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OBLIGATIONS of ema
ema undertakes to provide accreditation services, as well as surveillance, monitoring, evaluation or extraordinary monitoring and re-evaluations in accordance with the standards and procedures established in the Quality Infrastructure Law; the official Mexican norms (NOM), the standards andthe applicable international norms; your application guides; the Guidelines for the integration, organization and coordination of the Evaluation Committees; General Guidelines for the suspension, cancellation or revocation of the accreditation and approval granted to private bodies for the evaluation of conformity approved by the National Standardization Commission; the Evaluation and Accreditation Procedure in force and other manuals and internal procedures of ema.
If ema grants accreditation to a Client, it undertakes to grant the latter the use of the ema accreditation symbol in the terms of the Industrial Property Law and its regulations and the Procedure for the Use of the ema symbol; while the validity of the accreditation lasts as long as it is not suspended or canceled.
ema is obliged to safeguard the confidential information of clients and users and it is ema's responsibility to manage all the information obtained or created during the accreditation process.
RIGHTS of ema
ema will not provide accreditation services to Clients whose accreditation has been canceled during the previous five years, when said acts have been the consequence of the fraudulent commission or in bad faith or in bad faith of any infringement of the legal provisions and Contractual applicable to CABs
In the event that the Client's accreditation is canceled, once it has been subject to the disqualification referred to in the previous point, ema will not provide the accreditation service for the five years immediately following the date on which the accreditation is canceled. for the repeat offense in the fraudulent or bad faith commission of any infringement of the legal and contractual provisions applicable to the Conformity Assessment Bodies.
ema will not provide accreditation services to Clients and / or First-time Applicants, in which associates, shareholders, managers, directors, and / or, in general, any natural person who had previously had their accreditation canceled for having committed properly willful or bad faith an infringement of the applicable legal and contractual provisions.
ema will not provide accreditation services to Clients and / or First-time Applicants who have or designate personnel or experts who have participated in the issuance of opinions, results reports or certificates stating the results of the evaluation of the compliance with false information, and that said circumstance had motivated the cancellation or revocation of the accreditation or approval of the private body.
ema will not provide accreditation services to Clients and / or First-time Applicants when it is determined that, if granted, there could be a direct benefit for the person sanctioned with the cancellation or revocation who has acted with intent or bad faith, or who be a repeat offender. In the event that such circumstance is determined after the accreditation or approval of the applicant, the suspension of the same will proceed until it is determined what is conducive. This and the previous two limitations indicated in the two previous points will be applicable for a period of five years, as of the date when the cancellation or revocation of the accreditation or approval in question takes effect.
ema will not provide accreditation services to Clients whose accreditation has been canceled during the two immediate previous years, when the cancellation of the accreditation (s) has been the consequence of a failure to act with fraud, of any infringement of the legal and contractual provisions applicable to the CABs.
ema reserves the right to interrupt the evaluation and accreditation process in any of its stages or to suspend, cancel (withdraw) accreditation, in cases where it has evidence that:
- The client has incurred in illegal acts or conduct, in violation of the law and regulations referred to in this contract; the applicable laws, regulations and standards established by the Federal Government; acts of corruption; Willful acts against ema, the ethical and moral principles inherent to its legal status and other acts that in the opinion of ema put at risk or even put at risk the credibility and image of the entity and the accreditations it grants.
- Either the information provided by the Conformity Assessment Body for the evaluation and accreditation process is false or if the Conformity Assessment Body hides information.
- Either when there is evidence of fraudulent behavior, when the CAB intentionally provides false information or conceals information, ema will reject the application or terminate the process at the stage where it is.
Such interruption to the evaluation and accreditation process will last until the grievances are clarified, in the case of being confirmed, ema will terminate the evaluation and accreditation process, and in the case of an accredited person, the accreditation may be canceled.
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The Asia Pacific Accreditation Cooperation (APAC) was established on 1 January 2019 by the amalgamation of two former regional accreditation cooperations – the Asia Pacific Laboratory Accreditation Cooperation (APLAC) and the Pacific Accreditation Cooperation (PAC).
Role of APAC
APAC ‘s primary role is to manage and expand a mutual recognition arrangement (MRA) among accreditation bodies in the Asia Pacific region. The MRA facilitates the acceptance of conformity assessment results (e.g. test reports, test certificates, inspection reports, and certification) across the region and with other regions around the world. Conformity assessment results that are produced by conformity assessment bodies (CABs) that have been accredited by one APAC MRA signatory are accepted by all the other APAC MRA signatories. This mutual recognition and acceptance of conformity assessment results reduces the need to undertake duplicate testing, inspection or certification, thus saving time and money, increasing economic efficiency and facilitating international trade.
APAC’s members include accreditation bodies, accreditation focal points and other organisations that have an interest in accredited conformity assessment results.
APAC is recognized by the Asia Pacific Economic Cooperation (APEC) as one of four APEC Specialist Regional Bodies (SRBs) that support the work of the APEC Sub-Committee on Standards and Conformance.
ema received the endorsement from the Asia Pacific Accreditation Cooperation (APAC) for compliance with the requirements of the NMXEC-17011-IMNC-2018 standard (ISO / IEC 17011: 2017) that is mandatory for every accreditation bodies in the world. The result was rated with zero nonconformities, that is, with an excellence rating.
ema, is the only Acreditation Body in Mexico competent for the development of its activities in the accreditation and surveillance of conformity assessment bodies in our country, operating and controlling its competitiveness at the international level according to senior managers requirement in terms of accreditation such as the new version of standard 17011.
www.apac-accreditation.org
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Accreditation is the act of granting security and that guarantee that laboratories (calibration, testing, medical and forensic), verification units (inspection bodies) and certification bodies execute the corresponding regulations and standards with precision, so they can test, verify or certify the products and services consumed by our society.
Accreditation Bodies, as ema is, are organizations that guarantee that Conformity Assessment Bodies are trustworthy and have technical competence.
ema entidad mexicana de acreditación, a.c., is the first non-government Accreditation Body in México, whose objective is to accredit the Conformity Assessment Bodies, which are test laboratories, calibration laboratories, clinical laboratories, verification units (inspection bodies) and inspection bodies. certification, Proficiency Testing Providers and Greenhouse Gas Emission Verification / Validation Bodies ( OVV GHG ) Producers of Reference Materials and the authorization of Good Laboratory Practices from the OECD.
Proudly, ema has received the highest international recognition, by the International Accreditation Forum (IAF) and International Laboratory Accreditation Cooperation (ILAC) and regional recognition by the Asia Pacific Accreditation Cooperation (APAC) and the Inter- American Accreditation Cooperation (IAAC), the above confirms that ema works in accordance with national and international standards. In the same way, ema has been awarded the Ethics and Values Award in 2005, 2012, 2015, 2017 and 2019 granted by Confederación de Cámaras de Industriales de los Estados Unidos Mexicanos (CONCAMIN), wich reinforces its quality as a team and commitment as an institution, ema has also obtained the Golden Elite Awards for Quality in 2015, a Socially Responsible Company in 2014 and a Family Responsible Company by promoting good labor practices in 2017 and for the period 2019 - 2022; Great Place To Work since 2014, 2016, 2018, 2019 and 2020 for being one of the best places to work in Mexico in terms of Diversity and Inclusion.
ACCREDITATIONAct by which an accreditation body recognizes the technical competence and reliability of testing, calibration, and medical laboratories; as well as verification units (inspection bodies); and certification bodies for the Conformity Assessment
FINANCING SOURCES OF ema
- Initial accreditation services.
- Accreditation renewal services.
- Surveillance services.
- Accreditation services.
- Accreditation monitoring.
- Testimonials from Conformity Assessment Agents.
- Fees and travel expenses.
- Courses.
- Associate fees.
- Investment income.
- Projects.
- Rate increase.
- Other income.
FIRST PRIVATE MANAGEMENT ACCREDITATION BODY IN MEXICO
Formerly, Conformity Assessment Bodies were accredited by the Mexican federal government, more specifically through the Dirección General de Normas (DGN) (General Directorate of Standards) of the Secretaría de Comercio y Fomento Industrial (SECOFI) (Ministry of Commerce and Industrial Development), now known as the Ministry of Economy.
Given the changes in the foreign markets, the competitiveness required in a globalised commerce, and aiming to support the national productive plant, the Federal Law on Metrology and Normalization was reformed between 1992 and 1997. Because of this legal transformation, an impartial, inclusive, professional and privately managed body was created in order to perform this important task for Mexico’s productive sector. Thus, after the publication on the 15th of January 1999, in the Official Journal of the Federation of the Ministry of Commerce and Industrial Development’s authorization, ema begins to operate as the first accreditation body in Mexico.
IMPARTIALITY
ema’s organizational structure has been established in such a manner that in both, government and collegiate bodies, an impartial structure is kept to provide objectivity, transparency and reliability for accreditations and authorizations. Within this structure, participation of all sectors interested in the development of policies and principles related to contents and functions of the national accreditation system are considered, where no particular interests prevail. This is properly documented.
All members of ema take the task of ensuring that the policies and procedures under which the body operates are administered in a non-discriminative manner. The services the ema offers are accessible to all applicants whose activities are within the field of consideration. There are no conditions, financial or other, that restrict participation. Access to the services provided by ema is not conditioned by the size of the applicant, nor by membership of any organization or group, nor by the number of already accredited Conformity Assessment Bodies.
ema ensures that its General Assembly, Board of Directors, personnel, assessment committees and subcommittees, technical opinion commissions, appeal commissions, and the technical/testifier evaluators/experts, act always in an objective manner and that they are not collaborating under any undue pressure, be it financial, commercial or conflict of interests that could make them act in a non impartial or discriminatory manner.
ema ensures that a competent Assessment Committee reaches every decision to determine each accreditation, and that every determination is made by different personnel from that who performed the assessment.
ema limits its requirements, evaluations, and decisions to matters related to accreditation, and doesn’t offer the conformity evaluation services that Conformity Assessment Bodies provide, nor counseling that might compromise the objectivity and impartiality in the processes of evaluation, and in the decision over accreditation and acknowledgement.
ema also requires that the accredited CAB’s and the recognized PTB’s, maintain impartiality and integrity in their activities within the field of accreditation and recognition.
ema ensures that the activities performed by its related bodies do not compromise confidentiality, objectivity or impartiality of accreditations. The bodyhas properly analyzed and documented its relationship to these organizations.
arriba
The Organization for Economic Co-operation and Development (OECD) is an organization of international cooperation, which aims to coordinate their economic and social policies to exchange information and harmonize them with the aim of maximizing their economic growth and contribute to its development and the non-members too.
As part of the exchange of information and compliance with its objective, in 1978 the principles of good laboratory practices were developed and updated in 1997, aims to promote quality and validity of test data used to establish the safety of chemicals. GLP is a quality assurance system on the mode of organization of non-medical safety studies related to health and the environment. It means, how are planned, executed, monitored, recorded, archived and disseminated and are basis of mutual acceptance of data (MAD) between the various member countries.
The scope of GLP are studies of non-medical safety pharmaceuticals, pesticides, cosmetics, veterinary drugs, additives for human and animal consumption, industrial chemicals developed in laboratory, greenhouse or field.
- Physical and Chemical Testing
- Toxicity studies
- Mutagenicity studies
- Environmental toxicity studies in terrestrial and aquatic organisms
- Studies on behavior in water, soil and air; bioaccumulation
- Residue studies
- Studies on the effects of natural ecosystems mesocosmosy
- Analytical and medical chemistry tests
- Other specified studies
By official document DGN.312.01.2013.4068 issued December 3, 2013, the Ministry of Economy through the General Directorate of Standards issues permission to Mexican accreditation entity, acas an independent agency delegated to evaluate and certify compliance with the principles of Good Laboratory Practice non medical tests in the country.
The inspection is carried out based on the documents provided by the OCDE.
Some of the potential benefits of applying GLP.
- Avoid unnecessary conflicts or duplications for the risk assessment of products that are marketed in more than one country, generating savings of resources for industry, government and consumers as a whole.
- Participation in the global market as an evaluation services provider (MAD).
- Avoid duplication of procedures with countries that have implemented mutual acceptance of data according to GLP.
- Decrease in the number of animals and insects involved in studies, promoting animal welfare.
- It promotes the participation of Mexican industries in the global economy.
The adoption of procedures for assessing the conformity, harmonization and standardization of data and information developed as GLP; will boost the development of Mexican industries.
Based on the potential benefits of implementing the program, the Ministry of Economy through the General Directorate of Standards issues the authorization to the Mexican accreditation entity as an independent body delegated to evaluate and certify compliance with the principles of Good Laboratory Practices of non-clinical trials in national territory, being then responsible for issuing certificates of compliance as well as working together and notifying regulatory authorities of the result of Inspections or audited studies.
