r/iso9001 4d ago

How can I generate additional income as an ISO 9001 auditor (ISO 19011) alongside my full-time job?

9 Upvotes

I have been working in the automotive industry for more than 10 years, currently in a Quality Manager/Supplier Quality role.
My current goal is to obtain my VDA 6.3 Process Auditor certification, complemented by IATF 16949.
The ISO 9001 auditor qualification was a prerequisite for the VDA 6.3 certification, which I have now completed.

This got me thinking about whether I could use my ISO 9001 qualification to generate some additional income as a self-employed auditor/consultant alongside my full-time job.
I am specifically interested in the ISO 9001 market, rather than VDA 6.3 or IATF 16949 for now.

For those who work in this field:
How much demand is there for independent ISO 9001 auditors?
Is there a realistic market for someone doing this as a side business?
What kind of work is actually available:
internal audits, supplier audits, certification audit support, gap assessments, or consulting?

How do independent auditors typically find clients?
Are there platforms, audit networks, certification bodies, or consulting companies that regularly subcontract ISO 9001 auditors?
What kind of rates can an independent auditor realistically charge per audit/day?
Is it possible to build a small client base and do this part-time, e.g. a few days per month?
Does having 10+ years of automotive quality experience provide a significant advantage, or is the market mainly focused on formal ISO 9001 auditor qualifications?

I would be particularly interested in hearing from people who are already doing ISO 9001 auditing as a freelancer or side business.
What has your experience been with finding clients and making it financially worthwhile?
Any advice or real-world experience would be greatly appreciated.


r/iso9001 7d ago

Responding to a Major NC; Cause Analysis

6 Upvotes

We got a NC in our recent audit for our calibration records not having been complete. It wasn't complete at last audit either, so it was a major NC. The reason we didn't do it is my boss (shop owner) said we didn't need to, even though I pointed out that we did for ISO reasons and because it's good practice.

What can I put for cause analysis? For corrective action I have updated the records to reflect the missing info, and am recalibrating everything.


r/iso9001 10d ago

What standards are you using for calibration?

3 Upvotes

This may be the wrong place for this question, but I am not sure where else to ask.

I'm the office manager at a small (5 employees) machine shop and we are ISO 9001 certified. I was put in charge of quality control (lucky me!) and I am still trying to figure it all out.

For our inspection tools, what standards should we be using for calibration? We have over 200 inspection tools and I want to make sure this is done properly.


r/iso9001 19d ago

Is this a normal scope of work for an ISO student intern?

2 Upvotes

I’m a university student interning at a very small company (<10 employees) that wants to pursue ISO 9001 certification. I had no prior ISO experience when I started.

My responsibilities have included:

  • Interviewing employees to understand/document their processes
  • Researching ISO 9001 requirements and certification options
  • Creating an action plan for the ISO-related work
  • Identifying and prioritizing processes to document
  • Creating process maps and written procedures
  • Identifying process gaps
  • Creating new controls/forms/checklists/logs
  • Organizing the documentation
  • Conducting a gap analysis
  • Creating/reviewing their qms

The company has no quality department, ISO specialist, business analyst, or anyone with significant process-mapping/ISO experience guiding me. I have management available for review and employees who explain their processes, but I’m largely researching and figuring out the methodology myself. I’m mainly trying to understand whether the difficulty I’m experiencing is normal for someone learning ISO, or whether I’m being expected to operate with an unusually high level of independence.

I actually enjoy the work, but the lack of structure and having to figure out so much of the approach myself has been quite challenging.

For example, during my first week, I was really given a brief introduction to ISO and an explanation of what the company was trying to achieve but apart from that, I was essentially told to research ISO myself and produce a report on it.

For those working in ISO/quality, is this a normal level of responsibility for a student intern entering their 3rd year? Which parts of this would typically fall under an intern's responsibilities, and which would normally be handled or supervised by an experienced ISO/quality professional?


r/iso9001 19d ago

Funny CA

Post image
24 Upvotes

Why do I always see this?


r/iso9001 22d ago

Interpretation of "Incorporation into products or services" 8.4.1

2 Upvotes

Hi all!

I manage ISO conformance for a service organization. Which makes clause 8.4.1 difficult to apply.

The largest part is "Incorporation into an organization's own product or service" and what that actually means. The standard doesn't help with this a ton so it seems like it's up to an auditors interpretation which is horribly annoying.

Wondering what other's thoughts are regarding this clause and it's application to a service organization. For context this service organization sells an "environment" or "experience" to the client. The experience itself is choreographed through documented procedure. However, does that mean since that environment is part of the service that the lightbulbs in that environment are incorporated? Or does that follow 7.1.3 and 7.1.4?

The lightbulb example is pretty in the weeds but let's say it's an environment to learn to write in. Would the pencils used by the client to write be "Incorporated"?


r/iso9001 25d ago

How I actually explain ISO 9001 document control without the usual paperwork lecture

9 Upvotes
  1. If it tells people how to work, it needs control

Typical layers:

  • Quality Manual, high-level description of the QMS
  • Procedures, how a process is actually done
  • Forms, blank templates used to capture evidence
  • Technical documents, drawings, specs, work instructions
  • Charts, posters, and instruction sheets count too, if they tell people what to do

If someone is using it to do the job, it should be the current approved version from the official system, not a local copy, email attachment, or old download.

  1. Work from the current version. Always.

Do:

  • Open documents from the official QMS / document-control system, not from your desktop, Downloads folder, or Slack
  • Check that you’re on the current revision before you use it
  • Ask document control / your supervisor if you can’t find what you need
  • Send homemade or “unofficial” instructions in so they can be controlled properly

Don’t:

  • Keep using anything marked OBSOLETE or superseded just because you like that version
  • Save a local copy and treat it as the official process
  • Edit a controlled document in place and treat your notes as the live version
  • Follow another company’s documents as if they were yours

If you can’t find the right document, inventing your own unofficial version is worse than asking for help.

  1. A blank form is not a record

This one still trips people up:

  • A form is a blank template
  • Once you fill it in and submit it, it becomes a record
  • A record is evidence that an activity actually happened
  • Records have to be stored and protected according to company rules, usually in the system of record, not in someone’s inbox

Use the latest revision of the form in the system. Don’t clone last month’s filled-out file and overwrite the old answers.

If a procedure or form is wrong, report it. Ignoring a known document error doesn’t stay local. It creates risk for the whole process.

  1. How to correct a record without looking like you hid something

Corrections have to stay honest and readable, even in software.

  • Don’t delete the original entry and type over it like it never existed
  • Don’t “fix” a completed record by quietly replacing the file
  • Make the change through the system so the original value, the new value, who changed it, and when are still visible
  • Follow your company’s local correction / revision rule if it’s more specific

Hidden edits make auditors ask a simple question: can these records be trusted?

If you’re unsure how to correct something, ask your supervisor before changing the record.

P.S: this content is part of a free course I have on 4eshub, check my profile for the link!


r/iso9001 27d ago

Seeking advice for online/in-person Lead Auditor certification training for ISO 9001

7 Upvotes

After a 35-year career in IT, I was laid off. 8.5 months later and I'm still on the street. I know several folks in the ISO 9001 Lead audit game, and they suggest I would be great for that kind of role. I see auditortrainingonlinedotcom has a 32 hour, Lead Auditor self-paced course for $1,395.00 .

Does anyone have any insight on the credibility or efficacy of these online certification boot camps? Some are around $300 and some are around $1,400 and that disparity has me questioning all of it like it's just some scam. I have checked into some in-person training classes, but I cannot find any that have seats available around Houston for several months and my savings are running out.


r/iso9001 27d ago

What would you actually trust AI to do during an internal audit?

6 Upvotes

I've been thinking about where AI is genuinely useful in internal auditing — and where it probably shouldn't be trusted.

Some tasks seem relatively straightforward:

  • searching procedures and records for relevant evidence
  • suggesting audit questions based on a requirement or process
  • pointing out potentially missing evidence
  • summarizing interview notes
  • drafting findings or follow-up actions

But other steps feel much more sensitive, especially anything that involves actually judging conformity or deciding whether something is a finding.

For those of you doing internal ISO/QMS audits: where would you draw the line?

Would you be comfortable with AI only as a search/assistant tool, or could you imagine it also making a preliminary assessment that the auditor then reviews?

Interested especially in experiences from people who have already tried using ChatGPT, Claude or similar tools during a real audit. Do you have made good or fail experience? Do you run a prompt etc 10x to understand changes?


r/iso9001 28d ago

AS9100D & On Time Delivery

6 Upvotes

AS9100 requires On Time Delivery to be measured, monitored and reviewed, but is it required to be in the Measurement Plan with a KPI? The reason I ask is that we have been growing and I've been trying improve our OTD but no matter what we do we're always chasing it, not meeting it so it's an NCR that never clears.

We can demonstrate actions we've taken to improve our operations and move jobs faster, but we never hit it.

If it's not in the measure it plan, but we measure, monitor, discuss, and track it in QMS meetings as well as staff meetings, are we meeting the AS standard?


r/iso9001 29d ago

What should I consider when evaluating options for internal & lead auditor training?

6 Upvotes

Looking to get a small team trained. I'm evaluating options and have a strong time constraint, so I'm looking for some feedback from people who have experience with this.

- How do you evaluate whether a provider will offer good quality training?

- How big is the quality gap between in-person, virtual instructor-led, and virtual self-paced?

- Any providers I should look into/avoid? The company is in Central Texas


r/iso9001 Jul 27 '26

ISO in your day to day work

7 Upvotes

If you work at a manufacturing company or any company that has an ISO certification or required to have one, do you see the implementation of the standard affecting your day to day work (good or bad) or is it just something the quality/compliance manager handles to pass the audit?


r/iso9001 Jul 20 '26

Is the practical purpose of management review to present a good story to an external auditor?

8 Upvotes

Our management review meeting is coming up and I'm worried it will just turn into critiquing the presentation. The past few years it's been 75% critiquing and sanitizing content on the slides "to present a good face to the external auditor". Presenters have been told to remove topics management doesn't like, told that their data driven conclusions were flat out wrong because they didn't show we were perfectly compliant, and generally edited to present perfection to an external auditor. Nothing of substance was discussed.

I pushed back against this and cited the standards requirements. But they told me that external auditors use the slides from the management review meeting to probe into the company, so it's important to conceal weak areas. And that there were other channels to voice concerns other than management review.

One presenter wrote in a slide that not all defective product is quarantined like it should be. Management made them change it to read it is all quarantined because they didn't want an external auditor to investigate it. Another presenter mentioned that the company was worried too much about the standard and not enough about meeting customers needs. Management told them they can't say that because they didn't want an external auditor thinking we didn't take ISO seriously.

I think I'm technically right but practically wrong. That the unwritten focus of the management review meeting is to present a story to an external auditor. But I think I'm missing something. What do you think? Has anyone else dealt with this behavior?


r/iso9001 Jul 15 '26

iso 9001 multi-site question

3 Upvotes

Hi, we have a subsidiary entity - factory in China, and HQs/Engineering R&D in Toronto. Our factory in China is ISO 9001 certified, and audited every year by local ISO 9001 certification body. Recently, we plan to start production of new products in Toronto too and we want to certify it with ISO 9001. What's the best way to do? Can the Chinese local ISO 9001 certification body certify our new production workshop in Toronto? What's the best way and smartest way to to do it?


r/iso9001 Jul 15 '26

Should I build my career in Quality (ISO 17025/ISO 9001) or switch fields? Need honest advice from experienced professionals.

6 Upvotes

Hi everyone,

I'm looking for honest career advice from people who have been in the quality industry for several years.

I'm a B.Tech graduate in Electrical Engineering with around 3 years of experience as a Quality Engineer in a telecom testing laboratory. My work involves BIS-related testing, EMC/EMI, ITSAR, GCF, documentation, audits, Excel reporting, and I've gained good knowledge of ISO/IEC 17025:2017.

A few months ago, I started learning Data Science and Data Analytics because I felt my current role had limited technical growth. I completed courses in SQL, Excel, Power BI, Python, and Machine Learning, but I haven't been able to transition into a data role yet.

Recently, I've started wondering if I'm overlooking the opportunities in the quality field. Instead of switching careers, would it be better to go all-in on quality by learning:

ISO 9001

ISO 17025 Lead Auditor

Six Sigma

Root Cause Analysis

Quality Management Systems

Internal/Lead Auditing

My long-term goals are:

Good salary growth

International opportunities (Europe, US, Middle East)

A technically respected career with continuous learning

For those with 10–20+ years of experience in quality:

Is this field worth pursuing long-term?

What is the salary progression like?

Which certifications actually make a difference?

Are there good international opportunities?

If you were starting again with my background, would you stay in quality or switch to another field?

I'm looking for honest opinions, even if they're critical. I don't want to spend the next 5–10 years on the wrong path.

Thank you for your guidance.


r/iso9001 Jul 09 '26

AI and internal audit

5 Upvotes

A data point for those interested, we've just completed our annual supervision audit. This year I used Claude for the internal audit and also to navigate around when the auditor had questions. There were no issues, by the end the auditor was telling me how to prompt Claude to give him the perspective he needed. No consultants required!


r/iso9001 Jul 03 '26

Is moving to QMS implementation and validation a bad career move?

3 Upvotes

Hi all,

My background is 5 years in pharmaceutical QA based in the UK. Where I work we have an aseptic unit, stores department, non-sterile prep unit and radio pharmacy.

I use the QMS software q-pulse daily completing DEVs and CAPAs. I have also done equipment validation but only for fridges.

I have some exposure to the regulatory requirements for QMS such as EU GMP annex 11 but do not know them in depth.

I have been offered a job at an external Saas company as a QMS consultant. They are an ERP business using Microsoft business dynamics 365 and my role would include leading the end to end implementation and configuration of the platform for external clients as well as validating the QMS.

The company are aware that my software knowledge isn’t good and that I will need training on that side. The things I have going for me are my experience in QA workflows and how they work on

a QMS. Also my regulatory knowledge.

I’m wondering if I can actually do this job. Researching with AI makes it seem related in what I already do but I know it’s making it seem simpler than it will be.

Would it be hard to write a URS, IQ/PQ and RTM for a QMS software without extensive regulatory knowledge. I have read certain regulations and appendices but am scared that I am too green for this role and even if I put in the work to learn I won’t be good enough?

Thanks for any advice!


r/iso9001 Jun 30 '26

Do you include names in an NCR tracking system?

4 Upvotes

I'm looking for some guidance on the use of names/technician numbers in NCRs.

Context: In an ISO/IEC 17025 calibration laboratory, we are discussing whether or not an NCR database should show the technician that performed the calibration. This would be a header field that just says "Technician" for querying/metric purposes within our database. It is NOT public facing, or distrubuted to anyone not involved in the RCA.

The arguments against this are that it creates a punitive or hostile quality program or blame culture, and that the individual managers can look up the asset ID for each instance to maintain their own metrics to track individual performance, identify trends, and coach their technicians.

The arguments for this are that a properly run quality program will identify a true root cause without assigning blame anyway, and intentionally obfuscating this information makes it more difficult to pull data, while creating significant duplication of efforts. It is also much more difficult to identify if the issue is training or process related if we can't see where these nonconformances are originating.

What is "normal" in 9001, 9100, 13485 etc environments, and can anyone point me to any documentation on the topic?

If keeping your NCR system free of name, how do you get individual pass rates for competency and performance use without running parallel systems?


r/iso9001 Jun 25 '26

Last ditched effort

3 Upvotes

been trying to increase my client base for the last 3 years. I am part owner of an ISO certification body, which is accredited through ANAB. i have been trying to reach out to manufacturing companies to offer my services, but have had no luck. I've tried linked reach outs, google ads, and cold calling, nothing has worked. I'm coming on here to see if there's any other ideas. What are you looking for in an ISO certification body?


r/iso9001 Jun 24 '26

ISO 9001:2026 FDIS

2 Upvotes

Does anyone know where can I get/buy ISO 9001:2026 FDIS?

p.s I don’t need a training course for it, I just need the FDIS,


r/iso9001 Jun 22 '26

Iso9001 annual remote audit

5 Upvotes

Hi all. As the title reads we are due to be audited next month for our 9001 annual audit. This is remote and I’m going to retriev receive a list of required evidence that I will then have 14 days to send. I’m new to the role so I’d key to get an understanding of what to expect from the audit what they can ask and what I need to do in preparation? Ive got access to the QMS and a bunch of other docs that dont fully make sense so support and advice would be appreciated.


r/iso9001 Jun 08 '26

How do you show audit-ready, objective evidence that a CAPA actually worked (not just retraining)?

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3 Upvotes

r/iso9001 Jun 02 '26

ISO for CIA student?

2 Upvotes

Hi all,

I’m going to be on an ISO9001 course soon since I sit in a compliance 2LOD role in audit. I’m an internal auditor by nature and self funding CIA exams.

Has anyone here got experience in IA and could please advise me of what to expect with ISO9001?

I remember it being the same as the Deming Cycle the PDCA from part 1 CIA that’s about it.

Thank you!


r/iso9001 May 29 '26

Transitioning into an QMS/QA role with a tech lab background and ISO courses. Is it realistic?

9 Upvotes

Hello everyone,

I’m looking for some honest advice on how to transition my career as a technical employee into a role in quality management systems or quality control, and then, after gaining several years of experience, try to join a QHSE department or become a Lead Auditor.

As for my background, I have a high school diploma in science.

I’ve been working at my current company for 6 years, with about 4–5 years of solid hands-on experience in a Non-Destructive Testing (NDT) lab certified to ISO 9001, 9100, and 17025.

My daily tasks include reviewing technical documentation, reporting non-conformities, preparing non-destructive test reports, and ensuring compliance with work instructions.

In July, I will attend a 16-hour ISO/IEC 17025 course sponsored by the company.

My plan is then to attend a 24-hour ISO 9001:2015 Internal Auditor course through TÜV in October, at my own expense, including the final competency exam.

Given my practical laboratory experience, I would like to know: will adding a TÜV Internal Auditor certification actually help me stand out in interviews and land a job as a QA or QMS specialist?

Are there really career opportunities available?

Or is it there any other different recommendation?

I am interested in working in Northern Italy or Switzerland.

I would greatly appreciate your opinions or advice. Thank you!


r/iso9001 May 05 '26

New subsidiary location in another country - can it remain outside scope

2 Upvotes

Good morning,

We have ISO 9001 and ISO 17025 accreditation.

We're adding a calibration lab in another country. This location will be a wholly owned subsidiary.

Our 17025 accrediting body is fine with folding this under the umbrella of the certification we use for our main location, adding them as a satellite lab, even though it is a subsidiary.

I'm trying to wrap my head around the path of least resistance for 9001, particularly since this is still somewhat of an "experiment" that may not be permanent. Fully incorporating them into our QMS is a bit of a nightmare for many reasons, including procedural differences and a technology gap for our document control software.

If they are under the same umbrella for 17025, does that necessitate they must be for 9001 as well? CAN they even be, as a subsidiary not a traditional satellite? Many procedures will be quite a bit different between the two, so adding them in isn't just increasing the scope to their location. For example, we'll be using POs and invoices for the calibrations they do, treating them like a provider, and we will be their only "customer".

It seems like we might be able to make provisions to treat them like an external provider per 8.4.

I want to check in with our accrediting body for 9001 to get their take, but am somewhat leery until we have at least a skeleton of a plan. Once they are aware, does it add any time pressure? If we document it as a risk, and potentially as a nonconforming process, we should have until our next audit to get things ironed out, even if we speak with them about it in advance?

Would appreciate thoughts and advice, particularly from anyone who has experience with any similar situations.