ISO/IEC 17020:2012

Inspection bodies

Accreditation of bodies that inspect products, processes, installations and plants and assess their conformity.

About the scheme

Accreditation to ISO/IEC 17020 confirms that an inspection body performs inspections competently and impartially and that its findings can be relied on.

Independence requirements depend on the type of body: a type A body is an independent third party, while type B and C bodies may be part of an organization that designs, manufactures or uses the inspected items, with appropriate safeguards for impartiality.

Who it is for

Type A, B or C inspection bodies — for example for cleanrooms, HVAC systems and laboratory containment equipment.

What we assess

  • Independence according to the type of body (A, B or C)
  • Competence of inspectors
  • Inspection methods and procedures
  • Equipment and its calibration
  • Inspection records and reports
  • The body's management system

Accreditation number format

DCS-IB-0000

Fields of inspection

Fields we accredit

An inspection body's scope of accreditation lists the field, the type of inspection (initial or periodic) and the standards applied.

01

HVAC in operating theatres and intensive care

Ventilation and air conditioning in operating theatres, intensive care units and other hospital hygiene zones.

Inspections

  • Airflow, velocity and uniformity
  • Pressure differential
  • HEPA/ULPA filter leak test
  • Particle count and classification
  • Temperature and humidity
  • Recovery time and protection degree

Standards

  • EN ISO 14644-1/-2/-3
  • DIN 1946-4
  • ASHRAE 170
  • IEST-RP-CC006
  • IEST-RP-CC034
02

Production areas and laboratories

Cleanrooms and laminar airflow zones in pharmaceutical and medical production and laboratories.

Inspections

  • Cleanroom classification
  • Airflow visualization
  • Pressure differential
  • Recovery time

Standards

  • EU GMP Annex 1
  • FDA cGMP
  • EN ISO 14644-1/-2/-3
03

Biosafety cabinets

Protective performance of microbiological safety cabinets in laboratories and healthcare.

Inspections

  • Downflow and inflow velocity
  • HEPA filter leak test
  • Airflow visualization
  • Alarms and functions

Standards

  • EN 12469
  • NSF/ANSI 49
  • IEST-RP-CC034
04

Laminar airflow cabinets

Clean workstations with unidirectional airflow.

Inspections

  • Airflow velocity
  • HEPA/ULPA filter leak test
  • Airflow visualization
  • Particle count

Standards

  • EN ISO 14644-1/-2/-3
  • IEST-RP-CC002
  • IEST-RP-CC006
  • IEST-RP-CC034
05

Fume hoods

Extraction and operator protection in laboratory fume hoods.

Inspections

  • Alarms and functions
  • Face velocity
  • Exhaust volume flow
  • Room air velocity

Standards

  • EN 14175
06

Ventilation ductwork

Air tightness and strength of rectangular and circular ductwork before commissioning.

Inspections

  • Tightness and strength of rectangular ducts
  • Tightness and strength of circular ducts

Standards

  • EN 1507
  • EN 12237
  • SMACNA
  • BESA DW/143

Path to accreditation

From application to decision

Accreditation is granted after a document assessment and an on-site assessment, and is maintained through regular surveillance.

The full process
  1. 01

    Application and review

  2. 02

    Document assessment

  3. 03

    On-site assessment

  4. 04

    Decision and certificate

ISO/IEC 17020:2012

Apply for accreditation.

Send us the basics about your body and the scope you are seeking — we will reply with application guidance and a quote.

Apply for accreditation