ISO 17034:2016- Complete Documentation Kit

Our ISO 17034 consultant team had prepared the documentation for accreditation of reference material producers based on ISO 17034 2016 standard. The ISO 17034 documents consist of the following editable templates:

1. ISO 17034 Manual: A sample copy of ISO 17034 Manual which meets the requirements for accreditation of reference material producers. The manual document includes quality policy, organization structure, and macro level system for technical and production requirements.
2. Procedures: Total 31 mandatory iso 17034 procedures covering all the specific practice areas of 31 processes that help during iso 17034 certification to make the best system and quick process improvements.
3. Exhibits: Total 04 exhibits that covers training requirements and details ideas for process implementation and improvements.
4. Work instructions: It includes 23 work instructions for ISO 17034 for establishing a good quality control environment to link with significant aspects issues in the organization.
5. Forms and templates: Set of more than 55 standard forms and sample blank templates to maintain records to establish better control.
6. ISO 17034 2016 Audit checklist: It covers a set of over 250 audit questions, which can be customized to make your own ISO 17034 audit checklist for internal auditing of your system for quick iso 17034 accreditation.

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

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.

• The user can modify the templates as per their working system and create their own documentation quickly.
• Procedures and formats provided in the documentation kit, can help in fine-tuning the processes and establish better control for system establishment for reference material producers.
• It saves much time and cost in document preparation for iso 17034 certification. It gives value for money to customers and payback is very low.
• Readymade templates are available which can reduce your time in ISO 17034 accreditation documentation process as well as training to staff.
• It helps in making total documentation by providing readymade sample ISO 17034 manual, procedures and audit checklist that accelerate the accreditation process.
• By using this documentation guide, many organizations are implementing ISO 17034:2016 system and getting benefits of the improved quality system in their organizations.