PART A - DEFINITION OF TERMS
A1 For the application of these GCC, URS means the companies United Registrar of Systems Ltd (Scheme Office) hereandafter URS, which is responsible for compliance with accreditation conditions under the accreditation body UKAS, United Registrar of Systems GmbH (Scheme Office) hereandafter URS , which is responsible for compliance with accreditation conditions under the accreditation body DAkkS, United Registrar of Systems Czech s.r.o. (Scheme Office) hereinafter referred to as the URS, which is responsible for compliance with the accreditation conditions under the CAI accreditation body, and the respective URS regional representatives, which organise audits in specific regions (countries).
A2 Customer - This is an existing URS customer that already uses URS certification services or a customer who has concluded a certification service agreement with URS or through URS RR and will be audited first.
A3 Certification process (certification) – leads to the verification of the client’s established standard and the issue of a certificate, usually in a three-year cycle.
A4 Certificate – certificate of compliance.
A5 Auditor – the person who performs the certification audit by visiting the client and writing a report about the audit.
A6 Standard – the required standard established by the client established in their company.
A7 Audit report – a report which is drawn up by the auditor and which contains findings from the performed visit.
A8 Accreditation body – is the subject, which provided a permit to URS to perform accreditation based on the accreditation conditions for the individual standards, for which URS provides accredited certification.
A9 Accreditation – verification that the certification body performed the certification, and issues a certificate in accordance with the valid certification for the given standard.
A10 Initial audit – this is the entry phase of the certification process, with which a three-year certification process begins.
A11 Supervisory audit (monitoring audit) – an annual repeat visit when the auditor performs an inspection of the given standard.
A12 Re-certification audit – the subsequent cycle, usually three years long, which follows the previous cycle, usually also three years long
A13 Special visit - may be made in case on non-fulfilment of all requirements according to the assessment of the auditor.
A14 URS RR - Regional Representative is acting as a proxy for communication between United Registrar of Systems GmbH, acting as Scheme Office for DakkS Accreditation, United Registrar of Systems Ltd, which acts as Scheme Office for UKAS Accreditation and United Registrar of Systems Czech s.r.o. Scheme Office for CAI Accreditation and customer. The regional representative assists in the organization of the certification audit. The regional representative charges URS fees related to certification audit and registration.
A15 URS Scheme Office is responsible for customer certification, certification audit and certification decisions under the terms of the accreditation granted. The URS Scheme Office has operational, financial, legal and certification responsibilities in a certified organization under appropriate accreditation.
A16 The meaning of URS in these GCC means that the URS Scheme Office can communicate with the customer via URS RR in the local language. Likewise, the customer can inform URS RR or URS Scheme Office. URS Scheme Office
PART B - CERTIFICATION PROCESS
B1. Course of the Process
B1.1 If a contract is made for performing the certification process and does not stipulate the course of the process otherwise, the process of certification is divided into the following: the first certification audit, during which a certificate is first granted, or a re-certification audit, during which a certificate is granted for a second time, and systematic monitoring audits, which are performed in stages between initial certification and re-certification or between re-certification and another re-certification.
B1.2 After the first certification audit, the issue of a certificate and in the course of its validity, the client is obliged, under conditions in the contract with URS and the accreditation conditions, to begin a monitoring audit at the corresponding time, which will be performed by URS.
B1.3 Performance of subsequent monitoring audits at the specified times is a condition for maintaining validity of the certificate.
B1.4 At the end of the three-year certification process, a re-certification audit takes place for the purpose of prolongation of certificate validity. The re-certification audit must be performed prior to the expiration of certificate validity.
B1.5 If serious discrepancies are found during the audit, URS may order that an additional audit be performed. The additional audits must take place at the time set by URS auditor or URS office.
B1.6 Based on fulfilment of accreditation conditions of the URS certification company, authorised persons on the part of URS or subject accrediting URS may request that observational audits or special audits be performed at the client. The client undertakes to enable such types of audits to be performed.
B1.7 In case of significant organisational changes or requested extension of the object of certification, the Client is obliged to update his documentation and inform URS about all substantial changes in the organisation, which would have substantial influence on the scope of certification.
B1.8 In case the client asks URS to extend the scope of certified activities, URS may in such a case perform a special audit or extend the scope of certified activities within the monitoring or re-certification audit.
B1.9 In keeping with the accreditation conditions, URS will contact the client sufficiently in advance for the purpose of finding out up-to-date information and data for the purpose of fulfilling a contract on performance of certification services.
B1.10 If auditors, observers or assessors visit the client for the purpose of fulfilling their obligations, the client must ensure adequate protective equipment and provide corresponding training and instructions prior to the beginning of work. The client is also obliged to ensure that the auditor, inspector or assessor do not handle equipment without clear supervision and instructions from the client.
B2 Dates and Times
B2.1 The client can state the proposed dates for audits to be performed. URS will examine them reflecting its own performance capacities and the practiced form of realisation of the audits. The dates stated by the client are not of binding nature and URS need not meet them. URS and the client will agree on binding dates for performing the audit at an adequate time before the planned audit.
B2.2 Audits are fundamentally performed at the set binding dates and times. If the client does not cooperate on arranging a date of the audit and as a result it will not be possible for the audit to take place or to be performed in time, URS will be entitled to withdraw from the contract. Such withdrawal has no effect on other claims on grounds of requiring compensation or other requirements/obligations. In case the client already has a valid certificate, URS is, moreover, entitled to suspend its validity or withdraw URS certificate or mark.
B2.3 If the client cancels a planned audit or URS cancels a planned audit 3 days and less prior to the planned date, this cancellation is due to reasons on the part of the client, then the client is obliged to compensate incurred costs on the part of URS, at the sum 33% of the agreed price for the respective audit.
B2.4 If the client interrupts and audit that has already begun or URS interrupts and audit that has already begun and this cancellation is due to reasons on the part of the client, then the client is obliged to compensate incurred costs on the part of URS, to the full height of the agreed price for the respective audit.
B2.5 If in the place, where URS is to perform a planned audit, serious complications arise caused by force majeure (unrest, military or terrorist action), URS will be exempt from providing performance of the audit during the time of their occurrence and to the extent of their consequences, even if delay were to occur for this reason. Contractual parties are obliged to inform one another about these complications and to adjust their obligations to the changed conditions.
B2.6 The unannounced surveillance audit of standard GMP+ FSA will replace one of the announced surveillance audits during the certification cycle. Every 12 months, client can specify 15 days in that year during which the unannounced surveillance audit cannot be performed. If not indicated in advance the unannounced surveillance audit cannot be refused. The following prior notice periods to perform the unannounced surveillance audit is applicable: two working days.
B3 Appointment of Auditors
B3.1 URS is entitled to select and appoint an auditor or expert, who is suitable for the respective field of the clients activity. URS reserves a right to change the auditor/auditors – expert/experts, however, to ensure independence and objectivity, or if due to unforeseen circumstances it cannot arrange that the appointed auditor is available.
B3.2 In the event that it is not possible to provide an auditor in the local language for the customers audit, URS has the right to provide an interpreter to be present at the customers audit. The presence of an interpreter may increase the scope of the audit. The customer must be made aware of this before commencing an audit with the customer. If an interpreter is used for an audit at the customer, the customer will be charged for the interpreter.
B3.3 The client is entitled to disagree with the performance of the audit by an auditor appointed by URS only in case cooperation with the auditor does not progress duly or if the auditor in a significant way does not qualify for providing the service. The client is obliged to inform URS without delay about rejecting the audit to be performed by the auditor appointed by URS along with a justification of the rejection. In this case, URS is obliged to arrange another auditor, who has the corresponding qualification.
B4 Decision on Certification
B4.1 After a certification audit, a re-certification audit or monitoring audit has been performed, URS will issue a decision in the matter of granting a certificate, prolonging a certificate or extending the scope of a certificate (depending on the situation). URS will decide impartially based on recommendation from the auditor and examination of the audit report.
B4.2 URS will draw up an Audit report from the audit about the course of certification, which it will pass on to the client. URS will send the Audit report to the client in electronic form to his contact email.
B4.3 In case of a positive decision by URS, a certificate will be issued for the client and the use of certification marks and certification logos will be enabled for the client.
B4.4 In case the client, with regard to non-fulfilment of all requirements according to URS assessment, does not fulfil the conditions for obtaining a certificate (the decision on certification is negative), that is the issue of a certificate is rejected or an issued certificate is withdrawn or suspended, URS will inform the client about this fact. The granting of certificate may be subject to additional requirements. Removal of shortcomings can be requested from the client, for example. Shortcomings or options for improvement detected during the audit will be discussed with the client during the visit at the end of the audit. In case shortcomings are detected, the client is obliged to perform an analysis of their causes and adopt all necessary corrective measures, the aim of which will be to remove these shortcomings. The condition for obtaining (as well as for keeping) a certificate is that the client effectively removes all shortcomings within the deadline set by the auditor and the auditor evaluates these arrangements positively. An additional requirement may also relate to a special visit.
B4.5 URS is not liable for detecting discrepancies during audits and recommendations for their removal, what needs to be rectified by the client compared to the audited standard. Liability of URS is also excluded for implementation of the mentioned detected rectifying arrangements. The decisions, which the client makes for rectification of the findings, are exclusively within the competence of the client.
B4.6 Unless otherwise agreed in writing, the audit is conducted in the local language and the customer receives the audit report in the local language. Customer will receive GMP + audit reports in local and English language.
B4.7 The Customer shall allow the accreditation body or if applicable the owner of the GMP+ standard – GMP+ International to participate in the witness audit and/or parallel audit.
B5 Infringement of the Certification Process
B5.1 A significant infringement of GCC and of the contract is seen in the client refusing cooperation and thus disabling fulfilment of the contract and maintaining this state despite appeals for cooperation and specification of a respective deadline (non-fulfilment of requirements for removing discrepancies, observing the planned audits, special visits); the client is attempting to falsify the results of the order; a bankruptcy proceeding has been launched regarding the client; the client did not pay enforceable claims of URS in time and remains late with payment.
B5.2 In case of withdrawal from the contract prior to the end of its validity, or if the contract is terminated by URS without observing the notice period for reasons stated above in point B5, URS is entitled to demand payment of a contractual fine from the client, corresponding to 33 % of the price of the remuneration, which it is to obtain for the nearest performance stated in the contract until the time of an issued certificate, even in the case that no service or its part has been provided yet.
PART C - USE OF CERTICATES AND CERTIFICATION MARK AND LOGO OF URS
C1 In case the client obtains a certificate and certification mark/logo of URS, he also gains a right to use these objects in keeping with the stipulations below.
C2 URS remains the owner of the object of use and protective rights to trademarks and copyrights to the object of use. By granting or passing on the object of use, URS does not grant any exclusive right to the client for its use in the below-mentioned area/scope.
C3 The object to use cannot be used in a way, which could damage the reputation of URS or which could be misinterpreted. The client undertakes to use the object of use exclusively in compliance with applicable laws, especially in compliance with the act against unfair competition. The object o use may be used in such form, as it was granted and passed on. Modifications of the design, colour or text are inadmissible. The client is not entitled to use the object of use partially, that is the object of use can only be used as a whole.
C4 If the object of use is passed on to the client in electronic form as well, the client is entitled to change the size of the object of use. In case changes of size are made, the text mentioned on the object of use must be completely legible and the size proportion between the text and URS logo must not be disrupted.
C5 The client is obliged to maintain relation between the object of use and the object of certification and to present the object of use exclusively in a way that will enable average consumers to perceive it in the context of designation, which confirms the control, assessment and/or certification of activities, processes, systems or qualification. The object of use can be used exclusively in connection with activities, processes, systems or qualifications, for which it has been granted, and exclusively for the purpose of substantiating that these activities, processes, systems or qualifications correspond to the standards, based on which they have been audited, assessed and(or certified. The client is not entitled to use the object of use for promotion purposes and must not give the impression that URS performed evaluation of a specific product. The object of use cannot be used in case of changes arising in the object of certification.
C6 The object of use can be used exclusively during the period of validity stated on it, and until the certificate is suspended or withdrawn. If the period of validity of the certificate expires before re-certification has been performed, URS certificate and mark cannot be used until a new certificate is granted.
C7 URS is entitled to limit, suspend or withdraw the certificate at any time in the cases mentioned below.
C7.1 a contract on certification made between URS and the client is terminated;
C7.2 the required monitoring audit or another audit by URS does not take place at the specified time or does not take place in entirety;
C7.3 the requirements set by URS during a monitoring audit are not fulfilled;
C7.4 if the result of the audit is negative and the detected shortcomings have not been removed within the deadline set by URS;
C7.5 the object of use is not used in keeping with these conditions of use;
C7.6 the applicant does not fulfil obligations assigned to him in connection with certification, especially the duty to inform about changes, or he does not fulfil obligations ensuing from the contract made with URS, including obligations relating to payments;
C7.7 the conditions for granting a certificate are not fulfilled, especially in case of stating incomplete or untrue data during the certification process;
C7.8 the client withdraws from the contract or requests suspension of validity of the certificate;
C7.9 other reasons arise, which will entitle withdrawal of the certificate based on these GCC or the contract;
C8 In case of withdrawal of the certificate or expiration of the period of its validity, the client is obliged to end the use of the object in any way, especially refrain from all promotion activities (corporate documents, websites, social networks, leaflets, catalogues, means of transport and other), which refer to the object of use or a service provided on grounds of it on the part of URS. The client is obliged, moreover, to return objects of use related to the process of certification, the returning of which URS will request. The originals of certificates and all copies must be returned to URS.
C9 URS is not liable for damage ensuing on the part of the client due to justified withdrawal of a certificate.
C10 URS is not liable for unauthorised use of the object of use.
C11 In case there is a URS logo on the certificate, certification mark or document, the client is entitled to use it in keeping with these GCC.
C12 A client certified for the GMPplus standard is entitled to use the GMPplus logo of GMP+ INTERNATIONAL. A client certified in compliance with GMPplus is obliged to observe the conditions set by GMP+ INTERNATIONAL.
C13 In the course of the initial audit and the granting of certificate, the client will be familiarised in detail with the rules and option for correct use of the certification logo.
C14 In case of withdrawing a certificate, URS is also entitled to withdraw from the contract. This has not effect on other claims on grounds of demanding compensation or other claims.
PART D - SUSPENSION, WITHDRAWAL, EXTENSION OR LIMITATION OF THE SCOPE OF CERTIFICATION
D1 Certificate suspension
The validity of the certificate may be suspended both on the basis of a customer initiative and on the basis of internal URS processes. URS Scheme Office suspends the validity of the certificate if: - the supervisory audit cannot be performed in due time specified in the contract for reasons arising from the customer, and the client requests a written deferment of the supervisory audit and URS Scheme Office decides positively after considering the reasons . The suspension of the certificate lasts until the supervisory audit is properly performed, the term of which is fixed, but not more than 6 months from the originally set date, the date of issue of which is considered as the originally set date, - the supervisory audit shows that some prerequisites for systems certification management are no longer applied by the customer, and at the same time the certification body can legitimately assume the elimination of deviations within a specified period, but not more than 3 months from the performance of the supervisory audit. In both cases, if the set date of suspension of the certificate is not met for reasons arising from the customer, the URS Scheme Office will decide on the expiry of the certificate and it will be revoked. The customer is informed in writing about the termination and revocation of the certificate.
D2 Certificate Extensions and Limitations
The scope of the certificate is extended or reduced on the basis of the customers request or on the basis of the findings of the URS during the supervisory / recertification audit. The customer is obliged to inform URS about a significant change in the company, which could lead to a reduction or extension of the scope of certification.
In the case of notification by the customer, the URS Scheme Office will request the companys documentation for study and will decide in writing on the next steps - see the following points:
- In the event of minor changes in the companys processes or documentation without affecting the fields of production, any extension / reduction of the scope of certification will be consulted with the customer within the supervisory / recertification audit.
- In the case of formal changes in the legal aspects of the company (change in legal form, owners, etc.), the entry of changes in the companys documentation is checked as part of a supervisory / recertification audit and a new certificate is issued. The validity period is the same as the original certificate.
- In the event that there have been fundamental changes that fundamentally concern the production processes or processes of the management system, it is necessary to carry out a special visit to verify the entry of these changes in the companys process documentation. If a possible change in the scope of certification is discovered during a supervisory / recertification audit, the head of the audit team immediately informs the URS Scheme Office by telephone about this situation, who decides on the procedure according to the above-mentioned options.
D3 Certificate revocation Expiration and revocation of a certificate occurs automatically if:- bankruptcy was declared for the customer, - the company was taken over by another entity (so-called liquidation with a successor),- the contract on control activities has been terminated by withdrawal or termination by the customer,- the specified period of validity of the certificate has expired and the customer has not requested an extension (recertification).
D4 URS has the right to revoke the certificate if:- the certificate is misused (used for purposes other than those for which it was issued, eg for another not yet certified company or for another organizationally separate part of the company that has not yet been included in the subject of certification or for another subject of activity),- the supervisory audit demonstrates that the essential prerequisites for the certification of the management system are no longer applied by the customer,- supervision cannot be carried out for reasons arising from the customer,- the certificate holder rejects changes to the GTC in writing within 6 weeks after their entry into force or opportunities to get acquainted with them,- the payment for the performance of the certification body was not paid within the set deadline (even after a reminder),- there are other reasons for withdrawal arising from the contract with the customer or the customer breaches this contract, withdraws from it or behaves in violation of
PART E - EARLY WARNING SYSTEM FOR GMPplus CERTIFICATION - EWS
E1 In case of failure to respect the specified level of contaminating substance, the Client is obliged to report this fact to his certification body, the respective authorities and GMP+ INTERNATIONAL and send EWS report within 12 hours from confirmation of the contamination.
PART F - COMPLAINTS
F1 Should a client wish to make a complaint against the service offered by URS, they should, in the first instance, write to URS email addresses email@example.com
F2 All complaints shall be duly recorded and reviewed, any corrective action thought necessary shall be communicated to the complainant, within a reasonable time-frame. Should the action not be considered sufficient, the complainant should write to email firstname.lastname@example.org for the attention of the Independent Certification Board (ICB).
F3 Following the ICBs review of the matter, any actions considered necessary shall, once again be communicated to the complainant. If the above action is still not considered satisfactory, the complainant should address his/her concerns to the GMP+ International https://www.gmpplus.org
F4 The client is obliged to register and keep a record of all complaints made known to it relating to compliance with certification requirements and is obliged to make this records available to the certification body, when requested. The client should also take appropriate actions with respect to such complains and any deficiencies found in products that fall under certification and fill proper documentation concerning them.
PART G - APPEALS
G1 The Customer may appeal any decision by URS. The customer will write the appeal to email: email@example.com.
G2 All appeals will be properly recorded and reviewed and will take place within 30 calendar days of receipt of this notice and the appellant shall be informed of the time and place of the meeting at least 7 calendar days in advance. Any appeal must be submitted by written notice to firstname.lastname@example.org.
G3 All appeals are brought to the attention of the Independent Committee Board (ICB), which discusses appeals and recommends URS to issue decisions. The appeal decision will be taken by URS within 4 months of receipt of the appeal.
PART H - CONFIDENTIALITY PROVISION
H1 All of the provided information shall be dealt with as strictly confidential and, with the exception of the certification body, or if applicable the accreditation body or owner of the GMP+ INTERNATIONAL standard, it shall not be disclosed to any other party without the Customer’s consent.
H2 The confidentiality obligation does not relate to information which is already owned by the disclosing party, or is publicly accessible, or was obtained independently of the parties participating in the commitment relationships regarding the subject of this contract or was obtained from a third party without any restrictions.
H3 Regardless of the afore-mentioned provisions, information not considered confidential is information which:
- has become public knowledge without the receiving party causing this deliberately or by omission,
- was legally at the receiving party’s disposal before the conclusion of this contract, if such information was not the subject of another, previously concluded contract on the protection of information,
- is the result of an action during which the receiving party obtains it independently, and is able to substantiate this with its records or a third party’s confidential information,
- is provided to the receiving party after the signing of this contract by a third party, which at the same time does not obtain such information directly or indirectly from the party which owns it
H4 URS will publish on website information about certified clients under public access.
H5 When the certification body is required by law or authorized by contractual arrangements (such as with the accreditation body) to release confidential information, the client or individual concerned shall, unless prohibited by law, URS will these information provided.
PART I - DECLARATION OF IMPERTIALITY
I1 URS Scheme Office hereby declares that it understands the importance of maintaining impartiality in the performance of activities related to the certification of management systems and actively manages potential conflicts of interest or the threat of conflicts of interest.
I2 URS Scheme Office has approved internal procedures which ensure the objectivity of all activities in the certification of management systems. Necessary measures are taken in relation to impartiality and independence. These are incorporated into: company strategy and policy, risk analysis, certification decisions, audits, evaluation and selection of employees. It regularly reviews the independence, impartiality and credibility of URS staff, as well as the management of conflicts of interest and the objectivity of the activities and decisions of the certification body.
I3 The decisions of the URS Scheme Office in the certification process are always based on objective evidence of compliance. Interested parties have the opportunity to submit an initiative or ask a question on impartiality to email@example.com.
PART J - GENERAL PROVISIONS
J1 URS provides its services on the international market and is represented in various areas by its authorised regional representatives.
J2 A regional representative may be a natural person or a legal entity, which mediates communication between URS Scheme Office and the Client, assists with the course of the certification audit and collects fees relating to the certification audit and GMPplus registration to its own account on behalf of URS.
J3 United Registrar of Systems GmbH (Scheme Office) is responsible for certification of the client under DAkkS accreditation and deciding the certification audit according to the accreditation conditions. United Registrar of Systems GmbH (Scheme Office) will not pass this responsibility on to a third party.
J4 United Registrar of Systems GmbH (Scheme Office) is responsible for accreditation of the client under UKAS accreditation and deciding the certification audit according to the accreditation conditions. United Registrar of Systems GmbH (Scheme Office) will not pass this responsibility on to a third party.
J5 United Registrar of Systems Czech s.r.o. (Scheme Office) is responsible for customer certification under CAI accreditation and certification audit decisions under accreditation conditions. United Registrar of Systems Czech s.r.o. (Scheme Office) will not assign this responsibility to a third party.
J6 The stipulations of these rules and conditions apply within URS to all employees participating in the certification process, including regional representatives URS RR.
J7 Legal disputes will be resolved in compliance with the laws of the European Union.