医疗器械生产质量管理规范

医疗器械生产质量管理规范
医疗器械生产质量管理规范
医疗器械生产质量管理规范
医疗器械生产质量管理规范

医疗器械生产质量管理规范

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医疗器械生产质量管理规范

医疗器械生产质量管理规范

$43.35

内容简介

2009年12月16日,国家食品药品监督管理局就发布了《医疗器械生产质量管理规范(试行)》;《医疗器械生产质量管理规范检查管理办法(试行)》。2014年2月12日国务院审议通过《医疗器械监督管理条例(修订草案)》。此后,国家总局的《医疗器械生产监督管理办法》更加详细地规定了医疗器械生产企业建立生产质量管理体系的要求。作者岳伟参加了《医疗器械生产质量管理规范》及其两个《实施细则》的起草工作。在长年工作中,几乎每天都会接到许多电话或...

Product Details

内容简介

2009年12月16日,国家食品药品监督管理局就发布了《医疗器械生产质量管理规范(试行)》;《医疗器械生产质量管理规范检查管理办法(试行)》。2014年2月12日国务院审议通过《医疗器械监督管理条例(修订草案)》。此后,国家总局的《医疗器械生产监督管理办法》更加详细地规定了医疗器械生产企业建立生产质量管理体系的要求。作者岳伟参加了《医疗器械生产质量管理规范》及其两个《实施细则》的起草工作。在长年工作中,几乎每天都会接到许多电话或邮件咨询,要求讲解上述这些规范及其细则的条款。不解决这些问题,不解决企业的疑问,必然会对全面执行新法规、全面推行质量管理规范、全面促进医疗器械产业创新发展产生影响。《<医疗器械生产质量管理规范>的解析和应用》出版,对解决以上问题,大有帮助。

作者简介
岳伟,男,1955年1月出生。毕业于上海市第二工业大学,工学学士。长期从事于医疗器械工业生产的科研、管理。曾经担任上海医用核子仪器厂技术副厂长、上海医用激光仪器厂技术副厂长;自1990年代末从事医疗器械行政管理工作,担任上海市医药管理局科学技术处、对外经济合作处主任科员;上海市医药管理局综合处副处长;上海市食品药品监督管理局办公室副主任、信息中心主任。原上海市食品药品监督管理局医疗器械监管处处长。
  现受聘为:
  ·上海医疗器械行业协会法务咨询顾问;
  ·国家食品药品监督管理总局高级研修学院客座教授;
  ·上海医疗器械高等专科学院客座教授;
  ·上海市科委科学技术专家;
  ·上海市浦东新区科技局科学技术专家;
目  录
前言
绪论
章 总则
第二章 机构与人员
第三章 厂房与设施
第四章 设备
第五章 文件管理
第六章 设计开发
第七章 采购
第八章 生产管理
第九章 质量控制
第十章 销售和售后服务
第十一章 不合格产品控制
第十二章 分析和改进
前  言
在我长期的医疗器械管理工作中,对企业的质量管理体系的建立和运行占了较大的比重,具有了丰富的经历,也积累了一些经验。早在1985年,我在上海医用核子仪器厂担任技术副厂长时,我们工厂因为生产蒸汽压力消毒器而需要申请类压力容器生产许可证。在申请压力容器生产许可证和接受劳动安全监管部门组织的认证过程中,从产品设计文件、质量管理文件、原材料采购和检验、生产过程中的质量控制、生产过程的记录等各个方面做了大量的工作。现在回忆起来,实际上就是为压力容器的生产建立了一套完整的质量管理体系。那个时候,为了建立质量管理手册、为了建立金属材料实验室、为了对压力容器进行无损探伤等等,进行了大量的工作。虽然顺利地完成了取证的任务,但是对质量管理体系还是似懂非懂。1987年我国的GBlT19000系列质量管理体系标准正式发布以后,在全国掀起了一次宣传和学习的高潮,这时我已经担任了上海医用激光仪器厂的技术副厂长,所以在组织学习、贯彻实施中也做了许多工作。但是,真正对医疗器械生产质量管理体系的理解,是在2005年参加了国家认证认可机构组织的质量管理体系审核员学习和考核。通过系统地学习质量管理体系审核知识和质量管理体系标准,并经过实习审核员和正式审核员的考核,获得了国家审核员的资格。从2005年起,我担任上海市食品药品监督管理局医疗器械监管处处长的职务,直接担当起在上海市医疗器械行业推进建立医疗器械生产质量管理体系的工作。在十几年持续的工作中,不断地学习,不断地实践,并参加了国家相关医疗器械生产质量管理规范文件的研究、起草、解释、实施的工作。在长期的工作实践中,看到我国医疗器械生产企业随着质量管理规范的推行,企业的质量管理水平不断提高,医疗器械产品的水平也在不断提高,对此颇有感触。同时也看到在实施医疗器械生产质量管理规范中,产生了许多矛盾和问题,也有许多误解和误判,也对一些企业造成了伤害和损失。所以,在今天国家食品药品监督管理总局再次发布《医疗器械生产质量管理规范》时,我产生了一个强烈的想法,总结几十年来自己工作的经验和处理过的案例,对《医疗器械生产质量管理规范》的具体内容做一个原理上的解析,以求准确、全面地理解每一条款的基本原理和内涵。同时,对每一条款在执行应用中的要点,所涉及的范围和内容,需要引用的法规或知识等写出来。结果就写成了本书。

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

内容简介

2009年12月16日,国家食品药品监督管理局就发布了《医疗器械生产质量管理规范(试行)》;《医疗器械生产质量管理规范检查管理办法(试行)》。2014年2月12日国务院审议通过《医疗器械监督管理条例(修订草案)》。此后,国家总局的《医疗器械生产监督管理办法》更加详细地规定了医疗器械生产企业建立生产质量管理体系的要求。作者岳伟参加了《医疗器械生产质量管理规范》及其两个《实施细则》的起草工作。在长年工作中,几乎每天都会接到许多电话或邮件咨询,要求讲解上述这些规范及其细则的条款。不解决这些问题,不解决企业的疑问,必然会对全面执行新法规、全面推行质量管理规范、全面促进医疗器械产业创新发展产生影响。《<医疗器械生产质量管理规范>的解析和应用》出版,对解决以上问题,大有帮助。

作者简介
岳伟,男,1955年1月出生。毕业于上海市第二工业大学,工学学士。长期从事于医疗器械工业生产的科研、管理。曾经担任上海医用核子仪器厂技术副厂长、上海医用激光仪器厂技术副厂长;自1990年代末从事医疗器械行政管理工作,担任上海市医药管理局科学技术处、对外经济合作处主任科员;上海市医药管理局综合处副处长;上海市食品药品监督管理局办公室副主任、信息中心主任。原上海市食品药品监督管理局医疗器械监管处处长。
  现受聘为:
  ·上海医疗器械行业协会法务咨询顾问;
  ·国家食品药品监督管理总局高级研修学院客座教授;
  ·上海医疗器械高等专科学院客座教授;
  ·上海市科委科学技术专家;
  ·上海市浦东新区科技局科学技术专家;
目  录
前言
绪论
章 总则
第二章 机构与人员
第三章 厂房与设施
第四章 设备
第五章 文件管理
第六章 设计开发
第七章 采购
第八章 生产管理
第九章 质量控制
第十章 销售和售后服务
第十一章 不合格产品控制
第十二章 分析和改进
前  言
在我长期的医疗器械管理工作中,对企业的质量管理体系的建立和运行占了较大的比重,具有了丰富的经历,也积累了一些经验。早在1985年,我在上海医用核子仪器厂担任技术副厂长时,我们工厂因为生产蒸汽压力消毒器而需要申请类压力容器生产许可证。在申请压力容器生产许可证和接受劳动安全监管部门组织的认证过程中,从产品设计文件、质量管理文件、原材料采购和检验、生产过程中的质量控制、生产过程的记录等各个方面做了大量的工作。现在回忆起来,实际上就是为压力容器的生产建立了一套完整的质量管理体系。那个时候,为了建立质量管理手册、为了建立金属材料实验室、为了对压力容器进行无损探伤等等,进行了大量的工作。虽然顺利地完成了取证的任务,但是对质量管理体系还是似懂非懂。1987年我国的GBlT19000系列质量管理体系标准正式发布以后,在全国掀起了一次宣传和学习的高潮,这时我已经担任了上海医用激光仪器厂的技术副厂长,所以在组织学习、贯彻实施中也做了许多工作。但是,真正对医疗器械生产质量管理体系的理解,是在2005年参加了国家认证认可机构组织的质量管理体系审核员学习和考核。通过系统地学习质量管理体系审核知识和质量管理体系标准,并经过实习审核员和正式审核员的考核,获得了国家审核员的资格。从2005年起,我担任上海市食品药品监督管理局医疗器械监管处处长的职务,直接担当起在上海市医疗器械行业推进建立医疗器械生产质量管理体系的工作。在十几年持续的工作中,不断地学习,不断地实践,并参加了国家相关医疗器械生产质量管理规范文件的研究、起草、解释、实施的工作。在长期的工作实践中,看到我国医疗器械生产企业随着质量管理规范的推行,企业的质量管理水平不断提高,医疗器械产品的水平也在不断提高,对此颇有感触。同时也看到在实施医疗器械生产质量管理规范中,产生了许多矛盾和问题,也有许多误解和误判,也对一些企业造成了伤害和损失。所以,在今天国家食品药品监督管理总局再次发布《医疗器械生产质量管理规范》时,我产生了一个强烈的想法,总结几十年来自己工作的经验和处理过的案例,对《医疗器械生产质量管理规范》的具体内容做一个原理上的解析,以求准确、全面地理解每一条款的基本原理和内涵。同时,对每一条款在执行应用中的要点,所涉及的范围和内容,需要引用的法规或知识等写出来。结果就写成了本书。

Shipping Overview: 

Shipping: Standard Domestic Shipping within the United States charges USD 4.99. Standard International Shipping from United Kingdom, Germany and Japan to the United States charges 14.99. 

Order Processing: Please allow 1-2 business days for order processing and preparation before shipment. 

Domestic Shipping: Orders within the U.S. are shipped via USPS or FedEx, depending on the origin of the product. The average transit time is 3-7 business days. 

International Shipping: Currently, we only ship within the USA. 

Tracking Information: Every order is trackable. You will receive a tracking number once your order has been shipped. Products may be shipped from various global fulfillment centers.

Shipping Delays: 

Please note that shipping times may vary due to factors beyond our control, such as weather conditions, natural disasters, or peak holiday periods. While we strive to ensure timely delivery, the exact arrival time cannot be guaranteed and is managed by the shipping carrier.

Shipping Options:

  • Standard Delivery: Most orders are shipped within 3-7 business days. Larger items may utilize LTL shipping for safe handling.

  • Handling Time: We handle shipments on business days (Monday - Friday), with a preparation time of 1-2 days.

  • Additional Charges: Some items require additional shipping charges due to their size, weight, or special handling. These charges are specified on the product pages and are not eligible for shipping discounts.

  • Exclusions: Gift cards, packaging, taxes, and prior purchases do not count toward the minimum purchase requirement for free shipping. This offer is valid only for shipments to U.S. addresses, including Puerto Rico.

Delivery Details:

  • Estimates: Standard shipping within the US typically takes 3-7 business days. These are estimates and not guarantees.

  • Shipping Restrictions: We ship to all 50 states, Washington, DC, U.S. territories, and APO/FPO/DPO addresses. Shipping options vary based on the delivery address.

  • Remote Areas: Shipments to remote areas may incur additional charges or require pickup from a nearby shipping partner’s location.

Shipping Confirmation:

You will receive a shipping confirmation email with a tracking number as soon as your order is dispatched. If you do not receive this email immediately, please be assured that your items will arrive within the estimated delivery window provided at checkout.

Order Modifications:

If you need to cancel or modify your order, please contact our customer support immediately.

Issues with Delivery:

If your order shows as delivered but you have not received it, please contact the shipping carrier directly to resolve the issue. For persistent problems, contact our customer service at cs@everymarket.com.

Customer Support:

Our team is available 24/7 to assist you with any questions or concerns regarding your order. We are committed to ensuring a smooth shopping experience.

Return & Refund Policy Overview

Please review our return and refund policies below to ensure a smooth transaction process.

Return Policy

  • Duration: You have 30 days from receiving your item to initiate a return.

  • Condition: Items must be unworn, unwashed, with original tags and packaging intact.

  • Shipping Costs: Customers are responsible for return shipping costs.

  • Packaging: Ensure returned items are well-packaged to avoid damage during transit.

  • Tracking: Use a trackable and insured shipping method as we are not liable for items lost or damaged on return.

  • Initiating a Return: Contact us at cs@everymarket.com to start your return. We will provide a return shipping label and instructions upon approval. Returns without prior approval will not be accepted.

How to Return

  • Method: Returns must be sent back by mail to the address provided in the return instructions.

Return Label

  • Defective Products: Return labels are provided for defective items.

  • Non-Defective Returns: Customers are responsible for obtaining their return shipping label.

Product Conditions for Return

  • Eligible Products: Returns are only accepted for items in new condition.

Nonreturnable Items

Certain items are not eligible for return:

  • Electronic devices after 30 days (e.g., computers, laptops, Kindles)

  • Gift cards, prepaid game cards

  • Perishable goods, live insects, some jewelry, some health and personal care items

  • Customized or personalized products

  • Items with special shipping restrictions

Refund Policy

  • Window: Eligible products may be returned within 30 days of delivery for a refund.

  • Refund Method: Refunds are processed to the original payment method or as store credit for items purchased with gift cards.

  • Processing Time: Refunds are processed within 3-5 business days after we receive the return; please allow additional time for shipping and bank processing.

Claims

Inspect your order upon arrival and report any defects, damages, or incorrect items immediately to allow us to address the issue. For claims, contact our support team with details of the issue.

Exchange Policy

For the quickest service, return your original item and place a new order for the desired product once your return is accepted.

Return Address

EveryMarket Customer Service 2101 E Terra Ln, O'Fallon, MO 63366

Customer Support

Available 24/7 for any questions or assistance needed:

  • Phone: +1 636-312-5925

  • Email: cs@everymarket.com

 

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