ISO9001 for one man company

Dave Cx

Involved In Discussions
#1
All,
I have volunteered to implement ISO 9001 the business is a sub contract machine shop who make to print only. The business owner is the sole employee. The requirement for ISO 9001 is from the main customer who themselves have recently become 9001 accredited & so are asking their suppliers to do likewise. Because the certificate is 'a ticket to the game' there is a need for this not to be onerous.

I appreciate there are other threads on 9001:2015 documents / records but I would appreciate the actual insight of those who are working to it since its latest inception in 2015.

Being as there is 1 employee does recording scope, policy & objectives on his mobile phone 'notes' fail to meet the standard? I want to avoid any hard copy documents.
Being 'make to print' there is effectively 1 process - I don't believe this process needs documenting, there will be a work order, its intended to address clauses:-
7.1.5.1 Monitor & measuring - suitability
8.2.3.1 / 2 Contract requirements (+ changes to),
8.5.2 Identification & traceability
8.5.3 Customer property (samples to copy)
8.6 Release of product
The above will be retained for a set period after work order completion

Other records
8.4.1 Approved supplier list & Supplier orders
7.1.5.2 Monitor & measuring - traceability (calibration record)
8.7.1 Non conformance (CAPA report)
9.2.1 Internal audit report - how objective is it to self audit 'processes' that only you have performed previously
9.3.3 Management review (report) this will be comment against a)opportunities for improvement, b) Changes to management system c) Resources required
The above will be retained for a set period

I have excluded, 7.2 competence as not appropriate (or should you determine if you are 'fit' to operate your own business) & 9.1.1 Performance evaluation not appropriate.

Does anyone know a single employee company who is 9001 certified and if so how does this proposal compare? Is this feasible for certification?

Dave
 
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qualprod

Trusted Information Resource
#2
It seem you don't have enough knowledge on the ISO 9001, systems, Is not as easy as you think, have a consultant to help you in the implementation.you may have all the documentation in electronic form ,but first have assistance.
Hope this helps
 

AMIT BALLAL

Trusted Information Resource
#3
All,
I have volunteered to implement ISO 9001 the business is a sub contract machine shop who make to print only. The business owner is the sole employee. The requirement for ISO 9001 is from the main customer who themselves have recently become 9001 accredited & so are asking their suppliers to do likewise. Because the certificate is 'a ticket to the game' there is a need for this not to be onerous.

I appreciate there are other threads on 9001:2015 documents / records but I would appreciate the actual insight of those who are working to it since its latest inception in 2015.

Being as there is 1 employee does recording scope, policy & objectives on his mobile phone 'notes' fail to meet the standard? I want to avoid any hard copy documents.
Being 'make to print' there is effectively 1 process - I don't believe this process needs documenting, there will be a work order, its intended to address clauses:-
7.1.5.1 Monitor & measuring - suitability
8.2.3.1 / 2 Contract requirements (+ changes to),
8.5.2 Identification & traceability
8.5.3 Customer property (samples to copy)
8.6 Release of product
The above will be retained for a set period after work order completion

Other records
8.4.1 Approved supplier list & Supplier orders
7.1.5.2 Monitor & measuring - traceability (calibration record)
8.7.1 Non conformance (CAPA report)
9.2.1 Internal audit report - how objective is it to self audit 'processes' that only you have performed previously
9.3.3 Management review (report) this will be comment against a)opportunities for improvement, b) Changes to management system c) Resources required
The above will be retained for a set period

I have excluded, 7.2 competence as not appropriate (or should you determine if you are 'fit' to operate your own business) & 9.1.1 Performance evaluation not appropriate.

Does anyone know a single employee company who is 9001 certified and if so how does this proposal compare? Is this feasible for certification?

Dave
I beg to differ with you Qualprod. Dave Cx seems to have good understanding of the system and I don't think you always need a consultant for system implementation.

I agree with you Dave Cx, competence evaluation and the clause doesn't seem relevant. Hence can be excluded.
But please clarify why you want to exclude 9.1.1 - performance evaluation. Because you will need and might be monitoring performance of QMS through sources such as customer complaints, defect rates, etc.
 

John Broomfield

Staff member
Super Moderator
#4
Dave,

Beware ending up with a system that constrains your future.

As a one man band you avoid taking on work for which you are not competent. So, you have no basis to exclude competence.

Most one man bands, though, would supplement their competence with carefully selected suppliers so you may have no basis for excluding many of the clauses you list.

Instead of starting with possible exclusions why not apply the whole standard to your system of interacting processes as necessary to create more satisfied customers?

That way your system reflects a far more wholesome work life creating customer success.

Start perhaps with your mission and how your system can help you to fulfill it.

You may even end up with an App!

Good luck,

John
 

John C. Abnet

Teacher, sensei, kennari
#5
the main customer who themselves have recently become 9001 accredited & so are asking their suppliers to
Good day @Dave Cx ;
1- Even if the (a) customer requires implementation of ISO 9001, it is important that the business implement it in a selfish manner, i.e. serving the interests of the organization and not simply because a customer requires it.
2- Often the "requirement" is simply something that is blindly passed down the supply chain by an organization (or likely an individual within an organization) who may not understand the impact or WHY they are requiring it. I have successfully authored letters for organizations explaining their situation and status and asking for an exemption. If ISO 9001 will benefit the company your are volunteering for and is part of the company's strategic long term planning, then they should proceed. Otherwise, they may want to rethink and possibly seek exemption as I described above.

does recording scope, policy & objectives on his mobile phone 'notes' fail to meet the standard?
3- While this might not be a safe/ideal method of "documentation", there is no requirement by the standard as to how documentation is s
Is this feasible for certification?
4- Feasible, yes, but possibly not the best decision as I mentioned prior.

Hope this helps.
Be well.
 

Randy

Super Moderator
#6
Asking a 1 man shop to get certified (not accredited) is out of the norm and almost unreasonable. According to IAF MD-5, certification for 1-5 employees is 1.5 days, barring any reductions which ain't gonna happen and an annual audit will be 1 day every year. An initial certification could run in the neighborhood of $3000 - $5000 depending on the day rate, expenses, administrative fees and so forth, with an additional $2000 - $3000 per year. For a single 3 year certificate your client can be looking at in the neighborhood of $11,000 +/-. Unless your client is making a ton of money in profit, he'll starve, run naked in the street, turn off the lights and close his door.... Oh yeah, didn't add your fee which is what, $37.50 for the project?
 

Tagin

Trusted Information Resource
#7
Being as there is 1 employee does recording scope, policy & objectives on his mobile phone 'notes' fail to meet the standard? I want to avoid any hard copy documents.
I assume you mean he would use his phone to access documents stored in the cloud? The distinction has to to with document control: if its stored on his phone only, is his phone backed up and how? If its in the cloud, then dropping his phone will not cause a permanent loss of documents. As to the cloud provider, is this a top-tier provider (Google, Amazon, etc.), or otherwise how is he assured his cloud provider is backing up his data?

9.2.1 Internal audit report - how objective is it to self audit 'processes' that only you have performed previously
9.3.3 Management review (report) this will be comment against a)opportunities for improvement, b) Changes to management system c) Resources required
The above will be retained for a set period

I have excluded, 7.2 competence as not appropriate (or should you determine if you are 'fit' to operate your own business) & 9.1.1 Performance evaluation not appropriate.
  • 7.2 could just refer to a summary of the education/work experience (including the current company's history) of the owner, as to why he is qualified to be performing this work. Being in business for oneself is not itself a qualification.
  • The internal audit could be done by a consultant on behalf of the company.
  • I don't see how 9.1.1 can be excluded. At the least, it specifies:
    • The organization shall evaluate the performance and the effectiveness of the quality management system.
    • The organization shall retain appropriate documented information as evidence of the results.
    • In addition, Management Review requires as inputs 'monitoring and measurement results', which would first be determined in 9.1.1.

I imagine the entire QMS could probably be written as one document (excepting any forms, reports, etc.).
 

Dave Cx

Involved In Discussions
#8
All,
Thanks for the replies,:-
Amit,
Re 9.1 Performance Evaluation, as a 1 man band the client sees every aspect of the business as it occurs so he monitors everything in real time and readily see the results, out of all the clauses this is the 1 that I find most difficult to objectively implement. All that I can think of is either duplication at a later 'scheduled evaluation date', or postponing the evaluation to a later date, which in itself would be loosing control???

John B,
The work is largely dictated by the current machines physical capacity and availability. if further machines (processes) are added then he will train to use them.

John A,
Because the main customer hasn't defined why they have achieved certification, then I can't define what is driving their request, it would not appear to be receiving non conformance product nor delivery issues. I suspect the customer has gone down the generic route of approved suppliers need 9001. I fully agree this is not a good rational. But certification gaining will protect the business, it may also open other opportunities.

Re the APP idea, this business banks with an App, it manages accounts through an App, so maybe a certification App is the way to go..

Randy,
I agree costs could be prohibitive but I'm wonder if small business development funding could assist, I am in the UK in theory we support small enterprise:). Re my cost its for family so no charge, I have already exploited the 24 hour machined part service of the business (for free) & no doubt will again.

Targin,
Backing up the phone - agreed.
7.2 There are generic engineering qualifications already.
9.1 see response to Amit.

Thanks Dave
 

Tagin

Trusted Information Resource
#10
Re 9.1 Performance Evaluation, as a 1 man band the client sees every aspect of the business as it occurs so he monitors everything in real time and readily see the results, out of all the clauses this is the 1 that I find most difficult to objectively implement. All that I can think of is either duplication at a later 'scheduled evaluation date', or postponing the evaluation to a later date, which in itself would be loosing control???
Again, the requirement includes "The organization shall retain appropriate documented information as evidence of the results." So, even if he sees in real-time what is going, the documentation will be needed.

I'm sure he wants to 1) deliver products on-time, 2) with good quality (low returns/complaints). At a minimum, those are things to be measured and recorded. Those recorded entries can be later evaluated, e.g., avg on-time per month or per quarter, etc. against some target or threshold. It need not be extravagant or convoluted, but I imagine that he has in his mind already some set of parameters he uses to mentally measure how well his business processes are working, so it's just a matter of finding low-effort ways to record that data and perform occasional review/evaluation of that data.
 
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