Recommendations for a Low cost and Easy to Implement Quality Management System

[rameshdamani]

I am starting a company developing an IVD and need recommendations for low cost, easy to implement, low overhead, efficient quality management system that will allow me to stay compliant from the get go. Focusing on QSR and ISO 13485. I am leery about committing to a full blown electronic QMS and a paper based system may not be very scaleable. Hoping to find a good compromise solution that I can start working with and eventually port the information into a more sophisticated software package later as my business grows. Any recommendations? Thanks in advance.

[joshua_sx1]

Originally Posted by rameshdamani

I am starting a company developing an IVD and need recommendations for low cost, easy to implement, low overhead, efficient quality management system that will allow me to stay compliant from the get go...

...actually, that's everybody’s dream…

[atitheya]

Hi Rameshdamani,

Very simple, I'm sure you have already done most of it by now,

Identify your product/service, market, and market's requirement for that product/service.
Define your Quality.
Have objectives / goals (time bound) to achieve.
Plan your organisation's activities (start to finish) to achieve, fulfil above requirements and goals / objectives. Document this plan including forms/formats for records you need to keep. This should be done using the 5 Ws and an H, Who, What, Where, Why, When and How.
Determine resources needed to carry out these activities / processes
Determine what should be the end product / output at the end of each activity and how you will measure and compare it with the product / service requirements.

Get a copy of the standard, ISO9001:2000 (If you can, go for others in the 9000 series too, ISO9000, 9004, 19011 etc)
Go through the standard, word by word, understanding its intent.
Map your above plan against the requirements stated in the standard,

You will find gaps, plug these gaps by incorporating the absent requirement in your above plan.

Implement / Start your operations as per plan.

Periodically review if your work is being carried out as per plan.
Make changes for improvement or where you think it is not working as per plan.

Attending a sensitisation / awareness / implementation seminar / course on ISO9000 series will help.

OR

Employ people who have been part of such an implementation program, or are from similar industry that is certified and are knowledgeable about ISO9000 series.

OR

Hire a consultant who will help your organisation become ISO9001 compliant.


Identify a certification body to suit your requirement including your budgetory requirement among others.
Apply and invite the CB to audit your organisation and certify it ISO9001 compliant.


If you can do it yourself, you will save on the consultant's fee, you will only pay the Certification Body's fee - there is a wide variation in that, you may chose.
If you hire a consultant, you pay consultant's fee also (again there are variations)
Anyways, the cost should pay itself up in due course of time.

A QMS is as easy to implement as your own operations. It is nothing different than your own operations.

Overheads in an efficient and effective QMS are almost unheard of. Any cost incurred by way of survillance audits / consultation etc is only to benefit the organisation in terms of cost savings / increased revenue.

The Quality Management System will be as efficient as you want it and this is directly proportional to your commitment as top management.

I am a little confused when you say 'full blown QMS'.

[Duke Okes]

Originally Posted by rameshdamani

I am starting a company developing an IVD and need recommendations for low cost, easy to implement, low overhead, efficient quality management system that will allow me to stay compliant from the get go. Focusing on QSR and ISO 13485. I am leery about committing to a full blown electronic QMS and a paper based system may not be very scaleable. Hoping to find a good compromise solution that I can start working with and eventually port the information into a more sophisticated software package later as my business grows. Any recommendations? Thanks in advance.

Start with a simple printed, paper system and when it grows integrate the files into an electronic system.

To keep it simple don't write a lot of detailed procedures with Purpose, Scope, Responsibilities, Procedure, References, etc. Just title the document well and include what they need to know in simple sentences/flowcharts.

For example, a document control procedure can be a table with columns such as: type of document, who approves it, distribution location(s), what to do with obsolete versions. Record retention procedure can be a table with columns such as: record title, who keeps, how long, how to get rid of when out of date, etc.

[Ajit Basrur]

rameshdamani,

I am sure that you would have mapped up your activities before starting the IVD company. By your question, I feel you are only worried about the QMS and all the other things like hardware or infrastructure are in place.

Is that right ?

[CliffK]

Great advice from Duke. Just a few additional thoughts.

Originally Posted by Duke Okes

Start with a simple printed, paper system and when it grows integrate the files into an electronic system.

This is absolutely correct.

The expense of the QMS rises with complexity.

Dedicated QMS software requires extensive tuning and administrative overhead. I would stay away from it. The examples I've seen have bloated and bureaucratic workflows.

To keep it simple don't write a lot of detailed procedures with Purpose, Scope, Responsibilities, Procedure, References, etc. Just title the document well and include what they need to know in simple sentences/flowcharts.

Consider also eliminating the need for procedures and work instructions through task simplification, obvious visual indicators and general mistake-proofing.

For example, a document control procedure can be a table with columns such as: type of document, who approves it, distribution location(s), what to do with obsolete versions. Record retention procedure can be a table with columns such as: record title, who keeps, how long, how to get rid of when out of date, etc.

Think always about:

1. What is the real benefit to my company of this particular requirement in the standard?
2. What is this requirement really asking me to do? (As opposed to what some quality guru or outside auditor claims is "the right way" to meet the requirement.)
3. What is the lowest-cost way to get the benefit of the requirement?

For example, the requirement in ISO 9001 to have documents "reviewed for adequacy" can spawn a stunningly complex system of sign-offs, reviews and revisions. Don't let this happen.

[Jennifer Kirley]

Originally Posted by joshua_sx1

...actually, that's everybody’s dream…

I agree. If you are working in medical devices, your QMS is going to need sufficient complexity to satisfy ISO, and FDA approval if you sell to the U.S.

Your options are to educate yourself in these areas, or bring in an expert to help you.

The best advice I cab give is to reject the temptation to have someone "make you compliant." Use "canned" procedures as a guide only - do not try to squeeze your system into someone else's idea of what a QMS should look like.

[BradM]

For the most part, the standard addresses the major components that any successful business will eventually deal with over a five year period (IMHO). When I started my company, I wished I would have realized that better.

Parag has a good post, and one of the things I liked in it is the notion to buy the standard and know it. If it were me, I would write my quality policy and the quality manual. However you choose to do it, I would go ahead and develop a structure for the QMS and use it. I would push for a QMS that a customer would consider compliant to ISO9001:2000.

I would write your procedures in Word, using same format for all. You can use a paper system/ whatever you desire. Then, when you choose to go to one of the electronic systems, they should be able to migrate that work from Word (assuming you want to keep the format, and they are all consistent).

Just write the procedures you will need, and write them for your organization. Like Jennifer suggested, it's like in the movies when one guy tries to use the "tricks" of another guy to initially impress women; they usually fail miserably. Write procedures to cover the subject for your process. I would err on the side of too much brevity. As far as forms.. keep them brief and flexible.

Yes, whatever path you take is a lot of work. However, your business is an investment of your money and time. When you start performing well and hire additional people, you will need to train these people. If you are doing well, that means you will have less time to train each person one-on-one. A Good QMS will benefit you several times over just in training and repeating mistakes.