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Why the process approach matters
ISO 9001 clause 4.4 requires you to determine the processes needed for the quality management system – with inputs, outputs, sequence, interactions, criteria, resources, responsibilities, risks and opportunities. Auditors no longer check clause by clause; they follow processes: how does an order run from enquiry to delivery, and which requirements apply at each step?
Many companies have a process map as a drawing – separate from the documents that govern the processes. When a process changes, drawing and documents no longer match. docxpert connects both: every process knows its documents, and every document knows its process.
What process management in docxpert does
How to build your process landscape
- 1
Collect processes
Start with ten to twenty processes, grouped into management, core and support processes. More detail rarely helps at the start.
- 2
Assign owners
Each process gets an owner who keeps an eye on its objectives, metrics and documents.
- 3
Map clauses
Assign the main clauses to each process. Later you see which requirements are met by which process.
- 4
Link documents
Connect existing documents to processes. Processes without documents are candidates for a gap – or deliberately need no instruction.
- 5
Describe interactions
Record which outputs a process delivers to others. The process map from the template library brings this view together in one controlled document.
Example of a lean process landscape
| Process type | Examples | Typical ISO 9001 clauses |
|---|---|---|
| Management processes | Strategy and objectives, management review, internal audits | 5, 6, 9.2, 9.3 |
| Core processes | Sales and order review, design, purchasing, production, shipping | 8.2, 8.3, 8.4, 8.5, 8.6 |
| Support processes | HR and training, infrastructure and maintenance, document control, IT | 7.1, 7.2, 7.5 |
| Improvement | Complaints, deviations, corrective action | 8.7, 10.2 |
What belongs in a good process profile
A process profile answers the questions ISO 9001 clause 4.4 asks on a single page. It is the ideal complement to the process description in docxpert and can be linked to the process as a controlled document:
- Purpose and output: why does the process exist, and what does it deliver to whom?
- Triggers and inputs: what starts the process, and what information and materials does it need?
- Main steps: five to ten steps; details are in the linked instructions.
- Responsibilities: process owner and roles involved.
- Metrics and objectives: for example lead time, defect rate or on-time delivery, with target values.
- Risks and opportunities: the main risks with actions.
- Interfaces: upstream and downstream processes.
Audit processes instead of ticking off clauses
With a clear process landscape you plan internal audits along processes. The auditor uses the process profile and the linked documents as the reference, follows a real case – such as a customer order – and checks the evidence at each step. Findings are recorded as a CAPA and assigned to the process. Over time you see which processes run smoothly and where problems keep recurring. More in our guide to the internal audit.
Standards reference
| Standard | Requirement | Implementation |
|---|---|---|
| ISO 9001:2015, 4.4 | Determine processes with inputs, outputs, responsibilities and documented information | Processes with clause, owner and linked documents |
| ISO 9001:2015, 5.3 | Assign responsibilities and authorities | Process owner per process |
| ISO 13485:2016, 4.1.2 | Determine processes and control them using a risk-based approach | Process description linked to risk and document control |
| ISO 14001 / 45001, 4.4 | Management system with processes and interactions | Shared process landscape in an integrated management system |
What process management deliberately is not
docxpert is not a graphical BPMN modelling tool. The focus is on connecting processes with owners, standard requirements and controlled documents. You can maintain flowcharts as part of a document. For most SMEs, this combination of description, ownership and document links is exactly what the management system needs – without modelling training.
Frequently asked questions
Who should be the process owner?
Someone with subject matter expertise and decision-making authority for the process – usually a manager from the area that performs most of it.
How many processes should an SME describe?
Ten to twenty processes are usually enough. More important than the number is that owners, outputs and related documents are clear.
Do I need a graphical process map?
The standard does not require a drawing, but an overview of processes and interactions helps in the audit. The “process map and interactions” template covers this as a controlled document.
Can a document belong to several processes?
Yes. A document such as the document control procedure can be linked to several processes.
How are processes and audits connected?
Internal audits are often planned by process. The linked documents are the requirements audited against.
Does docxpert support BPMN?
No, BPMN modelling is not included. docxpert focuses on process description, ownership and links to documents and standard requirements.
Can I start from a template?
The process map and interactions template provides a structure with typical management, core and support processes that you adapt.