SDAB Strategy on the Development

SDAB Strategy on the Development of the Extent of Authorization of Certify Testing Labs and Examination Organizations

May 2016

This record subtleties general necessities for SDAB-authorize testing labs and examination organizations that longing to add test techniques or fields of assessment to their current extents of certification with SDAB.

References

• SDAB License Measures for Testing Labs.
• ISO/IEC Standard 17020:Latest, Congruity appraisal – Prerequisites for the activity of different sorts of bodies performing assessment.
• SDAB License Measures for Review Offices.
• ISO/IEC Standard 17025:Latest, General prerequisites for the capability of testing and alignment research facilities (ANS/ISO/IEC Standard 17025).

General

The requirement for extending the extent of license of review organizations might result from organizations’ adding new staff, acquiring extra skill through preparing, or getting demands from clients for examinations in another field. The reason for this report is to give common principles on how testing research facilities or potentially review offices ought to treat assist SDAB with speeding up demands for the extension of their license scopes.

An SDAB-certify testing research facility or investigation organization might demand extension of its extent of authorization whenever during the successful term of license. The requirement for extending the extent of license for testing labs might be because of the obtaining of new gear, the expansion of staff, or demands from the research center’s clients for tests that poor person been recently certify.

May 2016

• Present a composed solicitation distinguishing the test(s) to be added to your extension,
• Give a duplicate of the test standard (whenever mentioned by SDAB) and sample(s) of test information sheets created by the research center,
• Give a depiction of the important gear and its adjustment status, and the skill or staff preparing that has been gained relating to the test method(s) to be added,
• Give any material information relating to cooperation in capability testing (where accessible) or approval information as framed in Area 5.4.5 of ISO/IEC Standard 17025.

Appraisals

Testing research facilities looking for extension of their extent of license, in new fields of testing that are inconsequential to testing for which they are now certify, require an on location appraisal by SDAB to confirm ability. Scope developments to add test techniques that are connected with fields of testing for which a lab as of now holds license may not need an on location appraisal by SDAB.

SDAB will exhort testing research facilities from the get-go simultaneously if an on location evaluation is required. The time span to deal with a solicitation for development of your degree is subject to submittal of the data mentioned above, and the planning of an on location evaluation when considered significant to decide ability. Scope developments that do not need nearby evaluations can ordinarily be handled in 25 days or less. All costs and costs connected with scope developments will be the obligation of the lab according to the SDAB standard expense plan for testing lab authorization.

Assessment Bodies

• Present a composed solicitation recognizing the field(s) of investigation, and item or process assessed, to be added to your extent of certification,
• Give a duplicate of the examination strategy or system that will be utilized to lead examinations in the new field,
• Give an example of review reports or agendas for the new field,
• Give any material data (preparing, faculty affirmation, staff aptitude, important information) relating to the new examination field.

Noticed Examinations

The expansion of another field of investigation by and large expects that the assessment body plan an examination that will be seen by an SDAB assessor before that kind of investigation can be added to the extension. In certain occasions, another field of examination can be added to the degree forthcoming the booking of an evaluation to be seen by SDAB.

SDAB perceives the requirement for examination organizations to have the option to exhibit their capacities to possible clients previously they may really have a client in a specific field. SDAB will really bend over backward to work with development of your degree on the off chance that a practical review system has been given and the examination office has given proof of preparing, work force confirmation, staff mastery or other data showing that it has the capability to complete the investigation.

The length of time expected to finish development of your degree is subject to giving the above mentioned data with respect to strategies and staff, and the planning of a noticed assessment. Scope extensions that don’t need nearby evaluations can normally be handled in 25 days or less. All costs and costs connected with scope extensions will be the obligation of the examination organization according to the SDAB standard expense plan for review organization license.

Executive Summary & Purpose
Introduction & Scope
Definitions and Acronyms
Governing Principles and Regulatory Framework
- 4.1 Foundational Standards (ISO/IEC 17025 & 17020)
- 4.2 SDAB Licensing Criteria
- 4.3 Core Principles: Competence, Impartiality, Consistency
Drivers for Scope Expansion
- 5.1 Market and Client Demand
- 5.2 Technological Advancement and Innovation
- 5.3 Organizational Growth and Development
General Process for Scope Expansion Requests
- 6.1 Eligibility and Timing
- 6.2 Formal Request Initiation
- 6.3 SDAB Administrative Review
Detailed Requirements for Testing Laboratories (ISO/IEC 17025 Focus)
- 7.1 Prerequisites for Application
- 7.2 Documentation and Evidence Submission
- 7.3 Competence Demonstration: Personnel, Equipment, Methods
- 7.4 Validation and Verification of New Test Methods
- 7.5 Role of Proficiency Testing (PT) and Interlaboratory Comparisons (ILC)
Detailed Requirements for Inspection Bodies (ISO/IEC 17020 Focus)
- 8.1 Prerequisites for Application
- 8.2 Documentation and Evidence Submission
- 8.3 Competence Demonstration: Personnel, Methodology, Reporting
- 8.4 The Critical Role of Witnessed Inspections
SDAB Assessment and Decision-Making Methodology
- 9.1 The Assessment Triggers: Related vs. Unrelated Fields
- 9.2 Desktop Review Process
- 9.3 On-Site Assessment Protocol
- 9.4 Witnessing Activities for Inspection Bodies
- 9.5 Technical Assessor Selection and Criteria
- 9.6 Decision Gates and Approval Authority
Timelines, Fees, and Resource Considerations
- 10.1 Standard Processing Timelines (25-Day Target)
- 10.2 Factors Impacting Timeline (Complexity, Assessment Needs)
- 10.3 Fee Structure and Financial Responsibility
Obligations of the Certified Body Post-Expansion
- 11.1 Notification of Clients and Market
- 11.2 Integration into the Management System
- 11.3 Surveillance and Recertification Implications
Appeals and Dispute Resolution
Annexes
- Annex A: Application Form for Testing Laboratory Scope Expansion
- Annex B: Application Form for Inspection Body Scope Expansion
- Annex C: Checklist for Required Supporting Documentation
- Annex D: Flowchart of the Scope Expansion Process
- Annex E: Template for Method Validation Summary (ISO/IEC 17025)
- Annex F: Template for Inspection Scheme Description (ISO/IEC 17020)

1. Executive Summary & Purpose

This comprehensive strategy document outlines the formalized process and requirements established by the SDAB (Standards and Development Accreditation Board) for its accredited Testing Laboratories and Inspection Bodies seeking to expand their Scopes of Accreditation. The primary purpose is to ensure that any extension of accreditation is granted based on robust, evidence-based demonstrations of continued competence, in full alignment with international standards ISO/IEC 17025 and ISO/IEC 17020.

The strategy balances the needs of accredited bodies to respond dynamically to market demands and technological change with SDAB’s mandate to uphold the integrity and credibility of the accreditation system. It provides a clear, transparent, and consistent pathway for scope expansion, detailing the responsibilities of both the applicant and SDAB. By streamlining processes for low-risk extensions (e.g., related fields) and mandating rigorous assessment for high-risk ones (e.g., novel, unrelated fields), the strategy aims to maintain rigorous standards while offering operational efficiency, with a target processing time of 25 days for non-assessment cases.

2. Introduction & Scope

Accreditation is not a static achievement but a dynamic commitment to competence. The landscape of testing and inspection is continually evolving due to innovation, new regulations, and shifting global supply chain requirements. Consequently, accredited bodies frequently need to add new test methods, inspection fields, or product categories to their accredited scope.

This document applies to all SDAB-accredited:

Testing and Calibration Laboratories (hereafter “Testing Laboratories”), as per ISO/IEC 17025.
Inspection Bodies (hereafter “Inspection Bodies”), as per ISO/IEC 17020.

It governs all requests to extend an existing, valid accreditation scope. It does not cover initial accreditation applications or the process for reducing a scope. The procedures herein are mandatory and form an integral part of the contractual agreement between SDAB and the accredited body.

3. Definitions and Acronyms

Accreditation Scope: The official, detailed list of specific tests, inspections, calibrations, or types of inspection for which a body has been assessed and accredited by SDAB.
SDAB: Standards and Development Accreditation Board.
ISO/IEC 17025: International standard specifying general requirements for the competence of testing and calibration laboratories.
ISO/IEC 17020: International standard specifying requirements for the competence of inspection bodies and the impartiality and consistency of their inspection activities.
Field of Testing/Inspection: A defined area of technical activity (e.g., mechanical testing of metals, non-destructive testing, inspection of electrical installations).
Test Method: A documented, validated procedure for performing a specific test.
Inspection Scheme/Procedure: A systematic procedure defining how an inspection for a specific product, process, or service is to be conducted.
Witnessed Inspection: An inspection activity performed by the inspection body’s personnel that is observed in real-time by an SDAB assessor.
Proficiency Testing (PT): Evaluation of participant performance against pre-established criteria by means of interlaboratory comparisons.
Method Validation: Confirmation, through objective evidence, that the requirements for a specific intended use are fulfilled for a given test method.
On-Site Assessment: An evaluation conducted by SDAB assessors at the physical premises of the accredited body.
Desktop Review: An evaluation of submitted documentation and evidence conducted by SDAB assessors without an on-site visit.
Related Field: A new area of testing/inspection that is technically analogous, shares fundamental principles, and utilizes similar equipment, personnel skills, and methodologies to an already accredited field. (e.g., adding tensile testing of aluminum alloys when already accredited for tensile testing of steel).
Unrelated Field: A new area of testing/inspection that is technically distinct, requiring significantly different equipment, core knowledge, and methodologies. (e.g., a chemical lab accredited for water analysis seeking to add flammability testing of textiles).

4. Governing Principles and Regulatory Framework

Any scope expansion request is evaluated within a strict framework designed to protect the value of accreditation.

4.1 Foundational Standards (ISO/IEC 17025 & 17020): Compliance with the latest versions of these standards is non-negotiable. The expansion request is an application of the laboratory’s or inspection body’s management system to a new activity. All relevant clauses apply, most critically those concerning competence, impartiality, method validation/verification, equipment, personnel, and reporting.

4.2 SDAB Licensing Criteria: SDAB’s sector-specific documents (“SDAB License Measures for Testing Labs” and “SDAB License Measures for Review Offices”) provide additional mandatory requirements that may exceed or particularize the ISO standards.

4.3 Core Principles:

Competence: The paramount principle. Expansion is only granted upon conclusive, objective evidence of technical competence.
Impartiality: The new activity must not create any conflict of interest or threaten the impartiality of the body’s operations.
Consistency: The new activity must be integrated into the existing management system to ensure it is performed consistently and reliably over time.

5. Drivers for Scope Expansion

Understanding the drivers helps both the applicant and SDAB contextualize the request.

5.1 Market and Client Demand: The most common driver. Clients may require accredited services for new products, components, or to meet new regulatory or contractual obligations in supply chains.
5.2 Technological Advancement and Innovation: New materials, manufacturing processes, or product types (e.g., renewables, EVs, advanced composites) create demand for new testing and inspection methodologies.
5.3 Organizational Growth and Development: Strategic investment in new equipment, hiring of specialists with new expertise, or internal R&D leading to new service offerings.

6. General Process for Scope Expansion Requests

6.1 Eligibility and Timing: A request can be submitted at any time during the valid accreditation cycle. The existing accreditation must be in good standing, with no major non-conformities outstanding.

6.2 Formal Request Initiation: The request must be initiated formally by the organization’s Top Management or authorized signatory, using the official SDAB application forms (Annex A & B).

6.3 SDAB Administrative Review: SDAB conducts an initial administrative check for completeness. An incomplete application will delay the process.

7. Detailed Requirements for Testing Laboratories (ISO/IEC 17025 Focus)

The laboratory must proactively demonstrate competence. The request is a manifestation of clauses 6 (Resources) and 7 (Process requirements) of ISO/IEC 17025.

7.1 Prerequisites for Application: The laboratory must have a fully validated test method, competent personnel, and suitable, calibrated equipment before application.

7.2 Documentation and Evidence Submission: The application must include:

A formal letter/application form.
Test Standard/Method: A clear identification of the standard (e.g., ASTM, ISO, EN). A copy must be available to SDAB upon request.
Sample Test Data/Report: Evidence of the laboratory performing the test, including raw data and a draft/test report format. This demonstrates practical application.
Method Validation Report: Comprehensive documentation per clause 7.2.2 of ISO/IEC 17025. This is the core of the technical submission (see Annex E for template).
Equipment List and Calibration Certificates: For all critical equipment used in the new method, with valid traceable calibration.
Personnel Records: CVs, training records, competency assessments, and authorizations for all staff involved in the new testing activity.
Proficiency Testing/ILC Evidence: Where available and relevant, results from PT schemes or interlaboratory comparisons. This is highly regarded as objective evidence of competence. If PT is not available, the laboratory must detail its alternative approach for ensuring reliability (e.g., spike recovery, comparison with a reference method).

7.3 Competence Demonstration: The submitted evidence is cross-referenced to show that personnel have been trained on the specific method and equipment, and that the equipment is fit-for-purpose and controlled.

7.4 Validation and Verification: The laboratory must define and document the validation parameters (e.g., accuracy, precision, limit of detection, uncertainty of measurement, robustness) and how they were determined. For standard methods, “verification” (demonstrating the lab can achieve the method’s performance criteria) is required.

7.5 Role of Proficiency Testing (PT): Active participation in relevant PT is a powerful demonstration of competence. Historical PT results for related fields may be considered supportive evidence.

8. Detailed Requirements for Inspection Bodies (ISO/IEC 17020 Focus)

The focus is on the systematic application of a defined inspection procedure by competent personnel.

8.1 Prerequisites for Application: The body must have a finalized, documented inspection scheme/procedure and personnel trained and assessed as competent to execute it.

8.2 Documentation and Evidence Submission:

A formal letter/application form.
Inspection Scheme/Procedure: A detailed, standalone document describing the scope, criteria, sampling plan, methods, equipment, and reporting format for the new field (see Annex F).
Sample Inspection Reports/Checklists: Completed or simulated reports showing how findings will be documented and concluded.
Personnel Dossiers: CVs, qualifications, specific training on the new scheme, records of demonstrated competence (which may include internal witness activities), and independence statements.

8.3 Competence Demonstration: Evidence must link the specific requirements of the inspection scheme to the proven skills of the assigned personnel.

8.4 The Critical Role of Witnessed Inspections: Unlike testing, where a validated method can be assessed retrospectively, inspection competence is often best judged in real-time. Therefore, SDAB typically requires a witnessed inspection before granting scope expansion. This allows the assessor to evaluate:

Practical application of the procedure.
Interaction with the client/process (if simulated).
Decision-making and judgment of the inspector.
Proper use of equipment and recording of observations.
SDAB acknowledges the “chicken-and-egg” problem (needing a client to demonstrate competence but needing accreditation to attract a client). Therefore, it will accept a simulated or “dry-run” inspection on a real or representative product/process, conducted specifically for the SDAB assessor.

9. SDAB Assessment and Decision-Making Methodology

9.1 The Assessment Triggers: Related vs. Unrelated Fields: This is the key decision point.

Unrelated Field: An on-site assessment is mandatory. The technical discontinuity requires a full evaluation of the new setup.
Related Field: A desktop review of submitted documentation may be sufficient. SDAB will make an early determination and inform the applicant.

9.2 Desktop Review Process: A lead assessor and technical expert(s) review all submitted documentation against ISO/IEC standards and SDAB criteria. They may request clarifications or additional evidence. Approval can be granted based on documentary evidence alone.

9.3 On-Site Assessment Protocol: For unrelated fields or complex related fields, a focused on-site visit is scheduled. It reviews the submitted evidence in situ, interviews personnel, observes demonstrations, reviews equipment and records, and audits the integration of the new activity into the management system.

9.4 Witnessing Activities for Inspection Bodies: For inspection bodies, the on-site assessment will be scheduled to include a witnessed inspection. The scope cannot be extended without a satisfactory witnessed activity, unless under exceptional “pending” arrangements.

9.5 Technical Assessor Selection: SDAB will assign assessors with specific expertise in the new field of testing or inspection.

9.6 Decision Gates and Approval Authority: The assessment team recommends approval or non-approval to SDAB’s technical approval committee or decision-maker. The applicant is formally notified in writing. Upon approval, an updated Accreditation Certificate and Scope document are issued.

10. Timelines, Fees, and Resource Considerations

10.1 Standard Processing Timelines: SDAB targets a 25-working-day processing time for applications that only require a desktop review, from receipt of a complete application to final decision.

10.2 Factors Impacting Timeline:

Incomplete application submission.
Need for an on-site assessment (scheduling of assessors and the organization).
Complexity of the method/field.
Need for a witnessed inspection (scheduling alignment).
Time taken by the applicant to respond to queries or provide additional evidence.

10.3 Fee Structure and Financial Responsibility: All costs are borne by the applicant according to the published SDAB fee schedule. This includes:

Administrative Fee: For processing the application and desktop review.
Assessment Fee: Daily rate for assessors for on-site/witnessing activities, including travel and expenses.
Scope Extension Certificate Fee. The applicant will receive a cost estimate before any on-site activity is confirmed.

11. Obligations of the Certified Body Post-Expansion

11.1 Notification: The body may publicly announce the scope extension but must not misrepresent the effective date. The updated scope must be used in all advertising and proposals.
11.2 Management System Integration: The new activity is now part of the accredited scope and is subject to all internal audits, management reviews, and surveillance by SDAB.
11.3 Surveillance: The new field will be a specific focus during the next scheduled surveillance or reassessment visit to ensure it is operating sustainably in conformity with requirements.

12. Appeals and Dispute Resolution

If an applicant disagrees with a decision (e.g., denial of scope, requirement for an on-site), they may invoke the formal SDAB Appeals Process, as detailed in a separate SDAB document (SDAB-POL-002: Appeals Procedure).

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