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 ISO 17025:2017 Documentation kit for Environment / Chemical Testing Laboratory
Our documents are editable and many organizations and ISO 17025 consultants are using our documents. The contents of the environmental / chemical testing laboratory document kit include more than 100 document files as listed below:
- ISO 17025 Manual (with 8 chapters): A sample laboratory quality system – ISO 17025 2017 manual with the quality policy. Each ISO 17025 manual chapter is explaining macro-level management strategy and commitment and how the laboratory system is implemented in plain English.
- ISO 17025 Procedures (20 procedures): It includes 20 iso 17025 2017 procedures to implement the system in the test laboratory and comply with accreditation standard requirements. It covering the mandatory requirements of documented procedures.
- Exhibits (8 exhibits): The 8 exhibits including an exhibit for calibration periodicity of instruments.
- Standard Operating Procedures (02 sops): It includes operating procedures for good work practices.
- Blank and Filled Form (63 sample forms): A set of 63 templates and forms give a total idea to establish the system for the laboratory.
- Sample risk templates: The ready to use risk templates in an editable form is given to prepare the risk document for the organization. It is given in the format of the excel sheet and a sample filled sheet is given. It can be used to implement a risk approach as suggested in ISO 17025:2017.
- ISO 17025 Audit checklist (more than 200 questions): Audit questions in plain English helps to verify the laboratory system. Audit questions can be easily customizable for making your own audit checklist. The ISO 17025 2017 accreditation audit is done by accredited certifying body auditors.
The user can easily modify the name of the test laboratory, its logo, and other things required for the preparation of iso 17025 2017 accreditation documents of your test laboratory.
Documented information package:
- Maintain documented information (Scope, Quality manual, procedures, exhibits, Sop, etc.)
- Retain documented information (Forms / Templates)
1. 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 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):
- Procedure for Maintaining impartiality of laboratory activities
- Procedure for Personnel and training
- Procedure for Maintain laboratory environmental condition
- Procedure for Handling, transport, storage, use and planned maintenance of equipment
- Procedure for Intermediate checks
- Procedure for Measurement traceability and calibration
- Procedure for Procurement of externally provided products and services
- Procedure for Review of requests, tenders and contracts
- Procedure for Method verification and validation
- Procedure for Transportation, receipt, handling, protection, storage, retention, and disposal or return of test items
- Procedure for Evaluation of measurement uncertainty and statistical techniques for analysis of data
- Procedure for Ensuring and monitoring of validity of result
- Procedure for Receive, evaluate and make decisions on complaints
- Procedure for Control of non–conforming work
- Procedure for Control of data
- Procedure for Document and data control
- Procedure for Control of records
- Procedure for Risk assessment
- Procedure for Corrective action
- Procedure for Internal audit
- Procedure for Management review
- Procedure for Providing statement of conformity and decision rule
3. Exhibits (10 exhibits):
- Exhibits for Skill requirements
- Exhibits for Codification system
- Exhibits for Calibration periodicity
- Exhibits for Secrecy rules
- Exhibits for Communication process
- Exhibits for Impartiality policy
- Exhibits for Sample receipt checklist
- Exhibits for Scope of accreditation
- Exhibits for Acceptance criteria for internal quality checks
- Exhibits for Sampling plan
4. Standard Operating Procedures (11 SOPs)
- SOP for Protection and back–up of electronics records
- SOP for Laboratory safety
- SOP for Sampling
- SOP for Handling, Storage, and Use of CRM
- SOP for Intermediate Check on CRM
- SOP for Operation and Intermediate checks – Weighing Balance
- SOP for Operation and Intermediate checks – Oven / Furnace / Humidity chamber
- SOP for pH meter operation and standardization
- SOP for Conductivity meter operation and standardization
- SOP for Disposal method for retained samples
- SOP for Site testing
5. Blank sample formats for all the departments (76 sample formats)
- Test Request and Sample Receipt Report – Water and waste water
- Environment condition monitoring report
- Test Request and Sample Receipt Report – Process stack
- Facility supervision checklist
- Test Request and Sample Receipt Report – Ambient air
- pH meter calibration report
- Test Request and Sample Receipt Report – Sludge
- Inhouse calibration report
- Test Request, Sampling and monitoring – Noise
- Method verification report
- Customer Feedback Form
- Method validation report
- Complaint Report
- CRM Consumption report
- Inward Register
- Normality record sheet
- Equipment History Card
- List of critical consumables
- Preventive Maintenance Schedule
- Distil water test report
- Equipment Wise Preventive Maintenance Checkpoints
- Master List and Distribution List of Documents
- Control of non–conforming work
- Change Note
- Gate pass
- Corrective Action Report
- Work sheet – Chemical analysis of water / waste water
- Master List of Records
- Work sheet – Ambient air
- Quality objective monitoring report
- Work sheet – Process stack
- Audit plan / schedule
- Work sheet – Chemical analysis of sludge / solid waste
- Internal Audit Non–Conformity Report
- Test report – Chemical analysis of water / waste water
- Clausewise Documentwise Audit Review Report
- Test report – Ambient air
- Risk Assessment sheet
- Test report – Process stack
- Calibration Status of Equipment
- Test report – Chemical analysis of sludge / solid waste
- Clausewise audit report – Management system
- Test report – Noise measurement
- Clausewise audit report – Technical requirements
- Purchase Order
- Circular
- Indent – Purchase Requisition
- Minutes of Meeting
- Approved External Providers List
- Improvement log
- Supplier Registration Form
- Periodic document review report
- Open Purchase Order
- Impartiality check report
- Supplier Evaluation Report
- Training Calendar
- Inspection Report
- Training Report
- Sub–contractors / External service provider’s agreement
- Induction Training Report
- Sub–contracting work register
- Job Description And Specification
- Four Year Plan for Quality Control
- Skill Matrix
- Re–test plan / execution report
- Confidentiality Agreement
- ILC Analysis Report (Standard Deviation Method)
- Appointment Letter
- Uncertainty Of Measurement
- Employees Competence Report
- Re–test Analysis Report
- ISO/IEC 17025 Effectiveness Check Report
- Intermediate check report – Weighing Balance
- Technical Training Effectiveness check report
- Intermediate check report – Oven
- Interview report
6. Work Instructions (40 work instructions)
- Operating Instruction – Weighing balance
- Testing of Phenol of water and waste water
- Operating Instruction – Hot Air Oven
- Testing of Sodium of water and waste water
- Sample receipt
- Testing of Sodium Absorption Ratio of water and waste water
- Preparation of calibration curve using CRM
- Testing of Iron of water and waste water
- Testing of Colour of water and waste water
- Testing of Potassium of water and waste water
- Testing of Turbidity of water and waste water
- Testing of Sulfur Dioxide – SO2 in Ambient Air
- Testing of Total Dissolved Solids of water and waste water
- Testing of Oxides of Nitrogen – NOX in Ambient Air
- Testing of Total Suspended Solids of water and waste water
- Testing of Particulate Matter – PM10 in Ambient Air
- Testing of Chloride of water and waste water
- Testing of Particulate Matter – PM2.5 in Ambient Air
- Testing of Sulfate of water and waste water
- Testing of Sulfur Dioxide – SO2 in process stack
- Testing of Total Hardness of water and waste water
- Testing of Oxides of Nitrogen – NOX in process stack
- Testing of Calcium of water and waste water
- Operation and calibration of Spectrophotometer
- Testing of Magnesium of water and waste water
- Operation and calibration of Turbidity Meter
- Testing of Alkalinity of water and waste water
- Operation and calibration of Flame Photometer
- Testing of Ammonical Nitrogen of water and waste water
- Sampling of water and waste water
- Testing of Oil & Grease of water and waste water
- Testing of Particulate Matters – in process stack
- Testing of Chemical Oxygen Demand (COD) of water and waste water
- Handling, Storage and Use of Certified Reference Materials (CRM)
- Testing of Dissolved Oxygen of water and waste water
- Intermediate Checks on CRM
- Testing of Bio–Chemical Oxygen Demand of water and waste water
- Sampling of Ambient Air 20. Testing
- Testing of Fluoride of water and waste water
- Sampling of Stack / Vent
7. Sample MRM
8. Audit checklist (more than 200 questions)
9. ISO/IEC 17025:2017 compliance matrix
10. Sample risk template
How useful?
- The user can very easily modify the templates according to their testing work and create the documents for their laboratory.
- The documents give total help to users for making the best laboratory system and implement good practices. Such a ready tool kit of more than 200 ISO 17025:2017 audit checklists helps the organization to ensure the micro-level system is well established and quick auditing.
- Save much time and cost in document preparation.
- Our iso 17025 documents are highly sold globally and used by many global laboratories and had provided total customer satisfaction as well as value for money,
- In preparation of iso 17025 2017 document kits; it is been verified and evaluated at various levels of our team and more than 10000 hours are spent in preparation of this laboratory accreditation document kit.
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