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• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.7 Control of design and development changes (Created page with "7.3.7 Control of design and development changes Design and development changes shall be identified and records maintained. The changes shall be reviewed, verified and validat...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.6 Design and development validation (Created page with "7.3.6 Design and development validation Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.5 Design and development verification (Created page with "7.3.5 Design and development verification Verification shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the design and development output...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.4 Design and development review (Created page with "7.3.4 Design and development review At suitable stages, systematic reviews of design and development shall be performed in accordance with planned arrangements (see 7.3.1) a)...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.3 Design and development outputs (Created page with "'''7.3.3 Design and development outputs''' The outputs of design and development shall be provided in a form that enables verification against the design and development inpu...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.2 Design and development input (Created page with "'''7.3.2 Design and development inputs''' Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) functi...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.3.1 Design and development planning (Created page with "'''7.3.1 Design and development planning''' The organization shall establish documented procedures for design and development. The organization shall plan and control the des...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.2.3 Customer communication (Created page with "'''7.2.3 Customer communication''' The organization shall determine and implement effective arrangements for communicating with customers in relation to a) product informati...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.2.2 Review of requirements related to the product (Created page with "'''7.2.2 Review of requirements related to the product''' The organization shall review the requirements related to the product. This review shall be conducted prior to the o...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.2.1 Determination of requirements related to the product (Created page with "7.2.1 Determination of requirements related to the product The organization shall determine: a) requirements specified by the customer, including the requirements for deliver...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 7.1 Planning of product realization (Created page with "'''7.1 Planning of product realization''' The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consi...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO 14971 (Created page with "Type the text for 'New Tiddler' Category:quality")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 6.4 Work environment (Created page with "'''6.4 Work environment''' The organization shall determine and manage the work environment needed to achieve conformity to product requirements. The following requirements...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 6.3 Infrastructure (Created page with "'''6.3 Infrastructure''' The organization shall determine, provide and maintain the infrastructure needed to achieve conformity to product requirements. Infrastructure includ...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 6.2.1 General (Created page with "'''6.2.1 General''' Personnel performing work affecting product quality shall be competent on the basis of appropriate education, training, skills and experience. Category...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 6.1 Provision of resources (Created page with "6.1 Provision of resources The organization shall determine and provide the resources needed a) to implement the quality management system and to maintain its effectiveness,...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 6.2.2 Competence, awareness and training (Created page with "'''6.2.2 Competence, awareness and training''' The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provid...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.6.2 Review input (Created page with "'''5.6.2 Review input''' The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.6.3 Review output (Created page with "'''5.6.3 Review output''' The output from the management review shall include any decisions and actions related to a) improvements needed to maintain the effectiveness of the...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.6.1 General (Created page with "'''5.6.1 General''' Top management shall review the organization’s quality management system, at ''planned intervals'', to ensure its continuing suitability, adequacy and e...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.5.3 Internal communication (Created page with "'''5.5.3 Internal communication''' Top management shall ensure that appropriate communication processes are established within the organization and that communication takes p...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.5.2 Management representative (Created page with "'''5.5.2 Management representative''' Top management shall appoint a member of management who, irrespective of other responsibilities, shall have responsibility and authority...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - Responsibility and authority (Created page with "'''Responsibility and authority''' Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization. Top ma...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.4.2 Quality management system planning (Created page with "5.4.2 Quality management system planning Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements gi...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.4.1 Quality objectives (Created page with "'''5.4.1 Quality objectives''' Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at r...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.3 Quality policy (Created page with "'''5.3 Quality policy''' Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with req...")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.2 Customer focus (Created page with "5.2 Customer focus Top management shall ensure that customer requirements are determined and are met (see 7.2.1 and 8.2.1). Category:quality Category:ISO13485")
• 09:46, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 5.1 Management commitment (Created page with "'''5.1 Management commitment''' Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 4.2.4 Control of records (Created page with "'''4.2.4 Control of records''' Records shall be established and maintained to provide evidence of conformity to requirements and of the effective operation of the quality man...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Legible (Created page with "Readable (Good Documentation Practices) Category:quality Category:Term")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Document (Created page with "The organization needs to distinguish between documents that will be controlled and documents that will not be included under the QMS. A document is: * Plans, requirements, or...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Record (Created page with "Type of Records A record is evidence of performing a process or activity or an output of a process. According to the standard, records will serve two main purposes: Verifica...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 4.2.3 Control of documents (Created page with "'''4.2.3 Control of documents''' Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled accor...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Quality Manual (Created page with "The purpose of this Quality Manual is to demonstrate external regulations and requirements are fulfilled. Category:quality Category:Term")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 4.2.2 Quality manual (Created page with "'''4.2.2 Quality manual''' The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of an...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 4.2.1 General (Created page with "'''4.2.1 General''' The quality management system documentation shall include a) documented statements of a quality policy and quality objectives, b) a quality manual, c) doc...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - 4.1 General Requirements (Created page with "'''4.1 General requirements''' The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Advisory Notice (Created page with "An ''advisory notice'' is notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information and/or to advise what action sh...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - Clause 3 Terms & definitions (Created page with "'''Clause 3 Terms & definitions''' * Wherever the term “product” occurs, it can also mean “service” * Wherever requirements are specified as applying to “medical...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - Clause 1 Scope (Created page with "'''Clause 1 Scope''' 1.1 General * Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory require...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Category:ISO13485 (Created page with "{{category}}")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - Clause 2 Normative references (Created page with "ISO 9000 Quality management systems — Fundamentals and vocabulary Category:quality Category:ISO13485")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Category:ISO13485:2003 (Created page with "{{category}}")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485 - Clause 0: Introduction (Created page with "'''Clause 0: Introduction''' * Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, devel...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Category:13485 (Created page with "{{category}}")
• 09:45, 25 August 2020 Dirkjan talk contribs created page Category:ISO (Created page with "{{category}}")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO13485:2003 (Created page with "ISO 13485 is derived from ISO 9001 {{:ISO13485 - Clause 0: Introduction}} {{:ISO13485 - Clause 1 Scope}} {{:ISO13485 - Clause 2 Normative references}} {{:ISO...")
• 09:45, 25 August 2020 Dirkjan talk contribs created page ISO (Created page with "ISO is a International Standard published by the International Organization for Standardization Category:quality")
• 09:45, 25 August 2020 Dirkjan talk contribs created page EN (Created page with "EN is a European Standard published by European Commision for Standardization Category:quality Category:Term")
• 09:45, 25 August 2020 Dirkjan talk contribs created page NEN (Created page with "NEN is a Dutch Standard published by the ”nederlands normalisatie instituut” Category:quality Category:Term")

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