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isogorilla.com ISO 17034 2016 documentation toolkit

ISO 17034 2016 documents contain more than 115 editable MS-Word files. These editable iso 17034 documents address all the elements of reference material producer accreditation.

  • A Manual
  • Required Procedures
  • Formats
  • Sample Filled Forms

Original price was: $1,050.00.Current price is: $850.00.

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Description

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.

Content of ISO 17034:2016 Documentation Kit with Manual, Procedures, Forms and Checklists

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.

The ISO 17034 2016 standard is developed for Reference material producer accreditation by ISO in 2017. We have studied requirements of the documentation process for this quality standard and introduced new product D132- Documentation Kit for ISO 17034 2016 Accreditation, a set of ready made document templates. As other documentation kits, these ISO 17034 certification documents cover various technical and management documents like a quality manual, mandatory procedures, exhibits, work instruction, sample formats, and audit checklists, etc, which are primary requirements of documentation process during 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 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

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.

How useful?

  • 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.

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