Solution · ISO 9001 for SMEs

ISO 9001 as part of daily work

For manufacturing and service SMEs: vemix controls your quality manual and process descriptions, records training and competence, handles deviations and corrective actions, organises internal audits and management review. CRM, projects and time tracking run in the same suite.

  • Documented information controlled
  • Training and competence on record
  • Nonconformity and CAPA
  • Internal audits and management review
  • Compliance matrix per clause
The challenge

Why ISO 9001 often only comes alive for the audit

  • Quality manual in a file share

    Process descriptions are scattered across drives, revision status is unclear, and everything gets patched up right before the surveillance audit.

  • Training records in spreadsheets

    Who has been briefed on which process? The answer sits in lists nobody likes to update.

  • Actions without follow-through

    Complaints, audit findings and improvements are recorded, but rarely does anyone check whether they worked.

Quality management

ISO 9001 requirements mapped in the system

The ISO 9001 standard package ships with preconfigured document types, workflows and templates. The compliance matrix maps every clause to its evidence in vemix, so in the audit you can point to the right record for each requirement.

  • Documented information (7.5)

    Quality manual, process descriptions and work instructions with revisions, approval workflow and periodic review. The library always shows the current version, with full-text search.

  • Competence and training (7.2)

    Training assignments, knowledge tests and effectiveness checks. Qualification matrix, a training file per person and a "My team" view for managers.

  • Nonconformity and CAPA (10.2)

    Deviations with root cause analysis and linked CAPA with actions, deadlines, escalation and effectiveness checks. Recurrences within the last 12 months are detected.

  • Internal audits (9.2)

    Audit management for internal and external audits. Turn findings straight into CAPA with owners and due dates.

  • Management review (9.3)

    Run the management review as a record of its own in vemix. The QM cockpit supplies the metrics, with export for your files.

  • Supplier evaluation (8.4)

    Evaluate external providers in vemix. The QM tab on the CRM company brings together the QM records for that partner.

How the modules work together

  1. 01
    Adopt the standard package
    Start with document types, workflows and templates from the ISO 9001 standard package and bring over your quality manual, in the web editor or as Word files.
  2. 02
    Connect customers and suppliers
    Complaints and supplier evaluations attach to companies in the CRM. You maintain contacts once, for sales and QM.
  3. 03
    Get actions done day to day
    QM tasks land in the central vemix task inbox, with deadlines, reminders and escalation to managers.
  4. 04
    Go into the audit with evidence
    The compliance matrix shows the evidence for every clause. Auditors can get time-limited read-only access on request.
Standards

Designed for ISO 9001, extendable to ISO 27001

The ISO 9001 standard package maps the clauses of the standard to the evidence in the system. If you also run an information security management system, the ISO 27001 standard package lets you keep the statement of applicability (SoA) in vemix too. Your certification body carries out the certification audit of your management system as usual.

  • Clause 7.2Competence: training, effectiveness, qualification matrix
  • Clause 7.5Documented information: control, approval, revisions
  • Clause 8.4Externally provided processes: supplier evaluation
  • Clause 9.2Internal audit: findings and CAPA
  • Clause 9.3Management review: review with metrics
  • Clause 10.2Nonconformity and corrective action: deviation and CAPA
  • ISO 27001Statement of applicability (SoA), optional
FAQ

Frequently asked questions

Can we bring over our existing quality manual?
Yes. Keep working with existing Word, Excel or PowerPoint documents file-based, with check-out/check-in and editing straight from your file explorer via the WebDAV drive. Alternatively, move content into the structured web editor with templates and mandatory sections.
Is this too much for a mid-sized company?
You use what you need. The ISO 9001 standard package provides document types and workflows that you adapt to your size. You do not have to use features for heavily regulated industries, such as the electronic batch record.
How does vemix help with internal audits?
Plan internal audits as records of their own, document findings and turn them straight into CAPA with owners and deadlines. The compliance matrix shows the matching evidence in the system for every clause of the standard.
What do I gain from the link to CRM, projects and time tracking?
You maintain customers and suppliers once in the CRM; the QM tab on the company brings together the related QM records. QM tasks appear in the same task inbox as all other vemix tasks. You sign in once and work on the same data.
Can we cover ISO 27001 as well?
Yes. With the ISO 27001 standard package, you keep the statement of applicability (SoA) and related documents in the same system, with the same document control, training and audit trail.

Quality management sized to your company

See in a live demo how vemix connects document control, training, CAPA and audits with CRM, projects and time tracking in one suite.