1. |
What is accreditation? |
|
Accreditation is third party attestation of competence, of conformity assessment. It is about obtaining third party recognition for your organisation’s competence in producing consistent and reliable data for a defined set of activities that is detailed in a schedule of accreditation.
|
2. |
Is accreditation mandatory? |
|
Accreditation is a voluntary program for organisations. However, more and more regulators are relying on accredited conformity assessment bodies and they mandate accreditation prior to seeking regulatory approval.
|
3. |
How does a new organization get accredited for inspection body program? |
|
The first step is to gain an understanding of what standards needs to be implemented. For the purpose of accreditation in inspection, organization should refer to ISO/IEC 17020. The management system should be established as per requirements of ISO/IEC 17020 and all requirements should be addressed in a Quality Manual which is required to be prepared.
The inspection body seeking to apply for accreditation should document and control the procedures and necessary forms and formats. A training course on requirements of ISO/IEC 17020 can also be undertaken,
After completion of documentation and implementation of the system, NABCB application form has to be filled updating the necessary columns. The application form can be downloaded from NABCB website http://nabcb.qci.org.in/applicantlist/appli_acc_inspection_bodies.php . To download the application form, please go to section of Accreditation schemes in the side bullet review Inspection Bodies and download the application form. The other documents under this section i.e Accreditation Criteria (BCB (IV)-110_Mar 2017), Accreditation Procedure (BCB-201(IB)_Sep 2005), NABCB Fees, Self Assessment checklist (BCB_F_010 (4)) and draft agreement for accreditation should also be downloaded and reviewed.
The application form (with annexures) has to be submitted with fees, Quality manual, procedures (as relevant) and self-assessment checklist.
Inspection bodies will also need to define the scope of activities they are seeking accreditation for. A classification of scope sectors can be viewed in the document BCB 201 (IB)_ Sep 2005 – Accreditation procedure.
You may also like to refer to scope of other accredited inspection bodies from website http://nabcb.qci.org.in/accreditation/ reg_bod_inspection_bodies.php
|
4. |
What are the stages of accreditation process? |
|
After submission of the application form following are stages in the accreditation process:
- Acknowledgement in 3 working days
- Initial review of application and informing applicant IB about the shortcomings (if any)
- Application and Document Review by 2 assessors for 3 man days total
- Pre-assessment (voluntary/ if there are too many unresolved issues in Document review.)
- Initial office assessment by assessment team based on scopes applied for
- Witness assessments upon successful completion of initial office assessment.
- Technical review of reports after closure of all findings
- Decision by independent accreditation committee based on recommendations of NABCB secretariat
- Grant of accreditation
- Continued monitoring of accreditation status via surveillance office and witness assessments and re-assessments over a fixed accreditation cycle.
|
5. |
How long does the accreditation process take? |
|
The accreditation process depends on the readiness of inspection bodies and the implementation of management system in accordance with the requirements of ISO/IEC 17020 and accreditation requirements. NABCB will review the objective evidence that the facility is producing. Typically, timelines are a minimum of 6 months for the whole process, or it could take up to a maximum of 1 year depending on your state of readiness. The timelines for different stages are
- Acknowledgement of application: 5 days
- Initial scrutiny of application: 5 days
- Document review: 15 days
The above are timelines for different stages and are dependent on the nature of responses submitted and their correctness. Different stages are planned based on the satisfactory completion of previous stages
|
6. |
What are main steps where accreditation process gets delayed? |
|
Some specific issues that result in delay in the accreditation process
- Document review stage where in inadequate documents are submitted. It is observed self-assessment checklist is not appropriately completed during submission. Cross references are not adequately marked. In addition, all relevant procedures and forms mentioned in self- assessment checklist are not submitted at one go.
- Longer time taken for satisfactory closure of NC. It is essential that for early and satisfactory closure of NC appropriate root cause analysis is conducted and necessary actions initiated.
- Lack of competence in scope sectors as absence of same prohibits the stage of conduct of witness assessment therefore delaying accreditation process
- Scope is not properly defined.
|
7. |
What are main clauses of ISO/IEC 17020 which require special care? |
|
Inspection bodies need to address all the requirements with care showing special emphasis on the requirements of impartiality and independence in Clause 4.1. In addition, competence requirements also need to be adhered and qualification of inspectors need to be ascertained with appropriate review.
Record upkeep and control of documents have to be also ensured
Scope sought for accreditation should be clearly defined.
|
8. |
What is the total cost in the process? |
|
The cost for different stages are as described in BCB 002 (IB) – February 2015 of Fee structure_IB document. Typically the costs are related to :
Application fees
Document review costs for 3 Man days (upto 2 iterations)
Pre-assessment Man day cost if applicable
Initial assessment costs for total mandays (minimum 4 Man days, can be more based on scopes applied for)
Witness assessment costs (Minimum 2 Man days, based on scopes applied for)
Annual operating fees
Cost of travel of assessors and their lodging.
|
9. |
What are the benefits of accreditation? |
|
NABCB has a mutual recognition (MRA) with international bodies i.e International Laboratory Accreditation Cooperation (ILAC) and Asia Pacific Accreditation Cooperation (APAC) which allows the acceptance of inspection reports across MRA signatory nations worldwide. Besides this the other benefits include
- Recognition of Technical Competence
- Customer confidence & satisfaction
- Minimizes risks
- Avoids re-testing/inspection & Reduces costs
- Increased efficiency
- Marketing advantage & Increased business
- International Recognition
|
10. |
Who supports if there is are issues faced during process of preparation? |
|
NABCB staff would extend support to guide on queries faced during preparatory stage of accreditation. Details of staff can be referred under Contact Us section of NABCB website http://www.qcin.org/contact.php. |