Digital Signature Decree 2020
ISO 13485, now ISO 13485:2016 Medical device quality management systems, requirements for regulatory purposes, defines the basis of a quality management system for organizations involved in the life cycle of a medical device. Certification demonstrates your commitment to meeting your customers’ needs and supports regulatory compliance in many jurisdictions.
We offer an international ISO 13485 certification service accredited by UKAS (United Kingdom Accreditation Body). Our worldwide presence means that your audit will routinely be carried out by auditors in the local language.
ISO 13485:2016 is applicable to all medical device manufacturers and suppliers, component manufacturers, contract service providers and medical device distributors.
We can also help you build a solid foundation for your medical device certification strategy with our UKAS-accredited ISO 13485:2016 audit, which supports regulatory approvals globally.
Decree 203 of 2021
These “ad extra” actions of the Administrations are expressly mentioned in Article 105 of the Constitution, which establishes that the Law shall regulate the hearing of citizens, directly or through the organizations and associations recognized by the Law, in the procedure for the preparation of the administrative provisions that affect them, as well as the procedure through which administrative acts must be produced, guaranteeing, when appropriate, the hearing of the interested parties.
In accordance with the constitutional framework described above, this Law regulates the minimum rights and guarantees that correspond to all citizens with respect to administrative activity, both in the exercise of the power of self-regulation and in the exercise of regulatory power and legislative initiative.
There are several relevant legislative precedents in this matter. The legislator has made the concept of administrative procedure evolve, adapting the form of action of the Administrations to the historical context and the social reality of each moment. Apart from the well-known Azcárate Law of October 19, 1889, the first complete regulation of the administrative procedure in our legal system is contained in the Administrative Procedure Law of July 17, 1958.
Digital signature law
To obtain the registration, in the register of low voltage electrical installations, of new installations, extensions or major modifications, by means of the diligence of low voltage electrical installation certificates, electrical installation certificates to accredit the safety of an existing low voltage electrical supply or safety certificates for meter centralizations.
Royal Decree 560/2010 of May 7, 2010, which amends several Regulatory Standards on Industrial Safety to adapt them to Law 17/2009 of November 23, 2009, on Free Access to Service Activities and their Execution and to Law 25/2009 of December 22, 2009, on the Amendment of Several Laws for their Adaptation to the Law on Free Access to Service Activities and their Exercise. BOE May 22nd, 2010
Updated digital signature law
Mechanisms must be implemented to ensure the practical evaluation of the provisions of the Codes of Ethics, so that their results contribute to their development, strengthening and effective application.
Elected, appointed, freely appointed and career officials of the highest hierarchical level, individually or collectively, are also responsible for the correct and transparent administration of the entity under their charge, as well as for the reasonable results of their management in terms of effectiveness, economy and efficiency.
Article 22°.- (Job evaluation and remuneration) The entities, through the job evaluation and remuneration function, shall technically determine the scope, importance and convenience of each position, assigning it a fair remuneration linked to the national labor market, the availability of resources and the budgetary policies of the State.
Article 30°.- (Mobility) The mobility of career civil servants to positions of similar valuation shall observe the modalities, requirements and procedures established in the Basic Rules of the Personnel Administration System and specific regulatory provisions.