ISO 17034:2016 Internal Auditor Training- Complete Documentation Kit

The contents of the ISO 17034 auditor training kit, include ppt presentation slides, user guide (handouts), and other key documents that useful as ready reference tool for auditing as listed below:

1. ISO 17034 Training PPT Presentation: The presentation is covered by approx. 180 ppt presentation slides on ISO 17034:2016 auditing, which described in the following six key modules:
   • ISO 17034:2016 Overview and Awareness
   • ISO 17034:2016 Requirements
   • ISO 17034:2016 Documentation
   • ISO 17034:2016 Internal Audit
   • ISO 17034:2016 Internal audit records
   • Steps for ISO 17034:2016 Accreditation
2. Trainer’s Guide and Handouts: In this section, editable documents of 6 chapters with more than 90 pages are given for trainees to understand ISO 17034 requirements in detail.
3. Workshops and Case-study: To evaluate the effectiveness of participants on ISO 17034 audit, 02 workshops and 01 case study are given.
4. ISO 17034 Audit Checklist: More than 300 questions are covered to verify the effectiveness of the implemented system for the competence of reference material producers as per ISO 17034:2016 requirements.
5. ISO 17034 Audit Forms: Total of 03 sample auditing forms is given to perform an ISO 17034 internal audit in an organization.
6. ISO 17034 Internal Auditor Training Certificate: It includes a sample copy of the ISO 17034 internal auditor training certificate to provide to the participants after successful completion of training.

Documentation:-

Our document kit is having sample documents required for ISO 17034:2016 accreditation as listed below. You need to study it do necessary changes as per your company need and within 4 days your entire editable documents with all necessary details are ready as well as your team will got many ideas for system establishment to reduce the cost and effort with all 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 the help of our documents from any kind of stringent lead appraisal audit.
Under this directory further files are made in word document as per the details listed below. All the documents are related to ISO 17034:2016 for and user can edit it in line with their own processes.

1. Quality Manual:

It covers sample copy of quality manual for ISO 17034:2016. It describes how all requirement of ISO 17034:2016. It covers list of procedures as well as overview of covers tier 1 of ISO 17034:2016 documents.

ISO 17034:2016 Manual Index
1 Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2 Authorization statement and organization profile
3 Control and distribution
4.0 General requirements
4.1 Contractual matters
4.2 Impartiality
4.3 Confidentiality
5.0 Structural requirements
6.0 Resource requirements
6.1 Personnel
6.2 Subcontracting
6.3 Provision of equipment, services and supplies
6.4 Facilities and environmental conditions
7.0 Technical and production requirements
7.1 General requirements
7.2 Production planning
7.3 Production control
7.4 Material handling and storage
7.5 Material processing
7.6 Measurement procedures
7.7 Measuring equipment
7.8 Data integrity and evaluation
7.0 Technical and production requirements
7.9 Metrological traceability of certified values
7.10 Assessment of homogeneity
7.11 Assessment and monitoring of stability
7.12 Characterization
7.13 Assignment of property values and their uncertainties
7.14 RM documents and labels
7.15 Distribution service
7.16 Control of quality and technical records
7.17 Management of non–conforming work
7.18 Complaints
8.0 Management system requirements
8.1 Options
8.2 Quality policy (Option A)
8.3 General management system documentation (Option A)
8.4 Control of management system documents (Option A)
8.5 Control of records (Option A)
8.6 Management review (Option A)
8.7 Internal audit (Option A)
8.8 Actions to address risks and opportunities (Option A)
8.9 Corrective actions (Option A)
8.10 Improvement (Option A)
8.11 Feedback from customers (Option A)
Annexure
ANX–1 List of quality procedures
ANX–2 Responsibility and authority of management and technical personnel
Note : The amendment number given above is at the time of issue of this manual. If any page is amended then latest amendment number of such pages is recorded in amendment record sheet and on the table of content given above.

2. Procedures (31 Procedures):

It covers sample copy of mandatory procedures covering all the details of ISO 17034:2016 standard.

List of procedure

1. Procedure for establishing the quality of materials as a component of the management system
2. Procedure for data evaluation
3. Procedure for material handling, storage and transportation
4. Procedure for preparation of processing procedures
5. Procedure for undertaking characterization
6. Procedure for identification, labeling and packaging facilities, packing and delivery
7. Procedure for production of reference materials
8. Procedure for protection of customer’s confidential information and proprietary rights
9. Procedure to avoid involvement in any activities that might diminish confidence in its competence, impartiality, judgment or operational integrity
10. Procedure for Document and Data Control
11. Procedure for review of request, tender and contracts
12. Procedure for subcontracting
13. Procedure for procurement of services and supplies
14. Procedure for Complaint Handling
15. Procedure for Control of non–conforming work and reference materials
16. Procedure for Corrective Action
17. Procedure for Control of Records
18. Procedure for Internal Audit
19. Procedure for Management Review
20. Procedure for Personnel and Training
21. Procedure for production planning and implementation
22. Procedure for production control
23. Procedure for accommodation and environment
24. Procedure for material processing
25. Procedure for measurement method
26. Procedure for measuring equipments
27. Procedure for protecting the integrity of data
28. Procedure for metrological traceability
29. Procedure for assessment of homogeneity
30. Procedure for assessment of stability
31. Procedure for assignment of property values and calculation of uncertainty of measurement

3. Exhibits (04 Exhibits):

It covers sample copy of exhibits covering all the details of ISO 17034:2016 standard.

List of Exhibits

1. Skill Requirements
2. Codification System
3. Calibration Periodicity
4. Sampling Plan

4. Work instructions (23 work instructions):

It covers sample copy of work instruction covering production and quality control work instruction of ISO 17034:2016 standard.

List of work instructions

Production

1. Work instruction for Chemical Reaction
2. Work instruction for Filtration
3. Work instruction for Steam Boiler
4. Work instruction for Air Compressor
5. Work instruction for Water Softening Plant
6. Work instruction for Diesel Generator Set
7. Work instruction for Spray Drying
8. Work instruction for Blending
9. Work instruction for Reverse Osmosis Plant
10. Work instruction for Pulverizer
11. Work instruction for Hot Air Generator
12. Work instruction for Ice Plant

Quality control

1. Work instruction for Protection of electronic data
2. Work instruction for Preparation of calibration curves
3. Work instruction for Handling, Storage, Use of CRM
4. Work instruction for Intermediate Check on CRM
5. Work instruction for Laboratory Safety
6. Work instruction for Disposal method for retained samples
7. Work instruction for Spectrophotometer
8. Work instruction for Operating Instruction – Weighing balance
9. Work instruction for Operating Instruction – Hot Air Oven
10. Work instruction for Intermediate checks – Weighing Balance
11. Work instruction for Intermediate checks – Oven / Furnace / Dryer

5. Blank Formats (57 Formats):

It covers sample copy of blank forms required to maintain records as well as establish control and make system. The samples given are as a guide and not compulsory to follow to change the same to suit own requirements.

List of Formats

1. Packing Report
2. Delivery challan / deliver memo
3. Bill / Invoice
4. Work order
5. Customer feedback form
6. Complaint report
7. Complain register
8. Equipment History Card
9. Preventive Maintenance Schedule
10. Equipment Wise Preventive Maintenance Checkpoints
11. Non–Conforming Work Report
12. Production Plan
13. Batch manufacturing record
14. Purchase Order
15. Indent (purchase requisition)
16. Approved Vendor List
17. Supplier registration form
18. Inspection report
19. Suppliers re–evaluation report
20. Job order
21. Sub–contractor audit report
22. Environment condition monitoring report
23. Stability study report
24. Re-test Analysis
25. Uncertainty of Measurement
26. Spectrophotometer Calibration Report
27. Distilled water generation and test report
28. pH Meter Calibration Report
29. In-house Calibration Report
30. Intermediate check report – weighing balance
31. Intermediate check report – oven / furnace / dryer
32. Intermediate check report – Analyzer
33. Critical consumables
34. Normality record sheet
35. Housekeeping checklist
36. Sample Test Request Slip
37. Gate Pass
38. Master List Cum Distribution List of Documents
39. Change Note
40. Corrective Action Report
41. Master List of Records
42. Quality Objectives
43. Audit Plan / Schedule
44. Internal Audit Non–Conformity Report
45. Clausewise Documentwise Audit Review Report
46. Preventive Action Report
47. Calibration Status of Equipment
48. Internal audit programme
49. Training Calendar
50. Training Report
51. Induction Training Report
52. Job Description and Specification
53. Skill Matrix
54. Confidentiality Agreement
55. Appointment Letter
56. Employees Competence Report
57. Education, training and skill objective

6. Audit checklist (more than 350 questions)

It covers sample audit questions based on all the ISO 17034:2016 requirements. It helps the auditor to make own audit checklist for quick and perfect auditing to ensure all the ISO 17034:2016 requirements are fulfilled.

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