Conformity assessment procedures

These regulations establish the basic rules for assessing the conformity of specified products and are based on Annex II of Decision No. 768/2008/EC of the European Parliament and of the Council;the same procedures (modules) apply to specified products under Act No. 22/1997 Coll.
(The amendment by Act No. 87/2023 Coll. applies from April 6, 2023) and Act No. 90/2016 Coll. (The amendment by Act No. 236/2024 Coll. applies from January 20, 2027 and concerns machinery).

Note: For construction products, so-called systems for verifying and assessing the constancy of performance are used. Conformity

assessment procedures (modules) demonstrate that the essential technical requirements concerning the product, process, service, system, person, or entity, as set forth by a government regulation, have been met.

Act No. 90/2016 Coll. also sets forth the conditions under which the manufacturer’s in-house unit (referred to in EU legislation as an “accredited in-house body”) may be used for conformity assessment. The manufacturer’s in-house unit consists of in-house laboratories or testing facilities. Conformity assessment is carried out according to modules, a list of which is provided in Annex No. 1 to Act No. 90/2016 Coll. or in this table:

Module A	Internal production control
Module A1	Internal production control combined with supervised product testing
Module A2	Internal production control combined with supervised product inspections at random intervals
Module B	EU type examination
Module C	Conformity to type based on internal production control
Module C1	Conformity to type based on internal production control combined with products under supervision
Module C2	Conformity to type based on internal production control plus product inspections under supervision at random intervals
Module D	Conformity to type based on quality assurance of the production process
Module D1	Quality assurance of the production process
Module E	Conformity to type based on product quality assurance
Module E1	Quality assurance of final inspectionand product testing
Module F	Conformity to type based on product verification
Module F1	Conformity based on product verification
Module G	Conformity based on verification of every single product
Module H	Conformity based on full quality assurance
Module H1	Conformity based on full quality assurance together with design review

This overview of modules (procedures) is based on Annex II of Decision No. 768/2008/EC of the European Parliament and of the Council on a common framework for the marketing of products and repealing Council Decision 93/465/EEC.

TABLE: CONFORMITY ASSESSMENT PROCEDURES IN COMMUNITY

LEGISLATION

CONSTRUCTION	A. Internal production control	B. Type of testing				G. Verification of each individual product	H. Comprehensive quality assurance
	EN ISO 9001:2000 (4)
	The manufacturer keeps the technical documentation available to national authorities	The manufacturer submits to the notified body the technical documentation, evidence of the adequacy of the technical design solution, and a sample (samples) representative of the intended production, as required				The manufacturer submits the technical documentation	The manufacturer operates an approved quality system for design submits the technical documentation
	The notified body confirms conformity with the essential requirements, reviews the technical documentation and supporting data to assess the adequacy of the technical design of the sample(s): conducts tests if necessary, issues an EC type-examination certificate				The		Notified Body monitors the quality system
	H1
	The Notified Body verifies design conformity (1) and issues an EC design examination certificate (1)
PRODUCTION		C. Conformity to type	D. Production quality assurance	E. Product quality assurance	F. Product verification
	EN ISO 9001:2000 (2)	EN ISO 9001:2000 (3)
	A.	C.
	The manufacturer	The manufacturer	The manufacturer	The manufacturer The	manufacturer	The manufacturer The manufacturer
	declares conformity with the essential requirements affixes the required conformity marking to the product	declares conformity with the approved type affixes the required conformity marking to the product	operates an approved quality system for production, final inspection, and testing declares conformity with the approved type affixes the required conformity marking to the product	operates an approved quality system for inspection and testing declares conformity with the approved type affixes the required conformity marking to the product	declares conformity with the approved type affixes the required conformity marking to the product	submits the product declares conformity affixesthe product with the required conformity marking	operates an approved quality system for production, final inspection, and testing declares conformity affixes the required conformity marking to the product
	A1.	C1.	D1.	E1.	F1.
	An	accredited in-house body or	a	notified	body	declares conformity with the essential requirements	declares conformity with the essential requirements	declares conformity with the essential requirements
	the body tests specific aspects of the product (1)	the body tests specific aspects of the product (1)	affixes the required conformity marking to the product	affixes the required conformity marking to the product	affixes the required conformity marking to the product
	Notified body	Notified body	Notified body	Notified body	Notified body
	A2. Product checks at random intervals (1)	C2. Product checks at random intervals (1)	approves the quality system supervises the quality system	approves the quality system supervises the quality system	verifies compliance with essential requirements issues a certificate of conformity	verifies compliance with essential requirements issues a certificate of conformity	supervises the quality system
(1) Additional requirements that may be applied in sectoral legislation. (2) Except for subclause 7.3 and requirements relating to customer satisfaction and continual improvement. (3) except for subclauses 7.1, 7.2.3, 7.3, 7.4, 7.5.1, 7.5.2, 7.5.3, and requirements relating to customer satisfaction and continual improvement. (4) except for requirements relating to customer satisfaction and continual improvement.