$ 8,000.00 $ 16,800.00
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.
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.
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:
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.
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.
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.
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.
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.