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Liquid Bones QMS

LBEU000

Liquid Bones QMS

Liquid Bones QMS (Quality Management System) is your answer to the U.S. FDA and EU TPD – all in one set of documents. 

To stay in business in this new regulatory environment, e-liquid manufacturers must give assurance of their product’s safety. They must demonstrate control over their materials, processes and suppliers, and consistency in manufacturing processes.

How? By establishing and implementing a Quality Management System with the necessary organizational structure, policies, procedures, processes and resources in place.

The Only SOPs for E-Liquid Manufacturers

Liquid Bones QMS includes all the documents you need to comply with U.S. and European regulations, and ultimately achieve ISO 9001 certification (see Liquid Bones Ready).

Developed specifically for e-liquid and e-cig manufacturers, Liquid Bones QMS includes all the procedures and practices you need to ensure e-liquid safety and quality and achieve world class manufacturing results.

Liquid Bones QMS is “implementation ready,” and is delivered digitally so you can begin the process of becoming FDA and TPD compliant today.

What's Included

Liquid Bones QMS includes 36 SOPs and 31 forms that are divided into four major sections around the four major processes: Management, Customer, Quality and Support.

Liquid Bones QMS meets the requirements of:

  • 21 CFR Parts 1100, 1140, and 1143 (US FDA Tobacco Products Regulation)
  • European Commission Tobacco Products Directive 2014/40/EU, Title III, Article 20 regarding electronic cigarettes and Directive 2001/95/EC, Article 5 on general product safety
  • ISO 9001:2015 Quality management systems
  • PAS 54115:2015 Vaping products, including electronic cigarettes, e-liquids, e-shisha and directly-related products – Manufacture, importation, testing and labeling – Guide

We take a process approach, focusing on the most important “high risk” processes and identifying key process indicators, ensures conformity with all FDA and TPD requirements.

Management Processes

The purpose of the management process is to help top management improve their commitment, leadership, resources, review and decision-making processes. These processes generally interact with all QMS processes during planning and review and include business planning, management review, quality planning, resource planning and communication.

  • Context of the Organization Procedure
  • Risk Management Procedure
  • Outsourced Processes Procedure Template
  • Process Definition Customer Processes
  • Process Definition Management Processes
  • Process Definition Quality Management Processes
  • Process Definition Support Processes
  • Quality Manual for e-Liquids and e-Cigarette Manufacturers

Customer Processes

The purpose of the customer process is to provide the necessary resources to determine customer requirements (inputs), manufacture and distribute product (outputs) to customers, and determine customer satisfaction. These processes generally have the greatest degree of interaction with external customers and include marketing, sales, customer service, production, shipping, packaging and labeling, customer satisfaction etc., whether performed on- or off-site.

  • Adverse Effects Response Order Procedure
  • Clean, Sanitary and Safe Preparation of Products Procedure
  • Control of Third-Party Property Procedure
  • Customer Processes for E-Liquids and e-cig Manufacturers
  • Customer Survey and Feedback Procedure
  • Design and Development
  • Form, Design and Development Appendix 1 – Project Task
  • Form, Design and Development Appendix 2 – Project Plan and Review
  • Form, Design and Development Appendix 3 – Change Review Record
  • Form, Design and Development Appendix 4 – Design Review Minutes
  • E-Liquid Production Batch Record
  • Quality Standard
  • Equipment Validation Procedure
  • EU-TPD Annual Monitoring and Reporting Procedure
  • Form, Adverse Effects Response Order (AERO)
  • Form, Approved Supplier List
  • Form, Packing Slip
  • Form, Requisition
  • Form, SCAR Log
  • Form, Shipping Log
  • Form, Supplier Corrective Action Request
  • Form, Supplier Evaluation Record
  • Identification and Traceability Procedure
  • Market Requirements for e-liquids in the European Union
  • Packaging and Labeling Standard
  • Purchasing Procedure
  • Quoting and Orders Procedure
  • Recall Procedure
  • Risk Analysis Procedure
  • Shipping Procedure
  • Special Processes Procedure Template
  • Suspected Adverse Effects System Procedure
  • Vaping Products Monitoring and Testing

Quality Management Processes

The purpose of the quality management process is to provide the necessary resources to document, measure, analyze and improve all processes. These processes provide support and interact with all QMS processes and include document control, records control, monitoring and measurement of processes and product, internal audits, control of nonconforming product, corrective and preventive action, continual improvement, laboratory controls, and final release of product.

  • Change Management Procedure
  • Control of Documents Procedure
  • Control of Nonconforming Product Procedure
  • Control of Records Procedure
  • Corrective and Preventive Action Procedure
  • Form, Corrective Action Report
  • Form, Corrective Action Report Log
  • Form, Document Master List
  • Form, External Document Listing
  • Form, Internal Audit Log
  • Form, Internal Audit Report
  • Form, Management Review Meeting Minutes
  • Form, Nonconformance Report – NCR
  • Form, Out of Tolerance Impact Study
  • Internal Auditing Procedure
  • Management Review Procedure

Support Processes

The support process provides the necessary resources for the customer processes to facilitate product realization. These processes generally have the greatest degree of interaction at an operational level with the customer processes and to a lesser degree with other internal QMS processes, and include human resources, information technology, purchasing and receiving, environmental controls, maintenance, tooling and facility management.

  • Calibration Procedure
  • Form, Employee Evaluation
  • Form, Employee Opinion Survey
  • Form, Employee Training Matrix
  • Form, Employee Training Record
  • Form, Equipment Maintenance Record
  • Form, Position Description
  • Preservation of Product Procedure
  • Preventive Maintenance Procedure
  • Receiving Procedure
  • Training Procedure

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