Requirements of the HKZ standard
The HKZ standard asks for two things: a working quality system for your whole organisation, plus safe and traceable care that you can demonstrate around the client. Every HKZ scheme therefore consists of a generic part (equivalent to ISO 9001) and a care-specific part. The standards are managed by NEN .
On this page you can read how an HKZ scheme is structured and what the main requirements are. The goal is not a thick manual, but processes that work in practice. Want to know how to approach this? Then follow the step-by-step plan.
The structure: generic part and care part
Every HKZ scheme has the same two-part structure. This makes the schemes recognisable to one another and helps if you later choose a different scheme.
| Part | What is it about? | Does it differ by sector? |
|---|---|---|
| Care-specific part | The primary process around the client | Yes |
| Generic part | Your organisation as a whole (ISO 9001) | No |
The generic part follows the structure of ISO 9001: context, leadership, planning, support, operation, evaluation and improvement. This part is the same for a pharmacy and a youth care organisation. The care-specific part differs: a pharmacy has different requirements from youth care.
The care-specific part: around the client
This part follows the client’s journey through your organisation. It makes clear what good care means in practice.
Intake and access
You record how a client comes to you. Who assesses whether you can provide the right care? How do you agree on the care?
A care organisation for people with disabilities, for example, describes how it maps the care need and who draws up the support plan.
Delivery and the client file
During care you record what you do. The client file is the evidence that the care is correct and traceable. HKZ requires that this file is up to date and complete.
Safety and incidents
You show how you manage risks for clients and how you report and investigate incidents. Think of an incident reporting system (an MIC report: client incident report) and medication safety.
Completion and evaluation
You describe how you conclude and evaluate care. What did the client gain from the care? What do you learn from it?
Since 2025, a care agreement no longer has to be signed in writing under HKZ 144 VVT (nursing, care and home care) and HKZ 118 Care for people with disabilities . This reduces the administrative burden. Note that funders or supervisors can still ask for it.
The generic part: your organisation
This part is the same as ISO 9001 and covers how you govern your organisation. The main requirements at a glance.
Context and interested parties
You map out what affects your organisation and who your interested parties are. For a care organisation these include clients, family, the care insurer and the IGJ (Dutch Health and Youth Care Inspectorate) . How to set up such an analysis, with an example for a small organisation, is explained in context analysis at HKZ.
Leadership and policy
Management must take the lead. You record your quality policy and make sure responsibilities are clear.
Planning and risks
You set your objectives and the risks you run in pursuing them. Then you decide what you do to control those risks.
People and resources
You make sure your employees are qualified and competent. In care, this also means up-to-date BIG registrations (the Dutch register of individual healthcare professionals) and training at the right level.
Evaluation and improvement
You measure whether your system works through internal audits and a management review. Then you improve where needed. This is the core of the PDCA cycle: plan, do, check, act.
Which documents do you need?
HKZ does not prescribe a manual. You record what is needed to secure your care. A compact example is given in HKZ manual: do you need to write a quality manual?. In practice this means:
- a description of your main processes,
- an up-to-date client file for each client,
- a system for reporting incidents,
- evidence of internal audits and the management review,
- records of training and competences.
Many care organisations think HKZ requires a mountain of paperwork. That is not the case. The auditor checks whether it works in practice, not whether you have a thick manual. Keep it concrete and useful.