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YOUR EXPERT IN
CRITICAL ENVIRONMENT
INSPECTION

YOUR EXPERT IN CRITICAL ENVIRONMENT INSPECTION

HeX carries out inspections in all types of environments, especially those subject to contamination control to which legislation, standards, recommendations and other texts apply.

HeX Inspections are carried out in the form of an audit based on tailor-made checklists. These checklists include statutory requirements, compliance with standards and all recommandations applicable to your organisation and your industry.

The aim of HeX inspections is to provide precise information about the extent to which the subject submitted to inspection complies, or otherwise, to the appliable and relevant texts.


Advantages

An inspection of your facilities will provide you with:

  • An inventory of your system in relation to applicable texts and recommendations,
  • Verification of the implementation and operation of your quality system and an assesment of its compliance with the applicable texts,
  • A summary of results and trends observed in your facilites.
  • A summary of focal points for setting improvemnt targets.

The speed and quality of our work is assured through our specially developed Automated Computerised System.

You will be given thorough and precise reports.

MANY HeX
INSPECTIONS
INCLUDE
A PART
CARRIED OUT
UNDER ISO
17020 BELAC (464-INSP)
ACCREDITATION

MANY HeX INSPECTIONS INCLUDE A PART CARRIED OUT UNDER ISO 17020 BELAC (464-INSP) ACCREDITATION

1 - Inspection of endoscopic invasive medical devices

HeX assesses the compliance of infection prevention related to endoscope invasive medical devices in user institutions such as healthcare institutions, imaging centres and medical practices.

This assessment responds to Instruction DGOS/PF2/2014/338 of 8 December 2014 on the French national endoscopy audit concerning non-autoclavable flexible endoscopes with channels and Opinion n° 8355 of the Belgian Supeior Health Council: “Recommendations on the maintainance of heat sensitive flexible endoscopy equipment and prevention of infections”.

The inspection is available in 5 areas:

  • Personnel
  • Cleaning and disinfection methods
  • Environment of treatment and use
  • Equipment
  • Quality Assurance


2 - WEO (Werkgroep Extramurale Oogheelkunde) Inspection

HeX has drawn up an inspection grid for private opthalmological surgery centres (outside healthcare institutions). This checklist is based on the recommendations of the Werkgroep Extramurale Oogheelkunde (WEO) multidisciplinary working group and also on HeX 's experience of clean rooms in controlled environments. This combination means a WEO inspection under ISO 17020 accreditation can be carried out.

During the inspection HeX will audit:

  • the architecture of the premises, flows and access,
  • the management of equipment,
  • the management of the quality of surfaces,
  • the management of personnel and responsibilities.


3 - BSPC (Belgium Society for Private Clinics) Inspection

HeX has drawn up an inspection grid for private cosmetic surgery clinics (outside healthcare institutions). This checklist is based on the recommendations of the Belgium Society for Private Clinics (BSPC) multidisciplinary working group and HeX's experience of clean rooms in controlled environments. This combination means a BSPC inspection, in the process of ISO 17020 accreditation, can be carried out.

During the inspection HeX will audit:

  • the architecture of the premises, flows and access,
  • the management of equipment,
  • the management of the quality of surfaces,
  • the management of personneland responsibilities.





4 - Inspection of medicine preparation areas in hospitals

The aim of this audit is to verify that the facilities and mangement system of a hospital pharmacy department comply with the following standards:

  • The ISO 14664-1 international standard applicable to "Clean rooms or clean areas" in controlled environments,
  • The PIC’S PE 010-4 recommendations for the production of medicines in hospital institutions,
  • the management of surface quality, EudraLex - Volume 4 Good manufacturing practice (GMP) Guidelines, applicable to the production of medicines for human use.

The scope of the audit is all hosptial pharmacy activities such as:

  • Magistral Preparations,
  • Parenteral Preparations,
  • Cytotoxic Preparations.


5 - HACCP Inspection

The aim of the HACCP inspection carried out by HeX is to verify the effective implementation of the general requirements related to the design of premises used for the preparation of foodstuffs in a mass catering kitchen.

The scope of the audit is:

  • The environment of the kitchen,
  • The social areas,
  • The storage areas,
  • The production premises,
  • The choice of materials for the design.

The items on the HeX Checklist include the requirements of Regulation (EC) n°852/2004 of the European Parliament and the Council of 29 April 2004 on the hygiene of foodstuffs.


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