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.
Documentation:-
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:
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):
- Procedure for personnel and training
- Procedure for design planning for proficiency testing scheme
- Procedure for preparation of proficiency test item
- Procedure for assessment of homogeneity and stability of proficiency test item
- Procedure for calculation of assigned value and its standard uncertainty
- Procedure for Handling, storage, packaging, labeling, and distribution of proficiency test item
- Procedure for evaluation of proficiency testing scheme results
- Procedure for protection of participant’s confidential information
- Procedure for document and data control
- Procedure for operation of proficiency testing scheme and review of the nomination of participants
- Procedure for Review request, tender and contracts for the proficiency testing scheme
- Procedure for Subcontracting
- Procedure for Purchasing
- Procedure for Complaint Handling
- Procedure for Control of Non–Conforming Work
- Procedure for corrective action
- Procedure for preventive action
- Procedure for Control of Records
- Procedure for internal audit
- Procedure for Management Review
- Procedure for measurement traceability and calibration
- Procedure for Prevention of Collusion and Falsification while Conducting PT Programmes
- Procedure for impartiality
3. Blank Formats (48 Formats):
- Form No. 1, Participation in Proficiency Testing
- Participant feedback form
- Complaint report
- Complaint register
- Participants Data Bank Register
- Sample delivery note
- Annex–A, Result Sheet
- Proficiency test report
- Homogeneity check report
- Assigned value by other method
- Stability check report
- Sample Stock Register
- Proficiency Testing Design Plan
- Preservation Assessment Checklist
- Equipment History Card
- Purchase Order
- Indent
- Approved Vendor List
- Supplier Registration Form
- Open purchase order
- Supplier Evaluation Report
- Inspection Report
- Approved subcontractor list
- Work order
- Subcontractor audit report
- Master List Cum Distribution List of Documents
- Change Note
- Corrective Action Report
- Master List of Records
- Quality Objectives
- Audit Plan / Schedule
- Internal Audit Non–Conformity Report
- Clause wise Document wise Audit Review
- Preventive Action Report
- Calibration Status of Equipment
- Audit Checklist – Top Management
- Audit Checklist – Quality Manager
- Audit Checklist – Training
- Audit Checklist – Technical Operation
- Training Calendar
- Training Report
- Induction Training Report
- Job Description And Specification
- Skill Matrix
- Confidentiality Agreement
- Appointment Letter
- Employees Competence Report
- Education, training and skill objective
4. Standard Operating Systems (06 SOPs)
- SOP for preparation of stainless steel proficiency test item for chemical analysis by OES
- SOP for preparation of aggregate proficiency test item
- SOP for preparation of waste water (effluent part–1) proficiency test item
- SOP for preparation of Cement proficiency test item
- SOP for preparation of Bitumen proficiency test item
- SOP for preparation of waste water (Effluent Part–2) proficiency test item
5. Exhibits (03 Exhibits)
- Codification System
- Calibration periodicity
- Collection, Preservation and Analysis of Waste water samples
6. Proficiency Testing Design Plan
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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