ISO 9001:2015 Standards- Complete Documentation Kit

Description

Our documentation kit is written in simple language to make easily customized without having any expertise. it is user friendly, easy to learn and time saving.

There are 3 tiers of these documents. which means this product include:

Tier 1- Manual:

This provides the reference to each requirement of the standard.

Tier 2- Procedure:

This provide additional information about how to perform specific activity in your organization.

Tier 3- Formats:

These are the actual documents that are used to show compliance with the standard.

Sample Filled Forms:

Some filled forms are also added for your guidance and to understand.

The contents of the ISO documentation kit, which we offer, include more than 100 document files as listed below:

1. ISO 9001 Manual (14 files)
2. ISO 9001 Procedures (06 procedures)
3. Process Flowcharts (11 Flowcharts)
4. Standard Operating Procedures / Work Instructions (More than 30 SOPs)
5. Exhibits (07 exhibits)
6. Templates to retain documented information (Blank 59 sample forms in editable formats)
7. Filled formats to retain documented information (36 filled forms)
8. ISO 9001 Audit checklists (more than 400 questions)
9. ISO 9001:2015 compliance matrix (01 excel file)

Documented information package: –

Our document kit is having sample documents required for ISO 9001:2015 certification as listed below. All documents are in word and you can edit it. You can do changes as per your company need and within few days your entire documents with all necessary system requirements are ready. IN revised QMS 9001:2015 few places documented information are required. But for making better system we had given many templates and user can select and make own system with minor changes. Now ISO 9001:2015 standard is not requiring manual, procedures, records etc. and it requires 2 type of documented information as listed below.

1. Maintain documented informaiton9 Scope, quality policy etc. in Manual, process flow charts, Sop etc.)
2. Retain documented information ( Forms – record templates )

Under this directory further files are made in word Document as per the details listed below and you can edit it. All the documents are related to manufacturing / process industry.

1. Quality Manual (10 Chapters and 4 Annexure):

It covers sample copy of Quality manual and clause wise details for how ISO 9001 systems are implemented. It covers context of organization, sample policy, objectives, scope, organizations structure as well as macro level each requirements from 4 to 10 of QMS 9001:2015 how implemented in the organization and covers tier 1 of QMS 9001:2015 documents. It is having total 10 chapters covering company profile, amendment sheet, index, clause wise details as per ISO 9001 for implementation, sample process flow chart, sample Quality policy and organization chart.
It covers sample copy of Quality manual and clause wise details for how ISO 9001 systems are implemented.

(A) Table of Contents
Section – 1
1. Company Profile
2. Table Of Contents
3. Control And Distribution
Section – 2
4 to 10- Chapter 4 to 10 covers sample Quality policy, objectives, scope, context of organization and macro level quality management system explaining
how requirements are implemented by organization in making the QMS system as per revised 201 standard
ANX–I List of Documented information
ANX–II Glossary of terms
ANX–III Process flow chart
ANX–IV Organization structure

2. Procedures (06 procedures):

It covers sample copy of mandatory 06 procedures covering all the details of ISO 9001:2015 standard.

List of procedures

1. Procedure for documented information
2. Procedure for corrective action
3. Procedure for internal audit
4. Procedure for management review
5. Procedure for Risk Management
6. Procedure for Training

3. Process Approach for all the departments (11 process approach):

It covers guideline for processes, flow chart and process model useful for process mapping. It covers process flow chart and activities of all the main and critical processes as listed below with input-output matrix and reference of documented information generated by process for manufacturing organization. It helps any organization in process mapping as well as preparing process documents for own organization. In Input and output matrix process wise risk and opportunity as well as mitigation plan for risk is given.

List of Process approach

1. Process Flow Chart of Customer Service(Complaint handling and satisfaction survey)
2. Process Flow Chart of Engineering
3. Process Flow Chart of Marketing
4. Process Flow Chart of Purchase
5. Process Flow Chart of QMS coordinator processes( Audit, management review and control of documented Information)
6. Process Flow Chart of Research And Development
7. Process Flow Chart of Stores( Issue and receipt system)
8. Process Flow Chart of Despatch
9. Process Flow Chart of Training
10. Process Flow Chart of Production
11. Process Flow Chart of Quality Control

4. Standard Operating Procedures (30 SOPs)

It covers sample copy of SOP to link with good manufacturing practices and guide line for understanding to users to make own standard operating procedure for making good Quality management system. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements.

List of SOPs

Engineering

1. SOP for Diesel generating set
2. SOP for Steam boiler
3. SOP for Water softening plant
4. SOP for Air compressor
5. SOP for Thermic fluid heater
6. SOP for Chilling plant
7. SOP for Reverse Osmosis Plant
8. SOP for Hot Air Generator
9. SOP for Ice Plant

Operation( ETP plant, QA, General and production)

1. SOP for Finished product handling
2. SOP for Awareness regarding environmental, health and safety
3. SOP for Review of country specific requirements
4. SOP for Personnel security
5. SOP for Change control
6. SOP for House keeping
7. SOP for Label control
8. SOP for Ware house operations
9. SOP for Raw material issue
10. SOP for Operation of Power Plant
11. SOP for Effluent treatment plant
12. SOP for Waste Filling and Transportation
13. SOP for Testing of Raw materials
14. SOP for Chemical reaction
15. SOP for Filtration
16. SOP for Blending
17. SOP for Tray dryer
18. SOP for Product change over (cleaning and washing)
19. SOP for Product withdrawal
20. SOP for Research and development
21. SOP for General Requirement of Sampling

5. Exhibits (07 Exhibits)

It covers exhibits of Skill Requirements, Disposal of Non–Conforming Products, Quality Plan and inspection and test plan, Material Specifications etc.

List of Exhibits

1. Skill Requirements
2. Multi skill requirements
3. Disposal Of Non–Conforming Products
4. Operation control plan
5. Quality Plan – Incoming Inspection and Testing
6. Material Specifications
7. Document Identification and Codification System

6. Blank sample formats at for all the departments (59 sample formats)

It covers sample copy of blank forms required to maintain records as well as establish control and make system in the organization. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements. It can be used as templates and more than 59 blank formats are prepared as per list given below.

List of blank formats

1. Master List & Distribution List of Documents
2. Master List of Records
3. ISO 9001:2015 QMS Clause wise Audit Review Report
4. Corrective Action Report
5. Employee Wise Training & Competence Record Sheet
6. Training Report
7. Indent And Incoming Inspection Record
8. Annual Purchase Order
9. Customer Feed Back Form
10. Spray Dryer Log Sheet
11. Blender / Ball Mill Log Sheet
12. Sample Test Request Slip For In process / Finish product
13. Design Verification Report
14. Experiment Data Sheet
15. Preventive maintenance Schedule
16. Drum / Bag / Carton Inspection Report
17. Preservation Assessment Report
18. Performance Appraisal Records–Staff
19. Service Report
20. Risk analysis Sheet
21. Management review meeting
22. Purchase Order
23. Customer Complaint Report
24. Reverse Osmosis Log Sheet
25. Job Description & Specification
26. Disposal of Non–Conforming of Product & service
27. Research And Development Plan
28. Sample Test Request Slip For Incoming materials
29. Design Review Report
30. Quality Objective Plan
31. Breakdown History Card
32. Packing Slip
33. Audit Plan / Schedule
34. Installation Commissioning Progress Report
35. Material Issue Slip
36. Performance Appraisal Records–Functional Heads
37. Calibration Status of Instrument / Equipment
38. Training Calendar
39. Approved external provider list & Annual purchase order
40. Goods Receipt note
41. Preventive Maintenance Check point
42. Gate Pass
43. Design Review Minutes Of Meeting
44. Design and Development Monitoring Register
45. Research And Development Request Report
46. pH Meter Calibration Report
47. Spin Flash Dryer Log Sheet
48. Customer Property Monitoring Register
49. Order Form / Order Confirmation
50. External Provider Registration Form
51. Multi Skill Analysis
52. List of License / certificates
53. Induction Training Report
54. QMS Internal Quality Audit Non–Conformity Report
55. Quality Objectives Monitoring Sheet
56. Change Note
57. Process change form
58. Communication Report
59. Manpower Requirement form

7. Filled formats at for all the departments (36 filled formats)

It covers sample copy of filled forms required to maintain records as well as establish control and make system in the organization. The filled form given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements. It can be used as templates and more than 36 filled formats are prepared as per list given below.

List of filled formats

1. Master List & Distribution List of Documents
2. QMS Internal Quality Audit Non–Conformity Report
3. Induction Training Report
4. Indent And Incoming Inspection Record
5. Order Form / Order Confirmation
6. Sample Test Request Slip For In process / Finish product
7. Design and Development Monitoring Register
8. Breakdown History Card
9. Gate Pass
10. Manpower Requirement form
11. Installation Commissioning Progress Report
12. Customer Property Monitoring Register
13. Change Note
14. Spray Dryer Log Sheet
15. Design Review Minutes Of Meeting
16. Reverse Osmosis Log Sheet
17. Design Review Report
18. Packing Slip
19. Training Report
20. Corrective Action Report
21. Research And Development Request Report
22. Performance Appraisal Records–Functional Heads
23. Communication Report
24. Preventive Maintenance Check point
25. Master List of Records
26. Audit Plan / Schedule
27. Quality Objective Plan
28. Preservation Assessment Report
29. Job Description & Specification
30. Approved external provider list & Annual purchase order
31. External Provider Registration Form
32. Customer Complaint Report
33. Disposal of Non–Conforming of Product & service
34. pH Meter Calibration Report
35. Process change form
36. Service Report

8. Sample MRM

It covers sample copy management review meeting, agenda of management review meeting and objective review.

9. Department wise and ISO 9001:2015 requirement wise audit questionnaire (more than 700 questions).

There covers audit questions based on ISO 9001:2015 requirements as well as for each departments. It will be very good tool for the auditors to make audit questionnaire while auditing and make effectiveness in auditing. Total more than 800 questions are prepared for clause no. 4, to 10 of ISO 9001:2015. It also covers department wise questions like marketing, purchase, production, quality control, engineering and utility, maintenance, top management, stores, packing & dispatch, administration & training, research and development and M.R. areas and it can be used as a very good tool for logically auditing during internal audit for ISO 9001:2015.

10. QMS 9001:2015 compliance matrix

The QMS ISO 9001:2015 requirement wise list of documented information reference of this kit is given in compliance matrix for ready reference to user to understand how this system is made.

11. Filled job description

The QMS ISO 9001:2015 filled job description.

12. Sample filled risk template

The ready to use risk template in filled form is given to prepare the risk document for the organization. It gives complete risk methodology and sample filled risk details for quick reference to users to understand how risk to be identified.

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