What the standard expects, in plain language.
ISO 9001 refers to the information you decide you need as documented information. Clause 7.5 covers creating and updating it, and clause 7.5.3 covers controlling it: it should be available and suitable for use where and when needed, adequately protected, and handled with attention to distribution, access, retrieval and use, storage, control of changes, and retention and disposition. Documented information of external origin that you need for the system should be identified and controlled as appropriate.
Competence is covered in clause 7.2: determine the competence needed for work that affects quality performance, make sure people have it on the basis of education, training or experience, take action where they do not and evaluate whether the action worked, and keep records as evidence. Clause 7.3 covers awareness. This is a plain-language summary, not the standard text; read the current standard for exact wording.
A lean system still needs control.
Smaller plants often keep few procedures and rely on work instructions, inspection sheets and forms. That can be a strength. The audit risk is the same, though: a work instruction that exists in three versions, a form with no owner, or a procedure revised without anyone knowing who agreed. The fewer documents you keep, the more each one will be looked at.
What auditors tend to ask for: documents.
In an ISO 9001 audit, expect questions like these about the documents at the point of use:
- Which revision is current, and how do you know this one is it?
- Who reviewed and approved the last change?
- How do you prevent use of obsolete versions?
- How do you control documents that come from customers or standards bodies?
- Who can edit this, and how is that restricted?
- How do you retain records, and for how long?
What auditors tend to ask for: training records.
For competence, auditors tend to sample a person or a role:
- How did you decide what this role must know?
- What did this person complete before doing the work?
- How did you check that they understood or can do it?
- What happens when a procedure changes?
- Where is the record?
Where STRATUM helps.
STRATUM Document Control gives you a controlled library with revision history, a submission and approval workflow with a change summary, and private storage inside your company workspace. Approval includes department manager, document control and quality manager review stages. Locations and role-based permissions help you decide who can see and change documents.
STRATUM Training lets you create courses, assign them with due dates, use quizzes and sign-off requirements, and keep completion records. Training tracks and job-title matrix rules help organize learning by role. Together they give you records you can return to when you are asked the questions above.
What stays with you.
ISO 9001 puts the judgment with you, and software does not change that. You still decide which documents are needed, who approves them, how printed copies are handled, which tasks need practical authorization beyond a course, how training effectiveness is evaluated, and how long records are kept. A quiz or completion record shows that something was assigned and completed; it does not by itself show competence.
A sensible way to start.
Pick the ten or so documents operators use every day and the one job title with the most turnover. Put the approved documents in the library, run one revision through approval, assign a short course to the role, and then try to answer the audit questions from the records. Choose Document Control, Training or the Compliance bundle based on which problem is hurting most.
Document control checklist for manufacturersHow to build a manufacturing training matrixSee plans and pricing
Want an experienced outside view?
STRATUM is built by CauseLogic, which performs internal audits for automotive suppliers, including plants certified to ISO 9001 only. The audit services are separate from the software.
ISO 9001 internal audits (CauseLogic)Customer audit readiness (CauseLogic)
Frequently asked questions
Is STRATUM only for IATF 16949 plants?
No. The document and training workflows are general: controlled revisions and approvals, assigned learning and completion records. They suit plants certified to ISO 9001 only as well.
Does STRATUM make a plant ISO 9001 compliant?
No. Certification applies to an organization’s management system and is granted by a certification body. STRATUM helps you manage controlled documents and training records; your procedures and review practices still determine what evidence you need.
My automotive customer sends its own requirements. Does that matter?
Yes. Customers often add requirements through contracts, supplier manuals and audits. Read what applies to you; you decide how those requirements are controlled in your system.
Can I buy STRATUM today?
Paid subscriptions are not open yet. You can explore the interactive preview and begin account setup. ERP, MRP, Production and broader quality tools remain under development.