Quality managementReading time 12 min
ISO 9001 Records: Show the Work You Did
A process may be well run, but an audit still needs traceable evidence. Identify which records prove the work, who owns them and how to retrieve the right revision when it matters.
01Documents and records
| Documented information, maintained | Documented information, retained | |
|---|---|---|
| Commonly called | Documents | Records |
| Nature | States how the work should be done | Proves the work was done |
| Revised? | Yes, needs revision control | No, only added to |
| Examples | Procedures, work instructions, drawings | Inspection records, training sign-in sheets, audit reports |
02Records required by ISO 9001
- Calibration and verification records for monitoring and measuring equipment (7.1.5.2)
- Evidence of personnel competence (7.2)
- Results of the review of product and service requirements (8.2.3.2)
- Design and development inputs, controls, outputs and changes (8.3)
- Evaluation, selection and performance monitoring of external providers (8.4.1)
- Evidence of product release and the person authorizing it (8.6)
- Disposition of nonconforming output, including concession records (8.7.2)
- Monitoring and measurement results, internal audits, management review (9.x)
- The nature and results of nonconformities and corrective actions (10.2.2)
03Additional IATF 16949 records
| Topic | Additional IATF requirement |
|---|---|
| Product safety | A documented process is required, covering special controls and authorization of personnel for safety parts |
| Control plan | Required for prototype, pre-launch and production, and consistent with the PFMEA and work instructions |
| MSA | All measurement systems require a measurement systems analysis (GRR and so on) |
| SPC | Special characteristics require capability studies and ongoing monitoring |
| PPAP | New and changed parts require submission and customer approval |
| Embedded software | A software development capability self-assessment is required |
| Record retention | Production part records are kept for the length of production plus one year, plus one calendar year |
| Plant layout | Must be evaluated for material flow, space utilization and synchronous flow |
| Layout inspection | Performed at the customer-specified frequency, with records retained |
In automotive work, APQP, FMEA, MSA, SPC and PPAP form a connected set of planning and evidence tools. An auditor will compare documents such as the PFMEA, control plan and work instructions. If a special characteristic appears in one but not the others, the gap needs an explanation.
04Common audit findings
| Finding | Root cause |
|---|---|
| Control plan and work instruction disagree | One got updated and the other did not |
| Gauge past its calibration date still in use | No mechanism reminds anyone the date is coming |
| Corrective action never verified for effectiveness | Someone wrote a countermeasure and closed the case |
| A change made without going through change control | Someone on the floor "just tweaked it" |
| Drawing revision on the floor differs from the system | No process for pulling back paper drawings |
| Training with no evaluation of effectiveness | Only a sign-in sheet exists |
| Supplier evaluations done for form's sake | Last year's copied over each year |
05Making records usable
- Do not build a second set of documents for the auditor. Take the forms people genuinely use and add the signature, date and revision.
- Get revision control right on drawings first. It is the item that goes wrong most and costs the most.
- Move records off paper. Paper's real problem is not storage, it is that nobody can find anything.
- Consistency before completeness. Three documents that contradict each other is a far worse finding than one missing document.