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ISO 17043 documentation contains more than 80 editable MS-Word files. These editable documents address all the elements of conformity assessment for proficiency testing for testing labs.

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

Original price was: $1,050.00.Current price is: $950.00.

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Description

Our documentation kit (Technical file) contains sample documents required for CE certification as listed below. All documents are in MS Word files and you can edit them. You can make changes as per your organization’s need and within few days your entire Technical File with all necessary controls will be ready.

Content of Proficiency Testing Provider Accreditation Documentation Kit – based on ISO/IEC 17043:2010

The certification iso 17043 documentation for proficiency testing laboratory – ISO 17043 accreditation consists of the following:

  • Sample ISO 17043 Manual (05 chapters and 01 Annexure)
  • Conformity assessment iso 17043 procedures covering mandatory procedures (23 Procedures)
  • Set of more than 48 blank formats
  • Standard Operating Procedures (06 SOPs)
  • Exhibits (03 Nos.)
  • Proficiency Testing Design Plan covering all the details of ISO/IEC 17043:2010 standard.
The ISO/IEC 17043:2010 standard specifies Conformity Assessment- requirements for proficiency testing. The Proficiency Testing provider Documentation kit for the testing laboratory is prepared by us based on our experience in PT providers and based on ISO/IEC 17043:2010 required for Conformity Assessment for proficiency testing. The ISO 17043 Manual, procedures, SOPs, blank formats as well as pre-designed PT testing plans are the most important part of this iso 17043 document kit. Our quick editable documents are taking care of all the requirements for proficiency testing laboratory – iso 17043 accreditation.

Documentation:-

Our document kit is having sample documents required for ISO/IEC 17043:2010 certification 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 and many organization are certified globally in 1st trial with the help of our documents from any kind of stringent certification audit.
Under this directory further files are made in word Document as per the details listed below. All the documents are related to any kind of manufacturing/process industry.

1. Quality Manual:

It covers sample copy of quality manual for proficiency testing. It describes how all requirement of ISO/IEC 17043:2010 standard for proficiency testing for testing laboratories. It covers list of procedures as well as overview of organization and covers tier 1 of ISO/IEC 17043:2010 documents.
ISO/IEC 17043:2010 Manual Index
Section – 1
1 Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2 Authorization statement and organization profile
3 Control and distribution
Section – 2
4 Technical requirements
4.1 General
4.2 Personnel
4.3 Equipment, accommodation and environment
4.4 Design of proficiency testing schemes
4.5 Choice of method or procedure
4.6 Operation of proficiency testing schemes
4.7 Data analysis and evaluation of proficiency testing scheme results
4.8 Reports
4.9 Communication with participants
4.10 Confidentiality
5 Management Requirements
5.1 Organization
5.2 Management system
5.3 Document control
5.4 Review of requests, tenders and contracts
5.5 Subcontracting services
5.6 Purchasing services and supplies
5.7 Services to the customer
5.8 Complaints and appeals
5.9 Control of non–conforming work
5.10 Improvement
5.11 Corrective actions
5.12 Preventive actions
5.13 Control of records
5.14 Internal audits
5.15 Management review
Annexure
ANX–1 List of quality procedures

2. Procedures (23 Procedures):

It covers sample copy of mandatory procedures covering all the details of ISO/IEC 17043:2010 standard.
  1. Procedure for personnel and training
  2. Procedure for design planning for proficiency testing scheme
  3. Procedure for preparation of proficiency test item
  4. Procedure for assessment of homogeneity and stability of proficiency test item
  5. Procedure for calculation of assigned value and its standard uncertainty
  6. Procedure for Handling, storage, packaging, labeling, and distribution of proficiency test item
  7. Procedure for evaluation of proficiency testing scheme results
  8. Procedure for protection of participant’s confidential information
  9. Procedure for document and data control
  10. Procedure for operation of proficiency testing scheme and review of the nomination of participants
  11. Procedure for Review request, tender and contracts for the proficiency testing scheme
  12. Procedure for Subcontracting
  13. Procedure for Purchasing
  14. Procedure for Complaint Handling
  15. Procedure for Control of Non–Conforming Work
  16. Procedure for corrective action
  17. Procedure for preventive action
  18. Procedure for Control of Records
  19. Procedure for internal audit
  20. Procedure for Management Review
  21. Procedure for measurement traceability and calibration
  22. Procedure for Prevention of Collusion and Falsification while Conducting PT Programmes
  23. Procedure for impartiality

3. Blank Formats (48 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.
List of Formats
  1. Form No. 1, Participation in Proficiency Testing
  2. Participant feedback form
  3. Complaint report
  4. Complaint register
  5. Participants Data Bank Register
  6. Sample delivery note
  7. Annex–A, Result Sheet
  8. Proficiency test report
  9. Homogeneity check report
  10. Assigned value by other method
  11. Stability check report
  12. Sample Stock Register
  13. Proficiency Testing Design Plan
  14. Preservation Assessment Checklist
  15. Equipment History Card
  16. Purchase Order
  17. Indent
  18. Approved Vendor List
  19. Supplier Registration Form
  20. Open purchase order
  21. Supplier Evaluation Report
  22. Inspection Report
  23. Approved subcontractor list
  24. Work order
  25. Subcontractor audit report
  26. Master List Cum Distribution List of Documents
  27. Change Note
  28. Corrective Action Report
  29. Master List of Records
  30. Quality Objectives
  31. Audit Plan / Schedule
  32. Internal Audit Non–Conformity Report
  33. Clause wise Document wise Audit Review
  34. Preventive Action Report
  35. Calibration Status of Equipment
  36. Audit Checklist – Top Management
  37. Audit Checklist – Quality Manager
  38. Audit Checklist – Training
  39. Audit Checklist – Technical Operation
  40. Training Calendar
  41. Training Report
  42. Induction Training Report
  43. Job Description And Specification
  44. Skill Matrix
  45. Confidentiality Agreement
  46. Appointment Letter
  47. Employees Competence Report
  48. Education, training and skill objective

4. Standard Operating Systems (06 SOPs)

It covers sample copy of mandatory standard operating procedures and sanitation practices covering all the details as per ISO/IEC 17043:2010 standard requirements for proficiency the lists of operating procedures are listed below.
List of SOPs
  1. SOP for preparation of stainless steel proficiency test item for chemical analysis by OES
  2. SOP for preparation of aggregate proficiency test item
  3. SOP for preparation of waste water (effluent part–1) proficiency test item
  4. SOP for preparation of Cement proficiency test item
  5. SOP for preparation of Bitumen proficiency test item
  6. SOP for preparation of waste water (Effluent Part–2) proficiency test item

5. Exhibits (03 Exhibits)

It covers sample copy of exhibits covering all the details of ISO/IEC 17043:2010 standard.
  1. Codification System
  2. Calibration periodicity
  3. Collection, Preservation and Analysis of Waste water samples

6. Proficiency Testing Design Plan

It covers sample copy of proficiency testing design plan covering all the details of ISO/IEC 17043:2010 standard.

How useful?

  • The user can modify readymade templates as per their working system and create their own documentation.
  • Procedures and formats provided in the iso 17043 document kit can help testing laboratories in fine-tuning the processes and establish better control for system establishment for accreditation of PT providers.
  • It saves a lot of time and cost in document preparation. It gives value for money to customers and payback is very low.
  • Readymade templates are available which can reduce your time in document preparation as well as training to staff.
  • It helps in making total documentation including iso 17043 manual, procedures and PT design plans for faster accreditation of Proficiency testing laboratories.

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