Quality Management System (QMS)

Logidex has established a Quality Management System (QMS) to assure safety and effectiveness of manufactured products, customer satisfaction and conformity to mandatory regulations.



The quality program is developed to assure quality products and a conformance to the applicable laws and regulations, contract requirement and customers’ expectations.

Quality Manual

HIGHLIGHTS

Logidex has established a Quality Management System (QMS) to assure safety and effectiveness of manufactured products, customer satisfaction and conformity to mandatory regulations. This manual describes Logidex's Quality System Policies and Procedures. These policies and procedures control all activities from Supplier procurement to Customer shipment of products.

The quality program is developed to assure customer satisfaction by providing quality products. We will perform all activities in a manner, which meets or exceeds the expectations of our customers. The quality System described herein is mandatory for all activities performed at Logidex to assure product conformance to the applicable laws and regulations, contract requirement and customers’ expectations.

Logidex shall be working for increased satisfaction of all interested parties, including customers, personnel, suppliers, authorities and owners, by establishing their needs and expectations and by acting in a balanced way for fulfilling them.

We shall:

1. Sub-contract the manufacturing only to companies with a well-established quality system.

2. Only use high quality raw materials which are traceable to the original manufacturer.

3. Develop good relations to suppliers ensuring that the services do not compromise Logidex´ requirements and expectations.

4. Avoid involvement in any activities that would diminish confidence in our competence, impartiality, judgment or operational integrity.

5. Ensure that management and other personnel are free from any undue internal and external commercial, financial and other pressures that may adversely affect the quality of the work.

6. Have adequately educated and trained staffed.

7. Ensure compliance with all statutory requirements and regulations applicable to Logidex’ organization or the provided services.

8. Continually improve the effectiveness of the quality management system by periodical review.

REGULATIONS AND STANDARDS

The food supplements market is a regulated market. In Italy the regulations are issued in accordance with the European directives. The competent authorities are EFSA at European level, the Ministry of Health and AIFA (Italian Medicines Agency).

The food supplements’ manufacturers in order to operate need to be authorized by the local Councils (Regioni) according to Law 189/2012. The authorization is granted following the successful verification of the required hygienic and sanitary conditions and the technical requirements as per CE Regulations (CE) 852/2004 and (CE) 853/2004, art. 10 Legislative Decree 111/92.

Certifications recommended for manufacturers are HACCP, ISO 9001-2008, GMP.

Our products are categorized as Food supplement in the country of origin as per the current Law in Italy and Europe. For this category, the analysis of the identity and quantity of active ingredients are not compulsory, since they are not considered as drug/medicines.

Thus, the composition of the food supplement is verified by the manufacturer’s Quality Control (following the procedures established by the QMS), by, first of all, approving the raw material (considering the technical documents of the supplier, the appearance of the material, the history of the supplier…) and then by following an established procedure.

LOGIDEX – QMS

In Italy, the marketing of a dietary/food supplement can only occur after the product has been duly notified to the Ministry of Health, which is the competent authority to assess the correspondence of the formulation and the claims with current local regulations.

In case of a positive outcome the supplement, subject of the notification, will be included in the Register of dietary supplements available on the website of the Ministry and a Certificates of Free Sale will be issued.

All our products are duly authorized for sale.

Our manufacturers are authorized by the Ministry of Health to the production and sale of food supplements and adhere to the highest quality standards.

Our manufacturers possess the following certifications:

• GMP (CERTIQUALITY): CSQ ISO 9001:2008 & IMQ ISO 22716:2007

• HALAL CERTIFICATION: CERTIFICATE N.036-003-2014 REV.0

• BSE CERTIFICATION

• STABILITY: STANDARD STABILITY TESTS ARE PERFORMED INTERNALLY. ACCELREATED STABILITY TESTS ARE OUTSOURCED TO EXTERNAL LABORATORIES.

• ALL PRODUCTS ARE ACCOMPANIED BY A SAFETY DATA SHEET

• MICROBIOLOGICAL ANALYSIS IS PERFORMED ON EVERY BATCH

GENERAL REQUIREMENTS



Logidex has established a QMS and applies, updates, and maintains it according to the requirements of mandatory regulations.

Processes needed for the QMS, their sequence and relationship have been identified and defined. High level processes and their relationships are structured as the image.



MANUFACTURING

The subcontractors used for manufacturing are selected with care according to the Manufacturer Qualification procedure. The manufacturing is based on mutually agreed flows with subcontractors.

MONITORING AND MEASUREMENT

Logidex has implemented the collection and monitoring of information relating to customer satisfaction as this also represents a way to measure the performance of the company QMS.

This feedback includes:

• customer complaints, if any

• information and data gathered during visits and contacts with customers.

AUDITS

In order to ensure proper implementation, functioning and effectiveness of the QMS and to see if the results are in line with expectations and with the QP, Internal Audits are planned and implemented.

CONTINUOUS IMPROVEMENT

The continuous improvement of services offered to customers and of the quality management system is one of the primary goals of Logidex.

The organization will continually improve the effectiveness of the quality system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management reviews.



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