Iso 13485 Quality Agreement Template

In addition to the five key elements mentioned, there are a few key elements that should also be addressed in the agreement. 8 this provision. The list of agreed inappropriate or unenforceable requirements is included in the Other Standards Requirements Schedule The supplier must produce products in accordance with the requirements of the standards listed in the table below. If the supplier finds that a requirement of a listed standard is not appropriate or does not apply to the delivered product, the supplier must notify the customer within 30 days of this decision. The list of agreed exclusions also appears in the table below. Standards that apply specifically to the product, which is retained by the Standard Title 1.8 Third Party Use Provider The customer qualified the third parties in the table below to provide the listed goods or services. For the purposes of this agreement, the supplier is not obligated to challenge these suppliers. Note: Typical examples are an electrical transformer produced to your specifications, which bears a UL marking, or a previously validated sterilization process. Supplier provider provider recipient If used, applied, or in the product made available to the customer, the supplier must purchase the goods or services listed from the designated third party.

The supplier provides the customer with monthly performance reports on these third parties, which provide the number of order positions placed by the third party, the percentage of batches received late and the percentage of lots rejected at the time of acceptance (21 CFR (b) or ISO 13485:2003 Clause 7.4.3) Selected supplier If the supplier uses a supplier from a third party supplier, With the exception of a targeted supply, for the manufacture, packaging, marking, control or exit of products made available to the customer, the role of the third-party supplier is shown in the table below. When selecting third-party suppliers, the supplier applies the requirements of 21 CFR and ISO 13485:2003, paragraph 7.4. In addition, the supplier applies the principles in GHTF/SG3/N17:2008. Medical Device Quality Agreement S. 8 of 17 It is recommended that the quality agreement be separated from the supply agreement and other commercial or commercial agreements, so that it is independent of the pricing, payment terms, areas of work and other elements of these documents and can therefore be modified or separated independently. Documentation of these activities: evaluation, approval, follow-up and reassessment must be maintained. The meticulousness of diligence in selecting and tracking the supplier`s performance over time saves time and money, as the volume of product returns is reduced, the follow-up work is reduced, the quality of the products is improved and customer satisfaction increases. This supports a “just the first time” mentality that is always less expensive than doing it.

10 Quality Management Regulations The supplier and the customer each have a quality management system (QMS) that meets the requirements of the FDA Quality System Regulation (QSR) in accordance with Standard 21. CFR Part 820. If the supplier finds that a requirement of 21 CFR Part 820 is not appropriate or applicable to the product delivered, the supplier must notify the customer within 30 days of this decision. The list of requirements that are not suitable or applicable is listed in Appendix 1. ISO 13485:2003. The supplier and customer each have a quality management system (QMS) that meets ISO 13485:2003 requirements.

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