Following guidelines according to QMS (ISO 9001:2015) furthermore this required documents applicable for Technical Audit (TA).
- Scope of Quality Management System.
- Quality Policy.
- Quality Objectives.
- Context of the organization and Interest Parties determining procedure.
- List of Manpower, Machine and Raw Materials.
- Organization Organogram and Job Description with sign and seal.
- Organization Mission, Vision, Goal and Factory Layout.
- Line layout.
- All type of License for organization.
- Manpower Calibration record (Skill Matrix and Interview records).
- All types of Machine Calibration Records*.
- Machine Calibration Record.
- Maintenance Policy & Procedure.
- Preventive Maintenance Plan, Schedule & Record.
- Raw Materials (Fabrics & Accessories) inspection Report.
- Document Control Record and Procedure.
- Quality Manual (Document No., Version No., Revision No., Sign & History of changes)
- Document Control Procedure
- Stakeholders, Supplier and customer feedback. (For Stake holder – Comment Box and monitoring record, Customer and Supplier feedback with grading.)
- Training Record (Policy & Procedure, Plan, Progress, Notice, Schedule, Module, Evaluation- Learning level, Reaction level & Performance level, Pictorial evidence and Trainer competence).
- Product Specification (Technical Pack).
- Product Conformance record (Product approval record-if mail or any data).
- Production and Quality Plan (PP Meeting record, Production Sheet etc.)
- Customer comment record about changes on his property.
- Record of Product traceability.
- Product Re-call & Complaint Record.
- Production Change review record.
- Cutting parts replacement record & procedure
- Sewing and Finishing garments change (Alteration record and SOP)
- Sample requirements record.
- Sample functional & performance records.
- Sample code and failure record.
- Sample evaluation record.
- Sample input and output verification record.
- Sample SOP, monitoring, measuring requirements records and acceptance criteria.
- Sample change record with authorization sign and seal.
- Sample review result.
- Sample prevent and adverse impact record.
- Approved Supplier & Customer list.
- Supplier (also sub-contact) Evaluation, Selection, Monitoring of performance and Re-evaluation Criteria and procedure.
- Record of Customer Properties like- customer materials, tools and equipment, premises, intellectual property and personal data.
- Customer Property handling policy & procedure.
- Product/Service change records with authority sign and seal.
- Final Product Pass record.
- Disposal Policy and Procedure of Document, Product and material.
- Left over Product Procedure and Record.
- Record of Monitoring, Measurement, Analysis and Evaluation result of product.
- Quality Control Record product and process.
- Root-cause analysis record.
- Corrective and preventive action of product and process.
- Risk Assessment Records.
- Internal Audit Record (Policy & Procedure, Plan, Notice, Checklist, Report with pictorial evidence, Internal auditor authorization and job description).
- Record of Management Review Meeting (Policy, Procedure & Report with pictorial evidence)
- Corrective and Preventive Actions for Audit and Quality Management System findings.
*Note: Bold Colored are Mandatory documents.
MD KHAIRUL ISLAM (SAJIB)
Co-Founder & Consultant
Quality Engineer | QMS Auditor | Trainer | Blogger
Cell: +88 01714908292