SBS - The best value in QMS software

ISO 13485 Clause 1.2 Application Clarification

J

jscholen

#1
"The processes required by this international standard, which are applicable to the medical device(s), but which are not performed by the organization, are the responsibility of the organization and are accounted for in the organizations quality management system......" -ISO 13485

is this applicable downstream and upstream or just downstream, ie, if you have a subcontractor who sterilizes then you are responsible, but if your customer sterilizes the finished product, ie, product is out of your hands, then you are responsible or not.

Which is it? Seems common sense to me, but sometimes the standard can throw me for a loop.

Thanks.
 
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: 1.2 Application Clarification

It means that responsibility is not abdicated or avoided by outsourcing processes. If a critical process is sourced by a supplier, then supplier control and management needs to be implemented to ensure the product meets requirements.
 
Thread starter Similar threads Forum Replies Date
ebrahim QMS as per ISO 13485, Clause 4.2 Requirements for regulatory purposes for Medical Devices Authorized Representatives. ISO 13485:2016 - Medical Device Quality Management Systems 3
A ISO 13485 Sterilization Clause Applicability ISO 13485:2016 - Medical Device Quality Management Systems 7
K ISO 13485 clause 8.5.2 'Any necessary CA shall be taken without undue delay' ISO 13485:2016 - Medical Device Quality Management Systems 11
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 12
A ISO 13485 - Clause 8.3.3 appropriate actions in response to nonconforming product ISO 13485:2016 - Medical Device Quality Management Systems 2
K ISO 13485:2016, Clause 4.2.3 Medical Device File ISO 13485:2016 - Medical Device Quality Management Systems 4
F ISO 13485 8.2.3 Reporting to regulatory authorities: Question regarding a procedure for this clause. ISO 13485:2016 - Medical Device Quality Management Systems 4
L ISO 13485:2016 Clause 8.4 - Analysis of Audit Observations ISO 13485:2016 - Medical Device Quality Management Systems 8
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
S What is the clause in ISO 13485 for SAP Software Validation? ISO 13485:2016 - Medical Device Quality Management Systems 3
M Damaged Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 7
GoSpeedRacer ISO 13485:2016 Clause 4.2.5 - Control of Records - HIPAA Requirements ISO 13485:2016 - Medical Device Quality Management Systems 11
T Struggling with ISO 13485:2016 Clause 6.2 - Level of Risk Associated with Work ISO 13485:2016 - Medical Device Quality Management Systems 3
T ISO 13485:2016 Clause 7.4.2 regarding Supplier Quality Agreements ISO 13485:2016 - Medical Device Quality Management Systems 11
R ISO 13485:2016 Clause 6.2 - Effectiveness Check ISO 13485:2016 - Medical Device Quality Management Systems 1
E ISO 13485 Clause 7.3.2 - Purchased Data Approval and Record Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
S Interpreting clause 4.1.5 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 9
S Software Validation – Clause 4.1.6 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 12
P Which ISO 13485 clause(es) are applicable for Value Proposition Creation ISO 13485:2016 - Medical Device Quality Management Systems 1
J Definition Servicing - Definition - ISO 13485 Clause 7.5.1.2.3 - Servicing Activities Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 4
T ISO 13485 Clause 4.2.1 - Clarification of Intent ISO 13485:2016 - Medical Device Quality Management Systems 6
R ISO 13485 Clause 4.2.1 - Documentation Requirement question ISO 13485:2016 - Medical Device Quality Management Systems 4
D Taking an Exception to Clause 7.3 in ISO 9001 and ISO 13485 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
X Help with ISO 13485 Clause 8.3 "Rework" as applicable to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 39
X Help with ISO 13485 Clause 6.4 as it applies to Medical Device Servicing ISO 13485:2016 - Medical Device Quality Management Systems 25
C ISO 13485 Clause 7.5.1.2.1 Cleanliness of Product and Contamination Control Question ISO 13485:2016 - Medical Device Quality Management Systems 7
Project Man The "Ifs" in ISO 13485 Clause 6.4 Work Environment - Machine Shop which makes parts ISO 13485:2016 - Medical Device Quality Management Systems 1
A Human Resources (ISO 13485 Clause 6.2) example of SOP ISO 13485:2016 - Medical Device Quality Management Systems 1
T Quality Staff - Independence (ISO 13485 Clause 5.5.1) ISO 13485:2016 - Medical Device Quality Management Systems 1
P Control of Monitoring and Measurement Devices - ISO 13485 Clause 7.6 says ... ISO 13485:2016 - Medical Device Quality Management Systems 3
A Purchasing Information Requirements - ISO 13485 Clause 7.4.2 and FDA QSR Supplier Quality Assurance and other Supplier Issues 2
D Quality System Manual - Exclusions from ISO 13485 Clause 7.5 ISO 13485:2016 - Medical Device Quality Management Systems 4
N Validation of Special Processes - N/A of ISO 13485 Clause 7.5.2 ISO 13485:2016 - Medical Device Quality Management Systems 12
I Not having Training Records for Documentation Changes - ISO 13485 Clause 4.2.3 Document Control Systems, Procedures, Forms and Templates 22
K ISO 13485 Clause 7.4 Purchase Order Requirements Question ISO 13485:2016 - Medical Device Quality Management Systems 4
somashekar Calibration interval (Clause 7.6 ISO 13485:2003) - Biomedical test instruments ISO 13485:2016 - Medical Device Quality Management Systems 4
R ISO 13485 Clause 7.6 Control of Monitoring and measuring devices - Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
Q Interpreting Responsibility and Authority Clause 5.5.1 ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 18
Q ISO 13485 Clause 4.2.2 Documentation Structure - Quality Manual clarification ISO 13485:2016 - Medical Device Quality Management Systems 6
R Interpretation of ISO 13485 Clause 8.4 - Analysis of Data ISO 13485:2016 - Medical Device Quality Management Systems 20
J ISO 13485:2003 Clause 1.3 - Applicable Standards and Regulations ISO 13485:2016 - Medical Device Quality Management Systems 8
N Poor control of testing chemicals ? which ISO 13485/9001 clause does it contravene? ISO 13485:2016 - Medical Device Quality Management Systems 8
J How to accomplish ISO 13485 Clause 8.2.3 Monitoring and Measuring? ISO 13485:2016 - Medical Device Quality Management Systems 5
F ISO 13485 Clause 6.3 - System to determine and provide infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 5
V Planning of Product Realization - Risk Management - ISO 13485 Clause 7.1 ISO 13485:2016 - Medical Device Quality Management Systems 6
D Effective Control of Processes - ISO 13485 Clause 4.2.1 (d) ISO 13485:2016 - Medical Device Quality Management Systems 2
A ISO 13485 Clause 8.2.2 - Internal auditor from within the company to be audited Internal Auditing 2
L ISO 13485: 2003 - Clause 8.4 Analysis of Data - Seeking an example procedure ISO 13485:2016 - Medical Device Quality Management Systems 2
H New Clause Structure of ISO 13485:2003 ISO 13485:2016 - Medical Device Quality Management Systems 5

Similar threads

Top Bottom