Image is not available
Image is not available
Image is not available
Image is not available
arrow
arrow

companyAchille Sclavo develops the serum against anthrax in 1904 and founds the Istituto Sieroterapico e Vaccinogeno Toscano. In 1929, the Sclavo Institute begins producing the anatoxin against diphtheria and tetanus and later, the smallpox vaccine.

In 1934, the first diagnostic products are developed and in 1977, the U.S. Food and Drug Administration grants the registration of these products.In 1992, Sclavo Diagnostics International commences business, and in 2003 the plant is moved to the new, technologically avant-garde site in Sovicille (province of Siena).

SCLAVO Diagnostics International, an Italian company, developing, manufacturing and marketing In-Vitro diagnostics reagents and instruments for Clinical Chemistry, Specific and Urinary Proteins, Coagulation, Serology, R&D and production are based upon corporate quality orientation reflected by products and services to customers.

Our know-how, longstanding expertise and quality control processes ensure best price-to-quality ratio.

SCLAVO Diagnostics International is also the ideal partner for the production of OEM bulk and kit reagents based upon special product and packaging requirements.

The production cycle is fully managed and controlled in-house, starting from the purchase of raw materials, through their preparation steps all the way to the finished products.

The corporate state-of-the-art equipment is constantly updated through large investment programs for new products development.

production

Production

Classified environments, qualified personnel choice of the best raw materials allow to SCLAVO Diagnostics to excel in quality and reliability

quality control

Quality Control Laboratories

In our laboratories are available instruments for control and development of all the products.

biosafety

Biosafety Level 3 Laboratory (BL3)

The Biosafety Level 3 Laboratory (BL3) of approx. 6 sqm, located at the ground floor, is equipped and qualified for the handling of pathogenic microorganisms up to “class 3”.

The BL3 laboratory is equipped with two BioHazard cabinets, two incubators, two ultra-centrifuge, a ultra-freezer (-80 °C) and an autoclave for the decontamination of all the material used in BL3.

validation

Validation Laboratory

The complete systems (analyzer + dedicated reagents) are validated following the accredited guidelines.

In the Laboratory are installed some analytical systems, already validated, used as a reference for all the tests required by the international protocols (i.e. CLSI)

In compliance with the requirements set forth in the IVDD (EU In Vitro Diagnostic Directive), SCLAVO Diagnostics International adopted and maintained an excellent Quality Control System confirmed by ISO 13485 certification.
 

Sclavo Diagnostics International S.r.l. has the primary objective of marketing QUALITY products in order to guarantee CUSTOMER SATISFACTION in the context of the mission identified and defined in the Manual, respecting the HEALTH and SAFETY of the staff and the PROTECTION of the HEALTH OF THE PATIENTS. Customer’s satisfaction must be pursued and realized in respect with the safety of the people involved in the realization of the product and the service provided to the Customer, as well as all the binding regulations connected to them.

Therefore, it believes that all staff must be involved, each within their own responsibilities, and commit themselves with determination in the short and long term to the achievement of the following objectives:

 

  1. pursue the assigned objectives oriented to the continuous improvement of the products;
  2. focusing on continuous improvement of the quality of the products, with particular reference to the satisfaction of the requirements expressed by our customers, to our internal standards and to the legal requirements applicable to the products / services we offer;
  3. operate in compliance with legislations and regulations in force and other signed requirements regarding safety management and personnel management
  4. Reduce residual risks for the safety and security of staff at the workplace through the implementation of appropriate training and information programs, the adoption of appropriate work procedures and instructions and through an appropriate work organization
  5. Pursue continuous improvement of the process performance;
  6. Promote and guarantee the information, education and training process to ensure a proper application of the integrated management system.

In line with the strategies just described, Sclavo Diagnostics International S.r.l. is committed to pursue and achieve the following priority objectives:

  • Aim to the complete satisfaction of the Customer's needs, through compliance with the contractual terms, prevention and the management of non-conformities and complaints.
  • Maintain and progressively improve its standards of efficacy.
  • Promote studies and research in order to achieve continuous improvement of products and processes
  • Adopt the best available technologies to ensure the efficiency of the production process, using system solutions that optimize the quality levels of the products.
  • Optimize the level of control and influence on suppliers, through the systematic use of auditing and the proper management of successive follow-up.
  • Promote sensitivity to company policy and the professional growth of its employees and the intent with which it operates, through training and information.
  • Commit to the respect of applicable legal requirements and other prescriptions that concern its aspects, as well as the satisfaction of mandatory requirements relating to the activities carried out.
  • Act to prevent and minimize the environmental impacts of its activities.
  • Improve the management of hazardous substances in the company in the knowledge of impacts that these chemical agents have and could have on the environment and on the health of the workers who use them.
  • Promote the culture of Quality, the Environmental protection and the respect for Health and Safety of the workers in the company.
  • Develop, keep active and periodically check emergency procedures, in order to reduce possible environmental impacts related to such situations.
  • Promote consultation, as appropriate, of Workers, of Contractors and of relevant interested External parts.
  • Prevent injuries and occupational illness through appropriate protective measures, monitoring actions, control and surveillance and systematic analysis of events that have occurred.
  • Keep active and constantly improve the Integrated Management System (ISO 9001- ISO 13485) of the company by continuous updating and systematic application of processes, in order to maintain the document management system always efficient, effective and coherent with the business reality.
  • Allocate adequate human resources and materials to achieving the aforementioned objectives

 

The table below highlights in detail an identifier prospect of interested stakeholders and related needs/expectations.

 

STAKEHOLDER ANALYSIS IDENTIFIER PROSPECT OF INTERESTED STAKEHOLDERS AND RELATED NEEDS/EXPECTATIONS.

TYPE OF INTERESTED PART

INTERNAL/EXTERNAL

NEEDS/EXPECTATIONS OF THE PARTY CONCERNED TO THE ORGANIZATION

Management board

INTERNAL

Business growth both in economic terms and in group values

Reputation/good corporate image

Regulatory compliance (absence of legal pending and/or penalties)

 

Funds and property

INTERNAL/EXTERNAL

Reputation/good corporate image and guarantee of reliability

Continuous improvement of aspects of corporate sustainability and effective system management (achievement of expected results) and efficient (without waste)

Regulatory compliance (absence of legal pending and/or penalties)

Guarantee of production continuity (no risks of business interruption due to mandatory aspects of the product and services)

Willingness to collaborate in the company’s activity regarding Management System

Willingness to share experiences related to best Management System practices  

Ability to grasp competitive advantage in relation to possible opportunities regarding Quality management (access to funding for innovation in the field of development, access to benefits for certified companies)

Presence of an QMS which effectively allows to prevent crimes of the Management System (for example D. Lgs. 231/01)

Supervisory body

EXTERNAL

Regulatory compliance (absence of legal pending and/or penalties)

Presence of an RSGQ which effectively allows to prevent deviations or possible crimes.

(for D. Lgs. 231/01)

Employees

INTERNAL

Healthy working environment and protection of worker’s health

Availability of operating procedures, devices, infrastructure and working conditions adequate to manage the aspects of the Quality Management System and emergency situations.

Adequate information and training about the risks of Management System relating to activities of competence and involvement in the Management System

Clear identification of the company representatives in the field of Quality

Guarantee of production continuity

Trade Unions

INTERNAL/EXTERNAL

Healthy working environment and protection of worker’s health

Guarantee of production continuity (no risks of business interruption due to deviations or possible crimes related to d.lgs 231/01)

Banks

EXTERNAL

Reputation/good corporate image and guarantee of reliability

Regulatory compliance (absence of legal pending and/or penalties)

Guarantee of production continuity

Presence of an QMS which effectively allows to prevent deviations or possible crimes (for example D. Lgs. 231/01)

Insurance

EXTERNAL

Business solidity and guarantee of reliability

Correct assessment and monitoring of corporate risks

Regulatory compliance (absence of legal pending and/or penalties)

Reputation/good corporate image

Presence of an QMS which effectively allows to prevent environmental crimes (D. Lgs. 203/01)

Trade associations (UPI)

EXTERNAL

Reputation/good corporate image and compliance with contractual agreements

Regulatory compliance (absence of legal pending and/or penalties)

Guarantee of production continuity

Willingness to collaborate in the association's activities (studies, thematic working groups, etc. ...) in the matter.

Willingness to share experiences related to best Management Quality System practices 

Public Bodies (institutions and control bodies)

EXTERNAL

Transparency of information and environmental data and open available communication

Willingness to participate in initiatives/projects for redevelopment works promoted at an institutional level.

GENERAL PROVISIONS

The terms and conditions indicated below (the "General Conditions of Sale") are an integral part of the contracts concluded by Sclavo Diagnostics International S.r.l. (the "Seller") and the buyer (the "Buyer") for the supply of the Seller's products (the "Products").

The General Conditions of Sale is applied to all transactions concluded between the Seller and the Buyer without the need for an express reference to them or a specific agreement to that effect at the conclusion of each individual transaction. Any different conditions or terms is applied only if it is confirmed in writing by the Seller.

The seller reserves the right to modify, incorporate or observe the General Conditions of Sale at its unquestionable judgment by attaching these variations to the offers or any correspondence sent in writing to the Buyer.

PRICES

The prices of the Products (the Prices) are indicated in the price list attached to the General Conditions of Sale; the prices of the Products not in the price list will be communicated at the request of the Buyer. The Seller reserves the right to make any changes to the Prices that become necessary.

Prices do not include VAT, which must be paid when paying for the Products in accordance with the specific provisions indicated on the invoice.

If the supplies of the Products provide additional services and services, the necessary changes will be made to the Prices with an agreement between the Seller and the Buyer.

PAYMENT

Invoices will be paid as specified in them. Failure on the payment on the due date indicated on the invoice will determine the formal notice of the Buyer, pursuant to paragraph 2, point 3) art. 1219 of the Civil Code and Legislative Decree n. 231/2002, and the debit of default interests on late payments starting from the date on which the Seller's right to payment has matured.

PORT AND SHIPPING

The risks arising from the transportation of the Products are borne by the Buyer.

Transport costs will be borne by the Buyer.

COMPLAINTS AND REPLACEMENTS

At the moment of taking over the Products, the Buyer must immediately:

1-      Check the quantities and the packaging of the Products;

2-      Carry out a conformity check of the products in respect of what is indicated in the order.

Any discrepancies and / or anomalies of the packages and / or Products must be reported on the transport document by affixing a specific reserve, together with the signature, by the Purchaser, specifying the type of anomaly found (e.g. For missing packages, for broken packages, for tampered packages, etc.).

Any complaints must be communicated to the Seller in writing, within eight days of taking over the Products by the Buyer, attaching a copy of the transport document on which the reserve has been affixed.

After this deadline, the Products will be considered accepted by the Buyer, with the forfeiture of any right, claim and / or action in this regard.

Following the promptly proposed complaints, after verification by the Seller of their validity, the Seller will replace the Products to which the complaint refers or, alternatively (and at its sole discretion), credit the amount corresponding to the price of purchase of the same, upon return of the Products subject to the complaint authorized by the Seller.

RETURNS

The seller is not obliged to accept returns of products, unless expressly agreed in writing. Any costs incurred for this purpose are borne by the Buyer.

Unauthorized returns will be sent back to the Purchaser with the relative charge of shipping costs.

Expired reagents not properly stored after the Buyer takes over the Products will not be replaced.

WARRANTY

The Seller guarantees that the Products are free from defects and in compliance with the technical specifications declared by the Seller.

The equipment is guaranteed for twelve months from billing.

The operation of the guarantee is subordinate:

  1. to the compliance, according to current regulations, of the power supply system used for the instrumentation;
  2. to the use of reagents, controls and consumables in accordance with the technical specifications indicated by the Seller and having the qualities guaranteed by the Seller;

iii. to the compliance with the technical prescriptions for the use and maintenance of the Products set out in the "Instructions for Use" prepared by the Seller.

The warranty does not apply in the event of breakdowns due to tampering and / or non-compliance with the "Instructions for Use", in the event of improper use of the Products and / or improper storage of the same as determined in the following paragraph.

During the warranty period, the Seller will replace only the components that show manufacturing or operating defects.

SECURITY AND LIABILITY CLAUSES

The products must be used exclusively for in vitro diagnostic analysis (IVD) by suitably trained and qualified personnel.

The Seller will not be responsible for damage to people and / or things deriving from incorrect use and / or improper storage of the products supplied.

The Seller will not be responsible for the malfunction of the instrumentation connected to electrical systems that do not comply with current safety standards.

SUPPLY COMMITMENT

The supply commitment always means within the limits of availability, even if the Products are booked and possibly paid in advance.

 

FORCE MAJEURE

The seller cannot in any case be called to answer for damages manually or indirectly controlled by the delayed delivery of the products and / or the total or partial non-fulfillment of any contractual obligation in cases where a cause of force majeure is necessary and / or in any circumstances beyond the control of the Seller (such as, but not limited to, strikes, riots, wars, fires, epidemics, floods, earthquakes, interruption of transport).

PRIVACY PROTECTION

The Purchaser's personal data will be processed by the Seller in accordance with the provisions of current legislation on the protection of personal data.

PLACE OF JURISDICTION

Any dispute relating to the commercial relationship between Sclavo Diagnostics International S.r.l. and the Purchaser will be devolved to the exclusive territorial jurisdiction of the Court of Milan.

Click on the image below to download the pdf file of the company presentation in English and Italian