Keybridge prepares ISO/IEC 17025 accreditation in Iraq and Kurdistan.

ISO/IEC 17025 at a glance

Published

November 2017. ISO/IEC 17025:2017 is the current edition. It replaced the 2005 edition and the transition closed in 2021.

Structure

Not Annex SL. 8 clauses. Clauses 4 to 8 carry the requirements: general, structural, resource, process and management system. Clause 8 offers Option A, a system built inside this standard, or Option B for a laboratory already certified to ISO 9001.

Certifiable

No. The laboratory is accredited, the company is not certified. The assessment covers a named list of tests at a named address.

Certificate validity

The assessment body confirms the applicable schedule and continuing requirements for your scope.

Surveillance

The assessment body confirms the applicable schedule and continuing requirements for your scope.

Audit days, 10 to 50 people

The assessment body confirms the applicable schedule and continuing requirements for your scope.

What the scope covers

Only the tests, materials and ranges written into the scope, at the address named on it. Work left out of the scope is not covered.

What the schedule says

The laboratory name, the standard, the list of tests it is accredited for, and the address those tests are done at.

Language of the system

We write the documentation in the language the laboratory works in: Arabic, Kurdish or English. Test methods, uncertainty budgets and reports are usually kept in English because the source standards are in English.

What ISO/IEC 17025 is

ISO/IEC 17025:2017 sets what a laboratory has to do to show that its test and calibration results are valid. It covers impartiality and confidentiality, the competence and authorisation of each analyst, equipment with calibration traceable to the SI, method validation, measurement uncertainty, sampling, quality control and the way results are reported. A laboratory is not certified the way a company is. It is accredited for a named list of tests at a named address, and buyers read that list.

What the standard requires

1. Clauses 1 to 3 cover scope, normative references and terms. Clauses 4 to 8 are the requirements an assessor checks, and this standard does not use the Annex SL structure that ISO 9001 uses.
2. Clause 4, general requirements. Risks to impartiality are identified and controlled on paper, including commercial pressure from an owner who also sells the material being tested, and every client result is treated as confidential.
3. Clause 5, structural requirements. The legal entity, the management structure, the range of activities and the people authorised to sign each type of report are written down and kept current.
4. Clause 6, resource requirements. A competence and authorisation record for each person against each method, equipment with calibration traceable to the SI, and control of externally provided products and services.
5. Clause 6.4, equipment. Calibration certificates from an accredited laboratory, checks between calibrations, and a record for every item covering purchase, service, damage and disposal.
6. Clause 7.2, methods. Standard methods verified in your own hands before first use, non standard and in-house methods validated, and the validation report kept on file.
7. Clause 7.6, measurement uncertainty. An uncertainty budget for every method in the scope, and the uncertainty stated on the report when the client asks or when a decision rule is applied.
8. Clause 7.7, validity of results. Daily internal quality control with control charts, and participation in proficiency testing or an interlaboratory comparison for each major field in the scope.
9. Clause 7.8, reporting. Reports carry the method, the result, the uncertainty where it is required, and the decision rule whenever a statement of conformity such as pass or fail is given.
10. Clause 8, management system. Option A builds documents, records, audits and management review inside this standard. Option B applies when the laboratory already runs an ISO 9001 certified system and adds the technical clauses to it.

Who needs ISO/IEC 17025 in Iraq and Kurdistan

The buyers that ask for ISO/IEC 17025

What shapes your investment

• Number of methods and technical fields in the scope, which is the main driver of assessor days and of how many technical assessors travel.
• Number of addresses, and whether the assessors have to travel to Erbil, Sulaymaniyah, Baghdad or Basra, plus their international travel to reach Iraq.
• How many methods are standard methods needing verification and how many are in-house methods needing full validation.
• Headcount of analysts and signatories, because each one needs a competence and authorisation record per method.
• The proficiency testing schemes available for the field, their fees and how often each round runs.
• Condition of the equipment, and how much recalibration or replacement the equipment review finds.
• Whether the laboratory runs Option A or already holds ISO 9001 and can run Option B.
• Languages the management system and the work instructions are written in.
• Number of findings at the on site assessment and how much evidence is needed to close them.

The proposal names the scope, the deliverables and the dates before work starts.

Standards often taken with ISO/IEC 17025