What is the primary objective of **ISO 17025**?

**ISO/IEC 17025:2017 specifies general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories.** It ensures technical validity of results through metrological traceability, measurement uncertainty evaluation, method validation/verification, and risk-based controls across clauses 4–8, enabling global acceptance via ILAC mutual recognition.

Who is legally or professionally required to comply with **ISO 17025**?

**ISO 17025 applies to all organizations performing testing, calibration, or sampling activities seeking accreditation.** Suppliers, regulators, and customers in regulated sectors (e.g., manufacturing, environmental, forensic) refuse non-accredited results; accreditation bodies like ANAB, A2LA assess competence within defined scopes for market access.

Does **ISO 17025** require an external audit or third-party certification?

**ISO 17025 requires accreditation by an ILAC-signatory body via external assessments, not certification.** Assessments include document review, on-site evaluation, witnessed testing/calibration, and proficiency testing verification, attesting to technical competence per clauses 6–7 beyond management systems.

How often should an assessment for **ISO 17025** be performed?

**ISO 17025 accreditation involves initial assessment followed by annual surveillance and full reassessment every 2 years.** Internal audits occur at planned intervals (Clause 8.8), with management reviews at least annually (Clause 8.9), plus ongoing proficiency testing and risk-based monitoring.

What are the consequences of non-compliance with **ISO 17025**?

**Non-compliance risks accreditation suspension, loss of scope, or withdrawal by bodies like UKAS/ANAB.** This leads to rejected results, market exclusion, contractual penalties, regulatory fines, and reputational damage from invalid conformity statements or untraceable measurements.

Can **ISO 17025** be mapped to other international frameworks?

**Yes, ISO 17025 management system requirements (Clause 8, Option B) align directly with ISO 9001.** Commonalities include risk-based thinking, internal audits, and corrective actions, enabling integrated QMS while retaining unique technical clauses (6–7) for competence and processes.

What is the first step to begin implementing **ISO 17025**?

**Conduct a clause-by-clause gap analysis against current practices per clauses 4–8.** Prioritize impartiality risks (4.1), competence matrices (6.2), and uncertainty budgets (7.6), followed by executive sponsorship and risk register development.

What is the primary objective of **MLPS 2.0 (Multi-Level Protection Scheme)**?

**The primary objective of MLPS 2.0 is to establish a graded cybersecurity protection system ensuring security controls match the potential impact of system compromise on national security, social order, and public interests.** It classifies information systems into five levels (1-5) based on harm severity to individuals, organizations, or the state, mandating commensurate technical, management, physical, and personnel controls per GB/T 22239-2020 and related standards.

Who is legally or professionally required to comply with **MLPS 2.0 (Multi-Level Protection Scheme)**?

**All network operators in mainland China must comply with MLPS 2.0 under Article 21 of the 2017 Cybersecurity Law.** This includes domestic enterprises, foreign-invested entities, cloud providers, and operators of IT, IoT, big data, or industrial systems; critical sectors like finance and energy often classify at Level 3+.

Does **MLPS 2.0 (Multi-Level Protection Scheme)** require an external audit or third-party certification?

**Yes, MLPS 2.0 requires external security reviews by licensed Chinese firms for Level 2+ systems, with PSB approval.** Reviews score compliance (minimum 75/100) across technical and management domains; Level 3+ mandates annual evaluations per GB/T 28448-2019.

How often should an assessment for **MLPS 2.0 (Multi-Level Protection Scheme)** be performed?

**Assessments under MLPS 2.0 must occur biennially for Level 2, annually for Level 3, semi-annually for Level 4, and as mandated for Level 5.** Re-evaluations are also required post-major changes; self-inspections apply continuously.

What are the consequences of non-compliance with **MLPS 2.0 (Multi-Level Protection Scheme)**?

**Non-compliance with MLPS 2.0 risks fines up to 100,000 yuan, operational suspensions, system shutdowns, and intensified PSB inspections.** Enforcement links to business license renewals; severe cases involve blacklisting or criminal liability.

Can **MLPS 2.0 (Multi-Level Protection Scheme)** be mapped to other international frameworks?

**Yes, MLPS 2.0 control domains align with ISO 27001 Annex A and NIST CSF categories.** Organizational, physical, and technical controls map directly, enabling gap analysis via Statements of Applicability, though MLPS adds prescriptive grading and PSB oversight.

What is the first step to begin implementing **MLPS 2.0 (Multi-Level Protection Scheme)**?

**The first step is conducting a provisional self-assessment to classify systems into Levels 1-5 based on impact criteria.** Inventory assets, evaluate harm to national security/social order per GB/T 22240-2020, then file with local PSB within 30 days for Level 2+.

ISO 17025 vs MLPS 2.0 (Multi-Level Protection Scheme)

Standards Comparison

ISO 17025

Voluntary

2017

International standard for competence of testing and calibration laboratories

MLPS 2.0 (Multi-Level Protection Scheme)

Mandatory

N/A

China's mandatory multi-level cybersecurity protection scheme.

Quick Verdict

ISO 17025 accredits lab competence globally for trusted testing results, while MLPS 2.0 mandates graded cybersecurity for China's networks. Labs seek market access; China operators ensure regulatory compliance and avoid fines.

Laboratory Quality

ISO 17025

ISO/IEC 17025:2017 General requirements for competence of testing and calibration laboratories

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Mandates impartiality through ongoing risk identification and mitigation
Requires metrological traceability to SI units and uncertainty evaluation
Ensures personnel competence via full lifecycle management records
Integrates risk-based thinking across processes and management
Enables ILAC-recognized accreditation for global result acceptance

Standard

MLPS 2.0 (Multi-Level Protection Scheme)

Multi-Level Protection Scheme 2.0

Cost

€€€€

Complexity

Medium

Implementation Time

12-18 months

Key Features

Five-level impact-based system classification
Mandatory audits and PSB approval for Level 2+
Extended controls for cloud, IoT, big data, ICS
Governance, personnel, third-party risk management
Ongoing re-evaluations and incident reporting

Detailed Analysis

A comprehensive look at the specific requirements, scope, and impact of each standard.

ISO 17025 Details

What It Is

ISO/IEC 17025:2017 is the international standard specifying general requirements for the competence, impartiality, and consistent operation of testing and calibration laboratories. It employs a risk-based, performance-oriented approach, linking management system controls directly to technical validity of results, including metrological traceability and measurement uncertainty.

Key Components

Eight core elements: general (impartiality/confidentiality), structural, resource, process, and management system requirements.
Focus areas: personnel competence lifecycle, validated methods, equipment calibration, sampling, reporting with decision rules.
Built on risk-based thinking; Option A (standalone) or B (ISO 9001-aligned) for management systems.
Leads to accreditation by ILAC-signatory bodies attesting scope-specific competence.

Why Organizations Use It

Enables global acceptance of results via ILAC mutual recognition.
Meets regulatory/supply chain demands; mitigates risks of invalid data.
Drives efficiency, trust, and market access; reduces rework and disputes.

Implementation Overview

Phased: gap analysis, documentation, training, validation, internal audits, accreditation assessment.
Applies to all lab sizes/industries globally; requires technical evidence and ongoing surveillance.

MLPS 2.0 (Multi-Level Protection Scheme) Details

What It Is

MLPS 2.0 (Multi-Level Protection Scheme 2.0) is China's legally mandated cybersecurity framework under the 2016 Cybersecurity Law. It requires network operators to classify systems into five protection levels based on potential harm to national security, social order, and public interests, implementing graded technical, organizational, and governance controls.

Key Components

Core domains: physical security, network protection, data security, access control, monitoring, governance.
Standards like GB/T 22239-2019, GB/T 25070-2019 define baselines and extensions for cloud, IoT, ICS.
Built on impact-based classification; Levels 2+ require third-party audits scoring ≥75/100.

Why Organizations Use It

Mandatory for all China-based networks to avoid fines, suspensions, inspections.
Enhances resilience, aligns with data laws, builds regulator trust.
Enables market access, reduces breach risks for critical operations.

Implementation Overview

Phased: classify systems, gap analysis, remediate, external audit, PSB filing.
Applies to all sizes in China; Level 3+ needs annual re-evals.
Costs tens of thousands USD yearly for audits, tools.

Key Differences

Aspect	ISO 17025	MLPS 2.0 (Multi-Level Protection Scheme)
Scope	Laboratory competence, testing/calibration validity	Graded network cybersecurity protection levels
Industry	Testing/calibration labs globally	All network operators in China
Nature	Voluntary accreditation standard	Mandatory cybersecurity regulation
Testing	Proficiency testing, witnessed assessments	Third-party audits, PSB inspections
Penalties	Loss of accreditation, market exclusion	Fines, operational suspension, inspections