Guide 3.2 provides the control layer that turns policy and context into an actively managed QMS. These are the templates that usually determine whether the system behaves like a real management system or just a collection of static procedures.
The PDF explains how each record should be completed, reviewed, and retained. The Excel workbook provides the live templates for daily use, management review input, and audit evidence generation.
Included Templates
| Template | Primary Clause Coverage | Operational Role |
|---|---|---|
| Risk and Opportunity Register | Clause 6.1 | Translates context analysis into managed risk and tracked opportunity action. |
| Quality Objectives Tracker | Clause 6.2 | Turns policy commitments into measured targets, owners, timelines, and performance review. |
| Competence Matrix | Clause 7.2 | Defines required competence by role and highlights skill gaps before they become process failures. |
| Training Record | Clauses 7.2 and 7.3 | Maintains the evidence chain between training delivery, awareness, and competence verification. |
| Calibration Equipment Register and Log | Clause 7.1.5 | Maintains measurement integrity and traceability across monitoring and measuring resources. |
| Document Control Register | Clause 7.5 | Acts as the master inventory of controlled QMS documents and revision status. |
What This Set Is For
Planning Function
This set supports quality planning, risk governance, objective deployment, and ownership discipline. It is where leadership commitments become monitored obligations with names, dates, and evidence.
Control Function
This set also supports the support layer of the QMS: competence, training, measurement validity, and controlled documented information. Those controls determine whether operational records can be trusted later.
Recommended Deployment Sequence
Start with Planning
- Build the risk and opportunity register.
- Define quality objectives and assign performance owners.
- Align competence requirements to those objectives and key processes.
Then Lock Controls
- Deploy the training record and competence review cadence.
- Stabilize calibration control for all measuring resources.
- Use the document control register as the authoritative source of current QMS documents.
What Auditors Typically Test
| Record | Typical Audit Question | Evidence of Strength |
|---|---|---|
| Risk Register | Are risks specific, owned, scored, acted on, and re-evaluated? | Clear link from risk description to action, owner, target date, and effectiveness review. |
| Objectives Tracker | Are objectives measured, reviewed, and tied to the quality policy? | Regular data updates, trend review, and visible management action for off-target metrics. |
| Competence and Training | Can the organization show who must know what and how competence is verified? | Role-based mapping, completed records, and evidence that training is not treated as attendance alone. |
| Calibration | Are measurement resources identified, traceable, and controlled against overdue status? | Current equipment register, completed calibration records, and disposition for out-of-tolerance results. |
| Document Control Register | Can the organization reconstruct which documents were current and who approved them? | Master-list discipline, revision history, and alignment with point-of-use documents. |
Common Mistakes This Set Helps Prevent
- Generic risk lists with no ownership or action dates.
- Quality objectives tracked annually when the process needs monthly visibility.
- Training records that prove attendance but not competence.
- Calibration systems that do not show historical traceability or overdue control.
- Master lists that disagree with documents in use on the floor.
Related ISO 9001 Template Guides
Previous Template Set
Guide 3.1: Foundation Templates provides the Clause 4 and 5 document base these planning and control records depend on.
Next Template Set
Guide 3.3: Operational & Improvement Templates extends the template library into audits, NCRs, CAPA, management review, supplier evaluation, customer surveys, control plans, and process mapping.