10 Centennial Drive Phone: (978) 573-2500
Peabody, MA 01960 Fax: (978) 977-0157
USA E-mail:
www.tuv-sud-america.com /
Audit Agreement
This Audit Agreement (this “Agreement”) is made as of , 20__ between
ENTER BELOW NAME OF ORGANIZATION AND ADDRESS
Company NameStreet Address
City, State, Postal Code, Country
(the “Applicant”), all sites of the Applicant that fall under the scope of certification and TÜV SÜD America Inc., a corporation organized under the laws of the Commonwealth of Massachusetts (“TÜV”).
The Applicant desires to engage TÜV to audit the Applicant’s management system in accordance with
ISO 13485 CMDCAS Program MDSAP Program ISO 9001
Accordingly, the parties are entering into this Agreement to define the parties’ respective obligations and the terms on which that audit and related services shall be performed. The terms set forth in this Agreement shall be binding on the parties once a counterpart of this Agreement has been signed and delivered by both parties. This Agreement shall then continue in effect until terminated.
Either party may terminate this Agreement by giving the other party 30 days’ written notice of the termination; whenever such a notice is given, the Applicant shall immediately pay any fees that are owed to TÜV, and immediately upon the effectiveness of any termination, any Certificate or other materials issued by TÜV under this Agreement and any other printed materials under the Applicant’s control and bearing TÜV’s mark shall become invalid, and the Applicant shall return them to TÜV or destroy them and certify their destruction to TÜV.
In order to show their agreement to these terms, the parties have caused this Agreement to be signed and delivered by their authorized representatives on the dates specified below but in each case as of the date first written above.
TÜV SÜD America Inc.Applicant Company legal name
By / By
Signature / Signature
Name: / Name:
Title: / Title:
Date: / Date:
UCB_F_03.04, Rev 3 Effective 2015-05-05, Page 2 of 4
TÜV SÜD America Inc.10 Centennial Drive Phone: (978) 573-2500
Peabody, MA 01960 Fax: (978) 977-0157
USA E-mail:
www.tuv-sud-america.com /
Article 1. Background, Etc.
TÜV, with the Applicant’s cooperation, shall conduct on-site audits to determine whether the Applicant’s management system complies with the stated requirements of the applicable standard(s) and programs specified on the first page of the Agreement and also to determine whether that management system is effectively implemented. Without limiting its other obligations, the Applicant agrees to adhere to the requirements contained in the latest revision of this document as well as the TÜV SÜD America Standard Terms & Conditions or the Business Terms & Conditions of the TÜV SÜD Company contracted for the audits. The Applicant also agrees to comply with Modules A and B2 of the TÜV SÜD Group Testing and Certification Regulations, PZO TÜV SÜD_AB1B2C1C2C3C4C5. In the event of conflict this Audit Agreement takes precedent over PZO TÜV SÜD_AB1B2C1C2C3C4C5.
TÜV may use auditors who are its employees and/or contracted auditors. The Applicant has the right to object to the use of any auditor. If the Applicant objects to any auditor’s continuation of performance of services, then TÜV shall replace that auditor except for MDSAP (Medical Device Single Audit Program). For MDSAP Applicants must submit a formal appeal if they object to a specific auditor.
Article 2. Phases of the Certification Process
2.1. Preparation. The Applicant shall complete an application and return it to TÜV.
2.2. Stage 1 Audit
In accordance with PZO TÜV SÜD_AB1B2C1C2C3C4C5.
2.3. Stage 2 Certification Audit. Upon successful completion of the Stage 1 Audit, the audit team shall conduct an on-site audit to confirm conformance with the applicable standard(s) / programs and to evaluate the implementation, including effectiveness of the Applicant’s management system.
At the conclusion of the audit, the audit team shall inform the Applicant of the audit results. At the closing meeting, TÜV shall provide the Applicant a written list of any nonconformities.
The Applicant has the right appeal any nonconformity. The appeal must be submitted within 30 days of the on-site audit (15 days for MDSAP).
Under the MDSAP Program TÜV shall use the Global Harmonization Task Force document, GHTF/SG3/N19:2012, “Quality management system – Medical devices - Nonconformity Grading System for Regulatory Purposes and Information Exchange” to grade any nonconformity.
If re-auditing parts of the management system is necessary, the date and scope for the follow-up shall be set jointly between the audit team and the Applicant.
The audit team shall generate an Audit Report, summarizing the audit results.
2.4. Surveillance Audits and Recertification Audits.
(a) Surveillance Audits. After issuing a Certificate TÜV conducts periodic Surveillance Audits to verify the ongoing effectiveness of the Applicant’s management system.
(b) Recertification Audits. In order for the Applicant to maintain a valid Certificate, TÜV shall conduct a Recertification Audit once every three years.
(c) Short Notice / Unannounced Audits. TÜV or a Regulatory Authority may require TÜV to carry out, and the Applicant shall pay for, short-notice or unannounced audits to investigate complaints, or in response to changes, or as follow-up to nonconformities / suspensions or for any issue related to the safety and effectiveness of a medical device or a public health risk, or other reasons.
For the MDSAP Program Applicants shall have legally enforceable contractual documents with each critical supplier which allows TÜV SÜD or a Regulatory Authority to conduct unannounced audits.
For the MDSAP Program if a visa is needed to visit the country where the Applicant or a critical supplier is located, the Applicant shall attach to this agreement invitation(s) to visit the Applicant or contracted critical supplier at any time and an invitation which leaves the date of visit open. TÜV may cancel the contract as soon as permanent unannounced access to the premises of the Applicant or contracted critical suppliers is no longer assured. The Applicant shall cover the measures to be taken by TÜV to ensure the security of their auditors.
Article 3. Additional TÜV Obligations
3.1. Access to Records. For ISO 13485 CMDCAS (Canadian Medical Device Conformity Assessment System) Program audits, the Applicant agrees that TÜV may release to Health Canada (HC) any document that TÜV considers necessary to determine a medical device manufacturer’s conformance to ISO 13485. These documents would include those that TÜV auditors use to plan, perform or follow-up on HC investigations and to record observations or report results of an ISO 13485 quality management system audit. TÜV shall notify HC in writing of any change in a manufacturer’s registration certificate status relating to a reduction, suspension or withdrawal of that Certificate.
For the MDSAP Program, TÜV shall provide personnel from a recognizing Regulatory Authority access to records and documents pertaining to the manufacturer that is relevant to the audit and decision making process upon request. Regulatory Authorities may share all documents and records related to medical device audits with other Regulatory Authorities that have formal established confidentiality agreements between governments which covers provisions for protecting proprietary information and trade secret information.
TÜV may maintain records of the Applicant’s management system audit process for a retention period of at least fifteen years.
Article 4. Additional Applicant Obligations
4.1. General Obligations of the Applicant. The Applicant agrees to the following:
(a) The Applicant shall document and maintain a management system and demonstrate its practical implementation and effectiveness.
(b) Before the certification audit, the Applicant shall complete at least one internal audit cycle that covers the Applicant’s entire management system, and then complete at least one management review cycle.
(c) The Applicant shall allow and actively support TÜV performing its on-site and off-site audit activities during the validity of this Agreement.
(d) The Applicant shall provide TÜV with access to all applicable areas and documentation (including records) relating to the Applicant’s management system.
(e) The Applicant shall provide TÜV with access to the Applicant’s employees for the purpose of discussing with the TÜV auditors all relevant information relating to the Applicant’s management system, and the Applicant authorizes those individuals to discuss that information with the TÜV auditors.
(f) The Applicant shall maintain records of customer complaints and actions taken to address the complaints.
(g) The Applicant shall allow accreditation body personnel, applicable regulatory agencies and sector oversight authorities to witness TÜV auditors for the purpose of evaluating the competence of the TÜV audit team as well as the effectiveness of TÜV’s implementation of requirements.
(h) The Applicant shall provide corrective action plans for any nonconformities within 30 days from the last day of the on-site audit (within 15 days for MDSAP audits).
(i) For ISO 13485 CMDCAS Program audits, the Applicant agrees to keep TÜV informed of all medical devices for which a license is maintained or sought in Canada in accordance with the Canadian Medical Device Regulations. The Applicant is only eligible for a CMDCAS Program audit if they have a Canadian Medical Device License or intend to apply for a license within the following 12 months and can demonstrate conformance with requirements.
4.2. Use of TÜV Mark. The Applicant may only use the TÜV mark while the related Certificate remains in effect and only within the specific scope of that Certificate and any related accreditation. While the mark may be used for appropriate business and promotional purposes, such as to show the effectiveness of the Applicant’s management system to customers and authorities, the mark may not be placed on products, product packaging or otherwise used in a manner that could be interpreted as product certification. In case of certificate suspension the Applicant shall refrain from further promotion of its certification. TÜV shall make the suspended status of the certification publicly accessible and shall take any other measures it deems appropriate.
The Applicant shall not promote or advertise that a MDSAP certificate indicates that a product is endorsed or approved by any Regulatory Authority.
Article 5. Suspension / Withdrawal of Certificate
TÜV has the right to suspend or withdraw a Certificate:
(a) if the Certificate is used other than as provided for in the Agreement, or the Applicant breaches the Agreement in any other way; or
(b) if the certified management system has persistently or seriously failed to meet certification requirements, including requirements for the effectiveness of the management system, or
(c) if the Applicant does not allow surveillance or recertification audits to be conducted at the required frequencies, or
(d) the Applicant is found not be truthful with TÜV regarding the status and effectiveness of the Applicant’s management system or any of their obligations stated within this agreement; or
(e) if the Applicant has voluntarily requested a suspension / withdrawal; or
(f) if Applicant does not respond to nonconformities when due; or
(g) for non-payment of fees
Upon notice of suspension or withdrawal of certification the Applicant shall discontinue its use of all advertising matter that contains any reference to a certified status. (e.g., printed material, internet site, etc.)
Under the MDSAP Program, if TÜV suspends, withdraws, cancels, or reduces the scope of a certificate, TUV shall inform the recognizing Regulatory Authority(s).
If TÜV ends it relationship with the Applicant, upon request and with consent of the Applicant, TÜV shall make available to the next Auditing Organization a copy of all the audit reports from the current certification cycle and a valid certificate of the Applicant or manufacturing site(s).
UCB_F_03.04, Rev 3 Effective 2015-05-05, Page 2 of 4