TYPICAL DEPARTMENTAL DOCUMENTS FOR QMS (ISO 9001:2015) IN MANUFACTURING ORGANIZATION

For implementation and maintenance and of Quality Management System (ISO 9001:2015) there are several documented information which are mandatory. As required by International standard ISO 9001:2015, these documents are mandatory for compliance of Quality Management System and obtaining ISO 9001:2015 certification. Refer here for details regarding mandatory documented information and non mandatory documented information as per requirements of international standard.

While structuring Quality Management System, an organization can be divided into several departments for smooth running of organization's activities. Departmentalizing an organizations brings clarity regarding who's gonna do what. Every department is responsible and accountable for certain tasks. 

In doing so, a defined set of documents helps each department to perform and control its tasks in an effective way. These set of documents not only ensure easy going of department's activities but also helps in conforming requirements of Quality Management System.

Departmental structuring in a manufacturing organization

In a manufacturing organization a very common classification of departments are as follows:

1. Purchase
2. Stores
3. Design and Development
4. Production
5. Quality assurance and quality control
6. Maintenance
7. Marketing and Sales
8. Warehouse and dispatch
9. Human resource
10. MR Function

Documents commonly used in every department

Now, let know about commonly used documents for every department:

1. Purchase

• Procedure for approval and evaluation of suppliers/service providers
• Supplier/service provider registration form
• List of approved suppliers/service providers
• Purchase indent
• Purchase order
• Work order
• Supplier/service provider evaluation record

2. Stores

• Good receipt note
• Raw material/spare parts inventory record
• Requisition for material issue
• Purchase requisition
• Material return note

3. Design & Development

• Design & development procedure
• Product and components drawing
• Design planning record
• Design input record
• Design output record 
• Design verification record
• Design review record
• Design change record
• Design validation record
• Engineering Change Notice

4. Production

• Work instructions/Standard operating procedures
• Production planning record
• Process Flow Diagrams
• Process control plan
• Daily production record

5. Quality assurance and quality control

• Procedure of inspection and control of incoming material
• Procedure of testing
• Procedure for calibration
• Procedure for handling non conformities
• Incoming inspection and testing record
• In process inspection record
• Final inspection record
• Quality assurance plan
• Calibration record
• Performance test record
• Non conformity and corrective action record

6. Maintenance 

• Procedure for machine maintenance
• Equipment replacement policy
• List of machinery
• Preventive maintenance record
• Break down maintenance record
• Machine health card
• Inventory management of critical machinery spare parts

7. Marketing and Sales

• List of customers
• Quotation
• Proforma invoice
• Tax invoice
• Customer feedback form
• Customer complaint record
• Sales report
• Warranty/Guarantee certificate

8. Warehouse and dispatch

• Procedure for receiving and storing of finished goods
• Procedure for packing and labelling
• Procedure for control of sales return
• Pre dispatch inspection record
• Packing list
• Logistic documents
• List of sales return

9. Human resource

• Procedure for hiring and training
• Competence matrix
• Training need assessment
• Training and effectiveness record
• New employee orientation form
• Statutory and regulatory documents

10. MR function

• QMS manual
• Procedure for internal audit
• Procedure for management review
• Internal audit plan and schedule
• Internal audit report
• Summary of audit non conformities and closure
• Management review record