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News

15 August 2019:

Added the document set D 06v18 Food safety - Procedures and instructions ISO 22000 version 2018

  Promotion of the week Promotion of the week

For week 42 the pack of documents D 07 Environmental procedures version 2015 is at 12 euros (instead of 25 euros) 

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For October the training package T 68v18 ISO 45001 version 2018 is with a 50% decrease (from 225 euros to 112 euros)

D 13v16 - 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

 
$54.73
Ex. VAT
D 13v16 - Set of documents - Medical devices - Procedures and instructions version 2016
  • Added the: 03/03/2017
  • Last update: 22/07/2019
  • Number of pages: 281
See other documents

See the set of documents D 22v16 ISO 13485 Readiness

See the set of documents D 42v16 ISO 13485 Internal audit

See the set of documents D 72v16 ISO 13485 package

 

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 13v16 Procedures and instructions medical devices
Codification Title Sub-clause ISO 13485 version 2016 Pages
  Procedures (* mandatory)    
PQBD13v1601 Software validation*(first 3 pages) 4.1.6; 7.5.6; 7.6 5
PQBD13v1602 Documents and records* 4.2.4; 4.2.5  6
PQBD13v1603 Management review* 5.6  5
PQBD13v1604 Work environment* 6.4.1  4
PQBD13v1605 Feedback* 7.2.3; 8.2.1  4
PQBD13v1606 Complaint handling* 7.2.3; 8.2.2  4
PQBD13v1607 Advisory notices* 7.2.3; 8.2.3; 8.3.3  4
PQBD13v1608 Design and development* 7.3  5
PQBD13v1609 Purchasing* 7.4  5
PQBD13v1610 Production* 7.5.1; 8.2.6  4
PQBD13v1611 Servicing* 7.5.4  3
PQBD13v1612 Process validation*  7.5.6; 7.5.7; 8.2.5  6
PQBD13v1613 Identification and traceability* 7.5.8; 7.5.7 5
PQBD13v1614 Product preservation* 7.5.11  4
PQBD13v1615 Monitoring and measurement* 7.6  5
PQBD13v1616 Reporting to regulatory authorities* 8.2.3  3
PQBD13v1617 Internal audit* 8.2.4  6
PQBD13v1618 Nonconforming product* 8.3.1; 8.3.2 5
PQBD13v1619 Rework* 8.3.4  3
PQBD13v1620 Analysis of data* 8.4  9
PQBD13v1621 Corrective and preventive actions* 8.5.2 ; 8.5.3  5
PQBD13v1622 Risk management 4.1; 7.1; 7.3; 7.4; 7.5; 7.6; 8.2  5
PQBD13v1623 Medical device file 4.2.3  4
PQBD13v1624 Training 6.2  4
PQBD13v1625 Disinfection and sterilization 7.5.2; 7.5.5; 7.5.7  5
PQBD13v1626 Contamination 6.4.2; 7.5.2; 7.5.11  5
  Instructions    
PQBD13v160101 Software list    1
PQBD13v160102 Validation report   1
PQBD13v160201 Quality manual   22
PQBD13v160202 List of documents ofexternal origin    1
PQBD13v160203 List of standards    1
PQBD13v160204 Procedure    1
PQBD13v160205 Instruction    1
PQBD13v160206 List of procedures    1
PQBD13v160207 List of instructions    3
PQBD13v160208 Codification of documents    2
PQBD13v160301 Management review report    3
PQBD13v160401 Air cleanliness    1
PQBD13v160501 Satisfaction survey   3
PQBD13v160502 Feedback register    1
PQBD13v160601 Complaint register    1
PQBD13v160701 Advisory notice    1
PQBD13v160702 Advisory notice register    1
PQBD13v160801 Design and development stages    1
PQBD13v160802 Design and development inputs    1
PQBD13v160803 Design and development outputs    1
PQBD13v160804 Design and development review    1
PQBD13v160805 Design and development verification    1
PQBD13v160806 Design and development validation    1
PQBD13v160807 Design and development transfer    1
PQBD13v160808 Roles and competence of project members    1
PQBD13v160809 Design and development resources    1
PQBD13v160810 Design and development changes    1
PQBD13v160811 Design and development file    1
PQBD13v160901 List of approved suppliers    1
PQBD13v160902 Supplier evaluation questionnaire    3
PQBD13v160903 Product specifications    2
PQBD13v160904 Verification of purchased product    1
PQBD13v160905 Reception anomaly    1
PQBD13v160906 Supplier quality complaint    1
PQBD13v161001 Work instruction    1
PQBD13v161002 Maintenance intervention report   2
PQBD13v161003 Production report    1
PQBD13v161101 Servicing report    1
PQBD13v161201 List of processes    1
PQBD13v161202 Process validation report    2
PQBD13v161301 Follow-up form    1
PQBD13v161302 Output traceability    1
PQBD13v161401 Special conditions    1
PQBD13v161501 Equipment list    1
PQBD13v161502 Verification range    1
PQBD13v161503 Verification certificate    1
PQBD13v161601 Reporting register    1
PQBD13v161701 List of internal auditors    1
PQBD13v161702 Internal audit plan   3
PQBD13v161703 Internal audit program    2
PQBD13v161704 Internal audit report    2
PQBD13v161705 Process audit questionnaire   9
PQBD13v161706 QMS audit questionnaire   31
PQBD13v161801 Nonconforming treatment form    1
PQBD13v161802 Customer concession    1
PQBD13v161901 Rework form    1
PQBD13v162001 Capability study    1
PQBD13v162002 Machine capability    1
PQBD13v162003 R&R study    1
PQBD13v162101 Customer return    1
PQBD13v162102 Quality alert form    1
PQBD13v162103 Action plan    1
PQBD13v162201 List of risks    6
PQBD13v162202 Risk level    2
PQBD13v162203 Risk management plan    1
PQBD13v162301 List of medical device file    1
PQBD13v162401 Certificate of attendance    1
PQBD13v162402 Evaluation of training    1
PQBD13v162501 Daily cleaning    1
PQBD13v162502 Sterilization form    1
PQBD13v162601 Filter follow-up form    1
PQBD13List List of MD documents   3
Total   281