Auditing

Our certified teams will help you establish a QMS and guide you through audits

The production of healthcare must be consistent and strictly regulated to rise up to both local and global standards.

With the help of our experts, you can be sure that the quality management system is fully implemented on your services and products. Our certified teams of ISO 9001:2015 Lead Auditors are trained, certified and experienced in: Pharmacovigilance audits Internal audits External audits Preparation for accreditation and certification in healthcare on both the national and international level. We can help you implement the quality management system (QMS) in the context of your organization or your company, related to the specific services, products and processes.

What can we do for you

Understanding the principles, procedures and methods of auditing, we can:

  • Guide you through the process of designing and conducting your internal audit
  • Help you prepare for the audit performed by a third party
  • Assist you through the whole process of international certification and accreditation in healthcare, in English, Croatian, and other languages. Your team may need a lot of extra time in understanding the application of the regulations and the

preparation and conduct of an effective audit while your business goals do not allow for any waste of hours, days, weeks and often even months. We can help you with:

  • Education and motivation of staff
  • Paperwork
  • Organization and conduct of both internal and external audits in the context of the auditee’s organizational situation

Organizing and directing the audit

Planning and communication of the processes and goals to both the internal and external audience is a challenge, just as the interpretation of the results in the context of continuous improvement. We can help you organize and direct the audit and prepare the  audit report.

Competent QMS teams are important

By reading this text you already confirm that you interpret QMS as much more than just a simple control of consistency in your  operational activities. We share your attitude and will gladly partner with you in raising the competence and confidence of internal auditors, as well as in establishing and conducting the certification and/or
accreditation processes in your organization. A competent QMS team should have a positive impact on the QMS in a relatively short period of time, upgrading it from the compliance only issues to an output of predominately improvement opportunities.

Our services

Our qualified Lead Auditors are ready to help you with audit services of the pharmacovigilance system, and more. Within the services of Audit we offer:

  • External audits of your PV system
  • Education and coaching of internal auditors
  • Assisting in the documentation preparation
  • Audits in the field of medical devices – preparation for CE and ISO 13485 audit
  • Pre-inspection audits to make sure your system is fully compliant with the latest regulatory requirements
  • Assistance during the inspection processes, development of CA/PA, dealing with critical findings
  • Quality risk assessment Audit simulation
If you want to meet every requirement of quality management, we invite you to

Contact us

Headquarters

Lašćinska cesta 40
HR-10000 Zagreb
Croatia

Office

Planinska ulica 13/2
HR-10000 Zagreb
Croatia

Office: +385 1 2420 872
Pharmacovigilance: +385 1 5588 297
Registration: +385 1 242 0873
Marketing: +385 1 2420 890
Fax: +385 1 2420 860
info@martifarm.com

Pharmacovigilance

farmakovigilancija@martifarm.com
Tel: +385 1 5588 297

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Legal info

Full company name
Short company name
Headquarters
Office
Legal form
Court register
Registration number

Marti Farm Ltd. Trade and Services
Marti Farm Ltd.
Lašćinska cesta 40, HR-10000 Zagreb
Planinska ulica 13/2, HR-10000 Zagreb
a limited liability company
Commercial Court of Zagreb
080751121

 

OIB
Share capital
Authorized representative

29969122438
HRK 20,000.00 (paid in its entirety)
Martina Diminić Smetiško, director of the
company (Representing the company
individually and independently, Responsible
person for data protection)

 

Bank account

HR3623600001102197724 (Zagrebačka banka)
HR4324020061100628669 (Erste banka)

 

Full company name: Marti Farm Ltd. Trade and Services
Short company name: Marti Farm Ltd.
Headquarters: Lašćinska cesta 40, HR-10000 Zagreb
Office: Planinska ulica 13/2, HR-10000 Zagreb
Legal form: a limited liability company
Court register: Commercial Court of Zagreb
Registration number: 080751121

OIB: 29969122438
Share capital: HRK 20,000.00 (paid in its entirety)
Authorized representative: Martina Diminić Smetiško, director of the company (Representing the company individually and independently, Responsible person for data protection)

Bank account: HR3623600001102197724 (Zagrebačka banka), HR4324020061100628669 (Erste banka)