A final-year student who needs help conducting an external audit using ISO 9001:2015

[Jean_B]

2. I really need help working with ISO 9001:2015 to help a company solve a problem. It doesn't have to be complex, but it requires my effort to carry it out.

Leaving the details out try:

1. Find one uncertified company, supplying to a multitude of customers.
2. Request whether you can look into optimizing the way they meet the generic obligations of contracts.
3. Code generic obligations of contracts to ISO 9001 clauses (e.g. change control). Every variation that you can reduce to an ISO 9001 clause means overall simpler contracts, and technically less obligations to implement and monitor.
   1. This might mean advising on adjustments to processes so they can cover all variations.
4. Quantify reduction in variation of requirements as the simplicity gain.

 

[GStough]

Another option that hasn't been mentioned here is your local American Society for Quality section. Most sections have at least a few Certified Quality Auditors who may be willing to help you. Local sections may also have companies that work with them and could possibly provide what you need. It wouldn't hurt to reach out to your local ASQ section and at least inquire. Best of luck!

 

[Randy]

Another option that hasn't been mentioned here is your local American Society for Quality section

There are none where this person lives....At least according to the IP address

 

[AMIT BALLAL]

@Knifenat, I don't want to discourage you.
IMHO, you should not conduct an external audit without an auditor certification and with some experience in QMS and auditing.
And there is no point in helping an organization implement QMS and improve it unless you have relevant knowledge and experience. And based on your earlier input, you also don't seem to have access to direct guidance hence will be a difficult task.

Can you answer the following questions to help you better?
1. What is the title of the project?
2. What is the problem statement (you are trying to solve)?
2. What is the scope and what is excluded from the project?
3. What is the timeline for project completion?

 

[Jen Kirley]

Honestly speaking, all the knowledge I have about ISO is from my readings because it wasn't covered in depth in class, not to mention the editing parts. That's also the problem with me; there are so many papers, and I can't really narrow them down. I would really appreciate any help you can render. Thanks

I often recommend the book Iso 9001:2015 In Plain English. It does a very good job of explaining the standard.

 

[Randy]

I often recommend the book Iso 9001:2015 In Plain English.

In the past I've actually recommended material written by a name that can't be mentioned here, it's simple, easy to read and easily understood by a novice. (not meant to be a slander on the stuff).

 

[Jen Kirley]

The book "Internal Auditing in Plain English" is also very good.

 

[Randy]

Here's one I found years ago.

 

[Kronos147]

I'll describe what we do here in our internal audit. We look at a one of the defined processes, as per the organization's process definitions. I'll say "Production" as the example.

We look at the documents related to the process (what does it say in the manual, procedures, work instructions).

We identify the clauses in the standard that apply to the process (hopefully defined in one of the previously mentioned documents, else, defined in the internal audit documents).

We re-familiarize ourselves with the requirements from the standard for the process.

We pick out some of the key concepts that the documents describe (like take the output of contract review and convert it into a work order).

We sample these work orders to see that they were issued following the organizations documents.

We review the activities involved in fulfilling the steps as detailed in the work order.

We ensure that the process is following the requirements of 1) the standard, ISO 9001, 2) the organization, and 3) the customer. We look for conformance to requirements (not looking for non-conformance), and in the process, if there is something that does not meet the requirements, we will identify this as non-conformance.


The other method worth noting is the "source audit" approach. Source audits in this context are those types of audits conducted by the customer. Review the contract, review the planning, review the activities, review the outputs of the activities, and review the final output to make sure it meets the contract requirements.

Example: Contract/PO 8675309 is for 37 widgets, revision "X". The contract/PO states delivery dates, documentation requirements, and potentially post-delivery requirements. If the documentation requirements call for a detailed inspection report, look at the inspection report. If the contract states the material used must be DFARS compliant, review the certificates for the material. If the material is to be processed per a specification, review the spec, the certs, and the method that the organization confirmed the material meets these requirements. If the contract says to package the delivered product in a box with a pink bow, we look for the pink bow on the box....

I hope that helps.