ISO 13485:2016 Section 6.2 - Documenting the process for establishing competence

J

james

#1
Hello,

I am trying to satisfy ISO 13485:2016 section 6.2 Human Resources and I got stuck on how to go about documenting the process for establishing competence, do I have to create an SOP or does our Training SOP cover this?

Thanks,
James
 
Elsmar Forum Sponsor

racglobal

Involved In Discussions
#2
Hello
The staff training SOP covers the process for establishing competence or the method by which you would evaluate training effectiveness. One staff training SOP should cover it.
 
#4
Hello,

I am trying to satisfy ISO 13485:2016 section 6.2 Human Resources and I got stuck on how to go about documenting the process for establishing competence, do I have to create an SOP or does our Training SOP cover this?

Thanks,
James
Who is responsible in your organization for training people? Maybe instead of you doing this, they might be able to help.
 

Ed Panek

QA RA Small Med Dev Company
Trusted Information Resource
#5
Is this in regards to competence for hiring people to do work or competence in training them?
 

JoshuaFroud

Involved In Discussions
#6
At my organisation, we document this, by using two training matrices. One covers competency assessed processes and is updated quarterly with the shifting competency of the team. Each of the relevant staff members have a row against the tasks (columns), the staff are rated, "Skill not required", "Skill required", "Under Training", "Competent", "Trainer". This allows at a glance to see who is able to do each of the relevant competency assessed skills.

The other training matrix is "read and understand" of each of the Quality Procedures, each staff member has a list of assigned Quality Procedures relevant to their role, as and when they are updated they are notified by our document management system that an updated has been made, they read and acknowledge the procedure and the matrix is updated.

The handling of both of these matrices is covered by our training procedure. This was accepted as suitably addressing the requirement when we transitioned to 2016.

To answer your question directly, no, you do not require a separate procedure on competency it can be captured in whichever procedure you wish as long as it is captured somewhere and can be demonstrated to be fit for purpose, if and when required.
 

John Broomfield

Staff member
Super Moderator
#7
Recruiting and training for competence suggests this is a process owned by HR if you have such a function. If not it could be owned by the person who does most of your recruiting.

Work with that person and you may find it starts with supervisors specifying the required competence in terms of abilities, skills and knowledge.

Note that training alone does not necessarily deliver the competences required..
 
Thread starter Similar threads Forum Replies Date
K Contamination Control - Class Is medical devices (Clause 6.4.2 ISO 13485:2016 (E)) ISO 13485:2016 - Medical Device Quality Management Systems 11
H ISO 13485:2016 Gap Analysis by NB ISO 13485:2016 - Medical Device Quality Management Systems 7
S SOP for ISO 13485:2016 Quality related Software validation ISO 13485:2016 - Medical Device Quality Management Systems 8
JoCam Difference between Approval and Registration - ISO 13485:2016 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
T Document control ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 5
A We are ISO 13485:2016 should we be audited to ISO 14971 ISO 13485:2016 - Medical Device Quality Management Systems 16
E Equipment Qualification - IQ/OQ per ISO 13485:2016 section 7.5.6 Process validation ISO 13485:2016 - Medical Device Quality Management Systems 7
S Clinical Evaluation - Is this an ISO 13485:2016 requirement? 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
S When is ISO 13485:2016 6.4.2 Contamination Control appropriate? ISO 13485:2016 - Medical Device Quality Management Systems 11
L Templates for three ISO 13485:2016 SOPs ISO 13485:2016 - Medical Device Quality Management Systems 8
C What falls under the 'Customer Property' according to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 10
M Is it possible to get iso 13485:2016 certified as a one man band ISO 13485:2016 - Medical Device Quality Management Systems 1
F ISO 13485:2016 Quality Policy Requirements Other ISO and International Standards and European Regulations 3
M Contract Manufacturers and MDF Responsibilities, ISO 13485:2016, Clause 4.2.3 ISO 13485:2016 - Medical Device Quality Management Systems 3
J ISO 13485:2016 sample exam/test ISO 13485:2016 - Medical Device Quality Management Systems 1
M Informational Questionário – Análise crítica sistemática – ISO 13485:2016 (Portuguese-only) Medical Device and FDA Regulations and Standards News 0
M Informational ISO 13485:2016 under systematic review Medical Device and FDA Regulations and Standards News 5
C Updates on Documentation for outsourced OEM from ISO 13485:2003 to ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 4
GStough Informational SN EN ISO 9001:2015 and SN EN ISO 13485:2016 on Same Certificate? Registrars and Notified Bodies 7
E MDSAP Audit - Our QMS conforms to ISO 13485:2016 and FDA GMP Canada Medical Device Regulations 9
Ronen E Informational ISO 13485:2016 Transition Period End - 1 March 2019 ISO 13485:2016 - Medical Device Quality Management Systems 0
B ISO 9001:2015 vs ISO 13485:2016 for MDR Compliance EU Medical Device Regulations 4
T ISO 13485:2016 - Processes exempt from process validation ISO 13485:2016 - Medical Device Quality Management Systems 12
C Medical device manufacturing (class 2 ISO 13485:2016) - Is a Deviation allowed? Other Medical Device Related Standards 5
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
E Template of a Management Review Agenda or Report in compliance with ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 6
Q Any good Checklists for ensuring SOPs cover ISO 13485:2016 and 21CFR 820? ISO 13485:2016 - Medical Device Quality Management Systems 3
H Transition to ISO 13485:2016 together with ISO 9001:2015 ISO 13485:2016 - Medical Device Quality Management Systems 12
B Classes/ Online Training on ISO 13485:2016 and FDA QSR Part 820 ISO 13485:2016 - Medical Device Quality Management Systems 5
T Software Validation Certificate (ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 19
D ISO: 13485:2016 Sec. 7.5.2 (C) - Requirements for cleanliness of product or contamination control ISO 13485:2016 - Medical Device Quality Management Systems 2
M Internal Audit Assessment Criteria - ISO 13485:2016 Internal Auditing 21
C Software validation (4.1.6 ISO 13485:2016) ISO 13485:2016 - Medical Device Quality Management Systems 20
L Does anybody have quiz's available? ISO 13485:2016 Training Material Training - Internal, External, Online and Distance Learning 2
G ISO 13485:2016 and regulatory requirements - Contract Manufacturing ISO 13485:2016 - Medical Device Quality Management Systems 22
S ISO 13485:2016 and GDRP EU 2016/679 ISO 13485:2016 - Medical Device Quality Management Systems 5
JoshuaFroud Interpretation of Clause 5.5.2 in ISO 13485:2016 ISO 13485:2016 - Medical Device Quality Management Systems 2
R CNC Software Validation requirements as per ISO 13485:2016 Other ISO and International Standards and European Regulations 8
A ISO 13485:2016 Applicable regulatory requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
R ISO 13485:2016 Registration - NC on full cycle of internal audits ISO 13485:2016 - Medical Device Quality Management Systems 7
C Will anyone please share training material for ISO:13485:2016 for best practices Training - Internal, External, Online and Distance Learning 0
T ISO 13485: 2016 Internal Audit - Is sampling on projects allowed? ISO 13485:2016 - Medical Device Quality Management Systems 6
D Where I can find an ISO 13485:2016 Audit Schedule example? ISO 13485:2016 - Medical Device Quality Management Systems 4
S What records are required to show compliance to ISO 13485:2016? ISO 13485:2016 - Medical Device Quality Management Systems 1
B Non Applications in ISO 13485:2016 for component contract manufacturers ISO 13485:2016 - Medical Device Quality Management Systems 2
R Concessions - ISO 13485:2016 requires concession approval from customers Nonconformance and Corrective Action 2
D Having got ISO 13485:2016 are you dropping ISO 9001? ISO 13485:2016 - Medical Device Quality Management Systems 8
S ISO 13485:2016 - Risk-based Approach ISO 13485:2016 - Medical Device Quality Management Systems 3
Similar threads


















































Top Bottom