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Suggestion for Implementing ISO 9001 in a Start-Up Company

C

Calif

#1
Start-up company with two people. The owner and myself. However, owner is hands off and I am doing 99% of work. We sell one product to one customer using one equipment (process). Currently we have very little documentation. Our customer asked us to get ISO 9001 certified.

I am a newbie and came across this website while researching software called Isoxpress.

I have cGMP, Haacp, and SQC experience with a basic knowledge of ISO 9001. I have written numerous policy, procedures, work instructions, and forms for gmp compliance. My game plan was to purchase ISO 9001 regulation, purchase templates for ISO documentation, complete paperwork, find a registrar, and then file for certification(audit) with a couple of week of production data.

- Does this make sense?
- Also, Isoexpress is $490 and seems like a good value. Any opinions on this software. It is a management software.
- As I am a one man team. How do I audit myself on the annual audits?
- Company is in the bay area, northern California and would like suggestions on registrars in the area. I am trying to keep cost down and don't want to pay travel expense for audit.

I would appreciate any suggestions or comments.
 
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K

Ka Pilo

#2
Re: Suggestion for implementing ISO9001 in a start-up company

Start-up company with two people. The owner and myself. However, owner is hands off and I am doing 99% of work. We sell one product to one customer using one equipment (process). Currently we have very little documentation. Our customer asked us to get ISO 9001 certified.

I am a newbie and came across this website while researching software called Isoxpress.

I have cGMP, Haacp, and SQC experience with a basic knowledge of ISO 9001. I have written numerous policy, procedures, work instructions, and forms for gmp compliance. My game plan was to purchase ISO 9001 regulation, purchase templates for ISO documentation, complete paperwork, find a registrar, and then file for certification(audit) with a couple of week of production data.

- Does this make sense?
- Also, Isoexpress is $490 and seems like a good value. Any opinions on this software. It is a management software.
Document and do what’s the standard requires. i don’t recommend buying ready made documentation.
- As I am a one man team. How do I audit myself on the annual audits?
- Company is in the bay area, northern California and would like suggestions on registrars in the area. I am trying to keep cost down and don't want to pay travel expense for audit.

I would appreciate any suggestions or comments.
You can outsource internal audits.
 

John Broomfield

Staff member
Super Moderator
#3
Re: Suggestion for implementing ISO9001 in a start-up company

Start-up company with two people. The owner and myself. However, owner is hands off and I am doing 99% of work. We sell one product to one customer using one equipment (process). Currently we have very little documentation. Our customer asked us to get ISO 9001 certified.

I am a newbie and came across this website while researching software called Isoxpress.

I have cGMP, Haacp, and SQC experience with a basic knowledge of ISO 9001. I have written numerous policy, procedures, work instructions, and forms for gmp compliance. My game plan was to purchase ISO 9001 regulation, purchase templates for ISO documentation, complete paperwork, find a registrar, and then file for certification(audit) with a couple of week of production data.

- Does this make sense?
- Also, Isoexpress is $490 and seems like a good value. Any opinions on this software. It is a management software.
- As I am a one man team. How do I audit myself on the annual audits?
- Company is in the bay area, northern California and would like suggestions on registrars in the area. I am trying to keep cost down and don't want to pay travel expense for audit.

I would appreciate any suggestions or comments.
Calif,

You could try the envelope approach.

On one side of the envelope (an electronic folder or hardcopy) you leave space your your client's name and publish your quality policy, quality objectives and describe how you deal with product nonconformity and audit how well your system is working. On the other side you show how you translate the needs of your clients into satisfied clients who pay you promptly for having satisfied their needs. This flowchart will also show how you dissolve/solve problems before and after they happen. For each project you design a service specification which is approved by your client and later used to measure and record their satisfaction with your service. All records related to the project are filed in the envelope.

Limit the size of your envelope to make you more creative in how you document your system. It also acts as your procedure for controlling documented information and provides for growth.

Being as you are doing 99% of the work you will not have time for much else!

Look at the FedEx Kinkos envelope for inspiration.

Good Luck,

John
 

Wes Bucey

Prophet of Profit
#4
Re: Suggestion for implementing ISO9001 in a start-up company

Start-up company with two people. The owner and myself. However, owner is hands off and I am doing 99% of work. We sell one product to one customer using one equipment (process). Currently we have very little documentation. Our customer asked us to get ISO 9001 certified.

I am a newbie and came across this website while researching software called Isoxpress.

I have cGMP, Haacp, and SQC experience with a basic knowledge of ISO 9001. I have written numerous policy, procedures, work instructions, and forms for gmp compliance. My game plan was to purchase ISO 9001 regulation, purchase templates for ISO documentation, complete paperwork, find a registrar, and then file for certification(audit) with a couple of week of production data.

- Does this make sense?
- Also, Isoexpress is $490 and seems like a good value. Any opinions on this software. It is a management software.
- As I am a one man team. How do I audit myself on the annual audits?
- Company is in the bay area, northern California and would like suggestions on registrars in the area. I am trying to keep cost down and don't want to pay travel expense for audit.

I would appreciate any suggestions or comments.
I think you and boss/owner need to have a heart-to-heart with your customer. His request for a one-man shop to get ISO registration is outrageous and counter-intuitive if he is (as I suspect) purchasing your total output because it is cost-effective for him to do so.

Do you and boss have real plans to grow/expand your business to more products, employees, or more customers? If yes, what is the timetable for implementing this growth? How big do you plan to get? If these are big plans and imminent, THEN and only then, should you consider setting up an ISO registration goal. Not to satisfy this one customer, but to help market to more customers.

If the ISO registration is a deal breaker and there is absolutely no way around the requirement, then there are some inexpensive alternates to paying a sum of money for some joker's generic ISO forms. John is correct. All the documentation you need for a one customer, one product ISO house can be done by hand and stored in a FEDEX or UPS or USPS overnight envelope (they are Tyvek or generic like Tyvek, so they are waterproof and don't fray easily from handling).

We have sample one page quality manuals here in our archives. Many folks will weigh in on this topic, but I can almost guarantee not one will recommend you go out and pay for a generic template when you can get better ones for free here!
 
2

20110525R

#5
Re: Suggestion for implementing ISO9001 in a start-up company

Start-up company with two people. The owner and myself. However, owner is hands off and I am doing 99% of work. We sell one product to one customer using one equipment (process). Currently we have very little documentation. Our customer asked us to get ISO 9001 certified.

I am a newbie and came across this website while researching software called Isoxpress.

I have cGMP, Haacp, and SQC experience with a basic knowledge of ISO 9001. I have written numerous policy, procedures, work instructions, and forms for gmp compliance. My game plan was to purchase ISO 9001 regulation, purchase templates for ISO documentation, complete paperwork, find a registrar, and then file for certification(audit) with a couple of week of production data.

- Does this make sense?
- Also, Isoexpress is $490 and seems like a good value. Any opinions on this software. It is a management software.
- As I am a one man team. How do I audit myself on the annual audits?
- Company is in the bay area, northern California and would like suggestions on registrars in the area. I am trying to keep cost down and don't want to pay travel expense for audit.

I would appreciate any suggestions or comments.
As a note here, ISO 9001 does not require a company to be certified by a registrar, you can in fact be ISO 9001 compliant. You can use ISO 9001 for internal application to build your QMS and state your company meets the requirements of ISO, but you cannot state you are ISO certified unless you have a registrar certify you. So, depending on what your customer wants, unless they specifically ask you to certify, then all you need to do is build your QMS to the ISO standard and maintain it for compliance. Reference ISO 9001:2008 vii 0.3
 

Wes Bucey

Prophet of Profit
#6
Re: Suggestion for implementing ISO9001 in a start-up company

As a note here, ISO 9001 does not require a company to be certified by a registrar, you can in fact be ISO 9001 compliant. You can use ISO 9001 for internal application to build your QMS and state your company meets the requirements of ISO, but you cannot state you are ISO certified unless you have a registrar certify you. So, depending on what your customer wants, unless they specifically ask you to certify, then all you need to do is build your QMS to the ISO standard and maintain it for compliance. Reference ISO 9001:2008 vii 0.3
I believe the customer MEANT "registered" or "certified" because a newbie (the OP) probably wouldn't use the term otherwise " Our customer asked us to get ISO 9001 certified."

The idea of compliance is certainly one which the OP and his boss should discuss with the customer. Compliance would work nicely with John's one envelope suggestion. Good addition to the discussion, Missilegypsy.

Since the OP does not yet have the Standard, it is a good idea to include the pertinent wording of the Standard when making a reference to an ISO Standard. Short excerpts are fully permissible under "fair use" for educational or review purposes.
 

Jim Wynne

Staff member
Admin
#7
Re: Suggestion for implementing ISO9001 in a start-up company

Reference ISO 9001:2008 vii 0.3
Since the OP does not yet have the Standard, it is a good idea to include the pertinent wording of the Standard when making a reference to an ISO Standard. Short excerpts are fully permissible under "fair use" for educational or review purposes.
I think this is the part of 0.3 that Missile gypsy was referring to:

ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes.

ETA:
This is on page xi of my copy [ANSI/ISO/ASQ(E)] of 9001:2008 and not page vii.
 

SteelMaiden

Super Moderator
Super Moderator
#8
I fully agree that you need to look at your future first, do you want to stay a two man company with one customer? If so, certification may just be a little more than you want to get into. Talk to your customer and ask why?

Don't go out and buy ready made templates, there is tons of free stuff here. When I did our start-up, I just went through the standard and found where procedures were required, if I needed additional ones, what types of records, etc., etc. Don't let a salesman convince you that you need to purchase a package of anything. If you have the money, I suggest that you attend an ISO 9001 implementation class. It's the best money I ever spent to get my head in the game. Audits can be contracted, maybe you can find another small company and trade off?
 

BradM

Staff member
Admin
#9
I fully agree that you need to look at your future first, do you want to stay a two man company with one customer? If so, certification may just be a little more than you want to get into. Talk to your customer and ask why?
Exactly.:agree1: Getting and maintaining the certification is expensive, Calif. Not only calculate the initial up-front costs, but those associated with activities year after year.

That's a good point, Steelmaiden, about looking at the future. When it was just me and my wife, we had a pretty good system. But when I hired an employee, I had not taken into account the need to have a third person come into the system. Granted it was not a lot of changes, but changes nonetheless.

When I did our start-up, I just went through the standard and found where procedures were required, if I needed additional ones, what types of records, etc., etc.
:agree1::yes:

What we did was very similar, but kind of different. When I first started my business, I was not very knowledgable on the ISO standard and such. But doing calibration work, I needed to have procedures in place. I did know (or at least felt) that I needed some form numers and stuff. So all the procedures got a 100 designation, and the forms got a 300 designation. I wrote and generated what I needed. Later, I began to incorporate the procedures and stuff into an integrated QMS. Out of business necessity, I had already addressed many of the 9001 requirements.:)

Lesson learned: I did not start out with a consistent format for the procedures. They ended up all over the place. While I don't think they had to be perfect,:tg:, I wished I had started off more consistent, and like Steelmaiden suggest, that I had thought a little more about future growth.

There were a lot of different groups that audited my records, including FDA and FAA. I would show them my quality policy (1/2 page), the overview of the documents and such, and ask them what they wanted to see. When asked about certifications and the like, I would simply ask them what was not addressed in my QMS they would like to see. What I had seem to satisfy most everybody, without having to spend a ton on a certification. :)
 
2

20110525R

#10
Re: Suggestion for implementing ISO9001 in a start-up company

I think this is the part of 0.3 that Missile gypsy was referring to:

ISO 9001 specifies requirements for a quality management system that can be used for internal application by organizations, or for certification, or for contractual purposes.

ETA:
This is on page xi of my copy [ANSI/ISO/ASQ(E)] of 9001:2008 and not page vii.
Jim, yes, that is correct, since I am new here, wasn't sure if quoting a copyrighted document was acceptable on the forum.
 
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