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Services

About our sevices

We collaborate for compliance with standards requirement

Our organization provides advice to integrate the requirements of the different standards in the processes of your organization and to obtain the certifications or accreditations of the quality systems.

We evaluate the current management of your processes and propose improvements to these processes for their adaptation to the corresponding reference. We collaborate in the development of process documentation, we are with your organization for the updating of processes in change management.

We provide training in the quality system and accompany in certification or accreditation audits. We advise on the implementation of corrective actions, focused not only to meet requirements, but also to improve the effectiveness of processes.

Hemotherapy Standards: CAT, JACIE, SOHO

Consulting services for the implementation of the standards developed by the foundation for quality in blood transfusion, cell and tissue therapy (CAT) and Joint Commission standards (JACIE)

For Hemodonation Centers, Transfusion Services, Therapeutic Afferesis units.

This guideline, sets out, the requirements for all management and technical processes in the scope of the certification chosen, as well as, the professional qualification requirements. CAT , JACIE , SOHO

Services

Diagnosis of the quality system of the organization for the scope to be certified
Development of the quality system to meet the requirements
Internal Auditis
Maintenance of the management system

ISO 9001

Quality management system

This standard is the basis  to build a quality management system on which strategic decisions for the development of both production and service organizations are taken

In SISCALVG CONSULTORÍA we adapt the quality system to the measure of the organization, reducing the administrative costs of managing the quality system and allowing it to be integrated into the work routine of the company

Servicios

Diagnosis of the quality system of the organization for the scope to be certified
Development of the quality system to meet the requirements
Internal Audits
Maintenance of the management system

ISO 13485

Medical devices, quality management system, requirements for regulatory purposes

The standard for quality systems in medical device companies This standard allows the integral management not only of the medical device, but of all the processes of the organization, provides tools that give information for the management of the processes and risks of the organization which allows the achievement of objectives and goals

Services

Diagnosis of the quality system of the organization for the scope to be certified
Development of the quality system to meet the requirements
Internal Audits
Maintenance of the management system

ISO 14001

Environmental management systems

The first step in sustainable development begins with establishing requirements within our environmental responsibility.

By complying with this standard, the organization demonstrates that it has an environmental performance system.

In SISCALVG Consulting we implement the environmental management system so that it is integrated into the management of the organization and is another area of strategic development.

Services

Diagnosis of the quality system of the organization for the scope to be certified
Development of the quality system to meet the requirements
Internal Audits
Maintenance of the management system

ISO 15189

Clinical laboratories particular requirements for quality and competence

The standard
specifies requirements concerning the competence and quality of clinical
analysis laboratories.This standard follows the accreditation circuit with an
accreditation body, this process, in the case of Spain, is managed directly by
the Entidad Nacional de Acreditación (ENAC).It is suitable for demonstrating
the competence of laboratories in specific techniques.The organisation has to
adapt its quality system to meet the general requirements and technical
requirements applicable to the scope of accreditation.

Services

Diagnosis of the quality system of the organization for the scope to be certified
Development of the quality system to meet the requirements
Internal Audits
Maintenance of the management system

EXPERIENCE

20 years experience helping companies

Focusing on the work of the consultant in the improvements of the processes and activities of the company we achieve:

HOW WE WORK

Our collaborative, personalized approach

Diagnosis

We evaluate the current management of the organization's processes, how things are done and what information is obtained from the results, to be used in decision making..

Solution

We help with our experience and knowledge to develop the quality system, we collaborate in the implementation and evaluation of results with on-site and remote visits.

Support

We audit the quality system to assess its compliance with the standard and propose improvements.

We accompany you throughout the certification and accreditation process