Quality Manual
Purpose
To define and establish a Quality Management System (QMS) that allows and guarantees compliance with the requirements applicable to our family.
The family
Mission, vision and values
Mission
To create a loving and supportive environment where every member thrives.
Vision
To grow together while fostering kindness, resilience, and creativity.
Values
Respect, honesty, teamwork, and responsibility.
Description
We founded our family in 2020 after years of research and prototyping. The founders of the family are Taig Mac Carthy and Andy Aguilar. The headquarters are in Valencia, Spain.
We process the Christian faith and strive to reach our potential as human beings. We also aim at producing more human beings.
Organisational chart
Applicable regulations and standards
The Bible
Spanish Civil Code
Real Decreto de 24 de julio de 1889 por el que se publica el Código Civil.
Artículo 154
Los hijos e hijas no emancipados están bajo la patria potestad de los progenitores.
La patria potestad, como responsabilidad parental, se ejercerá siempre en interés de los hijos e hijas, de acuerdo con su personalidad, y con respeto a sus derechos, su integridad física y mental.
Esta función comprende los siguientes deberes y facultades:
- Velar por ellos, tenerlos en su compañía, alimentarlos, educarlos y procurarles una formación integral.
- Representarlos y administrar sus bienes.
- Decidir el lugar de residencia habitual de la persona menor de edad, que solo podrá ser modificado con el consentimiento de ambos progenitores o, en su defecto, por autorización judicial.
Si los hijos o hijas tuvieren suficiente madurez deberán ser oídos siempre antes de adoptar decisiones que les afecten sea en procedimiento contencioso o de mutuo acuerdo. En todo caso, se garantizará que puedan ser oídas en condiciones idóneas, en términos que les sean accesibles, comprensibles y adaptados a su edad, madurez y circunstancias, recabando el auxilio de especialistas cuando ello fuera necesario.
Los progenitores podrán, en el ejercicio de su función, recabar el auxilio de la autoridad.
Artículo 155
Los hijos deben:
- Obedecer a sus padres mientras permanezcan bajo su potestad, y respetarles siempre.
- Contribuir equitativamente, según sus posibilidades, al levantamiento de las cargas de la familia mientras convivan con ella.
Ley Orgánica 1/1996 de Protección Jurídica del Menor
Ley Orgánica 2/2006 de Educación
Ley Orgánica 2/2006, de 3 de mayo, de Educación.
Quality management system (QMS)
General requirements
The documentation of our QMS is structured in hierarchical levels as it is described in the figure below, wherein the criteria of the higher-level documentation prevails.
We have established, documented and implemented a Quality Management System (QMS) to constantly improve our effectiveness and efficiency of our software as medical device manufacturing processes, enabling our products to achieve the expectations of the Annex 1 Quality policy and satisfy the customer and regulatory requirements.
The implanted QMS standardizes the processes in all our activities to ensure consistency in providing quality and safe services to its customers. Our management ensures the availability of the resources and information necessary to support the monitoring of the processes. The use of self-assessments, data analysis, verification activities and review management ensure that the QMS is effective, as described in the procedure GP-002 Quality planning.
The adoption of a QMS is a strategic decision. Likewise, its design and implementation are influenced by varying needs, objectives, planned projects, employed processes, and the size and structure of the organization.
Finally, our QMS:
- Demonstrates its ability to consistently provide medical devices that comply with the applicable regulatory and customer requirements.
- Aims at its effective application, including the processes for continuous improvement and the assurance of conformity with the applicable regulatory and customer requirements.
All the internal documentation originating in the QMS is interconnected, every general procedure contains its related documentation such as other procedures, records and reports.
We have a general procedure to control and unify the formats and criteria for the preparation of all the documentation related to the QMS which is the GP-001 Documents and records control.
Procedures and records
The general procedures we have in place are the ones listed below. Their current version and approval date can be consulted in the documents themselves or at the R-001-001 Control of documents.
They contain all the procedures required for the QMS, manufacturing process and data protection, and we have also created, when required, detailed specific procedures of some specific processes and the corresponding records for both, the general and specific procedures. We compile a list of all of these documents at the R-001-001 Control of documents.
Control of documents
All our documents are controlled and archived as a special type of document according to the requirements implanted in the QMS, which are described in the procedure GP-001 Control of documents, where the responsibilities for each document are also detailed.
Control of records
We maintain all the records required by our QMS to provide evidence of control and conformity with the effective operation. They are controlled according to the requirements implanted in the QMS, that are described in the procedure GP-001, where the responsibilities for each document are also detailed.
External documentation
We also maintain a file with the external documentation we need to consider, mainly coming from regulations and standards applicable to our company and the products we manufacture, but they can also come from customers, health authorities, notified bodies or any other interested party. The management of this documentation is detailed in the procedure GP-001.
Process map
Signature meaning
The signatures for the approval process of this document can be found in the verified commits at the repository for the QMS. As a reference, the team members who are expected to participate in this document and their roles in the approval process, as defined in Annex I Responsibility Matrix of the GP-001, are:
- Author: Family members involved
- Reviewer: JD-002
- Approver: JD-001