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News

31 March 2019:

Added the document set D 10 - Quality tools

  Promotion of the week Promotion of the week

For week 21 the set of documents D 36v16 IATF 16949 internal audit version 2016 is at 14 euros (instead of 28 euros) 

  Promotion of the month Promotion of the month

For May the course T 41v16 AS9100D internal audit version 2016 is with a 50% decrease (from 100 euros to 50 euros)

D 07v16 - Set of documents - Medical devices - Procedures and instructions version 2016

Document set - 97 editable procedures and instructions for your medical devices quality management system ISO 13485 version 2016

 
$54.81
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D 07v16 - Set of documents - Medical devices - Procedures and instructions version 2016
  • Added the: 03/03/2017
  • Last update: 03/03/2017
  • Number of pages: 281
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You have an unlimited access for one year to the whole set of documents. This includes access to all the modifications (improvements) which could be made during that period.

D 07v16 Procedures and instructions medical devices
Codification Title Sub-clause ISO 13485 version 2016 Pages
  Procedures (* mandatory)    
PQBD07v1601 Software validation*(first 3 pages) 4.1.6; 7.5.6; 7.6 5
PQBD07v1602 Documents and records* 4.2.4; 4.2.5  6
PQBD07v1603 Management review* 5.6  5
PQBD07v1604 Work environment* 6.4.1  4
PQBD07v1605 Feedback* 7.2.3; 8.2.1  4
PQBD07v1606 Complaint handling* 7.2.3; 8.2.2  4
PQBD07v1607 Advisory notices* 7.2.3; 8.2.3; 8.3.3  4
PQBD07v1608 Design and development* 7.3  5
PQBD07v1609 Purchasing* 7.4  5
PQBD07v1610 Production* 7.5.1; 8.2.6  4
PQBD07v1611 Servicing* 7.5.4  3
PQBD07v1612 Process validation*  7.5.6; 7.5.7; 8.2.5  6
PQBD07v1613 Identification and traceability* 7.5.8; 7.5.7 5
PQBD07v1614 Product preservation* 7.5.11  4
PQBD07v1615 Monitoring and measurement* 7.6  5
PQBD07v1616 Reporting to regulatory authorities* 8.2.3  3
PQBD07v1617 Internal audit* 8.2.4  6
PQBD07v1618 Nonconforming product* 8.3.1; 8.3.2 5
PQBD07v1619 Rework* 8.3.4  3
PQBD07v1620 Analysis of data* 8.4  9
PQBD07v1621 Corrective and preventive actions* 8.5.2 ; 8.5.3  5
PQBD07v1622 Risk management 4.1; 7.1; 7.3; 7.4; 7.5; 7.6; 8.2  5
PQBD07v1623 Medical device file 4.2.3  4
PQBD07v1624 Training 6.2  4
PQBD07v1625 Disinfection and sterilization 7.5.2; 7.5.5; 7.5.7  5
PQBD07v1626 Contamination 6.4.2; 7.5.2; 7.5.11  5
  Instructions    
PQBD07v160101 Software list    1
PQBD07v160102 Validation report   1
PQBD07v160201 Quality manual   22
PQBD07v160202 List of documents ofexternal origin    1
PQBD07v160203 List of standards    1
PQBD07v160204 Procedure    1
PQBD07v160205 Instruction    1
PQBD07v160206 List of procedures    1
PQBD07v160207 List of instructions    3
PQBD07v160208 Codification of documents    2
PQBD07v160301 Management review report    3
PQBD07v160401 Air cleanliness    1
PQBD07v160501 Satisfaction survey   3
PQBD07v160502 Feedback register    1
PQBD07v160601 Complaint register    1
PQBD07v160701 Advisory notice    1
PQBD07v160702 Advisory notice register    1
PQBD07v160801 Design and development stages    1
PQBD07v160802 Design and development inputs    1
PQBD07v160803 Design and development outputs    1
PQBD07v160804 Design and development review    1
PQBD07v160805 Design and development verification    1
PQBD07v160806 Design and development validation    1
PQBD07v160807 Design and development transfer    1
PQBD07v160808 Roles and competence of project members    1
PQBD07v160809 Design and development resources    1
PQBD07v160810 Design and development changes    1
PQBD07v160811 Design and development file    1
PQBD07v160901 List of approved suppliers    1
PQBD07v160902 Supplier evaluation questionnaire    3
PQBD07v160903 Product specifications    2
PQBD07v160904 Verification of purchased product    1
PQBD07v160905 Reception anomaly    1
PQBD07v160906 Supplier quality complaint    1
PQBD07v161001 Work instruction    1
PQBD07v161002 Maintenance intervention report   2
PQBD07v161003 Production report    1
PQBD07v161101 Servicing report    1
PQBD07v161201 List of processes    1
PQBD07v161202 Process validation report    2
PQBD07v161301 Follow-up form    1
PQBD07v161302 Output traceability    1
PQBD07v161401 Special conditions    1
PQBD07v161501 Equipment list    1
PQBD07v161502 Verification range    1
PQBD07v161503 Verification certificate    1
PQBD07v161601 Reporting register    1
PQBD07v161701 List of internal auditors    1
PQBD07v161702 Internal audit plan   3
PQBD07v161703 Internal audit program    2
PQBD07v161704 Internal audit report    2
PQBD07v161705 Process audit questionnaire   9
PQBD07v161706 QMS audit questionnaire   31
PQBD07v161801 Nonconforming treatment form    1
PQBD07v161802 Customer concession    1
PQBD07v161901 Rework form    1
PQBD07v162001 Capability study    1
PQBD07v162002 Machine capability    1
PQBD07v162003 R&R study    1
PQBD07v162101 Customer return    1
PQBD07v162102 Quality alert form    1
PQBD07v162103 Action plan    1
PQBD07v162201 List of risks    6
PQBD07v162202 Risk level    2
PQBD07v162203 Risk management plan    1
PQBD07v162301 List of medical device file    1
PQBD07v162401 Certificate of attendance    1
PQBD07v162402 Evaluation of training    1
PQBD07v162501 Daily cleaning    1
PQBD07v162502 Sterilization form    1
PQBD07v162601 Filter follow-up form    1
PQBD07List List of MD documents   3
Total   281