AS9100C标准中英双版.doc

Quality Management Systems – Requirements for Aviation, Space and Defense Organizations1. Scope1.1 GeneralThis standard includes ISO 9001:2008 quality management system requirements and specifies additional aviation, space and defense industry requirements, definitions and notes as shown in bold, italic text.It is emphasized that the requirements specified in this standard are complementary (not alternative) to contractual and applicable statutory and regulatory requirements. Should there be a conflict between the requirements of this standard and applicable statutory or regulatory requirements, the latter shall take precedence.This International Standard specifies requirements for a quality management system where an organizationa) needs to demonstrate its ability to consistently provide product that meets customer and applicable statutory and regulatory requirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes for continual improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.NOTE 1In this International Standard, the term “product” only applies to a) product intended for, or required by, a customer,b) any intended output resulting from the product realization processes.NOTE 2 Statutory and regulatory requirements may be expressed as legal requirements.1.2 ApplicationAll requirements of this International Standard are generic and are intended to be applicable to all organizations, regardless of type, size and product provided.Where any requirement(s) of this International Standard cannot be applied due to the nature of an organization and its product, this can be considered for exclusion.Where exclusions are made, claims of conformity to this International Standard are not acceptable unless these exclusions are limited to requirements within clause 7, and such exclusions do not affect the organizations ability, or responsibility, to provide product that meets customer and applicable statutory and regulatory requirements.This standard is intended for use by organizations that design, develop and/or produce aviation, space and defense products; and by organizations providing post-delivery support, including the provision of maintenance, spare parts or materials for their own products.Organizations whose primary business is providing maintenance, repair and overhaul services for aviation commercial and military products; and original equipment manufacturers with maintenance, repair and overhaul operations that operate autonomously, or that aresubstantially different from their manufacturing/production operations; should use the IAQG-developed 9110 standard (see Bibliography).Organizations that procure parts, materials and assemblies and resell these products to a customer in the aviation, space and defense industries, including organizations that procure products and split them into smaller quantities for resale, should use the IAQG-developed 9120 standard (see Bibliography).2. Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 9000:2005, Quality management systems — Fundamentals and vocabulary.3. Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 9000 apply.Throughout the text of this International Standard, wherever the term “product” occurs, it can also mean “service”.3.1 RiskAn undesirable situation or circumstance that has both a likelihood of occurring and a potentially negative consequence.3.2 Special requirementsThose requirements identified by the customer, or determined by the organization, which have high risks to being achieved, thus requiring their inclusion in the risk management process. Factors used in the determination of special requirements include product or process complexity, past experience and product or process maturity. Examples of special requirements include performance requirements Imposed by the customer that are at the limit of the industry’s capability, or requirements determined by the organization to be at the limit of its technical or process capabilities.3.3 Critical itemsThose items (e.g., functions, parts, software, characteristics, processes) having significant effect on the product realization and use of the product; including safety, performance, form, fit, function, producibility, service life, etc.; that require specific actions to ensure they areadequately managed. Examples of critical items include safety critical items, fracture critical items, mission critical items, key characteristics, etc.3.4 Key Characteristic。