ACCREDITATION- NABCB
ACM EMB PVT LTD is now accredited by NABCB <National Accreditation board for certification bodies> in Quality Management system (ISO 9001:2015) & Medical Device Quality Management System (ISO 13485:2016)
NABCB is a constitution board of the Quality Council of India (QCI), and is the national accreditation body, which provides accreditation to certification, inspection and validation and verification bodies in accordance with ISO standards, International requirements/guidelines and NABCB Accreditation criteria.
NABCB is internationally recognized and represents the interests of the Indian industry at international forums through membership and active participation with the objective of becoming a signatory to international Multilateral / Mutual Recognition Arrangements (MLA / MRA)
NABCB is a member of International Accreditation Forum (IAF) & International Laboratory Accreditation Cooperation (ILAC) & & Asia Pacific Accreditation Cooperation (APAC) as well as signatory to its MRAs for Quality Management Systems, Environmental Management Systems, Product Certification. Global G.A.P., Food Safety Management Systems, Information Security Management Systems, Energy Management Systems, Inspection. NABCB is also MRA signatory of Asia Pacific Accreditation Cooperation (APAC) for Occupational Health Safety Management Systems.
What is the difference between IAF & Non-IAF ISO certification bodies?
It is beyond any doubt that the ISO certification process gives an authentic recognition to an organization as regards quality management and efficiency. As a matter of fact, every kind of recognition is considered authentic or genuine only if it is accredited by a globally recognized autonomous body. The task of accreditation of the business organizations worldwide is carried out by some highly acclaimed institutions called as accreditation bodies.
Accreditation bodies operate from various countries with the primary objective of ensuring that the ISO certified organizations aptly comply with the conformity assessment guidelines that are set by the International Organization for Standardization (ISO). On the basis of those clearly defined guidelines, different types of ISO certification in India are conferred to the applicant entities by the Accreditation bodies. These bodies strictly adhere to the directives of the ISO and make sure that the same is duly implemented by the certified entities.
Now the question arises-
a. Who does certify these accreditation bodies?
There’s a global federation for all the accreditation bodies worldwide, that regulates these accreditation bodies, which is known as International Accreditation Forum or IAF. The task of IAF is to check any sort of negligence by an accreditation body while implementation of the quality specifications and carrying out the ISO certification process.
b. What is meant by Accreditation?
Accreditation is the process of independent evaluation of entities against specified benchmarks to ensure their excellence and competence. Through the application of global standards, government, suppliers and consumers can gain trust in the validity of the audit, examination reports and ISO certification thus provided.
c. How does IAF ensure a fair process of certification by the Accreditation bodies?
For a quality management system (QMS) to be considered valid, the ISO certificate must be received from an unbiased, acclaimed Accreditation body upon quality assessment. The certificates can also be issued by unreliable bodies, and such certificates will be definitely questionable. IAF ensures uniform and unprejudiced implementation of ISO standard across all the Accreditation bodies that are its members. The IAF member bodies are required to conduct regular audits of the certified entities to ensure that they consistently conform to globally accepted quality standards.
d. Where is it necessary to get ISO certification services from IAF member body?
There are specific spheres where the preference is given only to the IAF approved ISO certificate. One such instance is of application for government tenders. Very importantly, the government and administrations approve civic work projects only to the IAF approved ISO certified companies, as they are deemed to be consistently compliant with global quality standards and fit for such works.
e. Which one of the 2 certifications should we opt for- IAF or Non-IAF?
An IAF (International Accreditation Forum) accredited certificate holds several benefits over a Non-IAF certificate:
Global Recognition: IAF accreditation ensures international recognition and acceptance of the certificate. It signifies compliance with internationally recognized standards and enhances credibility in global markets.
Assurance of Competence: IAF-accredited certificates are issued by certification bodies that have been rigorously assessed for competence and impartiality. This accreditation demonstrates the certification body’s adherence to stringent quality standards and procedures.
Regulatory Compliance: Many regulatory bodies and government agencies worldwide recognize and prefer IAF-accredited certificates. Having such accreditation can facilitate compliance with regulatory requirements in various jurisdictions.
Confidence and Trust: Businesses and consumers alike have greater confidence and trust in products or services certified with an IAF-accredited certificate. It provides assurance that the organization’s quality management systems meet internationally accepted standards.
Reduced Risk: IAF accreditation minimizes the risk of using unreliable or substandard certification services. It ensures that the certification process follows established protocols, reducing the likelihood of errors or inconsistencies.
Access to Markets: Holding an IAF-accredited certificate may facilitate access to new markets and opportunities, as many clients and partners require suppliers to have recognized certifications.
In summary, an IAF-accredited certificate offers greater credibility, acceptance, and trust in the global marketplace compared to non-IAF certificates, enhancing the competitiveness and reputation of the certified organization.
f. What is ISO ?
ISO, the International Organization for Standardization, is a global body that develops and publishes international standards to ensure quality, safety, and efficiency across various industries. ISO standards are created through a collaborative process involving experts from member countries who contribute to the development of consensus-based standards. The process begins with a proposal for a new standard or the revision of an existing one, followed by drafting, committee review, and public consultation. Once approved, ISO standards are published and made available to the public, providing guidance and best practices for organizations worldwide.
g. How Much does it Cost to get a ISO 13485 Certificate?
Several factors are taken into account when calculating the cost of certification by a certification body:
Size and Complexity of Organization: The scale and complexity of the organization’s operations influence the duration and intensity of the audit, which can affect the overall cost.
Scope of Certification: The scope of certification, including the number of sites, products, or services covered, impacts the extent of the audit and therefore the cost.
Man-days Required for Audit: Certification bodies often charge based on the number of auditor days required to complete the audit, which depends on the size and complexity of the organization.
Travel Expenses: If auditors need to travel to the organization’s location, travel expenses such as transportation, accommodation, and meals may be included in the cost.
Additional Services: Certification bodies may be increased if assessment is being planned in clubbing with additional services eg regulatory compliance audit etc.
Certification Body Fees: The certification body’s own fee structure, including administrative fees and overhead costs, contributes to the total cost of certification.
Renewal and Surveillance Audits: Beyond the initial certification, organizations must undergo regular surveillance audits to maintain certification, which incurs additional costs.
Accreditation and Reputation: Certification bodies with higher accreditation status or a strong reputation may charge higher fees for their services.
By considering these factors, certification bodies can provide organizations with accurate quotes tailored to their specific needs and requirements.
