Is it possible to start an ISO 9001 QMS from scratch (Really)

#1
Hello everyone,

I have spent numerous hours combing the pages of the internet searching for an answer to my question.

Is it possible to establish a draft of an ISO 9001 QMS within a company that is new, new as in there isn't any work, any past performance. The company's ownership would like to get the ball running as fast as possible and as a result would like as much of the QMS developed prior to the doors openeing.

Most of the "starting from scratch" scenarios involved companies that were at least having some sort of work going on.
 

leftoverture

Involved In Discussions
#2
Everyone started somewhere. I don't see why you couldn't do this. It will take planning, and may require several revisions as things get up and running, but in some ways it might even be easier because you won't have any bad habits to deal with.

Sent from my LG-TP260 using Tapatalk
 

AndyN

A problem shared...
Staff member
Super Moderator
#3
Hello everyone,

I have spent numerous hours combing the pages of the internet searching for an answer to my question.

Is it possible to establish a draft of an ISO 9001 QMS within a company that is new, new as in there isn't any work, any past performance. The company's ownership would like to get the ball running as fast as possible and as a result would like as much of the QMS developed prior to the doors openeing.

Most of the "starting from scratch" scenarios involved companies that were at least having some sort of work going on.
If what you are saying is that the business isn't yet launched, no orders taken etc. then yes it can be done, with the exception that it's only a plan. You can't do some of the things the standard requires since there is no "performance" to evaluate, to audit and review.
 

Golfman25

Trusted Information Resource
Trusted
#5
Sure you can do it, but why? To me it may just complicate things. You'll have enough work to do just getting started. Since 90% of ISO QMS is just regular business sense, why not focus on setting up your processes and procedures -- how are you going to run the business. Get some draft flow charts together. Then if you really want to, apply the ISO standard and fill in any gaps. To me it's more important that you apply the standard to your business (what works for you) rather than the business to the standard (simply trying to comply). Good luck.
 

Kronos147

Quite Involved in Discussions
#6
Since 90% of ISO QMS is just regular business sense, why not focus on setting up your processes and procedures -- how are you going to run the business. Get some draft flow charts together.

Great post right there!


I'll add that most successful companies already do many of the requirements, they would just have trouble showing effective documented information as objective evidence.


Do a gap analysis after you follow the Golfman approach and fill in the gaps.



Finally, find SIMPLE methods of creating effective documented information as evidence of compliance.
 

qualprod

Quite Involved in Discussions
#7
Esadady
Most of opinions are missing the more important thing.. knowledge and experience.
It is true, it is possible to start from scratch, but are you experienced enough for this task?
Have you evaluated, how long will it take to finish the project.
If you are novice, and want to achieve this alone, for sure will face a lot of problems, if you have a decent experience I don't see problems.
What I have seen , is if you have a short time frame to achieve this goal, and want to start the knowing of ISO, don't take risks, hire a consultant, if you have a long timeframe , ok you can try it, but if you are experienced go ahead it can be done in the short timeframe.
Hope this helps
 

Ninja

Looking for Reality
Trusted
#8
Funny, I thought something totally different was missing...

Why would you do this?
Why invest money (someone's time) into building out a QMS for a company that doesn't do anything yet?
Get customers first...get revenue first...then establish the QMS out of the profits.

If you need the QMS first, in order to get the first customer...then it is one of the extremely rare times I would point toward "ISO in a box".
Any QMS you establish before you have a functioning process is going to be pretty useless anyway...

Once you have revenue, rewrite the whole darned thing into something of value.
 

mikegospo

Starting to get Involved
#9
For a new start-up company you would start from scratch completely. The QMS would be developed based on risk which would meet the requirements of the particular standard. If you want to be certified, your CB would need to determine the extent of the records needed in order to prove that your system is effective.

For an existing company, the historical records are typically available as you have produced and shipped product. The missing information typically would relate to the evaluation of quality objectives evaluated during management review. I typically try to resurrect data from the past 6 months of previous production.
 
#10
I think it is important to start a discussion with the ownership so they understand the purpose of a quality management system (QMS), and that it is not a static system, but one the evolves over time. A QMS helps to create consistency in processes, attempts to prevent undesired results, and provides a method for corrective actions when results are different than desired, so they may be prevented from occurring in the future.

The ownership also needs to understand that drafts of procedures and methods can be created before processes are started, but these procedures will also change when the processes (production or services) actually start, and again when the processes are refined to make improvements.

Verification that the methods and procedures are being followed, are sufficient to describe the methods, and that the product or service outcomes meet the intended requirements, can only be completed after the processes are being performed.

A realistic time frame to implement a QMS from scratch is about two years. I am aware of organizations that have meet ISO 9001 in 6 months, but this is where most of the documents and procedures were already in place, and the entire organization, including management, was involved with the process.

ISO 9001 is only one of many possible QMS available. The organization should select the QMS that most closely aligns with the ownership's goals, and one that fulfills client or customer requirements.

Once a QMS standard is selected, carefully go through each element, assign responsibilities for a person to lead each area, set timelines, and monitor progress. Everyone, all departments, including management, and upper management, needs to be involved. This change is not something that can just be assigned to the quality manager or quality department, and expect it to happen on its own. Ownership and upper management must also understand that it will require resources in terms of time (labor hours), probably software development and implementation, and investment in equipment for process monitoring and control.

With a realistic timeline, ongoing implementation and feedback, a QMS can be created from scratch, just not one that is fully functioning on the day the organization opens for business.
 
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