Nonconformance to a Note in ISO13485 clause 6.2 Human Resources Effectiveness

SMBIZZQA

Starting to get Involved
#1
I was recently given a noncompliance against ISO 13485: 2016, clause 6.2 Human resources because of the NOTE " The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided."
I am a contract converter with simple processes, all training has been documented but not identified as one process riskier to the end product than another process.

First of all, can I get a noncompliance for a NOTE???? I'm confused.
 
Elsmar Forum Sponsor

SMBIZZQA

Starting to get Involved
#4
" Training guide was reviewed. Training records were reviewed. No evidence was found to show that training effectiveness checks are required to be proportionate to the risk associated with the work for which the training or other action is being provided."
and he references the note.
 

Golfman25

Trusted Information Resource
#5
I'm not a ISO 13485 person, but with ISO 9001 and IATF 16949 standards you can't be held to a non-conformance based on a note. Others will chime in, but I think you have a case to contest it. Good luck.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#6
First of all, can I get a noncompliance for a NOTE???? I'm confused.
In principle, no. Any competent management system auditor knows that you can only report a finding as a nonconformance, if there is a requirement associated with the finding AND evidence of lack of conformity. This should be an easy appeal.

ISO 13485:2016, Section 0.2, last paragraph states: Information marked as "Note" is for guidance in understanding or clarifying the associated requirement.
 

yodon

Staff member
Super Moderator
#7
This is a new item in the standard (added to the :2016 version) and it's apparently a focus of the registrar auditors. I wouldn't expect that an appeal would be all that easy. This is tightly coupled with the "risk based approach," a fundamental tenet of the standard. So while this is a note, it's how the risk-based approach is implemented for this aspect.
 

yodon

Staff member
Super Moderator
#9
Which claim? The risk-based approach is established in 4.1.2(c).

The note specifically states:

NOTE The methodology used to check effectiveness is proportionate to the risk associated with the work for which the training or other action is being provided.

That seems to indicate a clarification of the requirement.

In all 3 ISO 13485:2016 audits I've been involved in (2 different registrars), evidence of how effectiveness of the actions taken were proportionate to the risk.

To me, it makes sense. If you're being trained on an action that could result in a defect that could harm a patient, the training effectiveness should be assessed at a higher level than things that wouldn't.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#10
Your claim this is a focus of registrar auditors. Is there any source for that claim?

As for the NC, it is BOGUS, unless the auditor can substantiate his/her implication that higher risk processes have not been determined and commensurately robust competence establishment not been provided. The auditor has to identify what REQUIREMENT is not being complied with. According to the OP, they have assessed the processes.
I am a contract converter with simple processes, all training has been documented but not identified as one process riskier to the end product than another process.
So, the CB auditor now has to provide EVIDENCE that this assessment is flawed, to start with and, once again identify the REQUIREMENT being violated; not the note.

That's how conformity assessment of management system standards is supposed to work.
 
Thread starter Similar threads Forum Replies Date
C NCR (Nonconformance System) Software Nonconformance and Corrective Action 7
L How to deal with an ISO 13485 Supplier Audit nonconformance ISO 13485:2016 - Medical Device Quality Management Systems 17
E When to generate a nonconformance report ISO 13485:2016 - Medical Device Quality Management Systems 6
K Counterfeit parts prevention - Audit Nonconformance - AS9100 8.2.2 AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 25
Q When to write up a nonconformance and require a NCR - We produce labels ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 14
PhilM Nonconformance report, Customer complaint investigations and RMAs ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
M Medical Device Directive - Seeking common nonconformance write up scenarios CE Marking (Conformité Européene) / CB Scheme 2
CPhelan Nonconformance opened as incorrect expiration date placed on received product. Escalate to CAPA? Nonconformance and Corrective Action 4
Q Ineffective follow up of people performance - Audit Nonconformance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
Q AS9120 7.5.3.2 Control of Documented Information - Audit Nonconformance AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 20
Q Criteria to raise a Nonconformance based on KPI values ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 39
L AS9100 D- Handling Nonconformance Documentation for an organization that outsources most of the work. AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 11
G Timing allowed by IATF to close a Remote Site Minor Nonconformance IATF 16949 - Automotive Quality Systems Standard 2
R Visually impacting graphics for Nonconformance status metrics for Management Report Nonconformance and Corrective Action 5
J ISO 13485 Audit Nonconformance written against 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 25
PastorBee13 IATF 16949 Audit Nonconformance Responses per 5.1.1.2 - Format IATF 16949 - Automotive Quality Systems Standard 11
A What ISO 9001:2015 clause could be used to write nonconformance for not updating licensed driver list? General Auditing Discussions 8
A API Spec Q1 9th Edition - 12 month Internal Audit Schedule Audit Nonconformance Oil and Gas Industry Standards and Regulations 10
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
R ISO 9001:2015 9.3 - Required inputs to the management review - Audit Nonconformance Manufacturing and Related Processes 14
K Which clause would best fit this Nonconformance? (Supplier Related) Internal Auditing 2
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
J IATF 16949 registration - Major Nonconformance Finding IATF 16949 - Automotive Quality Systems Standard 9
Ajit Basrur Are inputs to the nonconformance process required to be identified? Nonconformance and Corrective Action 21
N Responding to NADCAP nonconformance - Control of External Documents AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 5
P Examples of Nonconformance, Corrective Action Requests, and Root Cause Analysis Nonconformance and Corrective Action 2
Q Should I initiate CAPA for a nonconformance not recorded? Nonconformance and Corrective Action 25
K Nonconformance on training - Not following own processes (IATF 16949) Internal Auditing 14
J Audit opportunity for improvement raised to nonconformance months after the audit General Auditing Discussions 7
GStough Pushback on a Nonconformance Found in a Supplier Audit General Auditing Discussions 22
K NCR or CA? We're taking any issue we have and saying its a nonconformance Nonconformance and Corrective Action 11
GStough Nonconformance Found Outside the Audit Scope - Supplier Audit General Auditing Discussions 16
R Closing out an API/ISO QMS Audit Nonconformance - Magnetic Particle Examination Inspection, Prints (Drawings), Testing, Sampling and Related Topics 5
Q Nonconformance Raw Material Treatment in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C Recurring Nonconformance - Missing Deadline for Closing a Corrective Action Problem Solving, Root Cause Fault and Failure Analysis 14
N Laboratory Audit Nonconformance - Maintenance of Standards ISO 17025 related Discussions 10
K Internal Auditing a previous Nonconformance? Internal Auditing 19
D Interpretation of new IAQG ruling - Audit duration for nonconformance verification AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 7
Q Customer Complaint Vs. Nonconformance - CAPA SYSTEM Customer Complaints 2
D Nonconformance on document control - Unapproved document on production server Document Control Systems, Procedures, Forms and Templates 4
P Ratio of Supplier with a nonconformance vs. Supplier without a nonconfomance Supplier Quality Assurance and other Supplier Issues 10
W Nonconformance Recurrence Response Help General Auditing Discussions 4
dubrizo If Quality Objectives are not known to employees, is it a Nonconformance? General Auditing Discussions 7
xfngrs Automotive Industry Nonconformance Database wanted - Preferably SharePoint based Quality Assurance and Compliance Software Tools and Solutions 5
Gman2 Processes sharing the same nonconformance during an audit General Auditing Discussions 13
T Audit Nonconformance - ISO 9001:2008 Clause 6.2.2 - Competencies ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
J Audit Nonconformance for Design of Choke Manifold Oil and Gas Industry Standards and Regulations 4
L How to avoid Nonconformance Reoccurrence problems IATF 16949 - Automotive Quality Systems Standard 20
M Corrective Action for a Recurring Nonconformance Nonconformance and Corrective Action 16
G Nonconformance Categories - QMS web app to support ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Similar threads


















































Top Bottom