aspects of implementing ISO 13485.

WRT the warehouse / distribution center, I'd handle it just like any other important supplier (via purchasing controls - you are purchasing a service). If the devices that initially go there are not yours, are delivered finished, packaged and labeled and the storage and further distribution are under control - you don't need to worry about device inspection, IMO (other than the ordinary incoming identity, quantity & packaging integrity checks anyone receiving goods would do).

WRT R&D, just follow design controls as in S. 7.3. Implementing manufacturing controls would only make sense when you actually start gearing up to manufacture something.

Good luck,
Ronen.
 
Elsmar Forum Sponsor
Thread starter Similar threads Forum Replies Date
Q Control of outsourced processes - drop shipped products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
D Approved Supplier Control Requirements for Outsourced Special Processes Supplier Quality Assurance and other Supplier Issues 4
A The auditor documented that we did not have control of Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
A Additional Control Measures for Outsourced Processes under ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
O Methods used to Control Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
J Control of Outsourced Processes defined within the Quality Management System ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
E Control of Outsourced Processes (not properly described in the quality manual) ISO 13485:2016 - Medical Device Quality Management Systems 44
Q Type and Control of Outsourced Processes - ISO 9001 Clause 4.1 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 38
P Definition and control of outsourced processes - Service Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R How Can We Show Control Over Outsourced Processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 37
somashekar Control Over Outsourced Processes - Share some experiences and methods ISO 13485:2016 - Medical Device Quality Management Systems 6
Sidney Vianna Outsourced Processes - Type and Extent of Control to be Applied - ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 40
F Outsourced special processes - How to control outsourced special processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
T ISO 9001:2000 - Clause 4.1 - How to control outsourced processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
R Outsourcing Processes - What is appropriate control over the outsourced operations? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Outsourced processes how to interact with projects - We are an governmental department with 2 persons ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
K ISO 14001:2015 clause 8.1 on outsourced processes ISO 14001:2015 Specific Discussions 1
K Outsourced Major Processes - Working for Two Sister Companies AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
D Clear definition of Outsourced Processes (IATF 16949) IATF 16949 - Automotive Quality Systems Standard 6
J ITAR flow down to Processors (Outsourced Processes) AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
J ISO 13485:2016 QMS: Outsourced Processes ISO 13485:2016 - Medical Device Quality Management Systems 11
P Records for outsourced special processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 11
C 7.2 Customer Related Processes - Everything we do is Outsourced ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
GStough "Outsourced Processes" in a Government Contract Service Provider Company ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C How to Define and Document Controls of Outsourced Processes Food Safety - ISO 22000, HACCP (21 CFR 120) 5
A Methods for Approval of Internal and Outsourced Manufacturing Processes 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
A Determining what are, and are not, Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 28
A 3rd Party Audit Finding Not Clear - 4.1 Outsourced Processes AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 36
Q Outsourced Process - Why certain "processes" are not included - ISO9001-2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
6 Description of Outsourced Processes in ISO 22000 Manual Food Safety - ISO 22000, HACCP (21 CFR 120) 4
E Does the ISO/TS 16949 scope have to include all processes, even if outsourced? IATF 16949 - Automotive Quality Systems Standard 7
R Determining which Processes are Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
L Support Processes, Exclusion and Outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 16
C API Q1 8th ed/ISO TS 29001 Maintaining Responsibility for Outsourced Processes Oil and Gas Industry Standards and Regulations 6
R Outsourced Processes - Firm examples required ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 34
kedarg6500 Third Party Logistics & Outsourced-Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
V Outsourced Maintenance Processes IATF 16949 - Automotive Quality Systems Standard 3
P Outsourced Processes - Delivery of our Products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
B Dealing with Outsourced Processes in a DMR ISO 13485:2016 - Medical Device Quality Management Systems 7
S Validation Of Outsourced Special Processes under AS9100 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
M Outsourced Processes & Process Design - Interpretation of the "Outsourced Processes" Design and Development of Products and Processes 8
R Validation of outsourced processes - Calibration - How do we validate that? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
F Outsourced Processes - Not all identified in the Quality Manual ISO 13485:2016 - Medical Device Quality Management Systems 6
H Definition Outsourced Processes - Definition and Identification of Outsourced Processes Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 5
Y ISO 13485:2003 Documentation Requirements for Outsourced Processes and Services ISO 13485:2016 - Medical Device Quality Management Systems 24
T ISO9001:2000-sec 4.1-relating to outsourced Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Identifying Outsourced Processes - Training, Calibration, Consulting - TS-16949 IATF 16949 - Automotive Quality Systems Standard 2
R Outsourced processes - Same Company, Different Location ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
B Outsourced Processes vs. Contract Personnel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 4

Similar threads

Top Bottom