Certification Withdrawal, Suspension or Scope Reduction

INTRODUCTION

HPi Verification Services (HPIVS) issues two types of product certificate:

  • Certificate of (product) approval: based upon design review/inspection/testing
  • Certificate of Quality System Approval: for product approvals based upon audits of quality management systems (QMS)

Some certificates may involved both types of certificate. Conditions for maintaining your product certificates are defined in the HPIVS Certification Agreement which can be found in the standard Terms & Conditions. Failure to meet these conditions may result in suspension or withdrawal of your certificate and termination of the Approval or scope reduction.

This document describes the procedures HPIVS will apply in the event of your failure to maintain discharge your responsibilities in line with the certification agreement or due to HPIVS being denied the opportunity to verify the continued implementation and compliance of production and or the QMS, where applicable.

Alternatively, you may, for your own reasons, request that your approval is suspended or withdrawn or scope reduced.

SUSPENSION OF THE CERTIFICATE

Failure to maintain your QMS

Whenever a Major Non-conformity Report (Major NCR) is issued during a routine surveillance or recertification visit, the maintenance of your approval will be dependent upon you implementing all corrective actions necessary to return to compliance with the Assessment Standard.

The Auditor will discuss and agree with your arrangements and timescales under which HPIVS will verify the action you have taken. The extent and means of the verification activities will be dependent upon the nature and severity of the non-conformity.

Normally, the Auditor will need to conduct an interim surveillance visit within 3-months of the Major NCR being raised, however, if verification can be done remotely without a need to visit your premises, this will be the preferred method.

When verification activities have concluded that the Major NCR can be closed, or downgraded to a Minor NCR or Observation, this will be confirmed in writing by HPIVS and the Surveillance Programme will resume.

Should it be confirmed that you have failed to take appropriate action and the Major NCR remains outstanding, you will be advised that your approval has been suspended.

Failure to demonstrate the continued Implementation and conformity of the QMS:

If HPIVS is unable to agree a visit with you within a reasonable timescale of it being scheduled, such that we are unable to verify the continued implementation and conformity of the system, your approval will be suspended.

If you are unable to demonstrate continuing implementation of your approval due to special circumstances, such as temporary lack of and/or disruption to business, a decision may be made to temporarily suspend your certification.

Client requests to suspend certification

If, for any reason, you wish to suspend your certification, you must notify HPIVS in writing giving reasons for the request.  HPIVS will need to review and authorise the suspension and will notify you in writing. To reinstate certification you will need to contact HPIVS who will arrange for an appropriate verification activity to take place.

 

WITHDRAWAL OF THE CERTIFICATE

Termination by HPIVS

HPIVS will terminate the Certification Agreement and withdraw certification if any of the following circumstances occur:

  • Failure to respond to a letter notifying you of HPIVS suspension of certification, or if you inform us that you do not intend to take corrective action in response to a Major NCR or suspension notice.
  • If, following a second Interim Surveillance Visit, corrective action remains unsatisfactory.
  • Failure to resolve issues that have resulted in a suspension of certification within a specified timescale.
  • Other (e.g. failure to pay certification or assessment fees)
Client request to terminate certification

You may request that the Certification Agreement be terminated and certification withdrawn any time in accordance with the termination terms of the Certification Agreement.

REDUCTION IN SCOPE

Reduction in scope by HPIVS

HPIVS shall reduce the scope of certification to exclude parts not meeting the requirements when a client has persistently or seriously failed to meet the certification requirements for those parts of the scope. Any reduction in scope shall be in line with the requirements of the standard used for certification.

Client request to reduce scope

A client may also request a reduction in the scope of certification.

IMPLICATIONS OF SUSPENSION, WITHDRAWAL OR SCOPE REDUCTION

Implications of Suspension of Approval

In the event that approval is suspended your management system certification is temporarily invalid and, you:

  • May no longer claim or promote approval by HPIVS.
  • May no longer accept orders or enter into contracts or agreements where approval is a condition of contract.
  • Must notify any customer, with whom you have contracts for which approval is a condition of the contract, that your approval has been suspended.

The suspended status of the certification will be made publicly accessible.

Implications of withdrawal of approval

In the event that approval is withdrawn, you will be required to:

  • Return all original relevant copies of HPIVS Certificates of approval and destroy any copies made by you.
  • Withdraw from circulation any documents bearing the HPIVS Certification Mark.
  • Review current tenders and contracts to identify if certification is a condition of contract and where appropriate, notify any customers imposing such requirements that your approval has been withdrawn.
  • Make no further claims to be approved by HPIVS.

HPIVS will notify any interested parties by whatever means we consider to be the most effective.  This will normally include the notifying authority that has granted HPiVS its Notified Body status who will circulate the information amongst surveillance authorities around the European Economic Area.

Implications of Scope reduction

In the event that the scope of your certification is reduced, you shall be required to:

  • Return all original relevant copies of HPIVS Certificates of Approval and destroy any copies made by you. Certificates will be reissued with the amended scope.
  • May only claim or promote approval by HPIVS within the revised scope.
  • Review current tenders and contracts to identify if certification is a condition of contract and where appropriate, notify any customers imposing such requirements that your scope has been reduced.
  • May no longer accept orders or enter into contracts or agreements where approval is a condition of contract and is not within the amended scope.

NOTIFICATIONS

HPIVS notification of suspension of certification

In case of suspension, HPIVS shall notify you that your approval has been suspended.  Such notification shall include:

  • Timescales by which you must respond – for failure to maintain the certified QMS this shall be within 14 days of notification.
  • Duration of suspension period
  • The implications of suspension

Note – suspension will remain in effect until appropriate verification of the QMS conformity is carried out by HPIVS this could be either as a result of a routine surveillance or recertification visit, depending upon the timescales since the Certificate was suspended and the stage of the certification process the QMS would have been at had suspension not been effected.  If a further verification visit is required, this will normally be undertaken within 1 month of the first Interim surveillance visit.

In most cases certificate suspension will not exceed 6 months.

Client response:

Upon receipt of notification that your certificate has been suspended as a result of your failure to maintain the QMS, one of the following courses of action is open to you:

  • You may notify HPIVS that appropriate corrective action has been taken and request HPIVS to verify the effectiveness of the corrective action in order to reinstate the approval.
  • If you do not agree with the reasons given by HPIVS for suspension, you may invoke the HPIVS appeals procedure; a copy of this is available on request to HPIVS.
  • You may choose to make no response or take no further action in which case HPIVS will institute the withdrawal of certification procedure or reduction in scope procedure as appropriate.
HPIVS notification of withdrawal of certification

In case of withdrawal, you shall be notified by HPIVS that your approval has been, or will be withdrawn, stating the date from which the withdrawal become effective and the action that you must take.

Client response:

If you do not agree with the reasons given by HPIVS for suspension, you may invoke the HPIVS appeals procedure; a copy of this is available on request to HPIVS.

HPIVS notification of scope reduction

In the case of scope reduction, you will be notified by HPIVS that your scope has been reduced, stating the date from which the amended scope become effective and the action that you must take – see Implications of scope reduction, above.

Client response:

If you do not agree with the reasons given by HPIVS for scope reduction, you may invoke the HPIVS appeals procedure; a copy of this is available on request to HPIVS.

Any future request to increase or reinstate the scope of certification will be handled by HPIVS in line with the arrangements for handling enquiries.

FURTHER INFORMATION

For further information regarding HPIVS products and services, please contact us.

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