ISO 17025:2017 Documentation For Calibration Laboratory- Complete Documentation Kit

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

1. ISO 17025:2017 Manual (8 Chapters and 1 Annexure): A sample ISO/IEC 17025 manual with a quality policy that meets the requirement of standard accreditation.
2. Quality Procedures (22 procedures): It includes 22 procedures to implement the system in the calibration laboratory and comply with iso 17025 accreditation requirements.
3. Exhibits (10 exhibits): The 10 exhibits including an exhibit for calibration frequency and technical contents.
4. Work Instructions (05 work instruction): Work instructions and sanitation control and hygiene control procedures for good work practices.
5. Calibration Method (02 methods): A sample copy of the calibration method of the Micrometer and Glass thermometer
6. Technical Documents(42 files): It covers sample copy of 30 blank work sheets, sample copy of blank and filled calibration certificates and sample copy of blank and filled uncertainty of measurement calculation sheets.
7. Formats (58 sample forms): A set of 58 readymade templates for ISO 17025:2017 accreditation and standard forms
8. Risk Templates (01 files): The ready to use risk template in editable form is given to prepare the risk document for the organization
9. ISO 17025:2017 Audit checklist (more than 200 questions): All these audit questions can be easily customizable for making your own audit checklist.
10. ISO/IEC 17025 Compliance Matrix: The documented information reference is given in the compliance matrix for easy reference of a user to understand.

All the calibration lab – ISO/IEC 17025:2017 accreditation documents provided are editable and the user can easily modify the name of the calibration laboratory, its logo and other things required by your laboratory.

Documented information package:

Our document kit is having sample documents required for laboratory accreditation for calibration laboratory accreditation as listed below. All documents are in MS-Word / excel format and you can edit it. You need to study it to do necessary changes as per your laboratory 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 can use it as per their need and many organization are accredited globally in 1st trial with the help of our documents from any kind of stringent lead appraisal audit.

1. Maintain documented information (Scope, Quality manual, procedures, exhibits, Sop, etc.)
2. Retain documented information (Forms / Templates)

Under this directory, further files are made in the word document as per the details listed below which you can edit it. All the documents are related to laboratory accreditation for calibration for and user can edit it in line with their own processes.

1. Quality Manual:

It covers sample copy of manual and clause wise details for how laboratory accreditation systems are implemented. It covers sample copy quality manual.
(A) Table of Contents
1 Cover page, Table of contents, amendment record sheet and glossary of terms (abbreviation)
2 Authorization statement and laboratory profile and context of organization
3 Control and distribution
4 General requirements
4.1 Impartiality
4.2 Confidentiality
5.0 Structural requirements
6 Resource requirements
6.1 General
6.2 Personnel
6.3 Facilities and environmental conditions
6.4 Equipment
6.5 Metrological traceability
6.6 Externally provided products and services
7 Process requirements
7.1 Review of requests, tenders and contracts
7.2 Selection, verification and validation of methods
7.3 Sampling
7.4 Handling of test or calibration items
7.5 Technical records
7.6 Evaluation of measurement uncertainty
7.7 Ensuring the validity of results
7.8 Reporting of results
7.9 Complaints
7.10 Nonconforming work
7.11 Control of data–Information management
8 Management system requirements
8.1 Options
8.2 Management system documentation (Option A)
8.3 Control of management system documents (Option A)
8.4 Control of records (Option A)
8.5 Actions to address risks and opportunities (Option A)
8.6 Improvement (Option A)
8.7 Corrective action (Option A)
8.8 Internal audits (Option A)
8.9 Management reviews (Option A)
Annexure
ANX–1 List of documents
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 (22 procedures):

It covers sample copy of mandatory procedures covering all the details of ISO/IEC 17025:2017 laboratory accreditation for calibration. The list of procedures provided is as below.

List of Procedures

1. Procedure for Maintaining impartiality of laboratory activities
2. Procedure for Personnel and training
3. Procedure for To maintain laboratory environmental condition
4. Procedure for Handling, transport, storage, use and planned maintenance of equipment
5. Procedure for Intermediate checks
6. Procedure for Measurement traceability and calibration
7. Procedure for Procurement of externally provided products and services
8. Procedure for Review of requests, tenders and contracts
9. Procedure for Method validation
10. Procedure for Transportation, receipt, handling, protection, storage, retention, and disposal or return of calibration items
11. Procedure for Evaluation of measurement uncertainty and statistical techniques for analysis of data
12. Procedure for Ensuring and monitoring of validity of result
13. Procedure for Receive, evaluate and make decisions on complaints
14. Procedure for Control of non–conforming work
15. Procedure for Control of data
16. Procedure for Document and data control
17. Procedure for Control of records
18. Procedure for Risk assessment
19. Procedure for Corrective action
20. Procedure for Internal audit
21. Procedure for Management review
22. Procedure for calibration certificate preparation, and application of decision rule

3. Exhibits (10 exhibits):

It covers sample copy of exhibits covering all the details of ISO/IEC 17025:2017 laboratory accreditation for calibration.

List of Exhibits

1. Exhibits for Skill Requirements
2. Exhibits for Codification System
3. Exhibit for Calibration and Intermediate check Periodicity
4. Exhibits for Secrecy rules
5. Exhibits for Communication process
6. Exhibits for Impartiality policy
7. Exhibits for Instrument receipt checklist
8. Exhibits for Acceptance norms for internal quality checks
9. Exhibits for Intermediate check frequency
10. Exhibits for Scope of accreditation

4. Work instruction and calibration methods

It covers sample copy of standard operating procedures and calibration methods covering all the details of ISO/IEC 17025:2017 laboratory accreditation for calibration.

List of work instruction

1. Work instruction for Site calibration
2. Work instruction for Instrument receipt checks
3. Work instruction for Laboratory safety
4. Work instruction for Housekeeping
5. Work instruction for Monitoring of illumination and noise level

5. Blank sample formats for all the departments (58 sample formats)

It covers a sample copy of blank forms that are required to maintain records as well as establish control and create system in the organization. The samples given area guide for the user to follow. The organization is free to change the same to suit their own requirements. It can be used as templates. A total of 58 blank formats are provided as per the list given below.

List of blank formats

1. Calibration service request and instrument receipt report
2. Master List and Distribution List of Documents
3. Customer Feedback Form
4. Change Note
5. Complaint Report
6. Corrective Action Report
7. Inward Register
8. Master List of Records
9. Calibration service request for onsite calibration
10. Quality Objectives
11. Equipment History Card
12. Audit plan / schedule
13. Preventive Maintenance Schedule
14. Internal Audit Non–Conformity Report
15. Equipment Wise Preventive Maintenance Checkpoints
16. Clausewise Documentwise Audit Review Report
17. Disposal Of Non–Conforming Work
18. Risk Assessment sheet
19. Gate Pass
20. Calibration Status of Equipment
21. Purchase Order
22. Clausewise audit report – Quality Manager
23. Indent – Purchase Requisition
24. Clausewise audit report – Technical Manager
25. Approved External Providers List
26. Circular
27. Supplier Registration Form
28. Minutes of Meeting
29. Open Purchase Order
30. Improvement log
31. Supplier Evaluation Report
32. Periodic document review report
33. Inspection Report
34. Impartiality check report
35. Subcontracting work register
36. Training Calendar
37. Sub–contractors / External service provider’s agreement
38. Training Report
39. Four Year Plan for Quality assurance
40. Induction Training Report
41. IQC Analysis report (Re–calibration and replicate calibration analysis)
42. Job Description And Specification
43. En Value calculation Report
44. Skill Matrix
45. Intermediate check report – Equipment (reference standard) wise
46. Confidentiality Agreement
47. CRM consumption report
48. Appointment Letter
49. Environment condition monitoring report – Temperature and Humidity
50. Employees Competence Report
51. Illumination, noise and power supply monitoring report
52. ISO/IEC 17025 Effectiveness Check Report
53. Facility supervision checklist
54. Technical Training Effectiveness check report
55. Method verification report
56. Interview report
57. Method validation report
58. Self study report for trainer

List of calibration method

1. Calibration method – Micrometer
2. Calibration method – Glass thermometer

6. Technical documents

It covers a sample copy of blank work sheets, sample copy of blank and filled calibration certificate and sample copy of blank and filled uncertainty of measurement calculation sheet.

7. Sample MRM

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

8. Audit checklist (more than 200 questions)

There covers audit questions based on laboratory accreditation for calibration requirements. It will be very good tool for the internal to make audit questionnaire while auditing and make effectiveness in auditing. Total more than 200 questions are prepared laboratory accreditation for calibration. It can be used as a very good tool for logically auditing during internal audit for laboratory accreditation for calibration. During internal audit verification of system to meet 17025 requirements helps for smooth accreditation audit.

9. ISO/IEC 17025:2017 compliance matrix

The ISO/IEC 17025:2017 calibration requirement-wise list of documented information reference of this kit is given in the compliance matrix for easy reference of user to understand how this system is made.

10. Sample risk template

The ready to use risk template in editable form is given to prepare the risk document for the organization. It is given in excel and can be use as ready to use template.