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PDF Price. Not a Member? ISO Risk management - Guidelines. ISO Biological evaluation of medical devices - Part 6: Tests for local effects after implantation. ISO Biological evaluation of medical devices - Part Sample preparation and reference materials. This standard is not included in any packages. We have no amendments or corrections for this standard. Request Proposal Price. All the requirements of this International Standard are generic and are intended to be applicable to any organization, regardless of its type or size, or the products and services it provides.
NOTE 1 In this International Standard, the terms "product" or "service" only apply to products and services intended for, or required by, a customer. In addition to ISO , this document specifies Good Manufacturing Practice GMP requirements applicable to primary packaging materials for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards.
In ISO the term "if appropriate" is used several times. When a requirement is qualified by this phrase, it is deemed to be "appropriate" unless the organization can document a justification otherwise.
ISO is an application standard for the design, manufacture and supply of primary packaging materials for medicinal products. Proof returned by secretariat 60 Publication Check out our FAQs. Buy this standard. Abstract Preview ISO specifies requirements for a quality management system when an organization: a needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and b aims to enhance customer satisfaction through the effective application of the system, including processes for improvement of the system and the assurance of conformity to customer and applicable statutory and regulatory requirements.
NOTE 2 Statutory and regulatory requirements can be expressed as legal requirements. Status : Published. Publication date :
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