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Title Application of the acceptance for a new conformity assessment scheme to be submitted for accreditation

Reference DR-02

Revision 02

Date 31-07-2017

Preparation Approval Authorization Application date

The Director of Department

The Directive Council The General Director 25-10-2017

Application for acceptance for a new conformity assessment scheme to be submitted for accreditation DR-02 rev.02 page 1/20Date:31-07-2017

CONTENTS

1. NOTES FOR COMPLETION........................................................................31.1. STRUCTURE OF THE APPLICATION.....................................................................3

2. GENERAL PART.......................................................................................42.1. GENERAL DATA OF THE ORGANISATION WHICH PREPARED THE SCHEME

(SCHEME OWNER)....................................................................................................4

3. CATEGORY/CONFORMITY ASSESSMENT SCHEME.......................................4

ALL.01 DR-02 – EVALUATION REPORT OF A CONFORMITY ASSESSMENT SCHEME (CAS) IN ACCORDANCE WITH EA-1/22 A:2016...........................................5

1. GENERAL INFORMATION..........................................................................5

2. EVALUATION OF THE MANDATORY PRE-REQUISITES FOR THE ESTABLISHMENT OF RELATIONSHIPS WITH SCHEME OWNERS (EA-1/22, §3)5

3. INFORMATION WHICH SHALL BE PROVIDED BY THE SO (ANNEX 1 OF EA-1/22)......................................................................................................8

4. INFORMATION TO BE PROVIDED BY THE SO ON THE VALIDATION OF THE CAS (ANNEX 2 OF EA-1/22)....................................................................14

5. SUPPLEMENTARY INFORMATION ON THE CAS PROVIDED BY THE SO........18

ALL. 02 DR-02 FAC PRESENTATON REPORT OF THE CONFORMITY ASSESSMENT SCHEME...............................................................................................19


1. NOTES FOR COMPLETION

1.1. STRUCTURE OF THE APPLICATION

The application for recognition for a new Conformity Assessment Scheme (CAS) to be submitted to ACCREDIA for accreditation, consists of a general part and some specific annexes based on the accredited scheme requested.

The organization which has prepared the scheme shall mandatorily complete: the general part; and shall attach the module for the evaluation of the scheme by ACCREDIA and a brief

presentation report of the scheme (see FAC SIMILE ALL. 01 DR-02 at the end of this document).

However, in cases where: the CAS is based on a normative document (e.g. ISO Standards, ISO/PAS Publicly Available

Specifications, ISO/TS Technical Specifications, ISO/TR Technical Reports) or other documents issued by standardization bodies (e.g. IWA of ISO, PdR UNI, PAS of BSI, CWA of CEN);

the CAS is applied internationally and it is based on an official standard (UNI, ISO, BSI..);

it is not necessary to complete the present application or the module ALL. 01 DR-02, but it is necessary to attach the report of the presentation of the scheme (see the ALL. 02 DR-02 at the end of this document).

The module ALL.01 DR-02 shall be completed in English (to enable evaluation by EA) if it is a scheme for international application, however:

there is no official standard (UNI, ISO, BSI..); the scheme can be offered by more than one certification body; it is not a mandatory/regulated scheme.


2. GENERAL PART

2.1. GENERAL DATA OF THE ORGANISATION WHICH PREPARED THE SCHEME (SCHEME OWNER)

2.1.1 Acronym or name of the organization

………………………………………………………………………………………………………………………………………………………………….

2.1.2 Address of head office

STREET

POST CODE CITY PROVINCE

PHONE

FAX

EMAIL WEBSITE

CEP

3. CATEGORY/CONFORMITY ASSESSMENT SCHEME

3.1 Type of conformity assessment activity

Certification of system

Tests Product/Service Reference materials

Calibration Persons Inspection Verification and validation

Medical tests

3.2 Name of the conformity assessment scheme

………………………………………………………………………………………………………………………………………………………………….

Date: Stamp of the Organization, Name and signature of the Head Officer

……………………………………………………………..


ALL.01 DR-02 – EVALUATION REPORT OF A CONFORMITY ASSESSMENT SCHEME (CAS) IN ACCORDANCE WITH EA-1/22 A:20161

1. GENERAL INFORMATION

Name of the Scheme Owner (SO)Identification of the CASScope of the CASDocumentation of the CASNormative documents applicable to the CAS WebsitesConformity assessment modalities(EA-1/06 A-AB:2013, rev.07, republished October 2015)(e.g.: certification standard, scheme, test method)Applicable accreditation standard(EA-1/06 A-AB:2013, rev.07, republished October 2015)

2. EVALUATION OF THE MANDATORY PRE-REQUISITES FOR THE ESTABLISHMENT OF RELATIONSHIPS WITH SCHEME OWNERS (EA-1/22, §3)

2.1 The SO has to be legally identifiable

To be completed by the SO

Evaluation comments of ACCREDIA

2.2 The SO has the authority to establish and modify the requirements of the CAS


Evaluation comments of ACCREDIA

1The use of this template is mandatory for dissemination among EA members for schemes that go international and that shall be evaluated in accordance with EA-1/22. For national schemes each NAB remains fully free to use their own system and template.


2.3 The SO shall have the mandate to cooperate with the ACCREDIA


ACCREDIA comments and evaluations

2.4 The SO shall be able to demonstrate market support for the CAS.



2.5 The process of conformity assessment described or chosen by the SO shall come within the scope of one of the standards of EA MLA Level 3 (see EA-1/06).



2.6 The specific requirements of the scheme requested by the SO with respect to the CAB shall not contradict or exclude any of the requirements included in the international standards referred to in point 2.5.



2.7 If any CAS specific requirements are placed on ABs they shall not contradict or exclude any of the requirements in ISO/IEC 17011, EU Regulation (EC) 765/2008 and/or EA, ILAC and IAF.




2.8 CAS in the voluntary sector with requirements applicable to objects of conformity assessment shall neither contradict, nor simply be the fulfillment of, applicable legal requirements.



2.9 The SO shall commit to accept results from CABs accredited by any EA MLA signatory (for the relevant scope) which follows the requirements laid down by the SO.



2.10 The SO shall demonstrate that the CAS has been validated. The validation shall be documented and include the descriptions and analyses as required in 3.10 of EA 1/22.



2.11 The SO shall have reserved the use of the scheme to accredited CABs with which an agreement has been entered into. Such agreement must guarantee at least that the CABs will use the scheme as it is, without any limitations and without any additions.



2.12 The SO shall be responsible for keeping all active NABs and CABs informed of any modifications made to the scheme.




2.13 The SO shall be prepared to pay for the costs of the evaluation of its CAS.



3. INFORMATION WHICH SHALL BE PROVIDED BY THE SO (ANNEX 1 OF EA-1/22)

1. Is the SO willing to use the NAB as the sole contact point for the evaluation of the CAS?



2. Is the CAS intended to be used only at the national level? If “no”, please specify.



3. Is the CAS currently used by CABs under accreditation by an EA member?

if “YES” please specify the EA member;

if “NO”, but has been previously evaluated by an AB, give details and results of the evaluation.



4. Provide a full description of the SO including

Data and description To be completed by the SOa) Name and acronym

b) Type of legal entity

c) Address and website address

d) Members (if relevant) and membership rules


Data and description To be completed by the SOe) Brief history

f) Any other activities performed (if relevant)

g) Relations to or links with other organizations and the authorities, both at European and national level ( if any)

h) Technical area of activity, for example aerospace, electrical testing, food safety, etc.;

i) Conformity assessment procedure suggested by the SO, for example product certification, inspection, etc.

j) Geographical area of acceptance, for example a few European countries, all of Europe or global.

k) Does the SO perform any kind of activity to confirm recognition of CABs which wish to work within the scope of the CAS?

If “YES” describe it and identify the scheme document where this is stated.


5. Please provide evidence of market support for the scheme.



6. Under what conformity assessment procedure(s) does the CAS operate? (For example product certification, inspection, etc.) Include the rationale for your choice and identify the scheme document where it is established.




7. Has the SO established scheme specific requirements for the operation of CABs wishing to operate within the CAS?

If “YES”, please describe the specific requirements and identify the CAS documents where these are described. State also how such requirements are made publicly available.



8. Does the SO (by itself or through another organization) perform any kind of assessment of the CAB?

If “YES”, describe it and refer to the scheme document where it is required.



9. If the answer to point 8 is “YES”, the SO shall request the NABs to accept and take into consideration the evaluation during the accreditation process?

If “YES”, identify the scheme document where this is stated and described.



10. Does the scheme require EA or EA members to cooperate with the SO on other issues than the accreditation of CABs?

If “YES”, specify the areas of cooperation required and refer to the scheme document where these are described.




11. Has the SO established specific scheme requirements for the NAB’s activities?

If “yes”, identify the scheme document where these are described.



12. What is the object of conformity assessment? Please, state as specifically as possible.

Objects of conformity assessment may be products (including services), materials, installations, processes, systems, persons or bodies.



13. What are the specific requirements relating to the characteristics of the object of conformity assessment? Please identify the scheme documents where these are stated.

The requirements shall be clearly, directly and precisely stated in order to enable an accurate and uniform interpretation so that parties using the normative document can take from the content of the normative document a common understanding of its meaning and intent.

Where it is applicable, the requirements shall be set out in terms of results, or results together with the allowance limits, where necessary.

The requirements shall be described unambiguously using objective, logical, valid and specific formulations.



14. Are all measurement values expressed in SI units (International System of Units)?




15. If the scheme involves sampling, what procedures are required for sampling?

To gain reliable and reproducible results, sampling methods should be based, whenever possible, on statistical methods provided in International Standards.



16. Are there test methods or inspection procedures involved in the scheme? What are they and where are they specified?



17. Does the scheme cover the following typical elements of a conformity assessment scheme: (ref. Annex 1 of the standard ISO/IEC 17000)?

Data and description To be completed by the SOa) Selection of the object/s of the conformity

assessment, including the selection of the specific requirements to be assessed and the gathering of information on the planning and on the sampling activities.

b) Determination, including the use of one or more determination methods (e.g. test, audit and/or examination) to develop complete information regarding fulfillment of the specified requirements by the object of conformity assessment or its sample.

c) Review and attestation, including the review of evidence from the determination stage, and a subsequent attestation that the object of conformity assessment has been reliably demonstrated to fulfill the specified requirements, and any subsequent marking or licensing and their related controls, where applicable.

d) Surveillance (if needed), including the frequency and extent of surveillance activities and reassessments to ensure the object of conformity assessment continues to fulfill the


specified requirements.


18. Does the CAS consider the use of marks of conformity?

If the answer is “yes” the SO needs to demonstrate that it has protected those marks and laid down rules for their use. The SO shall monitor compliance with those rules



19. Provide evidence that the CAS was designed by persons demonstrably competent in that capacity. The competence shall cover both the technical field of expertise and the conformity assessment procedure used.

Note: CABs may be involved in the development process of CASs within the limitations given in the standards used for their accreditation



20. Provide evidence that the interested parties for the CAS were analyzed, identified and consulted, and that their response supported the CAS.




21. Provide evidence that the CAS is validated, considering the details given in clause 3.10 of EA-1/22.

As a minimum, validation shall demonstrate that the CAS has successfully completed a test period, demonstrating that it is fit for the purpose. Some of the questions to considered are:

is the conformity assessment, as described, practicable?

do the determination activities as described quantify or in other ways identify and confirm the characteristics which the SO intends and expects to identify and which constitute the basis for conformity assessment?

are the requirements specified in a way that ensures reproducibility and reliability of results?



4. INFORMATION TO BE PROVIDED BY THE SO ON THE VALIDATION OF THE CAS (ANNEX 2 OF EA-1/22)

Before completing this document consult carefully and make reference to the following applicable normative documents:

EA-1/22, Annex 2; for certification of product/service/process: ISO/IEC 17067, ISO/IEC TR 17026; for certification of persons: ISO/IEC 17024, point 8; for management systems: apply the model of ISO 9001 and the relative IAF guides; it is also

useful to consult the document ISO/IEC Directives, Part 1 Consolidated ISO Supplement Procedures specific to ISO2

The questions which follow have the nature of a guide to the evaluation of a CAS, but it remains the CAB’s responsibility to demonstrate full compliance with the applicable normative documents and their subsequent updates.

1. Object

Information To be completed by the SOa. What is the object of the certification?

b. Which (groups of) products/services/processes/systems/competences shall the scheme cover?

2 See http://isotc.iso.org/livelink/livelink/fetch/-10469877/10469901/16474137/Annex_SL_-_ISO_Directives_2016_7th_edition.pdf?nodeid=17859835&vernum=-2


http://isotc.iso.org/livelink/livelink/fetch/-10469877/10469901/16474137/Annex_SL_-_ISO_Directives_2016_7th_edition.pdf?nodeid=17859835&vernum=-2

http://isotc.iso.org/livelink/livelink/fetch/-10469877/10469901/16474137/Annex_SL_-_ISO_Directives_2016_7th_edition.pdf?nodeid=17859835&vernum=-2

c. To which aspects of the products/services/processes/systems/competences does the scheme


2. Certificate

Information To be completed by the SOa. What declaration of conformity appears on the

certificates?

b. Which (groups of) products/services/processes/systems/competences shall the scheme cover?

c. To which aspects of the products/services/processes/systems/competences does the scheme


3. Certification mark

Information To be completed by the SOa. How is the meaning of the certification mark

communicated to the market?

b. Is there any risk that the certification mark is wrongly interpreted or improperly used?


4. Requirements of certification

Information To be completed by the SOa) Do the scheme documents identify where the

requirements are defined?b) How is it shown that it is possible to evaluate the

specified requirements?c) Have the legal requirements been included?d) Does the scheme contain only legal

requirements?e) How is the conformity to the legal requirements

determined?f) Do any documents exist providing explanations

or interpretations of the requirements?


g) Have the documents referred to in point “f” been published?

h) Who prepared the documents of interpretation?ACCREDIA comments and evaluations

5. Certification system

Information To be completed by the SOa) What is the method used for determining

conformity?b) How is it shown that the method is suitable to

support the declaration of conformity?c) What method is used for monitoring that the

owner of the certificate maintains conformity to the requirements over time?

d) How is it shown that the suitability of the method used for monitoring that the owner of the certificate maintains conformity to the requirements over time?


6. Conditions

Information To be completed by the SOa. What criteria are required for granting,

maintaining, expanding, reducing, extending, suspending or withdrawing certification?

b. Is the definition of nonconformity consistent with the CAB’s reference standards and with the EA/IAF guides?

c. What types of rights or obligations are established for the SO, for the CABs and for the applicants for accreditation?

d. What records are kept to show the continuity of conformity to the requirements?

e. How are the criteria established for the handling of complaints by the owners of the certification?



7. Procedures

Information To be completed by the SOa. Where are the certification procedures described?

b. Has the adequacy of the procedures been demonstrated?


8. Competence

Information To be completed by the SOa. Have the competences required for the

auditors/examiners been defined?

b. If “yes” identify the documents where the competences required for the auditors/examiners been defined

c. Have the competence requirements for persons deciding with regard to certification been defined?

d. If “yes” identify the documents where the competence requirements for persons deciding with regard to certification are defined


9. Information for the public

Information To be completed by the SOa. Where have the scheme documents been

published?

b. Are they publicly available?

c. Does the SO perform market surveillance activities, e.g. by means of lists of certified products, persons etc.?



5. SUPPLEMENTARY INFORMATION ON THE CAS PROVIDED BY THE SOTo be completed by the SO



ALL. 02 DR-02 FAC PRESENTATON REPORT OF THE CONFORMITY ASSESSMENT SCHEME

Presentation of the scheme

The characteristics of the scheme

The requirements of the scheme

The general framework and normative context

The national framework The European and international framework

Added value

Rules regarding the certification process

List of the interested parties (stakeholders) who approved the contents of the scheme (attach evidences) divided on the basis of the categories of interests which they represent


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