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 CE Mark Documents for Steel Structure – as per DIN EN 1090-2 / ISO 3834-2 Standards
The CE Mark Documentation Kit for Steel Structure- a set of total 70 editable files – is based on requirements of DIN EN 1090-2 and ISO 3834-2 standards., includes This kit contains following readymade templates that can be used as a ready reference to accelerate documentation process for CE Mark Certification.
- Manual – 01 editable file that defines DIN EN 1090 and ISO 3834 requirements.
- Mandatory Procedures – Total 05 procedures in word format for various requirements as well as technical reviews of products and welding process.
- QMS Procedures – Total 07 quality management system procedures for management, operation, training, and audit, etc., to use as reference documents.
- Exhibits – Total 05 editable exhibits in word files for EN 1090, part-2 technical requirements for Steel Structural and ISO 3834, part-2, quality requirements for fusion welding of metallic materials.
- Readymade Formats – Total 44 editable sample forms and templates to maintain records as well as establish control and make the system as per EN 1090 and ISO 3834 requirements.
- Standard Operating Procedures – Total 08 SOPs in editable formats required for defining standard operations as per EN 1090-2 and ISO 3834-2 requirements.
- Job Description and Specification – A sample copy of job description and specification covering all the details in the 01 file.
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 medical laboratories.
1. Manual:
Content
Section–1
1.0 General Information
1.1 Amendment record sheet
1.2 Glossary of Terms
1.3 Authorization Statement
1.4 Company Profile
Section–2
2. Scope
3. Normative References
4. Terms and Definitions
5. Use Of this parts of ISO 3834 and DIN EN 1090–2
6. Review Of Requirements and Technical Review
6.1 General
6.2 Requirements Review
6.3 Technical Review
7. Sub Contracting
8. Welding Staff (Personnel)
8.1 General
8.2 Welders
8.3 Welding Coordination Staff
8.4 Organization Welding Coordination
9. Staff Responsible For Inspection and Testing
9.1 General
9.2 Staff for non–destructive Testing
10. Equipment
10.1 Production Equipment and Testing
10.2 Equipment Description
10.3 Ability Equipments
10.4 Maintenance of Equipment
10.5 Storing Base Materials
11. Welding And Related Activities
11.1 Production Planning
11.2 Welding Planning Documents
11.3 Welding Procedure Specifications
11.4 Weld Joint Design
11.5 Welding Procedure Qualification Record Welding(Work Instruction)
11.6 Procedures FOR Preparation and Control of Documents
12. Storage and Handling of Welding Consumables
12.1 Batch Testing
12.2 Conformity of Welding Consumables
13. Storage Of Parents Materials
14. Post–Weld Heat Treatment
15. Inspection and Testing
15.1 General
15.2 Inspection and Testing Before Welding
15.3 Inspection and Testing During Welding
15.4 Inspection and Testing After Welding
15.5 Self–Inspection by the Welder or Welding Operator
15.6 Inspection & Test Status
16. Non–Conformance and Corrective Actions
16.1 Management of non–Conformance– General
16.2 Resolving of non–Conformance (Repairs)
16.3 Corrective Action
16.4 Documentation
16.5 Work Instruction for Weld Repair
17. Calibration and Validation of Measuring, Inspection and Testing Equipment
18. Identification and Traceability
19. Quality Records
2. Procedures (05 Procedures):
- Procedure for requirements and technical review of products
- Procedure for Preparation & Control of Welding Documents
- Procedure for Control of Welding Consumable
- Procedure for Welding Repair
- Procedure for UT
3. QMS Procedures (07 Procedures):
- Procedure for Management review
- Procedure for Document and data control
- Procedure for Corrective action & Preventive Action
- Procedure for internal Quality audit
- Procedure for Control of Quality records
- Procedure for Training
- Procedure for Disposable of Non Conforming Product
4. Exhibits (05 exhibits):
- Skill Requirements
- Multi skill requirements
- Disposal of Non–Conforming Products
- Inspection Test Plan
- Document Identification and Codification System
5. Formats (44 Formats):
- Preventive Maintenance Schedule
- Equipment Wise Preventive Maintenance Checkpoints
- Order Form / Order Conformation
- Customer Feedback Form
- Allocation Sheet
- Equipment History Card
- Purchase Order
- Technical Review of Requirements
- Tentative Month Wise Planning Sheet
- Approved external provider list & Annual purchase order
- Customer Complaint Form
- Annual Purchase Order
- Welder’s Welding Parameters During Welding
- Equipment Validation Report
- Calibration Status Of Instrument/Equipment
- Change Note
- Master List of Records
- QMS Audit Plan / Schedule
- QMS Internal Quality Audit Non– Conformity Report
- Corrective Action Report
- Preventive Action Report
- Route Card
- External Provider Registration Form
- Assembly Checking Before Welding
- Indent Cum Incoming Inspection Report
- Welding Inspection Report
- Material Inspection Report (MIR)
- Master List and Distribution List of Documents
- Calibration Status of Instrument / Equipment
- Quality Objectives Monitoring Sheet
- Gate Pass
- Quality Objective Plan
- QMS Clause wise Audit Review Report
- Preservation Assessment Report
- Training Calendar
- Induction Training Report
- Training Report
- Multi Skill Analysis
- Management Review Meeting
- Goods Receipt Note
- Disposal of Non–Conforming Products
- Material Issue Slip
- Job Description & Specification
- Employee Wise Training & Competence Record Sheet
6. Standard operating procedures (08 SOPs):
- SOP for Solid waste management
- SOP for Diesel Tanks filling and Re–fueling
- SOP for Working at Height
- SOP for Waste Management
- SOP for Material Handling and Lifting Guidelines
- SOP for Confined space guidelines
- SOP for Welding and cutting work
- SOP for Unloading, handling and storage of gas cylinders
7. Job description and specification (01 file):
How useful?
- Complete set of manual, procedures, templates, etc. takes care for all the sections and sub-sections to get better confidence as well as improve the system.
- The users can modify readymade templates as per their working system, and CE mark consultant can create own documents for quick accreditation.
- Procedures and formats provided in a documentation kit can help in fine-tuning the processes and establishing better control over the management system.
- Documentation kit saves much time and costs in document preparation for CE Mark Certification.
- It gives value for money to customers and the number of payback is very low.
- Ready-to-use templates in .doc format reduce your time in the documentation process as well as useful in giving training to staff.
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