What We Do

Management Systems Consulting

ISO 13485, ISO 9001, GDP, and AKAZ-based quality systems — built to fit how your organization actually operates, not just to pass an audit.

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Gloved hand pipetting a sample into a lab test-tube rack, representing quality management systems work

Who We Help

Built around how your organization actually works

QualityCert structures management systems consulting by organization type, because a manufacturer, a distributor, and a pharmacy carry very different regulatory obligations.

Device Manufacturers

Quality management system per EN ISO 13485:2016

The foundation for regulatory and operational management of medical devices.

For medical device manufacturers, a quality management system built to EN ISO 13485:2016 is the foundation for consistent planning, development, production, control, and post-market activities. A well-established QMS ties regulatory requirements, risks, responsibilities, and documented processes together into a single operational framework.

When the system is properly implemented and integrated into day-to-day operations, the organization gains greater traceability, more stable processes, and more reliable preparation for certification, conformity assessment, and market placement.

Our scope of support

Gap analysis of the current state and a QMS implementation plan
Defining processes, responsibilities, records, and documented information
Establishing CAPA, change management, and nonconformity handling

Key activities

Employee training and aligning operational practice with the standard's requirements
Support for internal audits and certification-audit preparation
Strengthening risk control, traceability, and supplier management

Business & regulatory outcome

A functional quality management system tailored to the medical device manufacturer
Better control over development, production, documentation, and records
Higher readiness for regulatory checks, certification, and further business growth

Wholesalers & Distributors

Building a quality management system per ISO 9001:2015 and ISO 13485:2016

Process discipline, traceability, and regulatory control in medical device distribution.

For wholesalers and distributors of medical devices, ISO 9001:2015 establishes a clear framework for process management, customer satisfaction, and continual improvement, while ISO 13485:2016 adds regulatory discipline and control over medical devices in circulation.

By integrating both standards, the organization gains a functional quality management system that supports traceability and control over procurement, storage, transport, complaints, recalls, and vigilance.

What we build

Mapping and standardizing key business processes
Documentation, responsibilities, records, and control criteria
A risk-based approach aligned with regulatory expectations

Where we help

Employee training and practical implementation of the standards' requirements
Aligning operational processes with distributor-specific realities
Preparation for audits, certification, and ongoing system maintenance

Benefit to the organization

Clearer, more stable, more measurable working processes
Better control over service quality and product integrity in circulation
Greater readiness for customers, regulators, and business growth

Pharmacies

Safety & quality system per AKAZ standards for pharmacies

A documented, safe, and sustainable system of work in pharmacy practice.

Pharmacies in the Federation of BiH are required to establish a safety and quality system in line with AKAZ standards. Practical implementation means clearly defined processes, documentation, working environment, responsibilities, records, and self-assessment mechanisms.

QualityCert provides technical and organizational support in preparing documentation, running workshops, gathering evidence, conducting self-assessment, and preparing for external assessment. After the system is established, we also support its ongoing maintenance, periodic checks, and targeted reviews.

What the service covers

Preparing and adapting the required system documentation
Workshops and hands-on support gathering records and evidence
Conducting the final self-assessment and preparing results for submission

Maintaining the system

Support for annual practice reviews and internal audits
Periodic review of procedures, policies, instructions, and other documents
Updating the system after changes in services or work organization

Value for the pharmacy

A more orderly, safer system of work for staff, patients, and other users
Greater process visibility and better readiness for external assessment
A sustainable model for continuous quality and safety maintenance

All Organization Types

Internal audits & compliance review

Independent verification of compliance, system effectiveness, and the real state of processes.

An internal audit is a key mechanism for verifying process compliance, system effectiveness, and readiness for external oversight. When the audit is carried out by an independent external auditor, management gets a more objective view of the real state of processes, risks, and improvement priorities.

QualityCert conducts internal audits against ISO 9001, ISO 13485, and ISO 19011 guidelines, with evidence-based reporting and practical recommendations for further action.

Audit focus

Verifying process compliance with standard and regulatory requirements
Assessing the effectiveness of the established quality management system
Identifying weak points, risks, and areas for improvement

How we work

Planning the audit by process priority and risk
Independent, evidence-based verification and interviews
A clear report with findings, conclusions, and recommended actions

Value for management

A more objective view of system performance and process quality
A stronger basis for corrective action and management review
Better preparation for customers, regulatory checks, and certification audits

Success Story

Management systems consulting in practice

Sample project profile shown below — illustrative until a real, client-approved case study is published for this service.

[Sample] Device Manufacturer

ISO 13485 implementation ahead of a certification audit

Challenge — a growing device manufacturer needed a certifiable ISO 13485 QMS in place before an upcoming Notified Body audit, without disrupting active production.

Approach — QualityCert ran a gap analysis, built the implementation plan, defined processes and documented information, and trained staff on CAPA and change management alongside daily operations.

Outcome — a functioning QMS integrated into daily practice, with stronger traceability and supplier control, ready for certification.

Ready to build a system that works for your organization?

Tell us about your organization type and where you are today — we'll recommend the right starting point.

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