ISO 9001
ISO 9001 software for manufacturers
Stop losing a fortnight to audit preparation. Produce traceability, inspection and process evidence from a system, in minutes, because it was captured while the work was being done.
Definition
What is ISO 9001 software?
There is no such thing as software that makes you ISO 9001 certified. Certification is awarded on your processes and your evidence that you follow them. What software does is remove most of the manual effort involved in producing that evidence.
In a manufacturing context that means capturing the things an auditor asks for as a by-product of production: traceability of material, records of inspection, control of non-conformances, evidence of corrective action, and demonstration that the process was followed as documented.
The honest framing is this. ISO 9001 does not require software. It requires evidence. Producing that evidence from paper is possible and it costs you people, repeatedly, forever.
See it live
The evidence, retrieved while the auditor waits
Pick any job and its complete record is already there: operations, operators, times, material batches, inspection results. The reporting suite turns clause 8.5.2 into a search box.
Preparation stops being a fortnight of pulling files, because there is nothing to pull.
- Full job history on demand
- Traceability both directions in minutes
- Export in the format the auditor asks for
How it works
How software supports certification
Four clauses account for most of the audit effort in a typical manufacturer, and all four are capture problems.
Identification and traceability
Auditors ask you to pick a product and show where its material came from. Captured at issue, this takes a search. Reconstructed from paper, it takes days.
Control of nonconforming output
Evidence that defects were identified, contained, dispositioned and recorded. A system does this as a by-product of the non-conformance being raised.
Monitoring and measurement
Evidence that checks happened, with results retained. Recording at the operation makes this automatic rather than a filing exercise.
Improvement and corrective action
Actions raised, assigned, closed and demonstrably effective, with the trail retained for the auditor to follow.
Capabilities
What it gives an audited manufacturer
Traceability on demand
Material to product and back, retrieved in seconds rather than reconstructed.
Complete job history
Who, what, when and on which machine, for any job the auditor picks.
Inspection records
Check results retained against the operation with timestamps.
Non-conformance trail
Raised, dispositioned and closed, with the evidence attached.
Corrective action tracking
Assigned and closed out rather than agreed and forgotten.
Retention
Records kept for the periods your sector and contracts require.
Day to day
Compliance as a by-product of production
Checks that cannot be skipped, non-conformances raised at the bench, records stamped with who and when. The system is the procedure being followed, and the proof of it.
Your certification does not change. What changes is what holding it costs you.
- Mandatory checks at the operation
- NCR and disposition trail built in
- Records retained and searchable for years
Benefits
What changes at audit time
The certification itself does not change. What changes is what it costs you to hold it.
Preparation stops consuming weeks
Most manufacturers lose serious time to audit preparation, pulling files and reconstructing histories. Captured data removes nearly all of that work.
Spot checks stop being frightening
When an auditor picks a job at random, the answer either exists or it does not. With capture at the operation, it always exists.
Findings get closed faster
Corrective actions with a tracked trail close cleanly. Actions living in meeting notes tend to reappear as repeat findings.
Certification stops blocking sales
Customers in regulated chains increasingly audit their suppliers directly. Being able to demonstrate control quickly is a commercial advantage, not just a compliance one.
Standards
ISO 9001 and its sector equivalents
If you supply into regulated chains you may need more than the general standard, and the traceability expectations rise sharply.
| What it demands | Standard | |
|---|---|---|
| ISO 9001 | General quality management system, traceability appropriate to risk | The baseline, applicable to any sector |
| AS9100 | ISO 9001 plus aerospace requirements, including unit-level traceability on critical parts | Aerospace and defence |
| ISO 13485 | ISO 9001 structure plus medical device controls, UDI and post-market surveillance | Medical devices |
| IATF 16949 | ISO 9001 plus automotive process controls and supplier requirements | Automotive supply chains |
| Common thread | All four expect evidence produced on request, not on notice | Capture at the operation is what makes that practical |
| Read more | ISO certification explained | Traceability software |
Right for you?
When this becomes worth doing
Usually the trigger is an audit that went badly, or a customer requirement that arrived without notice.
- Audit preparation regularly takes somebody out of their job for a week or more.
- You have had a finding relating to traceability or records.
- A customer has started auditing you directly as well as your certification body.
- You are pursuing AS9100 or ISO 13485 on top of ISO 9001.
- Inspection records exist on paper and are filed rather than analysed.
- You cannot produce the history of a specific job without going to the archive.
DynamxMFG
Evidence as a by-product of production
The manufacturers who find audits painless are not the ones with the best filing. They are the ones whose evidence was captured automatically while the work was being done, because nothing had to be assembled afterwards.
DynamxMFG records material batches, operators, machines, times, inspection results and non-conformances against each works order as it runs. When an auditor picks a job, its full history already exists.
Captured at the operation
Every job carries its own record. See shop floor data capture.
Traceable in seconds
Forward and backward from any batch or unit. See traceability software.
Quality records attached
Checks and NCRs against the job. See quality management.
Integrations
Connects to what you already run
Audit packs end up in emails and portals. DynamxMFG exports to Excel and connects to Outlook and your document tools, so evidence reaches the auditor without a printing session.
See all 33 integrations →
Customers
What manufacturers say about DynamxMFG
“DynamxMFG is an excellent choice for manufacturers looking to digitise operations without being overwhelmed by complexity.”
“As GMC has grown, it had become harder for me to have such a keen view on components to see if those parts were profitable or not. DynamxMFG enabled us to monitor the machine time and see whether we are making a profit or a loss on each component.”
“The ability to dynamically modify BOMs after release, adding or removing items from work orders, scrapping and reworking parts, has been the single biggest improvement for our business.”
“We chose the system over competitors because of its ease of use, strong customer support and friendly delivery team. So far, everything has matched what was promised.”
“With DynamxMFG, all our production processes are tracked and the relevant data is captured. This increases our control over the business and helps us identify more opportunities to enhance efficiency and quality.”
“Our experience has been positive, and it was definitely worth switching. The support we have received has been extremely helpful. My favourite feature is the integration and automation capabilities.”
Questions
ISO 9001 software questions, answered
Will software make us ISO 9001 certified?
No. Certification is awarded on your processes and your evidence of following them. Software reduces the effort of producing that evidence, often dramatically, but it does not replace having the processes.
Does ISO 9001 require traceability?
It requires identification and traceability appropriate to your product and risk. It does not specify batch or serial level. Sector standards such as AS9100 and ISO 13485 are considerably more demanding.
How long should we keep records?
Whatever your documented retention policy says, which must satisfy your sector and your customer contracts. In aerospace and medical devices that can run to decades.
Can auditors ask for records during the audit?
Yes, and typically will, choosing jobs at random. The question is whether you can produce the history while they wait or whether you have to go and look for it.
Do we still need documented procedures?
Yes. Software captures records, not procedures. You still need the documented management system; what changes is the effort of demonstrating you follow it.
What about document control?
Controlling the current revision of drawings and work instructions at the operation is one of the clearest wins, because building to a superseded drawing is both a quality failure and an audit finding.
Related reading
Read next
Background reading on ISO 9001 software from the DynamxMFG glossary and blog.
Make your next audit a short one
Book a 30 minute call and pick a job at random. We will show you what an auditor would see.
