MatrixbetweenISO13485Clauses,SterilitydetailedClausesandthe 1.0公司简介CompanyHistory17 ReferenceProcedures 2.0质量方针和目标QualityPolicyandObjective19 3.0组织与职责CompanyOrganizationResponsibility20 3.1组织架构OrganizationCharts20 3.2权力和职位AuthorityandPosition22 ...
AnISO 13485audit can make even the most seasoned medical device quality managers bite their nails. The standard includes 77 clauses, so there are a lot of ways to fall short—even if you're working with the most comprehensive of ISO 13485 audit checklists. Too many organizations fail their ...
ISO 13485质量管理体系设备控制程序(含全套表单).pdf,文件编号DN:QP040 版本号 Version: 主管部门 Resp.Dept.: 发放编号 Distribution 工程部 Engineering No: xxxxxxxxxxxx 有限公司 质量管理体系管理性文件 QUALITY SYSTEM PROCEDURE 设备控制程序 Equipment Contro
MatrixbetweenISO13485Clauses,SterilitydetailedClausesandtheReferenceProcedures 1.0 公司简介CompanyHistory 17 2.0 质量方针和目标QualityPolicyandObjective 19 3.0 组织与职责CompanyOrganizationResponsibility 20 3.1 组织架构OrganizationCharts 20 3.2 权力和职位AuthorityandPosition ...
Quality claim clauses; Acceptance standards and manners; Warranty and after-sales service requirement; The technical contract should be effective with the business contract; The training plan and requirement as well as technical documents should be identified, if necessary. 4.2.4设备验收The equipment ...
ISO13485医疗器械-供应商审核检查表(自动计算结果).xlsx,Audit Leader审核负责人: Audit Date审核日期:2022-12-18 Audit team member审核组成员: Vendor Name 供应商名称: Audit Location 审核地址: Contact Person 联系人: Contact Information 联系方式: Auditee
A list anizations represented on this mittee can be obtained on request to its secretary. ISO corrigendum August 2009 added the year of publication to the ISO 9001:2000 references in clauses , , , and Annex B. Reference [6] was also replaced in the ...
Get a detailed understanding of the ISO 15189:2022 requirements and sub-clauses. Understand, maintain, and retain documented information lists. Familiarize with ISO 15189:2022 accreditation process and steps for accreditation. WHO SHOULD ATTEND THIS COURSE?
ISO 9001 is a unique measure. An organization must demonstrate its ability to consistently provide products and services that meet customer expectations and comply with applicable statutory or regulatory requirements when a quality management system is required. A series of clauses define a specific set...
6.9. Agreement(s)协议 6.10. Labelling标签 6.11. Data monitoring committee (DMC)数据监查委员会 7. Clinical investigation conduct临床研究实施 7.1. General概述 7.2. Investigation site initiation研究中心启动 7.3. Investigation site monitoring 7.4. Adverse events and device deficiencies不良事件和器械缺陷 ...