ISO 13485, Clause 4.1.2 b)

S

SGquality

Quite Involved in Discussions
#1
#1
We are in an ISO 13485 audit and the auditor is questioning why we have not included "Distribution" process under risk based process.

Section 4.1.2 b) mentions to apply a risk based approach to the control of the "appropriate" processes needed for the QMS.

I explained to the auditor that we have identified Software, Internal Audits, frequency of Management Review, Training etc. and did not feel that "Distribution" needs to be risk based as the product does not have any special storage/handling requirements but he seems persistent on that.

What do you feel?
 
Download Free White Paper
Elsmar Forum Sponsor
John C. Abnet

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#2
#2
SGquality said:
We are in an ISO 13485 audit and the auditor is questioning why we have not included "Distribution" process under risk based process.

Section 4.1.2 b) mentions to apply a risk based approach to the control of the "appropriate" processes needed for the QMS.

I explained to the auditor that we have identified Software, Internal Audits, frequency of Management Review, Training etc. and did not feel that "Distribution" needs to be risk based as the product does not have any special storage/handling requirements but he seems persistent on that.

What do you feel?
Click to expand...
Good day @SGquality ;
I want to first be clear that "we" do not see what the auditor sees....i.e. "we" are not intimate with what your organization has in place and what is being called into question.

Having said that, ....you are correct in regards to the "risk" controls being applied to "appropriate processes needed for the QMS".
Has your organization had a history of nonconformances related to "distribution"?
Can the auditor state (he /she MUST) the actual ISO 13485 clause which they are claiming is not being conformed to?

Based on the LIMITED information we have here, it appears that the auditor is reaching beyond the requirements of the standard.

Also- It should be noted that "risk" in the context of ISO 13485 is different than within ISO 9001 (for example). Here is the statement in 0.2 of 13485 intended to clarify...
"When the term “risk” is used, the application of the term within the scope of this International
Standard pertains to safety or performance requirements of the medical device or meeting
applicable regulatory requirements"

Hope this helps.
Be well.
 
Last edited:
S

SGquality

Quite Involved in Discussions
#4
#4
John C. Abnet said:
Good day @SGquality ;
I want to first be clear that "we" do not see what the auditor sees....i.e. "we" are not intimate with what your organization has in place and what is being called into question.

Having said that, ....you are correct in regards to the "risk" controls being applied to "appropriate processes needed for the QMS".
Has your organization had a history of nonconformances related to "distribution"?
Can the auditor state (he /she MUST) the actual ISO 13485 clause which they are claiming is not being conformed to?

Based on the LIMITED information we have here, it appears that the auditor is reaching beyond the requirements of the standard.

Also- It should be noted that "risk" in the context of ISO 13485 is different than within ISO 9001 (for example). Here is the statement in 0.2 of 13485 intended to clarify...
"When the term “risk” is used, the application of the term within the scope of this International
Standard pertains to safety or performance requirements of the medical device or meeting
applicable regulatory requirements"

Hope this helps.
Be well.
Click to expand...
Thats the perfect answer :applause:
 
Y

yodon

Leader
Super Moderator
#8
#8
I don't disagree with anything said so far on this thread but there's sometimes there are some nuggets that can be gleaned. So just to play devil's advocate, why *isn't* there any risk with distribution? Can the product be damaged, can there be a mix-up of product shipped, can there be a loss of information regarding to whom the product was shipped?
 
S

SGquality

Quite Involved in Discussions
#9
#9
yodon said:
I don't disagree with anything said so far on this thread but there's sometimes there are some nuggets that can be gleaned. So just to play devil's advocate, why *isn't* there any risk with distribution? Can the product be damaged, can there be a mix-up of product shipped, can there be a loss of information regarding to whom the product was shipped?
Click to expand...
Totally understand but was trying to understand the requirements per Clause 4.1.2 (b). How do companies typically handle distribution of finished medical device that is a simple device - is it part of the PFMEA?
 
You must log in or register to reply here.
Thread starter Similar threads Forum Replies Date
K Clause 7.5.2 of ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
M ISO 13485 Clause 7.3.8 ---- on Business Transfer ISO 13485:2016 - Medical Device Quality Management Systems 2
A ISO 13485:2016 Clause 8.2.1 ISO 13485:2016 - Medical Device Quality Management Systems 3
FuzzyD ISO 13485:2016 Clause 8.2.6 ISO 13485:2016 - Medical Device Quality Management Systems 4
C ISO 13485 Clause 7.3.3 a) ISO 13485:2016 - Medical Device Quality Management Systems 2
M Customer Property - ISO 13485:2016 Clause 7.5.10 ISO 13485:2016 - Medical Device Quality Management Systems 9
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
J ISO 13485 Clause 1.2 Application Clarification ISO 13485:2016 - Medical Device Quality Management Systems 1
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

Similar threads

Top Bottom