Training Requirements for ISO 9001:2015

Crusader

Trusted Information Resource
#1
I am just curious if these 2 documents will suffice for ISO 9001:2015. I've seen many records, forms, training matrix docs and I was just hoping to keep the current methods that are employed now. We do have a new hire orientation checklist that captures the bare basics including the QMS Policy, Objectives, etc. All docs combined meet ISO 9001:2008.

Your thoughts, opinions, please?
 

Attachments

Last edited:
Elsmar Forum Sponsor

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#2
Re: Training Requirements for ISO 9001:2015 revision

The competency form would certainly work for me.

Job descriptions are common tools, but how would they help you deal with the risks associated with unexpected key persons not at work? What do you use to keep track of cross training, if any? How do you plan for backups? (all of these could be viewed as variants of the same question)
 
S

soldertraining

#3
Re: Training Requirements for ISO 9001:2015 revision

Hey! I want to know that whether the IPC certification courses also came under ISO 9001: 2015 revision?
 

howste

Thaumaturge
Super Moderator
#4
Re: Training Requirements for ISO 9001:2015 revision

Hey! I want to know that whether the IPC certification courses also came under ISO 9001: 2015 revision?
Training requirements have not been significantly changed in the new standard. Just like before, any product- or process-specific training will be defined by the organization.
 

Kronos147

Trusted Information Resource
#5
Re: Training Requirements for ISO 9001:2015 revision

I am just curious if these 2 documents will suffice for ISO 9001:2015... https://elsmar.com/Forums/showthread.php?t=69890#post591333
Your thoughts, opinions, please?
What I can't tell from these documents is the 'what, how, who, or when' training is/was conducted.

I am a fan of the matrix that shows names and specific training references. The cells are populated with dates of training.

If an organization does not train to specific references, how does it ensure training will be effective or be able to make corrections?

If the organization does not define specific training requirements, how does it measure the training program status?
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
Re: Training Requirements for ISO 9001:2015 revision

Great questions, Kronos147.

Organizational knowledge (7.1.6), along with competence (7.2a) ask us to determine what people need to be competent in, based on customer needs, and also risks and issues.

This information is usually sorted starting with organizational charts, and detailed in job descriptions. Auditors need to be aware, however, that neither of these things are required. Nor is a "skills library", another (a one page sheet is possible with a table, for smaller organizations or those with a lot of cross training, job sharing and/or needs for re-organizational flexibility) HR method of keeping track of competencies and identifying who can do what and any holes that exist or pop up, to meet with training.

Competency is a term we've discussed many times in the Cove. ISO 9000:2015 (3.10.4) defines competence as "ability to apply knowledge and skills to achieve intended results" which we can interpret to say "Do their work without errors." Errors can be detected by internal customers downstream (less costly, and we are asked to address that anyway in 8.7 nonconforming outputs) or end result (more costly, when we deal with corrective action based on customer satisfaction).

I do often see just a matrix with names on one axis and training items on the other, with dates of completion entered. This is documented information, and can work in an absence of clear issues with problems associated with people not doing their work properly.

Does this help?
 

Crusader

Trusted Information Resource
#7
Re: Training Requirements for ISO 9001:2015 revision

Thanks for all your input. I just hate to create mounds of paperwork. I guess we will stick with the matrix.
 

Kronos147

Trusted Information Resource
#8
Re: Training Requirements for ISO 9001:2015 revision

No. It would not help.

I'm always thinking about the whole system.

Example: the matrix says train an assembler "Assembly 101" every two years. Assembly 101 key points are added to a training form. Training is conducted, and logged on the matrix, and the training form is retained.

An NCR is discovered, a corrective action is launched, and the root cause assessment reviews records. If the root cause looks at training, you can see what training was conducted.

I understand the "train as you need" aspect too. If it ain't broke, why fix it, right?

I'm a believer that if you let the old hands in on the training, they may be able to contribute to the continual improvement of the training program.
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#9
Re: Training Requirements for ISO 9001:2015 revision

I see two different issues here: Knowledge Management and Corrective Action.

Can a matrix be used to help facilitate knowledge management? I think yes, as a matrix is an output of the considerations and the dates indicate completion of training. For recurring training, conditional formatting can be used to turn the cells a color if the dates exceed a =TODAY() formulated cell.

Competency is another thing of course. For this we so often question why training is a root cause. Why was the training not sufficient? Did the person decide to do his or her thing despite the training? Was there a change to the method and the person was not told? That isn't about training, it's change management. And so on.
 

Kronos147

Trusted Information Resource
#10
Re: Training Requirements for ISO 9001:2015 revision

For this we so often question why training is a root cause.
I believe we think along similar lines.

I like to remove training as a root cause. It's a cop out. If there is a matrix and you are training to it, it makes it hard to stop at the "employee was not trained" based thinking.
 
Thread starter Similar threads Forum Replies Date
Q Internal Auditor Training requirements for ISO 14001:2015 ISO 14001:2015 Specific Discussions 5
R ISO 50001 Awareness Training Requirements Training - Internal, External, Online and Distance Learning 9
M ISO 13485 Audit Questions - Internal Auditor Training and other Requirements ISO 13485:2016 - Medical Device Quality Management Systems 10
L ISO 14644 Class 7 Clean Room Requirements Training Presentation Training - Internal, External, Online and Distance Learning 2
S ISO 9001 - Training Record Content Requirements Training - Internal, External, Online and Distance Learning 5
R ISO 14001 Internal Auditor Training Requirements ISO 14001:2015 Specific Discussions 7
L ISO 13485 Lead Auditor Re-Training Requirements ISO 13485:2016 - Medical Device Quality Management Systems 2
B On The Job Training (OJT) requirements in ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
R Training Within Industry modules - JIB's and ISO 13485 Documentation Requirements Lean in Manufacturing and Service Industries 5
M ISO 13485 and FDA QSR Employee Training Requirements when Procedures are Revised Manufacturing and Related Processes 5
A Training Requirements for ISO 17025 Internal Auditor ISO 17025 related Discussions 19
S Training Requirements for ISO 9001 Internal Auditors Internal Auditing 6
F ISO 9001 Training Requirements (First Time Certification Attempt) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
H Annual Training Requirements (ISO 13485) Training - Internal, External, Online and Distance Learning 13
F ISO 9001 Clause 6.2.2.a Competence, Training, and Awareness Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
P ISO 13485 Competence, Awareness and Training Requirements ISO 13485:2016 - Medical Device Quality Management Systems 11
I Setting up of Group Training Procedure accordance with ISO/TS requirements Document Control Systems, Procedures, Forms and Templates 3
A Training on new ISO 9001: 2008 requirements? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
D Administrative personnel training - ISO 13485 and FDA QSR requirements ISO 13485:2016 - Medical Device Quality Management Systems 4
J Training Records - How detailed? ISO 13485 Requirements Training - Internal, External, Online and Distance Learning 7
Anerol C Is a Training Matrix Enough to cover ISO requirements? Training - Internal, External, Online and Distance Learning 47
A Training requirements for ISO 17025? ISO 17025 related Discussions 5
Douglas E. Purdy Calibration Training Requirements & ISO/TS 16949 General Measurement Device and Calibration Topics 4
C ISO 13485 - Cleanroom Operator Training Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
G Our employees are overwhelmed by ISO 9000 requirements - Is Training the Answer? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
T What Are ISO 9001:2000 Internal Auditor Training Requirements? Internal Auditing 18
R Addressing training requirements - 21 CFR Part 820.25 (1) & (2) Other US Medical Device Regulations 4
D Training for AS13000 - Problem Solving Requirements for Suppliers Training - Internal, External, Online and Distance Learning 14
Sidney Vianna Informational AS13100 A - Delegated Product Verification Training Requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 0
Q AS 9100D internal auditor training requirements Internal Auditing 16
D IATF 16949 - Internal Auditor Training/Certification Requirements Training - Internal, External, Online and Distance Learning 2
A Training material for interpretation & understanding Part 11 requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
D Training Material for Internal Auditor Requirements Training - Internal, External, Online and Distance Learning 4
I Meeting AS9100, FAA, Transport Canada, EASA Training Requirements - Vent/Rant Coffee Break and Water Cooler Discussions 2
P Work Area (Production Shop Floor) Training Matrix Requirements Training - Internal, External, Online and Distance Learning 4
S TS 16949:2009 Specific Internal Auditor Training Requirements Training - Internal, External, Online and Distance Learning 4
B What training requirements are needed for Medical Technologist in a CLIA ? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
Casana Training on Automotive OEM Requirements Customer and Company Specific Requirements 2
M OSHA Requirements for Fork Truck Training Occupational Health & Safety Management Standards 12
D Non-production personnel Training Records - ISO9001 Requirements Document Control Systems, Procedures, Forms and Templates 6
B Controlled document training requirements and structure ISO 13485:2016 - Medical Device Quality Management Systems 2
S Please help me define training requirements for a Career in Regulatory Affairs 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
W Product Training Requirements for Users of Product(s) ISO 13485:2016 - Medical Device Quality Management Systems 4
S Verbal Customer Requirements - Training Services Provider ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Third Party On-Site Servicing - Training Records Requirements ISO 13485:2016 - Medical Device Quality Management Systems 6
D E-Signature Compliance Requirements for Training Records Qualification and Validation (including 21 CFR Part 11) 3
JoCam Training Records - Content and System Requirements IATF 16949 - Automotive Quality Systems Standard 20
M Training and Competence requirements in a Small Machine Shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
A Training Requirements & Training Plans for specific Employees Training - Internal, External, Online and Distance Learning 4
M Medical Device Auditor - Training and other Requirements ISO 13485:2016 - Medical Device Quality Management Systems 3

Similar threads

Top Bottom