• 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 recognizsed 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-

1. 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.

2. 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.

3. 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.

4. 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.

5. Which one of the 2 certifications should we opt for- IAF or non-IAF?

In case of cost consideration, getting a non-IAF ISO certification is much feasible as it does not require quality audits at regular intervals. The IAF member bodies are supposed to conduct regular audits, for which they charge huge amount as audit fee. Small businesses with limited resources need not get IAF certifications. Such certification is mandatory mainly in case of the application for government tenders.   

What is ISO ?

ISO is a non-governmental organization that determines specifications for products, services and systems for quality and efficiency. Standards set forth by this organization are valuable to international trade as they have strict requirements that goods must meet. Their ultimate goal is to improve industrial welfare worldwide increasing the levels of safety and security for all.

It takes dedication and research to create a well-rounded standard. Experts in a particular subject area gather together to discuss ways of further improvement. At the end of these discussions, a voting process brings the organization to a consensus. The full process takes about three years on average. For the organization to create standards, the following four situations need to occur:

• • A need in the market

• • A gathering of global experts

• • Development through a multi-stakeholder process

• • All parties reach a consensus

• • How to Gain ISO 13485 Certification

How to Gain ISO 13485 Certification

• The quick answer is contact us, but there are common steps
• Review your operation compared to the Standard’s requirements & then document Implement, train & refining.
• Check internally (Audit) & Management Review; Continue the refining

External Check (NABCB accredited Assessor). When successful the Certification, then on-going yearly Surveillance visit.

How Much does it Cost

The cost of obtaining an ISO certificate in India depends upon various aspects, including in accreditation body from which you want to be ISO certified, nature of the business, size of organisation, level of ISO Compliance, etc. ISO certification cost vary body to body. Ask our adviser for best prevailing rate for get ISO Certificate.

Invest in your future by improving your Business. We have options to suit your situation including

• • Price Right -The Cost Effective Solution – if the Cost of achieving ISO is the critical factor. We personalize & document your Systems to comply with the relevant Standard & check compliance before NABCB accredited Assessment

• • Manage Right – The Time Effective Solution – We save you Time. If you do not have the internal resources for the Documenting, Project Management & Training, we assist.

• • Risk Right If you do not have the internal resources for the Documenting, Project Management, Admin & Training, we can assist as Deputy Quality Management Representative

• • Support Right – Support as & when you want it – whether Onsite assistance & Auditing / Convert documentation /Additional Standards <However no consulting services are provided).