Implementation of QMS

Seini1

Registered
Hi,

Yes I posted earlier this year and I honestly thought we would be somewhere in implementing of the QMS but...its a bit different.

So we put up a manual for QMS that wasn't reviewed as yet. Since we are fixing and improving as we go with procedures and forms, I thought I'd read your views on the possibility or how effective QMS would be if it was implemented in such a way.

- Through creating documents as we go through operations and find a break down or gap somewhere. Then these contribute to completing the QMS Manual.

I am really worried about the time taken or that has been taken to try and create the QMS.
 
M

malasuerte

Apologies - not sure what you are asking here?

Time taking to "create a QMS"....what timeline did you have?

Also, it is "implement" a QMS - your not creating it per se. :)

Not sure what the manual has to do with anything, other than capturing how your QMS operates?

Can you please expand a bit more on your ask...cheers.
 

John Broomfield

Leader
Super Moderator
Why create something that already exists?

Your organization already works as a system to fulfill customer requirements most of the time otherwise you’d be out of business!

Seek first to understand how your organization works as system then you’ll make a lot more sense of the standard.

You may even realize that you are developing the existing management system, of which you are part, so it is used and improved to satisfy more and more customers.

You may even find this system is already documented to the extent necessary for effective planning, operation and control.
 

mattador78

Quite Involved in Discussions
Why create something that already exists?

Your organization already works as a system to fulfill customer requirements most of the time otherwise you’d be out of business!

Seek first to understand how your organization works as system then you’ll make a lot more sense of the standard.

You may even realize that you are developing the existing management system, of which you are part, so it is used and improved to satisfy more and more customers.

You may even find this system is already documented to the extent necessary for effective planning, operation and control.
This was the hardest thing to get my head around when i first read standards and moved into quality. I agree that basically if your business is running you are pretty much going to be doing most of what you need already. However one thing i discovered and i think runs true is that the hardest thing you can ever do is get somebody to explain exactly what their job is without missing bits out. Usually they will miss out big chunks and when you question them about it the answer is "well i just do that anyway" without thinking about it. We found that moving from 9001 to 9100 was in the end nothing different from what we were already doing, however, it didn't stop us from not realising we were already doing it because we did it with out thinking about doing it.
 

John Broomfield

Leader
Super Moderator
the hardest thing you can ever do is get somebody to explain exactly what their job is without missing bits out.

Best to focus not on jobs but on processes, that is the work of cross-functional teams.

And why document (in unnecessary detail) the jobs of competent job holders?

Having flowcharted the process with the process owner (who also verifies accuracy with the process team members) you can link to additional detail only where necessary.
 

Big Jim

Admin
One of the early pitfalls of ISO 9001 that is less so today but still sometimes there is the tendency to over document. You seem to be heading in that direction.

If people know how to do a job from training and / or experience you probably don't need a detailed work instruction.
 

mattador78

Quite Involved in Discussions
Best to focus not on jobs but on processes, that is the work of cross-functional teams.

And why document (in unnecessary detail) the jobs of competent job holders?

Having flowcharted the process with the process owner (who also verifies accuracy with the process team members) you can link to additional detail only where necessary.
I get that what i was poorly trying to explain is that a lot of the time people work on instinct when they have done the process or job or whatever the analogy is and they will always miss an important part of what that is when explaining it, quite simply because they do it without thinking they just react.
 

John Broomfield

Leader
Super Moderator
Ah, yes.

We have to watch out for those Post it Notes™ too. Process owners (and auditors!) look out for these and evidence of other lapses or procedural weaknesses.

...but we can rest easy.

As we develop the organization's management system (for ongoing use and improvement) we do not have to make it perfect straight out of the box. I doubt we ever could.
 
Thread starter Similar threads Forum Replies Date
J0anne QMS Implementation Iran ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
R ISO 13485 QMS Implementation Training ISO 13485:2016 - Medical Device Quality Management Systems 7
R ISO 13485 QMS sequence of implementation ISO 13485:2016 - Medical Device Quality Management Systems 4
S Hi! First Post - New to AS9100 QMS Implementation AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 13
G Multi Site EMS and QMS Management System Implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
F ISO 9001 QMS Implementation in an Engineer To Order business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
S Fast growing small O&G Company QMS implementation - My path forward ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
0 Upgrade of our company QMS - Implementation Plan Quality Manager and Management Related Issues 7
M Research Proposal - Management/Employees Perception towards QMS Implementation Professional Certifications and Degrees 5
V Implementation of a QMS - Should I use a Preventive Action approach? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
O QMS (Quality Management System) in a Project Implementation Organisation Quality Manager and Management Related Issues 3
S Lack of Management Commitment and Cooperation in Implementation of QMS! Quality Manager and Management Related Issues 36
R ISO 9001:2000 QMS Implementation - How long will it take? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
B Strengths and weaknesses of the QMS implementation process against ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
R Oil / Gas / Mining sector QMS implementation - ISO 29001:2003 Various Other Specifications, Standards, and related Requirements 7
R QMS Implementation "Newest Newbie"... ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D ISO9001:2000 QMS (quality management system) implementation in Banks Service Industry Specific Topics 13
K QMS standard formats - Internship on implementation of QMS in a company Quality Management System (QMS) Manuals 4
S Quality (ISO 9001 QMS) Implementation Problems Software Quality Assurance 8
S QMS Implementation - Weird Situation - Need Suggstions Quality Management System (QMS) Manuals 2
M Profitability with an implementation of a QMS according to ISO 9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 12
P MDSAP Implementation Canada Medical Device Regulations 4
D Implementation deadline - non significant change acc. to MDCG 2020-3 EU Medical Device Regulations 3
Sidney Vianna Informational ISO 45002:2023 General guidelines for the implementation of ISO 45001:2018 Occupational Health & Safety Management Standards 1
C ISO Certified Company ERP implementation ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
H Regarding confusion of the validity of the European implementation of IEC standards Other Medical Device Related Standards 1
J Implementation, establishment and certification of IATF 16949. IATF 16949 - Automotive Quality Systems Standard 6
J UKCA direct marking implementation UK Medical Device Regulations 0
O Quality Management System Implementation framework and Gap analysis checklist Manufacturing and Related Processes 7
Pmarszal BS EN 20417:2021 - Implementation Timeline Aligned With MDR? Other ISO and International Standards and European Regulations 1
L UDI implementation in Saudi Arabi (KSA) Other Medical Device Regulations World-Wide 1
B ISO13485 Risk managment implementation for suppliers ISO 14971 - Medical Device Risk Management 2
P ISO 20400:2017 Sustainable Procurement Implementation Sustainability, Green Initiatives and Ecology 0
R ISO 27001 implementation IEC 27001 - Information Security Management Systems (ISMS) 3
R MEDDEV 2.12-1 rev 8 (Vigilance guidelines) still applicable with the MDR implementation? EU Medical Device Regulations 3
Talja SOC2 preparation and trainings for implementation team Other ISO and International Standards and European Regulations 2
SABRINA DJILALI SAIAH Implementation of the ISAS-MEDIA 9001 standard in a TV channel ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
S Sequence of ISO 9001:2015 Implementation Steps ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S ISO9001:2015 Implementation / update plan template ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M ISO14971:2019 - Verification of implementation and effectiveness of risk control ISO 14971 - Medical Device Risk Management 14
S ISO 9001 implementation in a Gold exporting business ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
K Implementation 2013/59/Euratom CE Marking (Conformité Européene) / CB Scheme 8
C Implementation ISO 9001: 2015 ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
G Issues/Roadblocks with APQP implementation APQP and PPAP 10
Dean Bell Implementation of Controls as per SOA for Stage 2 Audit IEC 27001 - Information Security Management Systems (ISMS) 0
O ISO13485 implementation - Are internal audits expected before stage 1 audit? Design and Development of Products and Processes 3
N ERP Software Implementation Manufacturing and Related Processes 3
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
F Will the EU postpone 2017/745 MDR Implementation - COVID-19 Impact Medical Device and FDA Regulations and Standards News 11

Similar threads

Top Bottom