Certificate

1            Introduction
1.1      Definitions

1.1.1         In these Regulations the term certification is understood to mean the activities carried out by IHMQ on the basis of which IHMQ declares that a clearly described process may be relied upon to meet the requirements laid down in an evaluation guideline or any other normative document.
1.1.2         Because of definitions of general terms, reference is made to the terms and definitions stated in EN-ISO 9001: 2000 as well as to the supplementary definitions given in the applicable standards.
1.1.3         In addition, the following terms in these Regulations shall have the meanings set opposite to them:

Evaluation guideline: a document declared binding by IHMQ and containing all the requirements employed by IHMQ as a basis for certification.
Board of Experts: board in which all the parties having an interest in certification are represented. The Board of Experts works on the basis of the IHMQ-Regulations for Boards of Experts: 2003.
Supplier: the party that is responsible for ensuring that products met and continue to meet the requirements on which the certification is based.
Entrepreneur: the supplier who implements the process under his own management.
Process: a process or service.
IQC scheme (internal quality control scheme): a description of the quality inspections carried out by the supplier.
IHMQ: international institute for Health Management and Quality

1.2      Rules

The rules in connection with certification have been recorded in these regulations.

1.2.1         If IHMQ makes use of a certification scheme of an external organisation, or of a (Central) Board of Experts not set up by IHMQ, the provisions of such scheme shall apply, even if they conflict with these Regulations.
1.2.2         The certification activities shall be carried out by IHMQ employees who are qualified to do so. The relevant Board of Experts in the sector concerned have laid down the qualification requirements.
1.2.3         IHMQ may instruct third parties (independent and impartial experts, research institutes or laboratories) to carry out certification work or parts thereof. If accreditation requirements have been laid down for such third parties, IHMQ shall solely instruct third parties meeting these requirements to carry out this work. The supplier may object only once to third parties to be called in by IHMQ.

2             Certification in general

2.1        Certificate holder
2.1.1         Suppliers meeting the definition under 1.1 may be certificate holders. If the supplier is not also the entrepreneur, the supplier’s responsibility should be laid down in a written agreement with the entrepreneur, in which at least the following subjects are arranged:

  • the manner in which the supplier verifies that the work carried out by the entrepreneur meets the requirements laid down in the evaluation guideline;
  • that the supplier may demand from the entrepreneur that the work is carried out in accordance with the specification stated in the certificate;
  • that IHMQ may carry out all the required work within the scope of the certification at both the supplier’s and the entrepreneur’s works, including the taking of measures if non-conformities are found.

2.2      Meaning of the certificate

 

2.2.1         A process certificate from IHMQ means that the work carried out by or under the responsibility of the supplier may be deemed to comply with the requirements applicable to such processes and that the work carried out may, in addition, be deemed to comply with the performance requirements to be imposed thereon in accordance with the evaluation guideline.

2.2.2         A process certificate does not entitle the supplier to affix a certification mark on his products.[1]

 

2.3      Contents of the certificate

 

2.3.1         The following shall in any case be recorded in the process certificate:
•   the supplier of the process;
•   the evaluation guideline against which the process was assessed;

  • • the specification of the process;
    • • the assessment of the work carried out against the performance requirements and the application conditions to be observed;
    • • tips for customers.

 

2.4      Period of validity

 

2.4.1         A certificate is granted for an indefinite period of validity[2] .
A certificate shall lapse upon termination of the certification agreement between IHMQ and the supplier. An adaptation of the certificate is required if there is any change in one or more of the points stated under 2.3.

 

2.5        Certification agreement
For the implementation of the certification work, the supplier and IHMQ shall conclude an agreement, in which at least the following shall be recorded:

  • the nature of the services rendered by IHMQ;
  • the applicable regulations;
  • the applicable evaluation guidelines;
  • the fee payable to IHMQ.

 

2.6      Terms and conditions of delivery

 

2.6.1         The supplier undertakes that he shall carry out all the work stated in the certificate which is intended to be used in accordance with the requirements laid down in the evaluation guideline.

2.6.2         The terms and conditions of delivery of the supplier may not be in conflict with these Regulations. If this should be the case, the provisions of these Regulations shall apply.

 

2.7      Publication

 

2.7.1         The supplier may publish the fact that his process has been certified, but solely and unequivocally in respect of the work stated in the certificate.
The supplier shall be obliged, when so requested, to provide each customer with a complete copy of the certificate.

2.7.2         The supplier may make it known by means of pictograms made available by IHMQ that his process has been certified. IHMQ may give further instructions on the use of pictograms.

2.7.3         IHMQ shall annually publish a summary in which all the IHMQ certificates are included.
In addition, IHMQ shall make all information on the certificates granted under a licence available to the licensor for publication purposes. On request, IHMQ shall provide anyone with information on the validity of the certificates.

 

3             Application procedure

3.1      Information

 

3.1.1         At a supplier’s request, IHMQ shall inform the former of the main points of the application procedure, the working method to be employed in this procedure and the costs involved in certification. In addition, IHMQ shall provide the supplier with a copy of the applicable evaluation guideline and a copy of these Regulations.

3.1.2         If no evaluation guideline has been prepared yet for a process, IHMQ shall inform the supplier that no application can for the time being be dealt with for the process concerned. At the supplier’s request IHMQ shall consult the Board of Experts concerned on the preparation of an evaluation guideline. In doing so, IHMQ shall not disclose the name of the supplier without the latter’s permission.

 

3.2      Offer

 

3.2.1         At a supplier’s request, IHMQ shall submit an offer for the performance of certification work. If the supplier declares in writing that he agrees with this offer, the certification agreement referred to in article 2.5 is thereby concluded.

 

3.3      Dealing with the application

 

3.3.1         After IHMQ has received the offer with which the supplier has agreed in writing, IHMQ shall contact the supplier in order to make arrangements in respect of the tests to be conducted.

3.3.2         IHMQ shall not make any statements to third parties about the application and its consideration, except with the supplier’s permission.

3.3.3         The supplier shall not create the impression that the process for which he has submitted an application has been certified as long as the certificate has not been granted.

 

3.4      Pre-certification audits

 

3.4.1         General
The pre-certification audit to be conducted by IHMQ shall take place on the basis of the applicable evaluation guideline and shall at least include the following:

  • assessment of the performance requirements which the work to be carried out must meet;
  • assessment of the process;
  • assessment of the quality system and the IQC scheme;
  • checking the presence and functioning of the other required procedures;
  • the testing of samples, if necessary.
  • The audit shall be carried out at the supplier’s works and at the places where the work is carried out.
    The supplier shall make all samples and information relevant to assessment available to IHMQ free of charge.

3.4.2         Assessment of performance requirements
IHMQ shall, where appropriate, ascertain whether the work carried out meets the performance requirements laid down in the evaluation guideline.

3.4.3         Assessment of the process
IHMQ shall ascertain whether the supplier’s process is implemented in accordance with the requirements laid down in the evaluation guideline. The assessment shall take place while the work is being carried out.

3.4.4         Assessment of the quality system and the IQC scheme
The assessment of the quality system shall in any case include the following:

  • the presence within the structure of the organisation, of an officer in charge of the management of the quality system;
  • the presence and functioning of the IQC scheme, this scheme should offer sufficient security that the work carried out continually meets the requirements.
  • For each of these elements the supplier should have demonstrably recorded:
    • the inspection aspects;
    • the inspection method used;
    • the inspection frequency;
    • the manner in which the inspection results are recorded and kept.

 

3.4.5         Assessment of procedures

  • IHMQ shall ascertain whether the procedures stated in the evaluation guideline are present and are being used. These procedures shall invariably include the following:
    • the procedure for dealing with products showing deviations;
    • the procedure for corrective actions to be taken if non-conformities are found;
    • the procedure for dealing with complaints.

 

3.5      Procedural aspects

 

3.5.1         If -in the course of the application procedure- it transpires that there is a likelihood of the budget or time schedule being seriously overrun, IHMQ shall consult the supplier on this matter.

3.5.2         If -during the tests- it transpires that a positive decision on the granting of a certificate cannot, in all fairness, be expected, the application procedure may be terminated by mutual agreement.

3.5.3         The supplier may always withdraw his application prematurely, in which case he shall be obliged to pay the costs already incurred by IHMQ.

3.5.4         IHMQ shall submit its report within one month of completing the pre­certification tests.

 

3.6      Decision in respect of the application

 

3.6.1         IHMQ shall decide on the application within one month after the pre-certification tests have been completed. The decision will be notified to the supplier in writing.

3.6.2         In the event of a positive decision the supplier shall receive the certificate.

3.6.3         In the event of a negative decision, IHMQ shall reject the application stating the reasons for its decision in writing. As a result, the certification agreement concluded with the supplier shall terminate.

 

4             Audits

4.1        Audits in general

 

4.1.1         IHMQ shall carry out audits to check whether the supplier complies with his obligations. These audits shall take place at agreed times with the supplier.

4.1.2         The supplier shall grant the co-operation required for the audits to be carried out.

 

4.2      Carrying out audits

4.2.1         The audits shall take place at the supplier’s works and at the places where the work is carried out. The audits shall in any case include the following:

  • audits to ascertain whether the process complies with the description laid down in the certificate;
  • audits of the IQC scheme in use and the results of the audits carried out by the supplier since the previous visit of inspection;
  • audits to ascertain whether the supplier is complying with the required procedures for dealing with complaints and corrective actions;
  • audits to ascertain whether the supplier is complying with the other obligations laid down in the evaluation guideline.

4.2.2         If the supplier is not the entrepreneur who carries out the work, IHMQ shall also audit whether the agreement referred to in article is being complied with.

4.2.3         In addition to the audits referred to in article 4.2.1, IHMQ shall be authorised to check in other ways whether the supplier is complying with his obligations.

4.2.4         IHMQ shall submit a report to the supplier on the audits carried out.

4.2.5         If non-conformities are found to be present during the audits, the supplier is obliged  to indicate what corrective actions he intents to take as well as what he will do or has done already.

 

4.3 Measures to be take in case of non conformities

4.3.1         If non-conformities are found to be present during the audits, it will depend on the seriousness of such non-conformities whether or not IHMQ sees cause for taking one or more of the following measures:

a. a written warning;

b.extra audits;

c. adjustment of the IQC scheme;

  • d. suspension of the right to make use of the certificate during a specific period of time;

d.immediate withdrawal of the certificate;

e. publication of the measures stated under e. or

  1. in the media that IHMQ considers suitable for this purpose.

4.3.2         IHMQ shall inform the supplier in writing of its decision while stating its reasons. The supplier will be charged for any extra costs involved in any measure taken.

4.3.3         Within the suspension period referred to in article 4.3.1 under e., the certification agreement shall remain in force. If no adequate corrective actions have been taken by the supplier within the period of suspension, IHMQ shall withdraw the certificate.

 

4.4      Changes

 

4.4.1         IHMQ shall inform the supplier in good time of any expected change in the evaluation guideline, of the date as from which it will be validated and of the transitional period, if any. In addition, IHMQ shall indicate the nature, scope and costs of any supplementary test that may be required.

 

  • If the supplier does not agree with the changes and/or the proposed supplementary audit, he shall inform IHMQ thereof in writing within a period to be determined by IHMQ. In that case the certificate shall lapse on the date as from which the changed evaluation guideline is validated.
  • If the supplier accepts the changes and the result of the supplementary audit turns out to be positive, he shall receive a new certificate.
  • If the result of the supplementary audit is negative, the certificate shall lapse on the date as from which the changed evaluation guideline is validated or after the transitional period has expired.

4.5        Termination of the certificate

 

4.5.1         A certificate may be withdrawn by IHMQ with immediate effect in the following cases:

  • serious non-conformities found during an audit; see article 4.3.1;
  • failure to take adequate improvement measures during a suspension period; see article 4.3.3;
  • if the supplier has acted in serious conflict with one or more of his obligations under the certification agreement, including his financial obligations;
  • if the supplier has seriously harmed the interests of IHMQ.

4.5.2         A certificate may be terminated with immediate effect by the supplier if IHMQ has acted in serious conflict with one or more of its obligations under the certification agreement or if IHMQ has seriously harmed the interests of the supplier.

4.5.3         In other cases than those mentioned above and without prejudice to the provisions of article 4.4.2 (termination as a result of a change in the evaluation guideline) the certificate may only be terminated while observing a period of notice of at least three full calendar months. The termination shall be notified to the other party by registered letter, stating the date of termination. In the event of a termination by IHMQ, IHMQ shall also state the reasons for the termination in the letter.

4.5.4         IHMQ may withdraw a certificate or suspend the right to use a certificate if the supplier has not been carrying out work under the certificate during a prolonged period of time such that IHMQ has cause to doubt whether the supplier is able to implement processes that comply with the evaluation guideline.

4.5.5         The termination of the certificate shall not affect the existing financial obligations of the supplier towards IHMQ.

4.5.6         Upon termination of the certificate the certification agreement concluded with the supplier shall lapse.

5             Further provisions

 

5.1      Complaints from third parties

 

5.1.1         The supplier shall have a procedure for dealing with complaints from customers. This procedure should arrange for the supplier to ensure that the complaint is investigated within a reasonable period of time and to inform the complainant of the result of this investigation.

5.1.2         If IHMQ receives a complaint from a third party about work carried out under the certificate, it shall contact the supplier as to the investigation to be carried out into the nature and the cause of the non-conformities and shall see to it that the complaint is dealt with within a reasonable period of time.

5.1.3         IHMQ reserves the right to institute an independent investigation on account of a complaint received. The costs of such an investigation may be charged by IHMQ either to the complaining party or to the supplier, depending on which of the parties is found to be in the wrong.

5.1.4         If a complaint proves well-founded, this may cause IHMQ to consult the supplier on improvement actions to be taken or revision of the IQC scheme or to take one of the measures referred to in article 4.3.1.

 

5.2      Liability

 

5.2.1         IHMQ shall not be liable for any damage, in any form whatsoever, arising in connection with the application for and the conclusion, implementation and/or termination of the certification agreement or the use of the certificate, except insofar as such damage may be attributed to an intentional act or omission, a gross fault or gross negligence on the part of IHMQ. The supplier shall hold IHMQ harmless against all claims and actions for damages in connection with third parties.

 

5.3      Fees

 

5.3.1         IHMQ shall invoice the supplier by way of advance for the estimated costs relating to the pre-certification tests, unless agreed otherwise. These costs shall always include any hotel and travelling expenses and the fees of the relevant IHMQ employees as well as the costs of any third parties called in by IHMQ. Upon termination of the pre-certification audit he supplier shall receive a final invoice.

5.3.2         If the supplier fails to pay the costs of the pre-certification audit in time, IHMQ may suspend the application procedure and/or the granting of the certificate.

5.3.3         The supplier shall pay IHMQ a fee for the right to use the certificate as well as to cover the costs involved in preparing and maintaining the certification scheme and carrying out audits.

5.3.4         The fee shall be fixed by IHMQ, if possible after consultation with a representative group of suppliers. IHMQ shall notify any changes in the fee in writing at least one month in advance.

5.3.5         The supplier shall pay the costs charged by IHMQ within the period stated on the invoice.

 

5.4      Working conditions

 

5.4.1         Without prejudice to his obligations under the occupational health and safety laws, the supplier shall ensure that the working conditions at his works are of such a nature that no danger is caused to the safety and health of the IHMQ employees when carrying out their work. If necessary, the supplier shall make available protective equipment together with instructions for use.

 

5.5        Improper use of certificates

 

5.5.1         The IHMQ undertakes actions to see to it that no improper use is made of certificates by third parties. This shall also include the use of a certificate during a period in which the right to use it is suspended or after termination of a certificate.

5.5.2         IHMQ may, whether alone or together with the suppliers of certified processes, bring an action against third parties making improper use of certificates.

5.5.3         As from the date of termination of the certificate, or during a period in which the right to make use of the certificate is suspended, the supplier shall not make use of the certificate nor shall he create the impression that he is still entitled to use the certificate.
In the event of a breach of this provision, the supplier shall pay IHMQ an immediately claimable fine of

  • € 5,000 as well as a fine of € 2,500 for each day such breach continues.

 

5.6      Secrecy

5.6.1         The employees of IHMQ shall be obliged to observe secrecy towards third parties in respect of all information that comes to their knowledge as a result of carrying out certification work.

5.6.2         When outside experts are called in to carry out certification work, they shall sign a declaration containing a pledge of secrecy as laid down in article 5.6.1.

6             Appeal

6.1        Against decisions or measures taken by IHMQ in connection with the technical or procedural aspects an appeal may be lodged by the parties concerned with the Disputes Committee within 30 days from the date of such decisions or measures, unless a different course of proceedings applies in the case in question.

6.2        Appeals shall be initiated on the basis of the Regulations for the Disputes Committee: 2003

6.3        The initiation of an appeal shall leave any decision or measure taken by IHMQ unimpaired until the Disputes Committee has given its decision on the matter.

 

7             Final provisions

7.1        These Regulations may be quoted under the name ‘IHMQ-Regulations for Certification: 2003

7.2        Any changes in these Regulations shall take effect only after publication by IHMQ, stating the effective date.

7.3        These Regulations shall take effect on 1 May 2003.

 

 


[1] The use of pictograms on letter paper, brochures, etc. is, however, permitted; please also see article 2.7.2. If desired, the name of the entrepreneur may also be stated on the certificate.

[2] To certificates granted under a license a period of validity may, however, be attached; see article 1.2.2. For the termination of certificates please also see article 4.6.

 

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