ISO, HACCP and GDP documentation services
Develop and update ISO, HACCP and GDP documentation around your actual processes. Practical procedures, work instructions and records for your team.
Request an initial assessment
Develop and update ISO, HACCP and GDP documentation around your actual processes. Practical procedures, work instructions and records for your team.
Request an initial assessment
ISO, HACCP and GDP documentation should describe how your company actually works and provide evidence that the relevant controls are working. ConsultHQ creates, adapts and updates procedures, records and other controlled documents according to current ISO, EU and Montenegrin requirements, without unnecessary duplication of existing documentation.
The company rarely runs out of paper.
A more common problem is that existing documents no longer fit the process, employees use several different versions, or forms ask for data that no one uses later.
Such documentation increases administration, but does not increase control.
Our approach is reversed: first we understand the process, then we document what the company really needs.
ISO, HACCP and GDP systems have different requirements.
The companies that apply them also differ.
A small service company with an ISO 9001 system does not need the same volume of documentation as a production plant. A restaurant does not need HACCP documentation from an industrial food producer, while GDP wholesale has a completely different regulatory level of control.
That is why the project does not start with a number of procedures.
It starts with asking what processes you have, what you already use, and what claim needs to be proven.
Only after that we define the necessary documentation system.
Companies often already have a good part of the system in place.
There may be work instructions, forms, production records, ERP or WMS records, internal policies and other documents that already provide the necessary control.
We do not change them just because they were not created in the ISO project.
First we check:
We keep what works.
This reduces the cost of implementation and employee resistance.
Modern ISO systems use the concept documented information.
Documented information can exist in different formats and on different media. The ISO framework for management system standards does not assume that each control must be a separate paper procedure. ISO standards for records management also acknowledge that controlled information can exist in a variety of formats and sources.
That is why an ISO project should not automatically produce dozens of new documents.
If the company already uses a functional digital system, we can include the existing information in the control system.
We document what is needed to operate consistently and demonstrate compliance.
Companies that are just introducing a quality system should develop documentation according to the current ISO 9001:2026.
With existing ISO 9001:2015 systems, not every document needs to be changed automatically.
First, a transition gap analysis is done.
If the existing procedure still supports the process and fulfills the relevant requirement, it can remain in the system.
We're changing what's affected by the new release or what's no longer relevant to the business in the meantime.
Thus, the transition does not become an unnecessary rewrite of the entire system.
Where the environmental liability framework applies, ISO 14001 documentation links incident scenarios to preventive measures, response procedures and records of action taken. We check whether existing procedures can demonstrate early response, notification and, if damage occurs, monitoring of remediation under the Law on Liability for Environmental Damage as amended in 114/2026.
For relevant organizations, ISO 14001 documentation includes a chemical inventory, current safety data sheets (SDS), storage procedures and related operational controls. We review these against the Law on Chemicals 114/2026 and, where applicable, Rulebook 136/2026 on classification and labelling and Rulebook 137/2026 on hazardous-chemical storage.
Dates of entry into force: Rulebook 136/2026 — 26 September 2026; Rulebook 137/2026 — 29 September 2026.
In ISO 14001, documentation should link environmental aspects, compliance obligations, objectives and operational controls.
The current ISO 14001:2026 retains the basic system of the previous edition, with added clarity and a stronger connection to climate change, resources, biodiversity and the wider context of the organization.
That is why we do not build the documentation system from a generic register of aspects.
First, we review the activity, locations and processes.
The documentation then tracks the company's relevant risks.
For ISO 14001 clients affected by the Waste Management Law as amended by 128/2026, we organise records of waste types and quantities, evidence of transfer to authorised operators, packaging and EPR data where applicable, and the process for reviewing a plan after a significant change. Food-contact specifications and packaging-waste records remain related but separate sets of documents.
Only for clients covered by the GHG rules in the Climate Change Law 149/2025 and 70/2026 and Regulation 116/2026 do we connect ISO 14001 documentation with an approved monitoring plan, emissions-data sources, records, responsibilities and report preparation. EMS documents support the legal process but do not replace a permit or formal verification.
For industrial clients with applicable EIA conditions, ISO 14001 documentation should connect the relevant decisions and approvals to operational controls, responsibilities, monitoring and records. The formal assessment study and other project documents remain part of the separate statutory process; EMS documents help put conditions into practice.
For covered industrial installations, the ISO 14001 compliance register should include the integrated permit under Regulation 75/2026, its conditions, applicable BAT conclusions, emissions monitoring and responsibility for records. Management system documents support compliance with the permit but do not replace it. See our guide to integrated permits for industrial installations.
For plants covered by Air Protection Law 117/2026 and Correction 120/2026, ISO 14001 documents should connect source and modification registers, emissions permits or another applicable regime, measurement reports, fuel records, emission-control equipment and reporting deadlines. See the Air Protection Law guide.
For innovative food development, documents should connect raw-material approval, supplier specifications, the status check under Regulation 126/2026 and List 127/2026, conditions of use and the label. This applies where a novel-food question actually arises. See our novel-food guide.
For fortified food, product-development records connect premix specifications, new raw-material approval, the chemical-form check under Regulation 47/2026, the recipe and the label. This applies where vitamins or minerals are deliberately added. See our guide to vitamins and minerals.
A review against the Food Hygiene Regulation (91/2026) goes beyond the HACCP plan. It also covers related hygiene procedures, allergen management, training, management responsibilities and records showing that controls are applied in practice.
Updating HACCP documentation includes a review against the Law on Food Safety (59/2026), the Law on Official Controls (72/2026) and the Food Hygiene Regulation (91/2026), along with other rules applicable to the product and facility. We align procedures and records with actual processes and current hygiene requirements.
Therefore, HACCP documentation should not be a copy of the system of another restaurant, hotel or manufacturer.
May include:
The exact scope depends on the activity.
The document exists because it controls the process or provides evidence, not because the HACCP folder looks more voluminous.
Where quick-frozen food is stored or transported, documentation includes controlled temperature records, identification of instruments and areas, responsibility for data review and a procedure for deviations. Records should allow conditions affecting the goods to be reconstructed without duplicating reliable digital data.
For products containing additives, documentation links approved recipes, additive specifications and technical sheets, the regulatory check of conditions of use, production records and labels. Formulation or supplier changes are recorded through change control so the version applying to a particular batch can be identified.
For food production, we organise packaging specifications, supplier documentation, declarations of compliance where required and traceability of relevant food-contact materials. Records should link the approved material and its intended use to the production batch without duplicating existing ERP or QMS data.
For manufacturers, we link lot and traceability records to production orders, raw materials, relevant microbiological test results and release or recall decisions. The record set follows the product and the applicable 58/2026 rulebooks without duplicating data unnecessarily.
The valid Montenegrin system of official controls enables verification of documentation, records and actual application of procedures throughout the food chain.
Therefore, subsequent filling of the tables does not solve the problem.
Records should be created as part of actual control.
At the same time, too many forms increase the risk that employees keep documentation formally.
That's why we check every important record during the project.
If the data does not have a clear purpose or already exists in a trusted system, we consider whether it really needs to be repeated.
GDP documentation includes current CInMED forms for authorisations and certificates, the standard post-inspection CAPA plan, a workable emergency recall plan and distribution records accessible for five years. Regulatory change control checks whether changes to premises, organisation or contracted transport also require an amendment to the wholesale authorisation under the Law on Medicines (Official Gazette Nos. 14/26 and 94/26).
The GDP system of drug wholesale has a special regulatory context.
On July 22, 2026, CInMED published the current Good Practice Guidelines in the distribution of medicines for human use, and during August additional EU-harmonized procedures and standardized inspection documents.
At GDP, the documentation can include:
Here, document control is of particular importance.
Outdated SOP procedure in the operation can directly lead to GDP deviation.
A long procedure is not automatically a good procedure.
A document that an employee has to read for ten minutes to find one piece of operational information will often not work under real workloads.
That's why we adapt the content to the user of the document.
A policy or system procedure may be broader.
The work instructions should be more specific.
The form should only ask for information that has a purpose.
Thus, the documentation system is built in layers instead of each document trying to explain the entire organization.
Changing the procedure has no value if the old version remains in use.
So we edit the way:
The system doesn't have to be complicated.
It must give a clear answer as to which version is currently valid.
For companies that use digital DMS, ERP or other systems, we first review the existing capabilities before introducing additional records.
ISO systems do not require documentation to be paper-based.
Modern systems can use controlled electronic information, databases and digital workflows.
ISO 15801:2026 additionally regulates the reliability and credibility of electronically stored information and the systems that preserve it over time.
This does not mean that every company needs new document management software.
For a smaller company, a simpler controlled system may be completely sufficient.
A larger organization may have reason to digitize documents, approvals and records.
We choose the solution according to the scope and risk.
Each form should have an owner and a purpose.
If no one reviews the data from the records, you should check why they are being kept.
With the ISO system, data can be used for KPI, audit or process proof.
With HACCP, it can demonstrate relevant food control.
With GDP, it can enable the reconstruction of events or decisions that affect the quality of the medicine.
Such an approach reduces "administration for the sake of administration".
An employee accepts documentation more easily when he understands why the information is created.
A procedure without an owner quickly becomes obsolete.
That's why we define for relevant documents who uses them, who monitors their application and who initiates changes when the process changes.
The same person does not have to be responsible for everything.
Quality can manage the system while the operations function remains the owner of its process.
This division is especially important in larger companies.
The quality department should not independently write the process that the operative knows best.
New equipment, product, supplier, transporter or way of working can make an existing procedure obsolete.
That is why we connect the documentation system with the change management process where it is relevant.
With HACCP, a change in product or process may require a new hazard assessment.
At GDP, a change of warehouse, WMS or conveyor can affect several SOP procedures.
In the ISO system, a new organizational structure can change responsibilities.
Documents need to change because the process has changed.
Not because the deadline for the annual "rewriting" has arrived.
An audit finding does not automatically mean that a new procedure should be made.
The problem may be in training, equipment, responsibility or application of an existing document.
That's why we first determine the cause.
If the document is really unclear or lacks control, we change it.
If the procedure is good, but the employee does not know it, a better measure may be training.
This prevents each audit from increasing the number of documents without actually improving the system.
We can adjust the engagement to the existing state of the system.
May include:
Not every project needs to include all of the above.
The initial review determines what the company really needs.
The result of the project is not just a folder of new files.
The client receives a documentation system that employees can use and maintain.
Depending on the scope, this includes:
It is more important than the total number of procedures.
A well-documented system can have fewer documents and better control at the same time.
The biggest problem with the generic system becomes visible after the consultant leaves.
The company receives a large number of procedures, but no one knows who maintains them.
After a few months, the practice changes, but the documents remain the same.
Such a system quickly loses its value.
That's why we include maintenance logic in the project.
The responsible employee should know when the document needs to be reviewed, who approves the change and how the new version is introduced.
Not every project is a complete implementation.
A company may have a good ISO system but poor documentation control.
A restaurant may have a functional HACCP, but too many forms.
GDP Wholesale may need to update several related SOP procedures after the inspection due to the CAPA plan.
In these cases, engagement can remain purposefully limited.
We do not insist on building a complete system if there is no real reason for it.
The best documentation project often begins by deleting the unnecessary.
First we review the existing structure and actual processes.
Then we divide the documents into those that can stay, those that need to be updated and those that no longer serve a purpose.
Only after that we create what is missing.
ConsultHQ thus helps the company to obtain a documentation system that corresponds to current ISO, HACCP or GDP requirements, but remains simple enough for employees to use on a daily basis.
An initial assessment helps us define scope and next steps based on your actual business.
Request an initial assessment