PQ 16.101.004 Certification regulation for personal ... · Manual for the Second Part Doc.: PQ...

Manual for the Second Part Doc.: PQ 16.101.004 Rev. 3

PROCEDURE PAGE 1 OF 29

PROCEDURE 16.101.004

Regulation for the Certification of Personal Protective Equipment

SUMMARY

0. INTRODUCTION ............................................................................................................... 3

1. SCOPE AND FIELD OF APPLICATION ........................................................................... 3

2. REFERENCES .................................................................................................................. 4

3. DEFINITIONS ................................................................................................................... 4

4. GENERAL CONDITIONS ................................................................................................. 6

4.1 EU Type-Examination procedure ....................................................................................................... 6

4.2 Application for EU type-examination .................................................................................................. 7

4.3 Payments ........................................................................................................................................... 7

4.4 Free access to areas, information and documentation ...................................................................... 7

4.5 Safety ................................................................................................................................................. 7

5. EU TYPE-EXAMINATION PROCEDURE ......................................................................... 7

5.1 Offer request for EU type-examination .............................................................................................. 7

5.2 Offer acceptance for EU type-examination ........................................................................................ 8

5.3 Presentation of the Application for EU type-examination .................................................................. 8

5.4 Initiating the EU type-examination process for the granting of the EU Type-Examination Certificate8

5.5 Initial tests .......................................................................................................................................... 9

5.6 Tests subcontracting ........................................................................................................................ 10

5.7 Issuing the EU Type-Examination Certificate .................................................................................. 10

5.8 Validity of the EU Type-Examination Certificate .............................................................................. 11

6. MODIFICATION OF THE DEVICE AND EXTENSION OF THE EU TYPE-EXAMINATION

CERTIFICATE ................................................................................................................ 12

6.1 Changes to the certified Product by the Client ................................................................................ 12

6.2 Extension of product EU Type-Examination Certificate ................................................................... 13

7. CERTIFICATION VALIDITY ........................................................................................... 15

7.1 EU Type-Examination Certificate validity conditions ....................................................................... 15

8. RIGHTS AND OBLIGATIONS OF CLIENTS HOLDING EU TYPE-EXAMINATION

CERTIFICATE ................................................................................................................ 15

8.1 Publicising the EU Type-Examination Certificate ............................................................................ 15

8.2 Client’s obligations ........................................................................................................................... 15

8.3 Changes to EU type-examination Certificate issuing conditions ..................................................... 16

8.4 Free access to the Client’s organisation .......................................................................................... 16

8.5 Forbidden use of EU type-examination Certificate .......................................................................... 16

8.6 Responsibilities ................................................................................................................................ 16



9. OFFICIAL CONTROL ON THE PRODUCT AND/OR ON THE PRODUCTION PROCESS

FOR CLIENTS WHO HOLD EU TYPE-EXAMINATION CERTIFICATES ....................... 16

9.1 Supervised product checks at random intervals (Module C 2) ............................................................... 16

9.2 Conformity to type based on quality assurance of the production process (Module D) ......................... 18

9.3 Client’s duties and responsibilities .......................................................................................................... 22

10. INCORRECT USE OF EU TYPE-EXAMINATION CERTIFICATE .................................. 23

11. EU TYPE-EXAMINATION CERTIFICATE SUSPENSION OR WITHDRAWAL .............. 23

11.1 Suspension ...................................................................................................................................... 23

11.2 Withdrawal ....................................................................................................................................... 24

12. WAIVING EC CERTIFICATION ...................................................................................... 25

13. AMENDMENTS TO EU TYPE-EXAMINATION CERTIFICATE VALIDITY TERMS ........ 26

13.1 Amendments made by Dolomiticert Scarl ........................................................................................ 26

13.2 Changes by the Client ...................................................................................................................... 26

13.3 Other changes ................................................................................................................................. 26

14. CONFIDENTIALITY ........................................................................................................ 27

15. ECONOMIC TERMS ....................................................................................................... 27

15.1 Rates ................................................................................................................................................ 27

15.2 Payment terms ................................................................................................................................. 27

16. USE OF DOLOMITICERT LOGO ................................................................................... 28

17. APPEALS ....................................................................................................................... 28

18. CLAIMS .......................................................................................................................... 28

19. DISPUTES ...................................................................................................................... 29

20. STOCKING OF REFERENCE SAMPLES ...................................................................... 29

Rev. Issue date Review reason Prepared by RSGQ Controller by DOC Approved by MANAGEMENT

3 07/03/19 Procedure update Zenarolla A. Tamburlin L. Boito L.



0. INTRODUCTION Since 2008 Dolomiticert S.c.a.r.l. has been providing a conformity evaluation service for personal protective equipment in categories II and III. Each manufacturer involved in the design, production and marketing of personal protective equipment (herein referred to as the Client), has free access to the certification services without any form of discrimination, and without being subject to any undue charges. Consultancy about the design, production and marketing of personal protective equipment (herein referred to as PPE) is not included in Dolomiticert Scarl services; consequently Dolomiticert Scarl does not provide any consultancy activities in the application of these regulations apart from providing normal information.

1. SCOPE AND FIELD OF APPLICATION Scope

This document is issued as Regulations, and is considered as a contractual document providing a series of provisions that govern the relationship between Dolomiticert Scarl and the Client throughout the duration of the EU type-examination Contract.

These Regulations define the methods and terms that the Client must observe to obtain and maintain the Product EU Type-Examination Certificate that is issued by Dolomiticert Scarl.

Upon sending the signed Application for EU type-examination the Client declares to fully understand and accept these Regulations.

Dolomiticert Scarl certification services are available for any Client who requires them, in observation of these Regulations.

The Impartiality Committee (IC) guarantees the conformity of these Regulations with applicable standards with any other EU Product Certification Plan Regulations.

The acceptance of the present Regulation is formalized with the signing of the Application for EU type-examination.

Field of EU Type-Examination Certification

“Product EU type-examination, as required by Regulation 2016/425 of the Parliament and of the Council of 9 March 2016 regarding personal protective equipment, repealing Council Directive 89/686/EEC, related to Personal Protective Equipment”.

Related to the following products:

1. Head protection devices;

2. Devices for protection against falls from a height;

3. Protective clothing, including anti-drowning devices;

4. Devices for the protection of the foot and of the leg, with anti-slip function, including those designed to protect against high voltage, molten materials, flame or infrared irradiance, with the exception of those intended to protect against ionizing radiation;

5. Devices for the protection of the hand and of the harm, with the exception of those designed to protect against ionizing radiation;

in accordance to with what is provided for by the following annexes of Regulation 2016/425:



- V (EU type-examination);

- VII (conformity to type based on internal production control plus supervised product checks at random intervals);

- VIII (conformity to type based on quality assurance of the production process).

2. REFERENCES � UNI CEI 70006:2008 “General rules for a standard product certification method by an

independent organisation”

� ACCREDIA Regulation RG-01 Rev. 03 – “Certification and Inspection Organisation Accreditation Regulation – General Part”

� ACCREDIA Regulation RG-01-03 rev.00 – Accreditation Regulation for Product Certification Organisation

� UNI CEI EN ISO/IEC 17020:2012 “Conformity assessment. Requirements for the operation of various types of bodies performing inspection”

� UNI CEI EN ISO/IEC 17021:2015-1 “Conformity assessment Requirements for bodies providing audit and certification of management systems – Part 1: Requirements”

� UNI CEI EN ISO/IEC 17025:2005 “General requirements for the competence of testing and calibration laboratories”

� ACCREDIA LS-02 rev.13 “List of reference standards and documents for the accreditation of Certification Bodies”

� Guide EA-2/17 “EA Guidance on the horizontal requirements for the accreditation of conformity assessment bodies for notification purposes”

� UNI EN ISO 19011:2012 “Guidelines for auditing management system”

� Directive of the Minister of Productive Activities on "documentation to be produced for the authorization of organizations for the EC" on 19 December 2002.

� ISO/IEC 17065:2012 “Conformity assessment — Requirements for bodies certifying products, processes and services”

� ISO/IEC 17067:2013 “Conformity assessment — Fundamentals of product certification and guide for product certification schemes”

� UNI CEI 70017:2008 (ISO/IEC Guide 67:2004) “Conformity assessment - Fundamental of product Certification”

� ISO/IEC GUIDE 28:2004 “Conformity assessment - Guidance on a third-party certification system for products”

� ACCREDIA Regulation RG-09 REV. 06 “Regulation for the use of the ACCREDIA Mark”

� Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016 on personal protective equipment and repealing Council Directive 89/686/EEC

� Technical sheets for coordination – Horizontal recommendation for use sheets (RFUs)

3. DEFINITIONS To some terms, recurrently used in the text, the definitions given below apply.



ACCREDIA: Italian Certification Organisation of Certifying Bodies for notification purposes.

EU Type-Examination Certificate: document in which Dolomiticert Scarl declares that, with reasonable reliability, a product conforms to the applicable basic health and safety requirements in accordance with the provisions of annex V of the Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016.

Product EU type-examination: activity during which Dolomiticert Scarl declares (by issuing the EU Type-Examination Certificate) that, with reasonable reliability, a given Product conforms to one or more regulatory documents.

Manufacturer: any natural or legal person who manufactures PPE or has it designed or manufactured, and markets it under his/her name or trademark.

Client: a term used to indicate the manufacturer or its delegate in the European Union, who supplies a product or service. N.B.: The manufacturer may be established in the European Union or not; the manufacturer may appoint a delegate who is established in the European Union, to act in the manufacturer’s name for certain activities. The appointment and the functions whereby the delegate represents the manufacturer must be established in a written contract.

Technical Documentation: technical documentation is the group of documents as established in Annex III of the Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016, and, in particular, it must include at least the following elements:

a) a complete description of the PPE and of its intended use; b) an assessment of the risks against which the PPE is intended to protect; c) a list of the essential health and safety requirements that are applicable to the PPE; d) design and manufacturing drawings and schemes of the PPE and of its components, sub-

assemblies and circuits; e) the descriptions and explanations necessary to understand the drawings and schemes

referred to in point (d) and of the operation of the PPE; f) the references to the harmonised standards referred to in Article 14 that have been applied

for the design and manufacture of the PPE. In the event of partial application of harmonised standards, the documentation shall specify the parts which have been applied;

g) where harmonised standards have not been applied or have been only partially applied, descriptions of the other technical specifications that have been applied in order to satisfy the applicable essential health and safety requirements;

h) the results of the design calculations, inspections and examinations carried out to verify the conformity of the PPE with the applicable essential health and safety requirements;

i) reports on the tests carried out to verify the conformity of the PPE with the applicable essential health and safety requirements and, where appropriate, to establish the relevant protection class;

j) a description of the means used by the manufacturer during the production of the PPE to ensure the conformity of the PPE produced with the design specifications;

k) a copy of the manufacturer's instructions and information set out in point 1.4 of Annex II; l) for PPE produced as a single unit to fit an individual user, all the necessary instructions for

manufacturing such PPE on the basis of the approved basic model; m) for PPE produced in series where each item is adapted to fit an individual user, a

description of the measures to be taken by the manufacturer during the fitting and production process to ensure that each item of PPE complies with the approved type and with the applicable essential health and safety requirements.

Application for EU type-examination: a document/contract in which the Client formally applies for the EU type-examination procedure be initiated, in compliance with these regulations.

EU Declaration of Conformity: a declaration issued by the Client under his/her exclusive responsibility, declaring that a given product conforms to a specific reference legislation document.



Product: result of the Client’s activities which must conform to preset specifications, national or international laws, requirements developed by the Client or to other identified documents. In the case in question, the definition of personal protective equipment is defined by Regulation (EU) 2016/425 of the European Parliament and of the Council of 9 March 2016, first paragraph of article 3. In this Regulation, the term “Product” carries the meaning of a product or product family belonging to the certification plan subject to Application for EU type-examination, and the contract for the models and variants that are defined therein.

Testing: a process applied by Dolomiticert Scarl to determine the product conformity to the applicable harmonized standards or technical specifications. In these Regulations, the initial tests are necessary for the first issue of the EU Type-Examination Certificate.

EU Certification Plan: actions carried out by Dolomiticert Scarl to confirm the Product conformity. The Certification Plan is based on the requirements defined in these regulations and on specific Product requirements.

Supervised product checks at random intervals: activity during which Dolomiticert checks that the conformity of a category III PPE, subjected to a EU Type-Examination Certificate, is maintained, following the methods proposed in Annex VII of Regulation (UE) 2016/425 (Module C 2).

Quality assurance of the production process: activity during which Dolomiticert checks that the conformity of a category III PPE, subjected to a EU Type-Examination Certificate, is maintained, following the methods proposed in Annex VIII of the Regulation (UE) 2016/425 (Module D).

Supervision: actions carried out by a qualified team of Dolomiticert Scarl that visits a place agreed with the Client (manufacturing sites, warehouses, etc…) in order to carry out the control procedures on the product and/or on the manufacturing processes following the method described in “Module C 2” and/or “Module D” of the Regulation (EU) 2016/425.

Production unit: site where the Client manufactures the product subject to Application for UE type-examination or has it manufactured.

PTA (Primary Type Approval): referred to an extended EU Type-Examination Certification, the manufacturer of the Personal Protective Equipment holder of the EU Type-Examination Certificate referred to the original product.

STA (Secondary Type Approval): referred to an extended EU Type-Examination Certification, third party to which the holder of the EU Type-Examination Certificate referred to a given product (PTA) grants, based on a previous commercial agreement, the possibility to place the same product on the market under his/her own name.

Auditor: personnel qualified to execute a systematic, independent and documented process to obtain evidence of the audit and to evaluate them with objectivity, in order to establish to what extent the audit criteria were satisfied.

4. GENERAL CONDITIONS

4.1 EU Type-Examination procedure

To enable Dolomiticert Scarl to begin the EU type-examination procedure, the Client shall:

- satisfy the requirements of the certification plan for the product subject to the Application for EU type-examination,



- accept the terms and conditions established in these regulations and the product certification

contract (herein referred to as the “Application for EU type-examination”). The client must give acceptance by signing the application form for EU type-examination and by sending it to Dolomiticert.

4.2 Application for EU type-examination

The Application for EU type-examination defines:

- The applicable EU certification plan

- The product(s) subject to EU type-examination certification

4.3 Payments

The issue of the EU type-examination Certificate is subject to the payment of the current rates.

4.4 Free access to areas, information and documentation

Once a Client has started the procedure for the assessment of conformity to type based on internal production control plus supervised product checks at random intervals (annex VII of Regulation (EU) 2016/425) or for the conformity to type based on quality assurance of the production process (annex VIII of Regulation (EU) 2016/425 Module D), with Dolomiticert Scarl for category III PPEs, he/she must ensure that Dolomiticert Scarl auditors, who may be accompanied by staff from ACCREDIA, the board which accredits the activities of Dolomiticert Scarl (in its capacity as observer of the work of the Dolomiticert Scarl auditors), and personnel of the relevant authorities, have free access to the areas, information and documentation as may be necessary to conduct the sampling program, to identify and/or take samples.

In the event the Client does not grant free access to the areas, information and documentation that are necessary for the Supervision visit by the Dolomiticert Scarl auditors and/or ACCREDIA personnel, the procedure for conformity to type based on internal production control plus supervised product checks at random intervals (annex VII of Regulation (EU) 2016/425) or for the conformity to type based on quality assurance of the production process (annex VIII of Regulation (EU) 2016/425) will be interrupted, or the EU Type-Examination Certificate may be suspended or revoked if it has already been issued to the Client.

Dolomiticert Scarl will carry out the visits for supervised product checks at random intervals, but in all events within one year from the previous visit or from the date of issue of the EU Type-Examination Certificate.

4.5 Safety

The Client must ensure that all the necessary safety precautions are taken in the workplace, for the work conditions and installations during the sampling program. Whenever necessary, the Client must also inform Dolomiticert Scarl auditors and ACCREDIA personnel and personnel of the relevant authorities of any known current or potential hazards and risks, which could concern the visit and test samples, including any risks due to radiation, toxic or harmful substances, explosive elements and materials, any polluting or poisonous substances.

5. EU TYPE-EXAMINATION PROCEDURE

5.1 Offer request for EU type-examination

The Client must make a request to Dolomiticert Scarl sales office (hereinafter referred to as COM) for a preliminary offer for the EU type-examination service, giving them all the necessary



information, which can be provided by filling in the Data collection form (form M.108.2.002 asking form it directly to Dolomiticert Scarl sales office, or alternatively using another method that Dolomiticert Scarl considers suitable and complete.

If the data supplied are considered sufficient, COM will send the Client a preliminary quote together with the Application for EU type-examination (form M.16.03.001.1). Note: the preliminary quote is not a final quote for the Product EU type-examination service, but an approximate quote that must be confirmed or updated further to sending the Application for EU type-examination, the Technical Documentation and the samples for the Initial Tests.

If the data are insufficient, COM will ask the Client further detailed information. However, no preliminary quote will be forwarded until Dolomiticert Scarl feels it has all the necessary data.

Dolomiticert Scarl performs its activity considering the dimensions of the firm, the sector in which it operates, the degree of complexity of the technology of the PPE under examination and the serial or massive nature of the manufacturing process.

To do this, however, DOLOMITICERT respects the degree of rigor and the level of protection necessary to assess the conformity of the PPE to the requirements of Regulation (EU) 2016/425.

5.2 Offer acceptance for EU type-examination

The countersigning of the Application for EU type-examination by the Legal Representative of DOLOMITICERT following the final acceptance of the quote by the Client and of the general terms, formalizes the acceptance and the formalization of the contract. In absence of the countersigning by the Legal Representative of DOLOMITICERT, the contract will not be registered and, for this, it will not be binding for the Client.

5.3 Presentation of the Application for EU type-examination

Once the preliminary quote has been accepted, the Client must send Dolomiticert Scarl the completed Application for EU type-examination form.

Together with the Application for EU type-examination, the Client must also send: - The Product Technical Documentation in compliance with Annex III of Regulation (EU)

2016/425; - The number of samples for the Initial Tests as indicated in the preliminary quote.

The Client must also send anything else is required to satisfy the requirements given in the EU Certification Plan for the type of product concerned.

The Application for EU type-examination must be completely filled in to be valid. Any parts that are not applicable must be crossed out.

Dolomiticert Scarl accepts Italian and English as languages for the Application for EU type-examination and the Technical Documentation; documents in any languages other than the two official ones may be accepted at the discretion of Dolomiticert Scarl, and further to having agreed it with COM during the preparation of the preliminary quote.

5.4 Initiating the EU type-examination process for the granting of the EU

Type-Examination Certificate

On receipt of the Application for EU type-examination, Dolomiticert Scarl records it in the relevant register. Normally Dolomiticert Scarl proceeds with the Application for EU type-examination in the order in which they are recorded.

Dolomiticert Scarl will then examine the Application for EU type-examination:

- to check that it has been correctly completed and filled in (e.g. Client ID, legal representative, product type, product use, etc.).



- to check that the Product Technical Documentation referred to in the Application for EU type-

examination is complete and sufficient.

Note: if the Technical Documentation is divided into sections, there must be a general index that clearly identifies the various sections. Note: the Technical Documentation must include a review index and/or an issue date, to enable identifying any subsequent reviews and/or updates.

If Dolomiticert Scarl feels that the documentation is insufficient or incomplete, they send a written communication to the Client, specifying the non-compliant sections and requesting an update. In this case, the dossier is suspended until the Client has complied with the officially communicated requests from Dolomiticert Scarl.

Once Dolomiticert Scarl has accepted the Application for EU type-examination, COM will send written confirmation of the acceptance to the Client, by confirming the preliminary quote or by sending an updated offer, further to analysing the Technical Documentation and the initial test samples that were sent.

If the preliminary quote is confirmed or the updated quote, further to acceptance, is confirmed by the Client, Dolomiticert Scarl begins the EU type-examination procedure, by countersigning the Application for EU type-examination and registering it in the suitable register.

The initiation of the EU type-examination procedure is followed by Dolomiticert Scarl, that carries out an accurate examination of the documentation in the technical dossier, which comprises the Technical Documentation, any additional documentation and the Application for EU type-examination.

5.5 Initial tests

Together with the Application for EU type-examination and the Technical Documentation, the Client must send the number of samples of the products in question, as indicated in the initial or updated quote, if present. Note: the sample(s) shall be representative of the production. For PPE produced in series where each item is adapted to fit an individual user, specimens shall be provided that are representative of the range of different users, and for PPE produced as a single unit to accommodate the special needs of an individual user, a basic model shall be provided.

The Client must precisely identify the samples for the initial tests that are to be sent to Dolomiticert Scarl, as indicated in the quote.

Dolomiticert Scarl carries out the initial product conformity evaluation tests in its own laboratories, if possible.

If the outcome of the initial tests does not conform to the requirements established in the Technical Documentation, Dolomiticert Scarl will inform the Client of the non-conforming areas with details of the discrepancies that were found.

The Client must then evaluate the causes of the non-conforming outcome and, in the timeline agreed with Dolomiticert Scarl, he/she may submit new samples to repeat all or part of the test cycle, in accordance with the indications in the quote sent by COM and/or the updated Technical Documentation and Application for EU type-examination.

In the event the non-conformity persists, or if the Client does not submit new samples to repeat the tests, Dolomiticert Scarl will consider the EU type-examination procedure as completed with a negative outcome.

Dolomiticert Scarl will charge the Client for the costs of sending the samples and carrying out the tests.



The outcome of the initial tests and any additional tests is documented by Dolomiticert Scarl laboratories in their Test Reports.

Where applicable, the quantity of samples required in the quote include also the reference samples, that are preserved as reference by Dolomiticert Scarl.

5.6 Tests subcontracting

Due to excessive workload or to lack of suitable equipment, Dolomiticert can subcontract the tests to external qualified laboratories. The name of the appointed laboratory will be previously communicated to the client who will be asked to approve it. Anyway, the appointed laboratory is kept under control by Dolomiticert; a preferential title of choice is the accreditation of the selected laboratory for the test which is subcontracted in compliance with standard UNI CEI/EN ISO 17025:2005.

5.7 Issuing the EU Type-Examination Certificate

5.7.1 The documentation concerning the examination of the Application for EU type-examination and the initial tests is checked by the Executive Technical Board of Dolomiticert Scarl.

After ascertaining that all the requirements of the EU type-examination plan have been fully satisfied, the Executive Technical Board sends its decisions to Dolomiticert Scarl Certification Board Manager, written in a decision report. Further to a mandate from the Board of Directors, Dolomiticert Scarl Certification Board Manager ratifies the decisions of the Executive Technical Board concerning the granting of the EU Type-Examination Certificate.

5.7.2 When Certification is granted, Dolomiticert Scarl Certification Board Manager issues the EU Type-Examination Certificate, which bears the certificate “number” and issue date on each page.

The EU Type-Examination Certificate is the official Dolomiticert Scarl document which declares that the product in question conforms to the provisions of current applicable legislation with reasonable reliability.

Two copies of the EU Type-Examination Certificate are issued: one is sent to the Client and the other is archived by Dolomiticert Scarl for a period of five (5) years from the deadline of the Certificate itself. The Client shall retain his/her copy of the EU Type-Examination Certificate for a minimum of ten (10) years from the date of the last placing on the market of the product. Each copy is signed and endorsed on each page with the stamp and initials of the legal representative or of the Certification Board Manager, if duly appointed to do so. Note: The EU Type-Examination Certificate is the property of Dolomiticert Scarl.

The official languages for producing the EU Type-Examination Certificate are Italian and English.

5.7.3 In the event that EU type-examination exam is not granted, the Client is notified in writing about the reasons of the decision, with details of any differences as against the requirements of the applicable EU type-examination plan. The Client has a maximum of 720 (seven hundred and twenty) days to correct these differences or any other shorter period of time as established by Dolomiticert Scarl.

After 720 (seven hundred and twenty) days, the Contract expires and the Client will have to begin the EU type-examination procedure from the beginning.

5.7.4 Should the Client not accept the decision of Dolomiticert Scarl, s/he may require an additional investigation explaining the reasons why s/he does not agree, following the method to be found under article 17 of these Regulations.



5.7.5 Once the EU Type-Examination Certificate has been issued, the Certification Board

Manager passes this information to the notifying authorities. Note: the Commission, the Member States and the other notified bodies could obtain, upon request, a copy of the EU Type-Examination Certificate and/or the relevant supplements. Upon justified request, the Commission and the Member States could obtain a copy of the Technical Documentation and of the results of the exams performed by DOLOMITICERT.

Particularly, DOLOMITICERT will inform the notifying authorities:

a) of any refusal, limitation, postponement or withdrawal of an EU Type-Examination Certificate or approval;

b) of any circumstance that could affect the scope or the condition of the notification;

c) of possible requests of information received by market supervisory authorities related to the activity of evaluation of conformity;

d) upon request, of the activities of evaluation of conformity executed in the scope of their notification and of any other activity, included cross-border and sub-contracting ones.

In addition, Dolomiticert will supply to the other notified bodies information regarding questions concerning negative outcomes and, upon request, positive outcomes regarding the evaluation of conformity.

5.7.6 Further to the issue of the EU Type-Examination Certificate, the Client is authorised to market the product subject to certification, and may apply CE marking to the product.

5.7.7 Dolomiticert Scarl reserves the right to retain one or more samples of the products that were submitted to tests in its archives.

5.8 Validity of the EU Type-Examination Certificate

The validity period for an EU Type-Examination Certificate is a maximum of 5 years from the date of first issue or the date of renewal.

The EU Type-Examination Certificate will not be renewed automatically.

If the Client wishes to renew the EU Type-Examination Certificate, a simplified review procedure is applied. The Client has to supply Dolomiticert with the following:

- his/her name and address and data identifying the EU type-examination certificate concerned;

- confirmation that there has been no modification to the approved type, including materials, sub-components or sub-assemblies, nor to the relevant harmonised standards or other technical specifications applied;

- confirmation that there has been no change in the state of the art;

- where not already supplied, copies of current product drawings and photographs, product marking and information supplied by the manufacturer;

- for category III products, where not already available to the notified body, information on the results of the supervised product checks at random intervals, or on the results of audits of the manufacturer’s quality system.

- a document signed by PTA and STA that includes what is referred to under points 1 to 6 or chapter 6.2, in case of renewal of an extended EU Type-Examination Certificate (for this scope forms M.16.03.005 or M.16.03.006 sent by Dolomiticert could be used).

If Dolomiticert confirms that no modifications have been made to the examined type and that no evolution on the state of the art has taken place, the simplified review procedure is applied and no



tests and exams are performed; in that case, Dolomiticert renews the EU Type-Examination Certificate.

The Client is free to submit any additional documents to support the application for renewal, e.g. independent product certifications, independent quality system certifications, etc.

The submitted documents will be reviewed against the requirements of the latest version of the PPE Directive within two (2) months after receipt of all the required information and data.

If, after analysing the documents as explained above, Dolomiticert Scarl finds any differences or failings, the Client will be requested to address these before certification is re-issued.

If Dolomiticert Scarl has any doubts about the current Product being the same as the one which was certified, it will be free to ask for more information, detailed drawings, photographs etc. and, if deemed necessary, a sample of the model that is being questioned.

If the harmonised standards, used to evaluate product conformity, have been revised and published in the Official Journal of European Union, Dolomiticert Scarl will review the changes against the existing data. Any requirements not satisfactorily addressed will be subject to Product testing before the EU Type-Examination Certificate is re-issued. If an EU Type-Examination Certificate is not based on a harmonised standard, the technical specification adopted shall be reviewed against the PPE Regulation to take into account evolution in associated or applicable standards.

The earliest application can be made 12 (twelve) months before the expiry of the EU Type-Examination Certificate and to ensure continuity of the certificate the application for renewal shall be made at least 6 (six) months before the expiry date.

If the harmonised standards and/or technical specifications used to assess Product conformity have been superseded / amended and published in the Official Journal of European Union within 12 (twelve) months before the expiry date of the EU Type-Examination Certificate, the validity of a certificate may be extended by a maximum of 12 (twelve) months to give the Client sufficient time to comply with the revised / amended version.

DOLOMITICERT follows the evolution of harmonised standards used to assess conformity and, in case of changes and revision of the standards, it evaluates if the Type-approved product is no longer compliant with the applicable essential health and safety requirements. DOLOMITICERT determines whether such changes require further investigation and, if so, it informs the manufacturer. The Client shall grant that PPE will continue to satisfy the applicable essential health and safety requirements in light of possible changes in harmonized standards. The Client will ask DOLOMITICERT to review the EU Type-Examination Certificate in the case of evolution of the technical harmonized standards. In case that the EU Type-Examination Certificate, following in the applicable harmonized standards, is modified, updated, extended or revised, this fact does not change its deadline date.

6. MODIFICATION OF THE DEVICE AND EXTENSION OF THE EU

TYPE-EXAMINATION CERTIFICATE

6.1 Changes to the certified Product by the Client

If the Client intends to make any changes to a Product that has already been granted EU type-examination Certificate, or changes to the EU type-examination Certificate that has been issued, a specific request must be sent to Dolomiticert Scarl.

If the changes the Client intends to make are minimum, such as they don’t alter substantially the protective and constructive characteristics the Product had been certified for (that is, modifications



that don’t influence the conformity of the product with respect to the essential health and safety requirements or to the conditions of validity of the Certificate), there is no need to review the EU type-examination Certificate. If required, the Client will send Dolomiticert Scarl a copy of the revised Technical Documentation. In the event Dolomiticert Scarl feels it is necessary, it will request a number of samples in order to carry out tests to confirm that the original protective features of the product have been maintained. The costs of these tests are charged to the Client. The Client must sign and return the offer received from COM to Dolomiticert Scarl, together with the number of samples that have been requested. If the outcome of the controls is successful, Dolomiticert Scarl sends the Client a written declaration stating that it has taken note of the request and authorizes the changes. If the outcome of the controls is unsuccessful, Dolomiticert Scarl sends the Client a written declaration stating that it does not authorise the production of the changed product.

If the Client intends making substantial changes to the Product, which alter substantially the protective and constructive characteristics the Product had been certified for (that is modifications that influence the conformity of the product with respect to the essential health and safety requirements or to the conditions of validity of the Certificate), or intends to add some variants or to extend the field of application, the EU type-examination Certificate must be reviewed. The costs for the review of the EU type-examination Certificate and the tests are charged to the Client. COM will send the Client a quote, and if the Client accepts the quote it must be returned signed to Dolomiticert Scarl together with the revised Technical Documentation and a new Application for EU type-examination, with the number of samples that are required for the tests as specified in the quote. If the outcome of the document analysis and the tests is successful, Dolomiticert Scarl will use a revised EU type-examination Certificate. If the outcome of the document analysis and/or the tests is not successful, Dolomiticert Scarl will send a written notification to the Client. In the timeline agreed on with Dolomiticert Scarl, the Client may then submit the Technical Documentation for a new review and/or new samples to repeat all or part of the tests. Dolomiticert Scarl documents the test results in their Test Reports.

If the review of the EU type-examination Certificate is successful, the original certificate number is maintained adding the code “Rev. X”, where “X” is the progressive review number that is issued, beginning from 1.

If the changes mean that the product is completely different from the original certified product, the EU type-examination Procedure must be repeated as if it were a new product. In this case the method is followed as outlined in Article 5 of these Regulations.

It is hereby specified that, if a Client requires some changes to the EU type-examination Certificate due to the change of the Corporate name and/or Headquarters, it is necessary to proceed with the revision of the EU type-examination Certificate.

6.2 Extension of product EU Type-Examination Certificate

The extension of the EU Type-Examination Certificate is the procedure by which a person, the client, holder of the EU Type-Examination Certificate valid for a particular product (hereinafter PTA - primary type approval), agrees to personalize its product with an identification, which declares another person as manufacturer (hereinafter STA - secondary type approval). STA will market the product under its own name and PTA will maintain the responsibility related to the conformity of the production of the certified device.

The extension of the product EU Type-Examination can only be activated if the PTA is the holder of a valid EU-Type Examination Certificate issued by Dolomiticert.

The request for extension is signed by the PTA; the quote made by Dolomiticert must be accepted by the PTA and the STA. The Application for EU type-examination and the Technical Documentation must be submitted and signed by the STA.



The procedure provided for in paragraph 5 of this Regulation must be applied in order to start the extension procedure. The tests, as provided for in paragraph 5, in this case are not required and, in particular, the client must:

- Submit a document signed by PTA and STA that includes what is provided for in points 1 to 6 listed below, as specified in FAQ RFU no. PPE-R/00.047 Version 1 dated 12/06/2017. The agreement must be to enclosed with the Application for EC Certification (section 5.3).

1. Declaration that the Product object of the extension is physically identical to the product covered by the EU Type-Examination Certificate, where the number and issue date shall be quoted.

2. Being understood what is stated in the previous point, a declaration on the possible differences between what is stated in the original EU Type-Examination Certificate and what is required (e.g. reduction in the number of versions of the certified product).

3. Declaration by the PTA who holds the original EU Type-Examination Certificate, that only the Product that conforms with the requirements of said original EU Type-Examination Certificate will be given to the STA for whom the extension of the EU Type-Examination Certificate is requested.

4. Declaration that PTA is obligated to inform the STA and Dolomiticert of any changes which may affect the validity of EU type-examination Certificate is that, in the case of class III PPE, the monitoring procedures of product/production in accordance with “Module C 2” and/or “Module D” of the Regulation (EU) 2016/425.

5. Declaration that PTA is obliged to inform and STA and Dolomiticert Scarl of any changes s/he proposes to make to the Product before implementing the change as specified in paragraph 6 of this Regulation.

6. Declaration that PTA and STA reciprocally exchange information about any incidents involving the Product subject of the agreement.

Once the procedure has been completed, Dolomiticert Scarl will issue a new EU Type-Examination Certificate to STA.

The expiration of the extended EU type-examination Certificate issued to the STA will match the expiry date of the original certificate issued to the PTA by Dolomiticert and in any case it will be of no more than 5 years. It may be revoked in advance in the event the aforesaid conditions are no longer valid, in particular if the EU Type-Examination Certificate issued to PTA to whom extension was granted should expire for any reason (paragraph 11). The extended certificates issued to STA are strictly linked to the relevant PTA primary certificate from which they descend (see § 11, 12 and 13).

Dolomiticert, except for specific agreements between PTA and STA, will perform – if applicable – the product/production surveillance according to “Module C 2” and/or “Module D” of the Regulation (EU) 2016/425 to PTA.

Dolomiticert, however, could perform checks at STA when deemed necessary to grant the conformity of products, also regardless of possible agreements between PTA and STA.

As for the product/production quality control procedure in accordance with “Module C 2” and/or “Module D” of the Regulation (EU) 2016/425, the following cases apply:

1. The PTA entrusted Dolomiticert with quality control: in this case Dolomiticert does not need to carry out a further control on the STA.

2. Both the PTA and the STA entrusted a body other than Dolomiticert with quality control: in this case Dolomiticert’s action is limited to the issuing of an EU type-examination certificate to STA.



3. The PTA entrusted a body other than Dolomiticert with quality control, and the STA wants

to entrust Dolomiticert with quality control: in this case Dolomiticert will carry out the control on STA.

7. CERTIFICATION VALIDITY

7.1 EU Type-Examination Certificate validity conditions

The validity of the EU type-examination is subject to the Client maintaining the conditions for which it was granted.

Any changes to the conditions whereby EU type-examination was granted must be immediately notified to Dolomiticert Scarl in compliance with Article 8.3 of these Regulations.

Further to the aforesaid notification, Dolomiticert Scarl reserves the right to decide any actions that should be taken to evaluate and guarantee that the conditions for which certification was granted are maintained.

8. RIGHTS AND OBLIGATIONS OF CLIENTS HOLDING EU TYPE-

EXAMINATION CERTIFICATE

8.1 Publicising the EU Type-Examination Certificate

The Client has the right to publicise its EU type-examination Certificate in the manner s/he considers most suitable, as long as s/he correctly refers to the field of application and the limits of the EU type-examination Certificate that has been obtained and/or the EU type-examination Certificate number.

In the user information, the Client must not give any information that could mislead them into considering that any product performances that are not provided in the applicable and/or applied EU type-examination Plan are covered by the EU type-examination Certificate. The instructions and other information that accompanies the product (instruction manual, etc.) and which refer to a specific EU type-examination Plan, must be approved by Dolomiticert Scarl if so required in the aforesaid EU type-examination Plan.

8.2 Client’s obligations

The Client who holds EU type-examination Certificate undertakes:

- to maintain unchanged all the conditions that enabled EU type-examination Certificate to be granted;

- to manufacture the product in compliance with the requirements established by applicable standards, these Regulations, the provisions of the Technical Documentation and other legislative documents used for the production of the samples that are approved by Dolomiticert Scarl;

- to allow access to Dolomiticert Scarl auditors and ACCREDIA personnel, in those circumstances provided for by these Regulations;

- investigation of complaints.



- to keep a record of all complaints made that s/he is aware of relating to compliance with

certification requirements and to make those records available to Dolomiticert when requested, and:

1. to take appropriate actions with respect to such complaints and any deficiencies found in production that affect compliance with the requirements for certification;

2. to record the actions taken;

- not to use its EU type-examination Certificate issued by Dolomiticert in such a way as to bring Dolomiticert into disrepute and not to make any statement regarding its product certification that Dolomiticert may consider misleading or unauthorized (see article 10);

- to present an application for EU type-examination for the device, which shall be certified, only to Dolomiticert and not to other Notified Bodies.

8.3 Changes to EU type-examination Certificate issuing conditions

If a Client wishes to change the conditions that enabled EU type-examination Certificate to be issued, a request must be made to Dolomiticert Scarl who begins the necessary process, as given in articles 13.1 and 13.2 of these Regulations.

8.4 Free access to the Client’s organisation

The Client who holds EU type-examination Certificate undertakes to grant fee access to Dolomiticert Scarl auditors and ACCREDIA personnel and personnel of the relevant authorities for their inspection and supervision visits, at any time during working hours, and to implement all corrective actions that may be required should they find any discrepancies.

8.5 Forbidden use of EU type-examination Certificate

The Client undertakes not to use the EU type-examination Certificate should it be suspended, revoked or if it has expired.

8.6 Responsibilities

The EU type-examination Certificate does not release the Client from its contractual obligations and responsibilities towards its Clients and the law regarding the supplied products. Dolomiticert Scarl is only responsible for third party liability if it can be clearly demonstrated that said damage is derived from the EU type-examination activities.

9. OFFICIAL CONTROL ON THE PRODUCT AND/OR ON THE

PRODUCTION PROCESS FOR CLIENTS WHO HOLD EU TYPE-

EXAMINATION CERTIFICATES

9.1 Supervised product checks at random intervals (Module C 2)

The Client who holds an EU type-examination Certificate for a category III PPE (products subject to the application of Annex VII of Regulation (EU) 2016/425 – Module C 2 – “Conformity to type based on internal production control plus supervised product checks at random intervals”), must adopt all the necessary measures to guarantee that the production process, including the intermediate and final controls, guarantees uniformity of production and conformity with the provisions of the EU type-examination Certificate.



If necessary, and if it is appointed to do so, Dolomiticert Scarl will implement the quality control procedure on the production by means of product tests under official control performed randomly (Module C 2) for the Client who holds EU type-examination Certificate for a category III PPE, in order to verify the homogeneity of the production and the conformity of the product compared with the whole production since the last control performed. This control procedure for production by means of product tests under official control performed randomly takes place through an adequate statistical sampling procedure of the product produced, followed by adequate tests based on the applicable technical harmonized standards and/or equivalent tests specified in other technical specifications in order to check the conformity of the PPE with the type described in the EU type-examination Certificate and with the applicable essential health and safety requirements.

The sampling of the product to be evaluated, performed by Dolomiticert Scarl auditors, who may be accompanied by ACCREDIA personnel, is carried out at least once a year in a place agreed with the Client, randomly, on the available stocks of the Manufacturer, in order to be representative of the product under examination.

Before placing the category III PPE on the market, the client shall submit an application for supervised product checks at random intervals to DOLOMITICERT or another notified body of its choice.

If the notified body chosen is DOLOMITICERT, the Client shall submit the Application for supervised product checks at random intervals (form M.16.108.2.004) duly filled in.

If DOLOMITICERT is not the notified body that has performed the EU type-examination procedure, this Application shall include:

- Technical Documentation of the Product; - Copy of the EU Type-Examination Certificate.

Note: DOLOMITICERT could contact the notified body that issued the EU type-examination Certificate in case of difficulty related to the evaluation of conformity for the product.

The application for supervised product checks at random intervals shall be filled in in every part to be considered valid. Non-applicable parts shall be barred.

Languages accepted by DOLOMITICERT for the application for supervised product checks at random intervals are Italian and English.

The sampling phase is normally notified to the Client by COM at least 15 (fifteen) calendar days beforehand, by sending a quote which includes the travel costs for the auditors and the tests on the sampled products. The Client must return the signed quote to COM before the date scheduled for the sampling. If the Client does not accept the sampling before the scheduled date, s/he must immediately send a written notification with the reasons for refusal (e.g. interruption of production or product check carried out by another notified body). In the event that no written statement is received within two months after COM sent the quote, Dolomiticert will initiate the procedure of suspension as provided for in paragraph 11.

Once COM receives the signed quote from the Client, the Supervision procedure begins as provided in the EU Type-Examination Plan.

DOLOMITICERT performs the sampling checking the homogeneity of the sample compared with the whole production of the product since the last check performed.

If, further to a scheduled or unscheduled sampling activity, it is found that production is not uniform or that the examined product samples do not conform with the type described in the EU type-examination Certificate, harmonised standards and/or applied specifications, Dolomiticert Scarl informs the Client in writing, calling on them to analyse and eliminate the discrepancies that were found within a set deadline. Further to analysis by the Client, the phases listed below will follow:



- The Client informs Dolomiticert Scarl of the result of their analysis of the non-conformities and

the solutions they have adopted to solve the problem. - Dolomiticert Scarl decides which and how many tests are required to evaluate the product

conformity. - Dolomiticert Scarl takes new product samples and carries out the tests. - If the tests are successful, the Supervision Procedure is concluded. - If the tests are unsuccessful, the above procedure may be repeated with new analysis by the

Client of the reasons of the non-conformity, and new sampling and tests as required by Dolomiticert Scarl.

- If the second additional series of sampling tests are still non-conforming, supervised product checks at random intervals is considered concluded and the procedure will be continued as defined in Article 11 of these Regulations.

All these additional activities are charged to the Client.

Further to each audit at the Client’s premises and at the end of the quality control procedure, a “Test Report” is issued summarising the results of all the activities that were carried out and their outcome. The test report will be sent to the Client that retains it for a period of ten (10) years from the placing on the market of the product.

For the treatment of the supervised product checks at random intervals for third category devices with STA certificate – secondary Type Approval, see the conditions indicated at chapter 6.2 “Extension of product EC Type-Examination”.

9.2 Conformity to type based on quality assurance of the production

process (Module D) 9.2.1 Initial Assessment of the system to ensure production quality

In compliance with this procedure, the Client must submit an application for the approval of his/her quality control system to DOLOMITICERT.

The application includes:

• the name and address of the manufacturer and, if the application is lodged by the authorised representative, his name and address as well;

• the address of the manufacturer's premises where the audits can be carried out;

• a written declaration that the same application has not been lodged with any other notified body;

• the identification of the PPE concerned;

• the documentation concerning the quality system;

• an undertaking to respect the obligations arising from the quality-control system and to maintain its adequacy and efficiency.

The documents on the quality control system shall in particular include an adequate description of:

• the quality objectives and the organizational structure, responsibilities and powers of the management with regard to product quality;

• the corresponding manufacturing, quality control and quality assurance techniques, processes and systematic actions that will be used;

• the examinations and tests that will be carried out before, during and after manufacture, and the frequency with which they will be carried out;



• the quality records, such as inspection reports and test data, calibration data and

qualification reports on the personnel concerned; • the means of monitoring the achievement of the required product quality and the effective

operation of the quality system; • description of the means employed by the manufacturer to grant the continuous conformity

and homogeneity of the products along the time.

Regarding the quality system assurance, the manufacturer will comprise tests on the product, performed with the modalities described in Annex VII of Regulation (UE) 2016/425, with the purpose to check the conformity of the PPE with the essential health and safety requirements of the Regulation.

DOLOMITICERT assesses the quality control system to determine whether it complies with the provisions of the previous paragraph.

DOLOMITICERT will carry out the tests and, after examining the documents and then by performing a specific audit at the Client’s premises, it will assess the specific components of the quality control system, by specifically checking if the system ensures the compliance of the PPE manufactured with the approved model.

DOLOMITICERT’s decision is communicated to the manufacturer (listing the group of products included in the field of application of the manufacturer’s quality system) and it contains the conclusions of the audit and the reasoned assessment decision.

The client must inform DOLOMITICERT of any plan to alter the quality control system. DOLOMITICERT will examine the proposed changes and decide whether the altered quality control system satisfies the relevant provisions, reserving the right to make any additional audits. DOLOMITICERT’s decision will be communicated to the manufacturer.

During the manufacturing process, the manufacturer applies, under the responsibility of DOLOMITICERT, identification number 2008 near CE marking.

9.2.1.1 – Planning of the initial activities of auditing and periodical monitoring in accordance with Module D

During the organization stage of the initial auditing and periodical monitoring, DOLOMITICERT prepares the audit plan in which the duration of stage 1, of stage 2 and of the monitoring activity are specified. This planning is written on the relevant forms and the duration of the above mentioned activities is worked out by DOLOMITICERT DOC in compliance with document IAF Mandatory Document For Duration of QMS and EMS Audits Issue 1 (IAF MD 5: 2009). Such information is communicated to the client by Dolomiticert sales department.

9.2.1.2 – Initial assessment

The initial assessment is made up of two stages:

- Phase 1: Analysis of the documents and assessment of the quality assurance system of the production process (STAGE 1);

- Phase 2: Audit on the quality assurance system of the production process (STAGE 2).

Stage 1 – Analysis of the documents and assessment of the quality assurance system of the production process

Phase 1 of the analysis of documentation is realized in the form of document review, which can be performed on-site or off-site. The activity of checking the management system is always carried out



at the headquarters of the organization. The activity of checking the setting of the management system is always carried out at the headquarters of the organization.

a) The documentary analysis includes the study of the documents / information and compliance with the requirements of specified standards.

• Manual of the quality system of the manufacturer; • Organization structure and related responsibilities; • Procedures and instructions that define the production process; • Procedures and instructions that define the controls to be performed on the product in the

various phases of the production process (beginning, during process, final, …); • Procedures that grant the supplying of components and raw materials in compliance with

the approved type, as described in the technical file; • Procedures that grant the metrological conformity of the measurement instruments used as

control of the production process in the control activities of the product along the phases of the production process;

• Procedures that describe the modalities adopted to check the documents and their revisions;

• The procedure for the management of the products not in compliance (remedial and preventive actions);

• The procedure for the management of training; • The procedure for the planning and the conduction of the internal audit with related records.

b) The audit carried out at the Client’s production department has the aim to verify mandatory elements such as: (list not-exhaustive):

• the field of application and the degree of the system operation; • the level of training and competence of Client’s employers, and the level of the Client’s

understandings regarding applicable requirements referred to each Standard; • the planning of internal audits and its execution and reviewing by management; • the level of implementation of the management system which shall provides evidence that

the organization is ready for the second stage audit;

Outcomes and conclusions of the initial check (stage 1) are included into an audit report. This audit report highlights the critical issues (reliefs) observed during the activity of checking. The report identifies issues that, in the audit of Phase 2, could be classified as non-conformities (major/minor).

Stage 2 – Audit on the quality assurance system of the production process

The assessment (production process assessment) is carried out in compliance with the pattern checklists (checklist developed in compliance with requirements of standard UNI EN ISO 9001:2008, specific checklists developed according to product technical standards) that shall be filled in with objective tests.

Non-conformities management methods to be followed by clients can be found in paragraph 9.3.

The client will be informed about the methods to effectively solve the Non-conformities found, which may include document review or an additional audit.

9.2.2 Verification activity for quality assurance of the production process

The purpose of supervision carried out by Dolomiticert is to ensure that a manufacturer correctly fulfils the obligations arising from the approved quality-control system.

The Client shall authorize Dolomiticert to have access, for inspection purposes, to PPE inspection, testing and storage sites and shall provide the body with all necessary information, in particular:



• documentation on the quality-control system; • technical documentation; • quality records.

Dolomiticert will carry out periodically, and however at least once a year, audits to ensure that the Client is maintaining and applying the approved quality-control system. At the end of the audit Dolomiticert will issue a detailed audit report. Dolomiticert reserves the right to make unannounced visits to the Client.

9.2.2.1 – Monitoring audit

The monitoring audit takes place in one single stage to be carried out at the production plant.

The assessment (production process assessment) must be carried out in compliance with the pattern checklists (checklist developed in compliance with requirements of standard UNI EN ISO 9001:2008, specific checklists developed according to product technical standards) which must be completed by objective tests.

Non-conformities management methods to be followed by clients can be found in paragraph 9.3

The client will be informed about the methods to effectively solve the Non-conformities found, which may include document review or an additional audit (see paragraph 9.2.1).

9.2.2.2 – Additional audit

The additional audit takes place in one single stage to be carried out at the production plant.

The assessment (production process assessment) must be carried out in compliance with the pattern checklists (checklist developed in compliance with requirements of standard UNI EN ISO 9001:2008, specific checklists developed according to product technical standards) which must be completed by objective tests.

In particular, the additional audit aims at assessing the effective solution of the main Non-conformities found during the initial audit (stage 2) or the monitoring audit.

For the final report on the outcome of the additional audit it is necessary to use a specific form which lists the facts related to the solution of the major NC previously noticed and/or the possible non-conformities/observations; this report is shared and subscribed by the Client for acceptance.

9.2.3 Classifying findings

Subsequent to the audit the following kinds of findings can be noticed, recorded and communicated to the Client (through the audit report): major non-conformities (impedimental to the certification of the quality system to ensure production quality), minor non-conformities (non impedimental to the certification of the quality system to ensure production quality, which must nonetheless be taken into account by the Client) and remarks. • In case of “major non-conformities”:

the Client must analyze their causes and tell DOLOMITICERT how s/he wants to solve the non-conformity within a time set by DOLOMITICERT (the actions planned by the client to solve a major non-conformity must be accepted by the GIAM). Further to the Client’s written communication of the closing of cause analysis and of the solution of the non-conformities found, COM sends the Client a written quote for a further visit, in order to organize another audit and ascertain the effective solution of the non-conformity. In the quote the cost of the audit is clearly stated together with the date of the scheduled visit. After the Client accepts the offer, the method explained in point 9.2.1.2 of this procedure must be followed.



If, during the visit, the GIA finds major non-conformities, which have not been solved effectively, the procedure explained in this point must be resumed with a second additional visit.

• In case of “minor non-conformities”: the Client must analyze their causes and tell DOLOMITICERT how s/he wants to solve the non-conformity within a time set by the client (the actions planned to solve a minor non-conformity must be accepted by the GIAM). The management of minor non-conformities will be reviewed during the monitoring audit scheduled for the following year.

• In case of “remarks”: they point out situations where improvement is possible, or situations of possible weakness which could potentially lead to a non-conformity if they are not previously corrected.

9.3 Client’s duties and responsibilities

9.3.1 Acceptance of conditions

The Client must accept the conditions set out in these regulations and in the quote drawn up by DOLOMITICERT.

9.3.2 Access to the premises

The Client must grant DOLOMITICERT’s inspectors free access to the production plant in order to enable them to carry out the planned and necessary activities to collect sufficient information and objective evidence about the compliance of the internal audit service.

If significant parts of manufacturing are carried out at the manufacturer’s suppliers’ plants, also such plants could be subject to the audit activities.

Pursuant to current laws on safety and accident prevention on the workplace, the Client undertakes to give DOLOMITICERT’s inspectors all the necessary information about possible risks of the workplace where they are also going to work, and s/he guarantees that all possible precautions to protect the inspectors’ health have been taken.

9.3.3 Presence of observers from Control/Accreditation Bodies

The Client undertakes to let observers appointed by Control/Accreditation Bodies enter the plants to carry out their tasks of control and monitoring of the activities carried out by DOLOMITICERT as Certification and Control Body.

Such observers will be accompanied by DOLOMITICERT staff at all times. The communication of these observers’ presence might be given with a short notice (less than 3 days), and the Client cannot claim this as a reason for not accepting their presence. Non-acceptance of the presence of these observers by the Client causes the suspension of the certification in force, and its possible future withdrawal, if such refusal persists. 9.3.4 Client’s responsibilities

By asking DOLOMITICERT to monitor the quality system of production in compliance with Annex VIII of the Regulation (EU) 2016/425, the Client takes on the responsibility to:

a) ensure that the approved production quality system is kept active and effective in order to guarantee the compliance of the manufactured PPE with the type approved.

b) detect the need to carry out the necessary adjustments to the PPE and/or to the technical documents describing it (technical file) in case of updates of the harmonized standards



which stand at the basis of the presumption of compliance of the PPE, which are manufactured and are subject to production check by DOLOMITICERT.

c) inform DOLOMITICERT about any significant change in manufacturing procedures or in assessment and control methods which could affect manufacturing uniformity. This point includes the change of the PPE manufacturing plant.

d) give full cooperation to the person sent by DOLOMITICERT to carry out the assessments.

10. INCORRECT USE OF EU TYPE-EXAMINATION CERTIFICATE It is incorrect to use the EU type-examination Certificate if it could mislead the users of the technical, commercial and advertising information.

In particular, the use is incorrect in the following cases, which are just an example and not a complete list:

- If EU type-examination Certificate has not been granted or has been suspended or revoked.

- If the Client makes changes to the product that have not been notified to and accepted by Dolomiticert Scarl.

- If the Client fails to implement a change to the conditions for the issuing of the EU type-examination Certificate that are issued by Dolomiticert Scarl.

- If there are circumstances that could have a negative effect on the conditions that enabled the issuing of the EU type-examination Certificate.

- If the Client has waived its EU type-examination Certificate.

11. EU TYPE-EXAMINATION CERTIFICATE SUSPENSION OR

WITHDRAWAL

11.1 Suspension

Suspension of the EU type-examination Certificate issued by DOLOMITICERT

Dolomiticert may decide to suspend the Product EU type-examination Certificate due to failure to observe the requirements of the Certification Plan, which are revealed by Supervision activities or which Dolomiticert has learned in any other way, or due to failure to observe these Regulations.

Dolomiticert informs the Client about the suspension by recorded delivered letter, stating the conditions according to which suspension can be revoked.

Suspension means that the Client cannot use the EU type-examination Certificate issued by Dolomiticert in any form, and cannot market the products with CE marking which are stocked in the warehouse or which are being produced.

Suspension can only be revoked once Dolomiticert has ascertained that compliance with the requirements of EU type-examination Certificate has been re-established. If suspension cannot be revoked within 180 (one hundred and eighty) days, Dolomiticert will revoke the EU Type-Examination Certificate and it will communicate suspension to the competent Body, which will act according to its own procedures. Expenses due to suspension procedures met by Dolomiticert for preliminary analysis and/or checks are charged to the Client.



Suspension of DOLOMITICERT identification code

Dolomiticert may decide to suspend the identification code marking on the device with supervision due to failure to observe the requirements of the Certification Plan, which are revealed by quality control activities, or due to failure to observe these Regulations.

Dolomiticert informs the Client and the Notified Body which issued the EU Type-Examination Certificate about the suspension by recorded delivered letter, stating the conditions according to which suspension can be revoked.

Suspension means that the Client cannot use the identification code marking on the device with supervision in any way.

Suspension can only be revoked once Dolomiticert has ascertained that compliance with the requirements of EU type-examination Certificate has been re-established.

Dolomiticert will communicate revocation of the suspension to the previously involved Notified Body.

If suspension cannot be revoked within 180 (one hundred and eighty) days, Dolomiticert will communicate this to the competent Notified Body, which will revoke the EU type-examination Certificate according to its own procedures.

Expenses due to suspension procedures met by Dolomiticert for preliminary analysis and/or checks are charged to the Client.

11.2 Withdrawal

Dolomiticert Scarl may decide to withdraw Product EU type-examination Certificate further to:

- serious failure to observe the requirements relative to the application of articles 7, 8, 9 and 10 of these Regulations;

- failure to reinstate the conditions that caused suspension within 180 (one hundred and eighty) days, as established in article 11.1 of these Regulations;

- repeated failure to observe the commitments undertaken with Dolomiticert Scarl to solve any discrepancies from the requirements that have been revealed and notified further to quality control activities;

- other serious breaches of the Contract;

- notice of revocation by another notified body responsible for quality control procedure of the product/production in accordance with Module C 2 or Module D of Regulation (EU) 2016/425;

- bankruptcy or winding up of the Client;

- the refusal of Dolomiticert Scarl to accept the changes as given in articles 13.2 and 13.3 of these Regulations.

Dolomiticert Scarl notifies the decision to revoke the certification by means of a registered letter to:

- the Client, ACCREDIA and the Relevant Authority in case of EU Type-Examination Certificate issued by Dolomiticert;

- the Client, ACCREDIA and the relevant Notified Body in other cases.

Further to withdrawal, the Client:

- must communicate DOLOMITICERT the withdrawal plan of the product subject to revocation specifying the number of items and the timetable which the withdrawal will follow. Such Plan will be communicated to the relevant body which will supervise the application of the plan itself;



- must return the original EU Type-Examination Certificate to Dolomiticert or the relevant

Notified Body;

- must not use any copies or duplicates of the EU type-examination Certificate;

- must eliminate all references or symbols regarding EU type-examination Certificate from all the technical and advertising documentation and from the products;

- must not market nor place into the EU or extra-EU market products with CE marking and/or with DOLOMITICERT identification code (which are stocked in the warehouse and/or which are being manufactured) referring to the EU Type-Examination Certificate which has been revoked.

Dolomiticert Scarl, acting as Notified Body of reference will cancel the Client’s EU type-examination Certificate from the Register as given in article 5.5.5 of these Regulations, and will publicise the matter as it thinks most suitable and will define any safeguarding actions to be taken.

If another Notified Body has been involved in the withdrawal process, it must be responsible for the above mentioned procedure, according to its internal policies.

A Client whose certification has been withdrawn by Dolomiticert Scarl or another Notified Body may only submit a new Application for EU type-examination for the same product only after demonstrating that all the measures that Dolomiticert Scarl feels are necessary to prevent the non-conformities that generated the withdrawal have been implemented in the meantime.

12. WAIVING EC CERTIFICATION A Client may waive the EU type-examination Certificate that has been issued:

- if the products are no longer produced in the factories indicated in the Application for EU type-examination, as given in article 5.1 of these Regulations;

- if the changes are not accepted as given in article 13.1 of these Regulations.

In the latter case, the waiver is effective 90 (ninety) days after the date the Client’s refusal to accept has been received. Such refusal must be sent within 30 (thirty) days from the date Dolomiticert Scarl notification regarding the changes to the conditions for issuing EU type-examination Certificate or the notification to the Client of the proposed changes has been received.

In the case of ceased production, the waiver has immediate effect on the date the Client sends written notification by means of a registered letter or equivalent official communication.

In the case of waiver, the Client is obliged to implement all the actions established in article 11.2 of these Regulations.

Further to waiver by the Client, Dolomiticert Scarl may decide actions to take regarding the EU type-examination Certificate, similar to those provided in article 11.2 of these Regulations.

Furthermore, waiver by the Client involves the cancellation of the issued EU type-examination Certificate from the Register as given in article 5.5.5 of these Regulations and subsequent actions.



13. AMENDMENTS TO EU TYPE-EXAMINATION CERTIFICATE

VALIDITY TERMS

13.1 Amendments made by Dolomiticert Scarl

In the case Dolomiticert Scarl makes any amendments to the terms for issuing or maintaining EU type-examination Certificate further to changes:

- in reference legislation for the product,

- in these Regulations,

- in the evolution of the generally recognised state of technology,

Dolomiticert forwards the revised Regulations to the Committee for Impartiality which must give its advice, and to Accredia.

The same revised Regulations are then sent to all Clients registered in the Record of Clients holding EU type-examination Certificates, or who have submitted their Application for EU type-examination Certificate, by using a method giving proof of correct transmission. Clients must adapt to the new provisions within the deadline which is set and is considered the best by Dolomiticert depending on the extent of the changes which have been applied.

If the Clients do not accept the change/s, they may waive their EU type-examination certificate as long as they notify Dolomiticert in compliance with the method stated in point 12 of these Regulations. After 30 (thirty) days with no communication from the Client, the new version of the Regulations is considered accepted by tacit consent.

Dolomiticert reserves the right to verify the conformity of the adequacy of the certified product to the new provisions, by repeating the type testing on the new product samples or by requesting additional documentation.

The expenses for any additional controls are charged to the Client.

13.2 Changes by the Client

A Client who intends to apply some changes that could affect the conformity of the product with the applicable EU type-examination procedure, must immediately notify Dolomiticert Scarl.

Dolomiticert Scarl:

- notifies the Client in writing within 30 (thirty) days from receipt of the notification, of the need to repeat all or part of the checks stated in articles 5.2, 5.3 and 5.4 of these Regulations;

- notifies the Client if the changes have not been accepted.

If the Client does not accept the decisions of Dolomiticert Scarl, s/he may waive their EU type-examination Certificate as long as s/he notifies Dolomiticert Scarl in the way set in article 12 of these Regulations.

The expenses for the new checks are charged to the Client.

13.3 Other changes

Changes to the Client’s organisation, company name or ownership will not affect EU type-examination Certificate, as long as:

- Dolomiticert Scarl is immediately notified in writing;



- Dolomiticert Scarl has controlled that the changes comply with the applicable EU type-

examination procedure.

The costs regarding the checks carried out by Dolomiticert Scarl are charged to the Client.

14. CONFIDENTIALITY

All paperwork (documents, letters, notifications, etc.) and information regarding certification, from when the Application for EU type-examination is submitted, are considered as confidential and access to them is governed by a specific procedure.

The only information that Dolomiticert undertakes to communicate to all those who require it, with a specific written request to be sent by fax and / or to the email address listed on the website of Dolomiticert, are those contained in the issued certificate (without need of any authorization by the Client).

Dolomiticert Scarl personnel is obliged to secrecy for all the information concerning the activities referred to Annex V, VII and VIII of Regulation (EU) 2016/425 or any other provision of national law that could affect it, but not the relevant Authorities of the Member State where it performs its activity.

Property rights are protected.

Dolomiticert Scarl personnel at all levels, and external personnel involved in the supervision, tests and EU type-examination procedures who may gain knowledge of the information contained in these documents and other information regarding the Clients that Dolomiticert Scarl has EU type-examination agreements with, are all subjected to the professional secrecy act.

In the event law establishes that certain information should be notified to any Control Authorities who request it, Dolomiticert Scarl will inform the Client of the information they have disclosed.

Further to instructions from the Client, Dolomiticert Scarl is irrevocably authorised to transmit the reports, test reports, EU type-examination Certificates and any other information, to any third parties in compliance with the current privacy law.

15. ECONOMIC TERMS

15.1 Rates

The rates for Dolomiticert Scarl services are specifically defined for each EU Certification Plan (according to the product type).

All requests for further issuing of the EU Type-Examination Certificate, except for renewal, will be subject to an additional charge as defined in the Pricelist.

15.2 Payment terms

All payments for the certification services must be paid to Dolomiticert Scarl in the manner and time as established in the quote.



16. USE OF DOLOMITICERT LOGO

The use of Dolomiticert Scarl logo must be authorized by Dolomiticert Scarl, upon request by the Client.

The Client must send a draft of how the logo will be used and details of the documents it will be used on.

The logo must respect the original proportions and colours, or must be monochrome.

The logo may only be used once express authorisation has been received from Dolomiticert Scarl.

Every EU Type-Examination Certificate, issued by DOMITICERT, within the scope of accreditation, will bear the mark ACCREDIA following the rules defined in ACCREDIA Regulation RG-09.

17. APPEALS The Client may appeal against a decision taken by Dolomiticert by sending an e-mail at the address [email protected], or by sending written communication by fax or recorded delivery letter. In order to be receivable, the appeal must:

• contain a description of the decision which is appealed against • contain a clear and detailed statement of reasons supporting the appeal • be sent to Dolomiticert within 45 days from the date of the communication which is object of

the appeal Within 7 (seven) days from receipt of the appeal, Dolomiticert gives formal communication to the Client if the appeal has been judged receivable or not and, in case of acceptability, the date within which a decision will be taken (maximum 30 days from the receipt of the appeal). Decisions taken about the appeal are communicated to the Client by fax and/or recorded delivery letter. Claims/appeals will be evaluated by Dolomiticert operators not directly involved in the case analysis.

18. CLAIMS The Client can file a claim against Dolomiticert for activities carried out within the scope of these Regulations. Dolomiticert formally manages every claim received in writing (letter, fax or email); claims made verbally are handled in a formal way if considered appropriate. The management of the claim implies:

• written reply (by letter, fax or e-mail) within 7 (seven) days from reception of the claim, with the analysis of the claim and possible actions envisaged for its management and relevant timing;

• written reply (by letter, fax or email) upon completion of the envisaged actions. Claims/appeals will be evaluated by Dolomiticert operators not directly involved in the case analysis.



19. DISPUTES Any disputes that may arise between the parties that are directly or indirectly related to the application or interpretation of these Regulations, which cannot be amicably settled between the parties, shall be referred to the exclusive jurisdiction of the Court of Belluno, as defined in the Agreement included in the Application for EU type-examination.

20. STOCKING OF REFERENCE SAMPLES Dolomiticert ensures, where possible, that at least one intact sample of the tested product is kept in its warehouse.

Date post:	22-Jun-2020
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