Quality Management System Template

QUALITY MANAGEMENT SYSTEM TEMPLATE

This Quality Management System Agreement (the "Agreement") is entered into as of Effective Date: by and between Client Name: and Provider Name: .

WHEREAS

WHEREAS, Client Name: seeks to establish, implement and maintain a quality management system to ensure consistent product and service quality; and

WHEREAS, Provider Name: has the personnel, expertise and systems necessary to design, document, implement, train and audit the Client's quality management system in accordance with the Scope of Work specified below; and

WHEREAS, the parties desire to record the obligations, deliverables, schedule and terms by which Provider will deliver quality management system services to Client.

SCOPE OF WORK

Provider shall perform the services described in this Scope of Work. The Scope of Work shall include, at a minimum, the following elements, and Provider shall document and deliver work products as set forth below.

Deliverables shall include system documentation, process maps, documented procedures, training materials, internal audit reports, corrective action plans, and a final Management Review report. Provider will coordinate on-site and remote activities as agreed in the schedule.

QUALITY OBJECTIVES AND STANDARDS

The QMS shall be designed to achieve the following measurable objectives: reduction in defect rate, improvement in on-time delivery, and measurable customer satisfaction targets. Applicable standards and frameworks (select all that apply):

ISO 9001 (Quality Management)
ISO 13485 (Medical devices quality management)
Other Standard (specify in scope)

PAYMENT TERMS

Client agrees to pay Provider for the services and deliverables as follows. Unless otherwise stated, amounts are in lawful currency.

Invoices are due net thirty (30) days from the invoice date unless otherwise agreed in writing. Overdue amounts shall accrue interest at the rate specified above and Client shall reimburse Provider for reasonable collection costs.

TERM AND TERMINATION

This Agreement commences on Start Date: and continues until End Date: , unless earlier terminated in accordance with this section.

Either party may terminate this Agreement for convenience upon written notice delivered to the other party at least prior to the effective termination date. Either party may terminate immediately for material breach if the breach is not cured within thirty (30) days of written notice. Termination does not relieve Client of the obligation to pay for services performed and reasonable costs incurred through the effective date of termination.

CONFIDENTIALITY

"Confidential Information" means any non-public information disclosed by one party to the other, whether orally or in writing, that is designated confidential or that reasonably should be understood to be confidential given the nature of the information. Each party agrees to: (a) use Confidential Information solely for the purposes of performing under this Agreement; (b) restrict disclosure to those employees, contractors or agents who have a need to know and who are bound by confidentiality obligations; and (c) exercise at least the same standard of care to protect Confidential Information as it uses with its own confidential information, but in no event less than reasonable care.

Confidential Information does not include information that is: (i) already known to the receiving party without obligation of confidentiality; (ii) publicly known through no breach by the receiving party; (iii) rightfully received from a third party without obligation of confidentiality; or (iv) independently developed without use of the disclosing party's Confidential Information. Upon termination, receiving party shall return or destroy Confidential Information as directed by disclosing party and certify such destruction upon request.

AUDIT RIGHTS AND RECORDS

Client shall maintain records sufficient to demonstrate compliance with the QMS requirements. Provider may conduct audits, with reasonable notice, to verify compliance with the Scope of Work and implementation of agreed procedures. Client shall provide reasonable access to facilities, records and personnel for such audits. Consent to audits: Client consents to Provider audits as described above.

CHANGE CONTROL AND CONTINUOUS IMPROVEMENT

Provider shall advise on corrective and preventive actions and support Client's continuous improvement program. Proposed changes to procedures or scope must be documented, assessed for quality impact, and approved by authorized representatives of both parties in writing prior to implementation.

INTELLECTUAL PROPERTY

Unless otherwise agreed in writing, Provider retains ownership of its pre-existing tools, templates and methodologies used to develop the QMS. Client shall own final deliverables specifically created for Client under this Agreement, subject to Provider's rights in pre-existing intellectual property. The parties shall grant each other a non-exclusive, royalty-free license to use any materials solely for performance and compliance with the QMS.

GOVERNING LAW

This Agreement shall be governed by and construed in accordance with the laws of the State of without regard to its conflict of laws principles.

ENTIRE AGREEMENT; AMENDMENT

This Agreement, including the Scope of Work and any written attachments executed by the parties, constitutes the entire agreement between the parties with respect to the subject matter hereof and supersedes all prior and contemporaneous agreements, proposals and communications, whether written or oral. No amendment shall be effective unless set forth in writing and signed by authorized representatives of both parties.

NOTICES

KEY CONTACTS

MISCELLANEOUS PROVISIONS

Neither party may assign this Agreement without the prior written consent of the other, except to a permitted successor by merger or sale of substantially all assets. The parties are independent contractors and nothing in this Agreement creates a joint venture, partnership or employment relationship. If any provision is held unenforceable, the remaining provisions shall remain in full force.

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