SBS - The best value in QMS software

Help a newbie to develop a QMS (Quality Management System)

J

Jason PCSwitches

#21
We provide design and consultancy services for electrical engineering projects.(street lighting, power distribution networks). We presently have less than 12 employees.
We use computers, CAD & other electrical software to do design works...which to the best of my knowledge are capital assets. Except for concept designs, we basically work on supplied drawings.
For a typical project, from tender inquiry/bidding==contract review== design planning===design==handing over to the client, we don't buy anything

Enlighten me if I'm missing something. Thanks for your contribution.
No enlightenment necessary, just curious. I don't run across to many companies that are certified, yet make no purchases for realization.
 
Elsmar Forum Sponsor

Colin

Quite Involved in Discussions
#22
We provide design and consultancy services for electrical engineering projects.(street lighting, power distribution networks). We presently have less than 12 employees.
We use computers, CAD & other electrical software to do design works...which to the best of my knowledge are capital assets. Except for concept designs, we basically work on supplied drawings.
For a typical project, from tender inquiry/bidding==contract review== design planning===design==handing over to the client, we don't buy anything

Enlighten me if I'm missing something. Thanks for your contribution.
As mentioned earlier, purchasing would also include any work which you outsource, so if you subcontract any of your design work, that would be included under the purchasing controls.
 

Helmut Jilling

Auditor / Consultant
#23
Hi:
In my experience i have found very usefull to have roadmap, a general plan to show progress toward certification, can collored when finished an activity.
This Roadmap can have:
1. Integrate a steering committee ( top management)
Established date for certify, appoint Management Rep.
2. Process Approach: Define Main Processes in your company ( can use de octopus diagram-automotive industry) this processes are Customer Oriented Processes, then internal processes (support, management etc) and all of them make them visible, in other words, Flow diagram ( can use the turtle /flow again for automotive).
3. Once processes are defined, identify the need or having procedures ( make sure to include those mandatory by the standard) and/ work instructions, formats..
4. Gap Analysis
5. Develop Document structure: Quality Policy ( if not previously defined), Quality Manual, Procedures/WI
6. At the same time there is the need for training: Standard, Audit, Writting documentation, etc
7. Schedule: Management Review, Internal Audits (complete system), visits of certification body....
8. Develop a Plan describing activities.

Attached is one example..it might give you an idea.(it´s in spanish)
It would be useful to include training or at least reading/learning the standard in there somewhere. You will find the cost of a couple days of good training will save you much time and wasted motion.
 

Helmut Jilling

Auditor / Consultant
#24
We provide design and consultancy services for electrical engineering projects.(street lighting, power distribution networks). We presently have less than 12 employees.
We use computers, CAD & other electrical software to do design works...which to the best of my knowledge are capital assets. Except for concept designs, we basically work on supplied drawings.
For a typical project, from tender inquiry/bidding==contract review== design planning===design==handing over to the client, we don't buy anything

Enlighten me if I'm missing something. Thanks for your contribution.
It is common that a company providing service as their primary product may not have a need to define Purchasing as an important process. You still buy things, but they tend to fall into supply categories - office, equipment, coffee, etc.
 

Helmut Jilling

Auditor / Consultant
#25
Hmmm, there some interesting findings on the list but it is difficult to comment too specifically without seeing the manual itself.

A couple that come to mind are No 4 - Job descriptions not found - these are not a requirement of ISO 9001 and No 10 - all procedures are not matched - ISO 9001 does not specify how procedures should look.

Was this a document review (stage 1 audit) done by a 3rd party certification body?
"Job descriptions" may not specifically be a requirement of ISO 9001. However, they are required to identify the skills needed, and competencies, and those are frequently documented on a "job description sheet" of some sort, simply because that is the most common HR format. An alternate doc would also work, but I doubt they had anything, since the auditor flagged it.
 

Helmut Jilling

Auditor / Consultant
#26
Thank you all for your advice! It has calmed down my nerves and broaden my understanding of the whole process.

The organization chart is available and I'm working on the work flow diagram now. I did identified the following processes:
- client inquiry
- Inquiry review
- Go-no-Go (kind of checks to know if its worth going in)
- Bid
- If bid is successful - project manager appointed to negotiate price and other things with client
- Negotiations Ok, the legal contract signed
- Project team is setup & project file is created, holding key drawings, specification and standards
- Various persons are in charge of different aspects...like CAD operator, Electrical Engineer etc
- Milestones for various phases and the entire project are laid out under the supervision of the Manager.
- During the work process meetings are held with client for updates and reviews.
- Upon completion the project it is reviewed and signed by the Manager and then handed to the client-the cash comes in.
It's consultancy company in HV electrical lighting and design works using autocad.
Guide me if I got the processes and some ideas on the design of the work flow chart.

Thanks
In fact, the whole list sounds like sub-parts of just two processes - Sales and Design/Engineering (or whatever titles you use at your firm). Each of those activities are likely subprocesses under those. Don't forget the supporting processes. Common examples may include Management, IT (computer systems mgt), Quality System things like internal audits, corrective action, calibration, etc need to be addressed somehwere.

When you are finished with your list, it must include all the activities your organization does. I find it useful to separate the list into the primary or core processes and the supporting ones. Makes it easier for peopl to learn and understand.
 
N

npryde

#27
Thanks so much for the advice. "what an old man can see while sitting, a young man cannot see even being on a tree top".

I have learned much from this forum than I did from the iso course. I'll create a procedure for purchasing. Apart from that is there any justification for any exclusions given our scope of work?
 

Helmut Jilling

Auditor / Consultant
#28
Thanks so much for the advice. "what an old man can see while sitting, a young man cannot see even being on a tree top".

I have learned much from this forum than I did from the iso course. I'll create a procedure for purchasing. Apart from that is there any justification for any exclusions given our scope of work?
Remember, you do not have to document your methods and procedure for purchasing, if it is simple, unless you feel it would help you control it better (ref. cl 4.2.1.c&d). However, if you define it as a process, perhaps it would be beneficial. As to exclusions, you really would have to decide that. When you read clause 7, what do you see that you would say, "We don't do any of this activity." Perhaps calibration, SPC, perhaps others, but there won't be many. I think it will be more a function of you do some a very little bit. At the beginning, I would not focus on what you don't do (exclusions), I would focus on what you do perform. The exclusions will become apparent pretty quickly.
 
J

JaneB

#29
All excellent advice from various people.

I note you now say you're going to create a procedure for purchasing. Recall (& this has been said several times) you don't have to document this. You only document things/create procedure where you (ie, company) decide it is needed (eg, in this case that purchasing would work more smoothly /you'd get greater control etc), and of course where mandated (document control, internal audit, etc).
 
J

JaneB

#30
No enlightenment necessary, just curious. I don't run across to many companies that are certified, yet make no purchases for realization.
Many, many service organisations fall into this category. It isn't that they 'make no purchases' at all, it's that what they do buy is often of very low consequence/available widely as standard office equipment/software, etc.
 
Thread starter Similar threads Forum Replies Date
S Informational Please help this newbie understand ISO 9001 Work Instructions ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 44
Q ISO 9001 - 3 BIG questions to help a Newbie's Sanity ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C A total newbie to AS 9101 needs general help AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 16
N I have 2 groups to compare - Minitab and stats newbie - Please help Using Minitab Software 18
G Newbie in IMDS - Please help me understand what I have to do RoHS, REACH, ELV, IMDS and Restricted Substances 4
L VDA Product Submission Form - Please help a Cove newbie answer a VDA question VDA Standards - Germany's Automotive Standards 12
B Looking for PPAP help for newbie QS-9000 - American Automotive Manufacturers Standard 6
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
S Need help on "Country of Origin" Medical Device and FDA Regulations and Standards News 0
M Need Help With Information Security Asset Risk Register IEC 27001 - Information Security Management Systems (ISMS) 2
T Help with BS EN ISO - IEC 80079-34 2020 (Explosive atmospheres QMS) Other ISO and International Standards and European Regulations 0
J Help settle a disagreement: Should external providers of preventive maintenance be on your ASL? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
N Help with basic understanding of Competence requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
C ISO/ IEC 17021 Resource requirement (need help) Document Control Systems, Procedures, Forms and Templates 5
D Supplier Quality level category help - high level ISO 13485:2016 - Medical Device Quality Management Systems 6
D Amendment Class II - Please confirm if the submission is by email (Canada) - Help Canada Medical Device Regulations 0
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
T Help to Suggest name for a new certification and inspection company Coffee Break and Water Cooler Discussions 7
SocalSurfer AS9100 new certificate, but need QMS software, help Quality Assurance and Compliance Software Tools and Solutions 2
L Manufacturing Process Audit Help IATF 16949 - Automotive Quality Systems Standard 6
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Beginners help with ISO3951-2 Combined control s-method n>5 what is Phi ?? Inspection, Prints (Drawings), Testing, Sampling and Related Topics 0
MDD_QNA Medical Device Software - Is a Help Button required? IEC 62304 - Medical Device Software Life Cycle Processes 1
S Need help with analysing a survey on minitab Using Minitab Software 1
M Help me improve the definition for internal PPM Manufacturing and Related Processes 3
I Help: QFD House of Quality Quality Tools, Improvement and Analysis 1
C New to Site - Request Help with API Q2 Implementation Oil and Gas Industry Standards and Regulations 9
O Please, help with document on ISO/ TS 17758 and (IDF 87: 1979). Thank you. Manufacturing and Related Processes 1
A Class medical device (MDD) - Classification help EU Medical Device Regulations 1
K A proposal for the model Quality Management - I need help for the project ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
A Help with Drawing Review - ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
Q % Study variation low, % tolerance high - GR&R Interpretation help Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 3
R Probability - Need a help to solve the below question Statistical Analysis Tools, Techniques and SPC 5
M Thanks for the help Coffee Break and Water Cooler Discussions 0
Judy Abbott Can any one help me with an urgent BIOCOMPATIBILITY Impact assessment? Internal Auditing 9
A Help establishing regulatory requirements - Plastic dental cartridge syringe US Food and Drug Administration (FDA) 0
A Medical Device Contract Manufacturing Requirements and Information - Help wanted ISO 13485:2016 - Medical Device Quality Management Systems 5
8 Need Help - Runout - Function Gage Inspection, Prints (Drawings), Testing, Sampling and Related Topics 7
T Burn out - Tips to help combat QC burnout Career and Occupation Discussions 9
Emran.mi Measurement system analysis - Can you help me about implementation MSA for CMM device Manufacturing and Related Processes 2
S New to FAIR, need help in filling it out AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Informational From RAPS: Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance Medical Device and FDA Regulations and Standards News 0
M Reliability Testing - Weibull Analysis Help Reliability Analysis - Predictions, Testing and Standards 4
L Help me to decide which test to use - If each proportion belongs to the same population Using Minitab Software 7
M Informational US FDA issued the first warning letter for UDI violations to help ensure compliance Medical Device and FDA Regulations and Standards News 0
T QMS Template Help - Small machine shop/job shop Manufacturing and Related Processes 1
R Pls help --- Need expert advice on Video Measurement Measurement Uncertainty (MU) 0
B Will you please help me with my academic project? Repair & calibration service for test equipment ISO 17025 related Discussions 0
B [Help] Customer Engagement Survey for MBA Project - due Apr19 Manufacturing and Related Processes 0

Similar threads

Top Bottom