Welcome to Scribd, the world's digital library. Read, publish, and share books and documents. See more
Download
Standard view
Full view
of .
Save to My Library
Look up keyword
Like this
1Activity
0 of .
Results for:
No results containing your search query
P. 1
ISO 13485 Documentation

ISO 13485 Documentation

Ratings: (0)|Views: 82 |Likes:
Published by isoconsultant
ISO 13485 Documentation, which covers ISO13485 manual, quality system procedures, SOPs, formats and ISO 13485 audit checklists. The entire ISO 13485 document is designed in editable .doc format and can be used as best ready to use tool while ISO 13485 certification. More Information Visit : http://wwww.globalmanagergroup.com/
ISO 13485 Documentation, which covers ISO13485 manual, quality system procedures, SOPs, formats and ISO 13485 audit checklists. The entire ISO 13485 document is designed in editable .doc format and can be used as best ready to use tool while ISO 13485 certification. More Information Visit : http://wwww.globalmanagergroup.com/

More info:

Published by: isoconsultant on Aug 26, 2013
Copyright:Attribution Non-commercial

Availability:

Read on Scribd mobile: iPhone, iPad and Android.
download as PDF, TXT or read online from Scribd
See more
See less

11/11/2013

pdf

text

original

 
D126: DEMO OF ISO 13485 Medical Device Document KitPrice 399 USD 
Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, audit checklist etc.)
Web site:www.globalmanagergroup.com 
www.globalmanagergroup.comE mail sales@globalmanagergroup.comTele: +91-79-2656 5405 
 
Page 1 of 8
A. The Total Editable Document kit has 6 main directories as below in Ms. word.Sr.No.List of Directory Document of Details1. Quality Manual 37 Pages in Ms. word2. Procedures 18 procedures in Ms. word3. Exhibits 03 exhibits in Ms. Word4.Formats / Templates
Name of departments
 37 formats in Ms. Word
Marketing (MKT) 02 formats in Ms. WordManufacturing(Operation) 15 formats in Ms. WordSystem (SYS) 13 formats in Ms. WordTraining (TRG) 07 formats in Ms. Word
5.Standard Operating Procedures(SOPs)06 SOPs in Ms. word6. Audit Checklist 02 files of more than 700 audit questions
 
Total 67 files quick download in editable form by e delivery
To get more information about ISO 13485 documentation kit Click Here 
Chapter-1.0 
CONTENTS OF ISO 13485:2003 DOCUMENT KIT(More than 65 document files)
 
 
D126: DEMO OF ISO 13485 Medical Device Document KitPrice 399 USD 
Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, audit checklist etc.)
Web site:www.globalmanagergroup.com 
www.globalmanagergroup.comE mail sales@globalmanagergroup.comTele: +91-79-2656 5405 
 
Page 2 of 8
Part: B Documentation:-
Our document kit is having sample documents required for implementation of ISO 13485:2003. Thedocuments are prepared by the highly experienced team of people with rich experience of processimprovement and process enhancement and many companies are certified successfully under ISO13485:2003 with our help. You need to study the document kit and do necessary changes as per your company need and within 1 week your entire documents are ready as well as your team willgot many ideas for system establishment to reduce the cost and effort to increase the profits withall necessary controls and your total documents are ready.We had given all type of templates and organization use it as per their need and many organization are certified globally in 1st trial with thehelp of our documents from any kind of stringent lead appraisal audit.Under this directory many files are made in word Document as per the details listed below. All thedocuments are related to ISO 13485:2003 for and user can edit it in line with their own processes.
 
1. Quality Manual:
It covers sample copy of quality manual and requirement wise details for how ISO 13485:2003 isimplemented. It covers sample policy for all process areas, Quality policy and organization structure andcovers 1
st
tier of ISO 13485:2003 documents.
(A) Table Of Contents
 Chapter No.SubjectPageNo.ISO 9001 +ISO 13485ReferencesSection
 –
11.
Cover page, table of contents and authorization statement 1
 –
4 ==========
2.
Company profile 5
 –
7 ==========
3.
Control and distribution 8
 –
10 ==========
Section
 –
24.Quality Management System
11
 –
134.0General requirements 4.1Documentation requirements 4.2
5
.
Management Responsibility
14
 –
175.0Management commitment 5.1Customer and environment focus 5.2Quality Policy 5.3Planning 5.4Responsibility, authority and communication 5.5Management review 5.6
6.Resource Management
18
 –
196.0Provision of resources 6.1Human resources 6.2Infrastructure 6.3Work environment 6.4
7.Product Realization And Implementation and Operation
20
 –
267.0Planning of product realization and operational control 7.1Customer and Environmental Related Processes 7.2Design and development 7.3
 
D126: DEMO OF ISO 13485 Medical Device Document KitPrice 399 USD 
Total editable documentation packageComplete editable document tool kit (Quality manual, procedures, exhibits, formats,SOPs, audit checklist etc.)
Web site:www.globalmanagergroup.com 
www.globalmanagergroup.comE mail sales@globalmanagergroup.comTele: +91-79-2656 5405 
 
Page 3 of 8Purchasing 7.4Production and service provision 7.5Control of monitoring and measuring equipment 7.6
8.Measurement, Analysis And Improvement
27
 –
318.0General 8.1Monitoring, measurement and evaluation of compliance 8.2Control Of Nonconforming Product and non
 –
conformances,corrective and preventive action8.3 Analysis of data 8.4Improvement 8.5
Annexures
 ANX
 –
I List of procedures 32 ========== ANX
 –
II Glossary of terms 33 ========== ANX
 –
III Process flow chart 34
 –
35 ========== ANX
 –
IV Quality Policy 36 ========== ANX
 –
V Organization structure 37 ==========
2. Procedures (18 Procedures)
:
 
It covers sample copy of procedures covering all the specific practice areas of 18 processes. Our procedures help the organization to make the best system and quick process improvements. All proceduresas listed below.
List of Procedures (18 procedures)
Sr.No.ProcedureNo.Name of Procedure Total Pages
1. PRO/SYS/01 Procedure for Management review 032. PRO/SYS/02 Procedure for Document and Data Control 073. PRO/SYS/03 Procedure for Control of records 034. PRO/SYS/04 Procedure for Internal Audit 035. PRO/SYS/05 Procedure for Training 036. PRO/SYS/06 Procedure For Corrective And Preventive Action 047. PRO/SYS/07 Procedure For Control of Monitoring And Measuring Equipments 048. PRO/SYS/08 Procedure for Control of Monitoring of work environment 029. PRO/SYS/09 Procedure for validation of sterilization process 0310. PRO/SYS/10 Procedure For Monitoring And Measurement of Processes 0311. PRO/SYS/11 Procedure For Analysis of Data 0212. PRO/SYS/12 Procedure For Issue And Implementation of Advisory Notices 0213. PRO/MKT/01 Procedure for customer satisfaction survey 0214. PRO/PUR/01 Procedure for Purchasing 0515. PRO/PRD/01 Procedure for Control of Non
 –
Conforming Products 0216. PRO/STR/01 Procedure for identification of products 0217. PRO/STR/02 Procedure for traceability 0218. PRO/STR/03 Procedure for preservation 02
Total Pages
 
 
54

You're Reading a Free Preview

Download
/*********** DO NOT ALTER ANYTHING BELOW THIS LINE ! ************/ var s_code=s.t();if(s_code)document.write(s_code)//-->