ISO 15378:2006 医疗制品一次包装材料 伴随优良制造实施标准（GMP）的引用，采用ISO 9001-2000的特殊要求事项

标准编号：ISO 15378:2006

中文名称：医疗制品一次包装材料 伴随优良制造实施标准（GMP）的引用，采用ISO 9001-2000的特殊要求事项

英文名称：Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)

发布日期：2006-03

标准范围

1.1 GeneralThis International Standard specifies requirements for a quality management system where an organizationneeds to demonstrate its ability to provide primary packaging materials for medicinal products, whichconsistently meet customer requirements, including regulatory requirements and International Standardsapplicable to primary packaging materials.In this International Standard the term “if appropriate” is used several times. When a requirement is qualifiedby this phrase, it is deemed to be “appropriate” unless the organization can document a justification otherwise.ISO 9001:2000, Quality management systems — Requirements1.1 GeneralThis 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 regulatoryrequirements, andb) aims to enhance customer satisfaction through the effective application of the system, including processes forcontinual improvement of the system and the assurance of conformity to customer and applicable regulatoryrequirements.NOTE In this International Standard, the term “product” applies only to the product intended for, or required by, a customer.1.2 ApplicationThis International Standard is an application standard for the design, manufacture and supply of primarypackaging materials for medicinal products. It is also applicable for certification purposes.ISO 9001:2000, Quality management systems — RequirementsAll 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 andits product, this can be considered for exclusion.Where exclusions are made, claims of conformity to this International Standard are not acceptable unless theseexclusions are limited to requirements within clause 7, and such exclusions do not affect the organization's ability, orresponsibility, to provide product that meets customer and applicable regulatory requirements.

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