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Conformity assessment bodies

Accreditation is a different problem from certification.

If you run a testing laboratory, a medical laboratory, a calibration facility, an inspection body or a certification body, you are not seeking a management system certificate. You are seeking recognition that your results can be relied upon. That is assessed against different standards, by different bodies, to a different depth.

CKB Enterprise is led by the former National Accreditation Focal Point for Guyana, who spent a decade running conformity assessment at the national standards body and chaired the CARICOM regional standards organisation.

Talk about your scope See the route
Candelle Bostwick, former National Accreditation Focal Point for Guyana and Head of Conformity Assessment at the Guyana National Bureau of Standards
Candelle BostwickFormer National Accreditation Focal Point for Guyana. Former Head of Conformity Assessment and Executive Director, GNBS. Former Chairperson, CROSQ.
Photograph: Department of Public Information, Guyana.

The distinction that costs people money

Certification and accreditation are not the same thing.

Organisations lose months, and sometimes a tender, by pursuing the wrong one. The difference is not pedantry. It determines which standard applies, who assesses you, and what you are allowed to claim afterwards.

For an organisation

Certification

A certification body audits your management system against a standard such as ISO 9001 or ISO 22000, and issues a certificate. It says your processes are managed and controlled.

  • Assessed against a management system standard
  • Issued by a certification body
  • Answers: is this organisation run under control?

See our certification programmes →

For a conformity assessment body

Accreditation

An accreditation body assesses your technical competence to produce valid results, against ISO/IEC 17025, ISO 15189, ISO/IEC 17020 or a sister standard. It says your numbers can be trusted.

  • Assessed against a competence standard, scope by scope
  • Granted by an accreditation body, not a certification body
  • Answers: can the results this body issues be relied upon?
  • Covers method validation, measurement uncertainty, traceability, proficiency testing and personnel competence, not only documentation
Why this matters commercially in Guyana right now. Operators, regulators and tier-one contractors increasingly require test and inspection results from an accredited body. A laboratory holding a quality management certificate but no accreditation may still find its results rejected, because the certificate never spoke to technical competence in the first place.

Standards

Where we work.

Auditor training and implementation support in the conformity assessment standards, delivered by someone who assessed against them for a living.

ISO/IEC 17025

Testing and calibration laboratories

The competence standard for laboratories that test or calibrate. Covers method validation, measurement uncertainty, metrological traceability, proficiency testing, sampling and the impartiality of results.

ISO 15189

Medical laboratories

Quality and competence for medical laboratories, from pre-examination through examination to post-examination processes, including patient safety, turnaround and the clinical reliability of a reported result.

ISO/IEC 17020

Inspection bodies

Competence, impartiality and consistency for bodies performing inspection. The route for non-destructive testing, engineering inspection, lifting equipment and third-party verification work.

ISO/IEC 17021

Certification bodies

Requirements for bodies providing audit and certification of management systems. Relevant to any organisation intending to operate as a certification body, or to understand what its own certifier is held to.

ISO 9001

The system underneath

Most conformity assessment bodies benefit from a coherent management system beneath the competence standard. Where that is the gap, it is treated as part of the same programme rather than a separate sale.

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Another scheme?

Conformity assessment is a family of standards, and a scope can straddle more than one. If yours is not listed, describe it and we will tell you honestly whether it is work we should take.

Describe your scope

The route

How a body actually reaches accreditation.

The sequence below is the one that works. Most bodies that stall have skipped stage two or three and discovered it at assessment.

Define the scope, precisely

Accreditation is granted scope by scope: which tests, which methods, which measurement ranges, which matrices. An over-broad scope is the most common and most expensive early mistake, because every line of it must be defended with evidence.

Gap analysis against the competence standard

Clause by clause, and then technically: are methods validated, is uncertainty estimated and documented, is traceability demonstrable to national or international standards, is equipment calibrated and the calibration itself traceable.

Build the technical evidence

Method validation records, uncertainty budgets, control charts, proficiency testing participation and the analysis of its results, personnel competence records and authorisation. This is the stage documentation-first consultants skip, and it is the stage assessors examine hardest.

Management system and impartiality

The system that holds it together: document and record control, non-conforming work, corrective action, risk and opportunity, complaints, and the impartiality and confidentiality arrangements the standard requires you to evidence rather than assert.

Internal audit and management review

Conducted by people trained to audit against the competence standard, not against ISO 9001 habits. A full internal audit cycle and a real management review must be on the record before assessment.

Pre-assessment

A dry run to the depth an assessor applies, including witnessing of testing where relevant, with findings graded as they would be graded. This is where the readiness decision gets made on evidence.

Application, assessment and closing out

Support through the application to the accreditation body, through the on-site assessment, and through the closure of findings, which is where many bodies lose months for want of a disciplined corrective action process.

Holding it

Accreditation is maintained through surveillance and reassessment. Proficiency testing continues, uncertainty is reviewed, competence is re-demonstrated. Mentorship through the first full cycle is the point at which it becomes yours.

Where accreditation is granted. In Guyana, the Guyana National Bureau of Standards operates as the National Accreditation Focal Point for CROSQ, the CARICOM Regional Organisation for Standards and Quality, and bodies seeking accreditation approach the GNBS focal point or the CROSQ Secretariat for the process. CKB Enterprise does not grant accreditation and is not an accreditation body. We prepare a body to be assessed by one.

Why her

She held the national role this process runs through.

NAFP

National Accreditation Focal Point for Guyana

The national position through which conformity assessment bodies engage the regional accreditation process.

10 yrs

Head of Conformity Assessment, GNBS

A decade running the function, including the national laboratory certification programme and the assessment of quality practitioners.

CROSQ

Chairperson, and Vice Chairperson

Of the CARICOM Regional Organisation for Standards and Quality, the regional body under which Caribbean accreditation is coordinated.

Lead

Lead Assessor for Laboratories

Assessed laboratories against the standard, rather than only advising on it.

15 yrs

Delivering auditor training

Including auditor training for ISO 15189, ISO/IEC 17025 and ISO/IEC 17020, alongside ISO 9001, 14001 and 22000.

100+

ISO certification audits led

In Guyana, across ISO 9001, 14001, 45001 and 29001, for an internationally recognised certification body.

Common questions

What laboratories and inspection bodies ask.

What is the difference between certification and accreditation?

Certification assesses an organisation's management system against a standard such as ISO 9001 and results in a certificate issued by a certification body. Accreditation assesses a conformity assessment body's technical competence to produce valid results, against a standard such as ISO/IEC 17025, ISO 15189 or ISO/IEC 17020, and is granted by an accreditation body. A certificate says the organisation is run under control. Accreditation says the results it issues can be relied upon.

Which standard applies to my laboratory?

ISO/IEC 17025 applies to testing and calibration laboratories. ISO 15189 applies to medical laboratories. ISO/IEC 17020 applies to inspection bodies. Some organisations perform more than one activity and need more than one scope. Establishing which applies, and to precisely which activities, is the first conversation.

Does an ISO 9001 certificate mean my laboratory is accredited?

No. ISO 9001 addresses the management system. It does not address method validation, measurement uncertainty, metrological traceability or proficiency testing, which are the technical requirements an accreditation assessment examines. A laboratory can hold ISO 9001 certification and still have its results rejected by a client requiring accredited testing.

Who grants accreditation in Guyana?

The Guyana National Bureau of Standards operates as the National Accreditation Focal Point for CROSQ, the CARICOM Regional Organisation for Standards and Quality. Conformity assessment bodies seeking accreditation approach the GNBS focal point or the CROSQ Secretariat. CKB Enterprise is not an accreditation body and does not grant accreditation; it prepares bodies to be assessed.

How long does accreditation take?

It depends almost entirely on the state of the technical evidence rather than the documentation. A laboratory already validating methods, estimating uncertainty and participating in proficiency testing is in a very different position from one starting those practices. The gap analysis exists to answer this question with a number you can budget against, rather than a guess.

Can you help a body that has already failed an assessment?

Yes, and it is common work. Findings from a previous assessment are the most useful starting document there is, because they tell you exactly what the assessor could not accept. The task is then root cause and evidence, not redrafting the manual.

Start here

Tell us your scope.

Which tests or inspections, to which methods, for which clients. That is enough to establish which standard applies and what the honest distance to assessment is.

Email your scope WhatsApp +592 684 1061