ISO/IEC 17025 accreditation in Japan

ISO 17025 accreditation in Japan at a glance

Calibration laboratories accredited under the Japan Calibration Service System, JCSS, have to satisfy two sets of requirements at once: those of the Measurement Act and its regulations, and those of ISO/IEC 17025. IAJapan, part of the National Institute of Technology and Evaluation, is the JCSS accreditation body, and calibration certificates carrying the JCSS symbol are acceptable abroad through the ILAC and APAC mutual recognition arrangements. Testing laboratories have parallel routes through IAJapan's JNLA and ASNITE programmes, and the Japan Accreditation Board accredits testing, medical and calibration laboratories as well. Whichever body is chosen, accreditation follows an assessment of competence, impartiality, method validation, measurement uncertainty and proficiency testing; it is not a certificate. Sterling's Tokyo office prepares laboratories for that assessment, from the quality manual to uncertainty budgets and traceability records, with Effivity and Sterling Academy included, while the accreditation body makes the decision.

Who needs ISO 17025 in Japan, and what happens without it

In Japan the question rarely comes from a law. It comes from the buyer, the regulator or the partner that wants proof before it signs. These are the organisations that get asked.

• Calibration laboratories seeking JCSS accreditationJCSS accreditation requires the Measurement Act requirements and ISO/IEC 17025.
• Testing laboratories serving industrial and export customersJNLA and JAB accredit testing laboratories against ISO/IEC 17025.
• Laboratories whose reports must be accepted abroadJCSS calibration certificates are acceptable through the ILAC and APAC MRA.

ISO 17025 requirements in Japan

Strip away the vocabulary and ISO/IEC 17025 requires a laboratory to prove six things about its competence and the results it reports.

In Japan these six sit alongside the local laws and regulations listed under drivers below; one system can evidence both. The detail is on the global hub: ISO/IEC 17025 explained →

• ISO 17025 requirements, clause by clause in plain language
• The documents ISO 17025 expects
• ISO 17025 checklist

How to get ISO 17025 accreditation in Japan

One team from the Tokyo office carries the work from scoping to accreditation. Nationwide from the Tokyo office, on-site where the scope requires; remote delivery for distributed teams.

1. Discovery call and scopeEntities, locations, regulators and target date, agreed before any proposal.
2. Gap assessment against ISO/IEC 17025 and the Japanese requirements that apply to youControls you already run for your regulators and customers are reused, not rebuilt.
3. Your system built with your team in EffivityRisks, controls, evidence, incidents and reviews in one live system the auditor can see.
4. Internal audit, management review and corrective actionsYour internal auditors trained by Sterling; the evidence proven before any external review.
5. The accreditation body assessmentThe accreditation body assesses and decides. Sterling supports the assessment.

The Sterling Promise: 100% on-time completion, 100% success, 8,100+ client engagements.Sterling does not certify. Certification decisions stay with independent bodies.

• ISO 17025 gap analysis
• ISO 17025 implementation plan
• ISO 17025 internal audit

How long does ISO 17025 accreditation take in Japan?

There is no standard duration: it depends on your scope and on how much of the system already runs. In Japan these are the factors that set the timeline.

• Number of tests or calibrations in the requested scope
• Measurement uncertainty and traceability to national standards
• Proficiency testing results available before assessment

Sterling agrees a dated plan with you on the discovery call, once the scope is known.

• What drives the ISO 17025 timeline
• Scope and timeline estimator

How much does ISO 17025 accreditation cost in Japan?

The cost has two parts: the consulting work to build and prove the system, and the accreditation body’s fees, which are quoted separately. In Japan these factors move both.

• Size of the accreditation scope
• Accreditation body application and assessment fees, separate from consulting
• Equipment calibration and reference standard needs

Sterling gives one customised, all-inclusive proposal after the discovery call, never before the scope is agreed.

• What makes up the cost of ISO 17025

ISO 17025 consultants and assessors in Japan

Two different organisations are involved. A consultant helps you build the system and prove it works; the accreditation body then audits or assesses it and decides. Keeping the two separate is what makes the result credible to buyers and regulators.

• Check that the body’s accreditation or approval covers ISO 17025 and your sector, and that its certificates can be verified online.
• Ask the consultant how the local requirements in Japan are mapped into the same system, so nothing runs twice.
• Ask for client references in your sector; Sterling’s client letters are available on request.
• Agree who owns the evidence and the tool after the engagement; with Sterling the system stays yours, in Effivity.

ISO 17025 in Japan: questions clients ask

More on ISO 17025 for Japanese organisations

• ISO/IEC 17025: the complete guide
• Watch: How to implement ISO/IEC 17025
• Calibration laboratories: ISO/IEC 17025 for the sector
• Chemical and microbiological testing: ISO/IEC 17025 for the sector
• Construction materials testing: ISO/IEC 17025 for the sector
• Environmental laboratories: ISO/IEC 17025 for the sector
• Food and agriculture: ISO/IEC 17025 for the sector
• Government and forensic laboratories: ISO/IEC 17025 for the sector
• In-house manufacturing laboratories: ISO/IEC 17025 for the sector
• Sterling in Tokyo
• ISO 17025 accreditation in Japan and every other standard Sterling delivers there

Other standards Japanese businesses ask Sterling for

Organisations in Japan often combine ISO/IEC 17025 with one of these, under one management system where the scopes allow.

All 21 standards Sterling delivers in Japan →