ЭКСПЕРТ ГРУПП

Section:

7.2.1 c,d

Section Title: Statutory and regulatory requirements related to the product, and

9100 C Clause

Determination of Requirements Related to the Product: The organization shall determine:
statutory and regulatory requirements related to the product, and any additional requirements considered necessary by the organization.  NOTE: Requirements related to the product can include special requirements.

Generic Expectation

It is expected, as part of the product realization process, that the supplier (seller) will determine the requirements for the products to be manufactured by or under the seller contract. The specified requirements shall cover the statutory and regulatory requirements as agreed with the customer and seller country(ies) regulatory authorities governing seller's operation. The regulatory and statutory requirements applied to seller operation may include airworthiness, environmental, defense (internal, international agreements), health and safety, industry specific and others, as applicable. The applicable regulatory and statutory requirements shall be agreed with the customer and country specific regulatory agency, and any differences solved in advance prior to product execution. Above note refers to definition listed in AS9100 § 3.2.

Product Type:

COTS/Standards

Raw Material

Build-to-Print 

Supplier Design

Specific Expectation

Organization (Buyer)

Buyer to identify statutory and regulatory requirements, which are not included in AS9100 7.4.2 Purchasing Information, in their contractual documents or Terms & Conditions, such as Import/Export Licensing Procedure, ITAR/EAR, Control of Government Property, Government Source Inspection. 

Supplier (Seller)

Seller will have an established process to determine applicable regulatory and statutory requirements and validate the requirements with the customer.

Seller will complete a review of the contractual documents for customer and regional statutory and regulatory requirements.
Seller shall account for all applicable statutory and regulatory requirements. Seller shall plan for the implementation of the requirements not covered by the supplier quality management or business system.

Prompt notification to buyer if any requirements are missing or inability to comply with any of the requirements.

Documentation to demonstrate conformance to expectation (what the auditor would look for)

Organization (Buyer)

Contractual documents or Terms & Conditions to list statutory and regulatory requirements.

Supplier (Seller)

Contractual documents or Terms & Conditions to list statutory and regulatory requirements.

Contract Review checklist.

Examples (Best Practices)

Organization (Buyer)

FAR 52.245; DRAR 252.211-7013; 22CFR; Parts 120-130; 15 CFR 768-799

Supplier (Seller)

Maintain internal processes to latest applicable statutory and regulatory requirements.

Keep track and maintain log with applicable regulatory and statutory requirements. Review requirements for changes at least once a year.

Источник: Supply Chain Management Handbook (SCMH)

The SCMH is provided by the IAQG to assist with the advancement of quality practices. The use of the SCMH is entirely voluntary, and its applicability and suitability for any particular use, is the sole responsibility of the user. IAQG maintains intellectual property rights to the SCMH material.

Руководство по управлению цепочкой поставки выпущено IAQG для оказания практической помощи по улучшению качества. Использование Руководства является полностью добровольным. Принятие решение о его применимости и пригодности для любого практического использования остается на исключительной ответственностью пользователя. IAQG сохраняет права на интеллектуальную собственность материалов, представленных в Руководстве по управлению цепочкой поставки.