ISO 13485 ¼Ò°³

Medical devices - Quality management systems - Requirements for regulatory purposes

ISO 13485´Â ÀÇ·á±â±â Ç°Áú°æ¿µ½Ã½ºÅÛ ±¹Á¦±Ô°ÝÀ¸·Î ÇØ´ç Á¶Á÷À» ±âÁØÀ¸·Î °í°´ ¹× Àû¿ëµÇ´Â ±ÔÁ¦Àû ¿ä±¸»çÇ×À» Áö¼ÓÀûÀ¸·Î ÃæÁ·ÇÏ´Â ÀÇ·á±â±â¿Í °ü·Ã ¼­ºñ½º¸¦ ÀÏ°üµÇ°Ô Á¦°øÇϱâ À§ÇÑ ¿ª·®À» Àû¿ë ¹× ½ÇÁõÇÒ ÇÊ¿ä°¡ ÀÖ´Â Á¶Á÷ÀÇ Ç°Áú°æ¿µ½Ã½ºÅÛ¿¡ ´ëÇÑ ¿ä±¸»çÇ×À» ±ÔÁ¤ÇÏ°í ÀÖ½À´Ï´Ù.

ISO 13485:2016 °³¿ä

ISO13485:2016Àº µ¶¸³ÀûÀÎ ±Ô°ÝÀÌÁö¸¸, ISO 9001:2015·Î ´ëüµÈ ISO 9001:2008À» ±â¹ÝÀ¸·Î ÇÏ°í ÀÖÀ¸¸ç ISO 13485:2003°ú ISO/TR 14969:2004À» ´ëüÇÕ´Ï´Ù. ¿ä±¸»çÇ×ÀÇ Àû¿ë¿¡ À־ ´Â ISO13485:2016ÀÇ 6Ç×, 7Ç×, ¶Ç´Â 8Ç×ÀÇ Æ¯Á¤ ¿ä±¸»çÇ×ÀÌ Àû¿ëµÇÁö ¾ÊÀ» °æ¿ì Á¶Á÷Àº ±×·¯ÇÑ °áÁ¤¿¡ ´ëÇÑ Á¤´ç¼ºÀ» Á¦½ÃÇÏ¿© Ç°Áú°æ¿µ½Ã½ºÅÛ¿¡¼­ ÇØ´ç ¿ä±¸»çÇ×À» Á¦¿ÜÇÒ ¼ö ÀÖ½À´Ï´Ù.

ISO13485:2016ÀÇ ISO13485:2003 ´ëºñ ÁÖ¿ä º¯°æ»çÇ×Àº ´ÙÀ½°ú °°½À´Ï´Ù.

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ISO 13485:2016 Àû¿ë °¡´É Á¶Á÷

ISO13485: 2016Àº ISO13485:2003°ú ´Þ¸®, ÀÇ·á±â±â Á¦Á¶¾÷ü¿¡ ±¹ÇѵÇÁö ¾Ê°í, ÀÇ·á±â±âÀÇ ¼³°è ¹× °³¹ß, »ý»ê, ÀúÀå, ¹è¼Û, ¼³Ä¡, ¼­ºñ½º Á¦°ø, ÀÇ·á±â±âÀÇ Æó±â, ¶Ç´Â °ø±Þ°ú °ü·ÃµÈ È°µ¿À» Æ÷ÇÔÇÑ ÀÇ·á±â±âÀÇ Àü °úÁ¤ ´Ü°è¿¡¼­ Çϳª ¶Ç´Â ±× ÀÌ»óÀÇ ´Ü°è¿¡ °ü°èÇÏ´Â Á¶Á÷¿¡ Àû¿ëµÉ ¼ö ÀÖ½À´Ï´Ù.

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ISO 13485:2016 ¿ä±¸»çÇ×

4 Ç°Áú°æ¿µ½Ã½ºÅÛ Quality management system
4.1 ÀϹݿ䱸»çÇ× General requirements
4.2 ¹®¼­È­ ¿ä±¸»çÇ× Documentation requirements
  • 4.2.1 ÀϹݻçÇ× General
  • 4.2.2 Ç°Áú ¸Å´º¾ó Quality manual
  • 4.2.3 ÀÇ·á±â±â ÆÄÀÏ Medical device file
  • 4.2.4 ¹®¼­°ü¸® Control of documents
  • 4.2.5 ±â·Ï°ü¸® Control of records
5 °æ¿µÃ¥ÀÓ Management responsibility
5.1 °æ¿µÀÚ ÀÇÁö Management commitment
5.2 °í°´Á᫐ Customer focus
5.3 Ç°Áú¹æħ Quality policy
5.4 ±âȹ Planning
  • 5.4.1 Ç°Áú¸ñÇ¥ Quality objectives
  • 5.4.2 Ç°Áú°æ¿µ½Ã½ºÅÛ ±âȹ Quality management system planning
5.5 Ã¥ÀÓ, ±ÇÇÑ ¹× ÀÇ»ç¼ÒÅë Responsibility, authority and communication
  • 5.5.1 Ã¥ÀÓ ¹× ±ÇÇÑ Responsibility and authority
  • 5.5.2 °æ¿µ´ë¸®ÀÎ Management representative
  • 5.5.3 ³»ºÎ ÀÇ»ç¼ÒÅë Internal communication
5.6 °æ¿µ°ËÅä Management review
  • 5.6.1 ÀϹݻçÇ× General
  • 5.6.2 °ËÅäÀÔ·Â Review input
  • 5.6.3 °ËÅäÃâ·Â Review output
6 ÀÚ¿ø°ü¸® Resource management
6.1 ÀÚ¿ø°ø±Þ Provision of resources
6.2 ÀÎÀûÀÚ¿ø Human resources
6.3 ±â¹Ý±¸Á¶ Infrastructure
6.4 ¾÷¹«È¯°æ°ú ¿À¿°°ü¸® Work environment and contamination control
  • 6.4.1 ÀÛ¾÷ȯ°æ Work environment
  • 6.4.2 ¿À¿°°ü¸® Contamination control
7 Á¦Ç°½ÇÇö Product realization
7.1 Á¦Ç°½ÇÇöÀÇ ±âȹ Planning of product realization
7.2 °í°´°ü·Ã ÇÁ·Î¼¼½º Customer-related processes
  • 7.2.1 Á¦Ç°°ú °ü·ÃµÈ ¿ä±¸»çÇ× °áÁ¤ Determination of requirements related to product
  • 7.2.2 Á¦Ç°°ú °ü·ÃµÈ ¿ä±¸»çÇ× °ËÅä Review of requirements related to product
  • 7.2.3 ÀÇ»ç¼ÒÅë Communication
77.3 ¼³°è ¹× °³¹ß Design and development
  • 7.3.1 ÀϹݻçÇ× General
  • 7.3.2 ¼³°è ¹× °³¹ß ±âȹ Design and development planning
  • 7.3.3 ¼³°è ¹× °³¹ß ÀÔ·Â Design and development inputs
  • 7.3.4 ¼³°è ¹× °³¹ß Ãâ·Â Design and development outputs
  • 7.3.5 ¼³°è ¹× °³¹ß °ËÅä Design and development review
  • 7.3.6 ¼³°è ¹× °³¹ß °ËÁõ Design and development verification
  • 7.3.7 ¼³°è ¹× °³¹ß ÀÔÁõ Design and development validation
  • 7.3.8 ¼³°è ¹× °³¹ß Àüȯ Design and development transfer
  • 7.3.9 ¼³°è ¹× °³¹ß º¯°æ°ü¸® Control of design and development changes
  • 7.3.10 ¼³°è ¹× °³¹ß ÆÄÀÏ Design and development files
7.4 ±¸¸Å Purchasing
  • 7.4.1 ±¸¸Å ÇÁ·Î¼¼½º Purchasing process
  • 7.4.2 ±¸¸Å Á¤º¸ Purchasing information
  • 7.4.3 ±¸¸ÅÇÑ Á¦Ç°ÀÇ °ËÁõ Verification of purchased product
7.5 »ý»ê ¹× ¼­ºñ½º °ø±Þ Production and service provision
  • 7.5.1 Á¦Ç° ¹× ¼­ºñ½º °ø±Þ°ü¸® Control of production and service provision
  • 7.5.2 Á¦Ç°ÀÇ Ã»°á Cleanliness of product
  • 7.5.3 ¼³Ä¡È°µ¿ Installation activities
  • 7.5.4 ¼­ºñ½º È°µ¿ Servicing activities
  • 7.5.5 ¸ê±ÕÀÇ·á±â±â¸¦ À§ÇÑ Æ¯Á¤ ¿ä±¸»çÇ× Particular requirements for sterile medical devices
  • 7.5.6 Á¦Ç°°ú ¼­ºñ½º°ø±ÞÀ» À§ÇÑ ÀÔÁõ ÇÁ·Î¼¼½º Validation of processes for production and service provision
  • 7.5.7 ¸ê±Õ°ú ¸ê±Õ½Ã½ºÅÛÀ» À§ÇÑ °ËÁõÇÁ·Î¼¼½º Particular requirements for validation of processes for sterilization and sterile barrier systems
  • 7.5.8 ½Äº° Identification
  • 7.5.9 ÃßÀû¼º Traceability
  • 7.5.10 °í°´ÀÚ»ê Customer property
  • 7.5.11 Á¦Ç°º¸Á¸ Preservation of product
7.6 ¸ð´ÏÅ͸µ ¹× ÃøÁ¤±â±â°ü¸® Control of monitoring and measuring equipment
8. ÃøÁ¤, ºÐ¼® ¹× °³¼± Measurement, analysis and improvement
8.1 ÀϹݻçÇ× General
8.2 ¸ð´ÏÅ͸µ ¹× ÃøÁ¤ Monitoring and measurement
  • 8.2.1 Çǵå¹é Feedback
  • 8.2.2 ºÒ¸¸Ã³¸® Complaint handling
  • 8.2.3 ±ÔÁ¦±â°ü º¸°í Reporting to regulatory authorities
  • 8.2.4 ³»ºÎ½É»ç Internal audit
  • 8.2.5 ¸ð´ÏÅ͸µ ¹× ÃøÁ¤ ÇÁ·Î¼¼½º Monitoring and measurement of processes
  • 8.2.6 ¸ð´ÏÅ͸µ ¹× ÃøÁ¤ Á¦Ç° Monitoring and measurement of product
8.3 ºÎÀûÇÕ Á¦Ç°°ü¸® Control of nonconforming product
  • 8.3.1 ÀϹݻçÇ× General
  • 8.3.2 ¿î¼Û Àü ¹ß°ßµÈ ºÎÀûÇÕ¿¡ ´ëÇÑ ´ëÀÀÁ¶Ä¡ Actions in response to nonconforming product detected before delivery
  • 8.3.3 ¿î¼Û ÈÄ ¹ß°ßµÈ ºÎÀûÇÕ¿¡ ´ëÇÑ ´ëÀÀÁ¶Ä¡ Actions in response to nonconforming product detected after delivery
  • 8.3.4 ÀçÀÛ¾÷ Rework
8.4 µ¥ÀÌÅÍ ºÐ¼® Analysis of data/dt
8.5 °³¼± Improvement
  • 8.5.1 ÀϹݻçÇ× General
  • 8.5.2 ½ÃÁ¤Á¶Ä¡ Corrective action
  • 8.5.3 ¿¹¹æÁ¶Ä¡ Preventive action

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