ISO Elements



We are working on becoming ISO 9000 compliant. We're using the ISO 9001:1994 standards. We're a software consulting group. We provide a service to our customers; we do not create products (our contractors are our product). We find contractors/consultants for our customers. Our full-time staff consists of 6 employees. Currently, we have approx. 10 contractors.
Now my question:
After reading and reading the standards, I have concluded that only 9 of the 20 elements really apply to our business. Is this o.k? Can we say that the other elements just don't apply to us and still become ISO 9000 certified?


I am quite sure that most of the 20 elements do apply.

Management needs to review the system; Contracts with customers need to be established and reviewed; Documentation and Data needs to be controlled; You purchase the services of the contractors and consultants, and any product used for the outcome of the service quality you provide; Identification and Traceability of the service (tracking contractors, consultants and their projects; the service processes, outlining what is indicated in the standard;.
4.10 could be addressed in a number of ways, for instance: inspection and verification of the consultants and contractors (how do you determine the criteria for using a contractor or consultant, verifying their references, application, portfolios,etc.)Keep in mind this element ties in with 4.6.
Element 4.10 can be tied in with Test Status, Verification Status, etc. Nonconformance for service problems requiring a disposition; Corrective Action for systemic problems requiring a Corrective Action Plan; 4.15 take into consideration how your company delivers the services you provide to your customers, etc.; records need to be kept, Internal Quality Audits need to be conducted; training will need to be established for the owners/management and other full time personnel of the
company; servicing if you guarantee any aspect of your work.
Statistical Techniques could be the trends and analysis you identify from tracking nonconformances, corrective actions, customer complaints, etc.

If you are just starting outwith your ISO Project, I suggest you identify your processes and sub-processes, then when you have a true picture of your business as it is take and line the processes against the ISO elements and go from that point to fill in any deficient areas.

You may also want to consider ISO 9001:2000, which is due out December,28,2000.

Service areas can actually be great fun in both documenting and implementing, especially if you are creative.


Jim Triller

A product is the output of a process. Your product is the service you provide to your customers - to find them contractors/consultants that meet their needs.

I have implemented an ISO 9002 registered system for a service company that has one employee and uses several subcontractors. Only one element, Control of Inspection, Measuring and Test Equipment, did not apply. I suspect that if you want your company to be fully compliant the same might hold true for your organization.

Please feel free to contact me via email if you have specific questions on how the elements may apply to your situation.

Rick Goodson

In a word, no.

Assuming you are looking at ISO 9000 registration, you will need to register under the new revision ISO 9000: 2000 (standard to be issued December 15, 2000). There is an exclusion allowance, but only for items in clause seven, Product Realization. Even within clause seven there are sub clauses I believe will apply to your organization. By the way, I believe that your product is not your contractors but the service of determining customer needs, contractor capability and linking the two. Depending on the contractual arrangements with both your contractors and your customers, the software that is provided may be part of the product you supply under ISO.

Shifting back to ISO 9001: 1994, at a minimum I see 13 elements that apply without spending to much time thinking about it:

4.1 Management responsibility
4.2 Quality System
4.3 Contract review
4.4 N/A
4.5 Document and data control
4.6 Purchasing (maybe, need to understand your business, could be qualification of the contractors under the concept of a approved supplier list)
4.7 Control of Customer Supplied Product (this can be interpreted to include intellectual property your customers provide so you can source the software contractors)
4.8 N/A
4.9 Process Control
4.10 Inspection and Testing (Could be interpreted to be qualification of the contractors)
4.11 N/A
4.12 N/A (could apply depending on the definition of your product)
4.13 N/A (could apply depending on the definition of your product)
4.14 Correctine & Preventive Action
4.15 N/A (could apply depending on the definition of your product)
4.16 Control of Quality records
4.17 Internal Quality Audits
4.18 Training
4.19 N/A
4.20 Statistical techniques

I am sure some of the other forum contributors will have comments as well.

Hope this helps.


Fully vaccinated are you?
Originally posted by MRW:

After reading and reading the standards, I have concluded that only 9 of the 20 elements really apply to our business. Is this o.k?
What elements do you believe do not apply? Why? That's what the auditor is going to ask.
Top Bottom