# ISO 17025 Externally Provided Products & Services

> Build and validate procedures for managing externally provided products and services per ISO/IEC 17025:2017 Clause 6.6. Covers supplier evaluation criteria, approved supplier lists, subcontracting of tests/calibrations with customer notification, and ongoing monitoring of external providers. Extension tools validate evaluation completeness and subcontracting compliance.



Tags: ISO 17025, External Providers, Subcontracting, Purchasing, Clause 6.6, Suppliers


## Example Prompts

- Create a supplier evaluation procedure for our laboratory's external providers
- Build an approved supplier list with evaluation criteria and records
- Document our subcontracting policy with customer notification requirements

URL: https://rakenne.app/skills/iso17025-externally-provided-services/index.md

Try this skill: https://rakenne.app/a/?skill=iso17025-externally-provided-services



## Overview

No laboratory operates in complete isolation. Every lab depends on external providers for calibration services, proficiency testing, consumable supplies, reference materials, and sometimes for subcontracting tests that fall outside its own scope. ISO/IEC 17025:2017 Clause 6.6 requires laboratories to have procedures for defining requirements, evaluating, selecting, and monitoring these external providers to ensure they do not compromise the quality of laboratory activities.

This skill builds the complete external provider management system. It starts by identifying all the types of external providers the laboratory relies on — calibration laboratories, proficiency testing providers, chemical and consumable suppliers, reference material producers, and any subcontracted testing laboratories. For each type, it defines evaluation criteria appropriate to the criticality of the service: calibration labs and subcontractors need accreditation evidence, while consumable suppliers may be evaluated on quality history and certificate availability.

The subcontracting policy is a particularly sensitive area. When a laboratory subcontracts testing to another lab, Clause 6.6.2 requires customer notification and, where specified, approval before the work is sent out. The laboratory retains full responsibility for the subcontracted work and must identify it in reports. Many environmental testing laboratories subcontract specialized analyses — radiochemistry, dioxins, asbestos — and the policy must cover all of these arrangements clearly.

### What It Covers

- **Supplier categories** — calibration laboratories, PT providers, consumable/chemical suppliers, reference material producers, subcontracted labs
- **Evaluation criteria** — accreditation status, competence evidence, quality history, certificate availability per provider type
- **Initial evaluation** — how new suppliers are qualified before first purchase or engagement
- **Periodic re-evaluation** — annual or periodic review of approved supplier performance
- **Approved supplier list** — register of evaluated and approved providers with status and evaluation records
- **Subcontracting policy** — customer notification, selection criteria, preference for accredited subcontractors
- **Subcontractor monitoring** — ongoing oversight of subcontracted work quality and timeliness
- **Responsibility** — laboratory retains responsibility for subcontracted work
- **Reporting** — subcontracted results identified in test reports

### Output Documents

| Document | Purpose |
|----------|---------|
| Externally Provided Services Procedure | Procedure for evaluation, selection, monitoring, and subcontracting |
| Approved Supplier List | Register of approved suppliers with evaluation status and records |

## Example Conversation

> **You:** We need to document our supplier management and subcontracting procedures for A2LA. We're LabTech Analytical, 12 analysts in Austin, drinking water and soil testing. We buy from maybe 15-20 different vendors and we subcontract radiochemistry and asbestos testing since we don't have the capabilities for those.
>
> **Agent:** Good — let's map out all your external providers by category. Let me start with the critical ones. Who calibrates your instruments, and are they accredited?
>
> **You:** Agilent handles our ICP-MS and GC-MS under service contracts. Thermo Fisher does the IC systems. Our balances are calibrated by a local company, Austin Metrology Services — they claim to be A2LA accredited but I've never actually verified it. And our pipettes have never been calibrated, that's a gap we already know about.
>
> **Agent:** We need to verify Austin Metrology Services' accreditation — A2LA maintains a public directory that we can reference. For Agilent and Thermo Fisher, their field service operations are typically accredited for PM and calibration, but we should confirm the specific scope covers what they're doing on your instruments. For the pipette calibration, you'll need to select a provider and add them to the approved list.
>
> Now, where do you buy your chemicals and consumables?
>
> **You:** Calibration standards from Inorganic Ventures and High Purity Standards — both are ISO 17034 accredited, which I know matters. CRMs from ERA. General lab chemicals from Fisher Scientific and VWR. Gases from Airgas. Consumables like autosampler vials, IC columns, things like that from the instrument vendors.
>
> **Agent:** Good. The ISO 17034 accredited suppliers (Inorganic Ventures, High Purity Standards, ERA) have the highest level of qualification built in. For general chemical and consumable suppliers, the evaluation criteria will be different — focused on certificate of analysis availability, lot traceability, and delivery quality.
>
> Now the subcontracting — tell me about the radiochemistry and asbestos arrangements. Who do you use, and how does the customer know?
>
> **You:** We subcontract radiochemistry to TestAmerica — well, Eurofins now — their Austin facility. For asbestos PLM and TEM we use a lab in Houston, EMSL Analytical. Both are NELAP accredited. When a customer's project includes those analytes, we just send the samples out and include the results in our report. I'm not sure we explicitly tell the customer we're subcontracting.
>
> **Agent:** That's a compliance gap. Clause 6.6.2 requires you to inform the customer when you plan to subcontract work and, when the customer specifies, obtain their approval before proceeding. You also need to clearly identify subcontracted results in your test reports. We'll document a customer notification procedure.
>
> Do you have a preference for using accredited subcontractors?
>
> **You:** Definitely — we'd never send work to an unaccredited lab. Both Eurofins and EMSL have the specific accreditations for what we send them.
>
> **Agent:** Good — we'll document that as policy. Let me compile the full procedure and approved supplier list now.
>
> Running `supplier_evaluation_validator`...
>
> **Supplier Evaluation Validator — PASS**: Approved supplier list referenced, evaluation criteria defined, initial evaluation process documented, periodic re-evaluation process present, critical supplier criteria (accreditation) addressed, evaluation records requirement documented, supplier categories identified.
>
> Running `subcontracting_compliance_checker`...
>
> **Subcontracting Compliance Checker — PASS**: Customer notification process defined, subcontractor selection criteria present, preference for accredited subcontractors stated, subcontractor monitoring process documented, responsibility statement included, subcontracted results reporting requirement defined.
>
> Here's the approved supplier list summary:
>
> | Category | Supplier | Accreditation | Status | Next Review |
> |----------|----------|---------------|--------|-------------|
> | Calibration | Agilent Technologies | ISO 17025 (to be verified) | Approved — pending scope verification | 2027-03-01 |
> | Calibration | Thermo Fisher Scientific | ISO 17025 (to be verified) | Approved — pending scope verification | 2027-03-01 |
> | Calibration | Austin Metrology Services | A2LA (to be verified) | Conditional — accreditation verification needed | Immediate |
> | Reference Material | Inorganic Ventures | ISO 17034 | Approved | 2027-03-01 |
> | Reference Material | High Purity Standards | ISO 17034 | Approved | 2027-03-01 |
> | CRM Provider | ERA (Waters) | ISO 17034 / ISO 17025 | Approved | 2027-03-01 |
> | Chemicals | Fisher Scientific | Quality system certified | Approved | 2027-03-01 |
> | Chemicals | VWR International | Quality system certified | Approved | 2027-03-01 |
> | Gases | Airgas | Certificate of analysis provided | Approved | 2027-03-01 |
> | Subcontractor | Eurofins (Austin) | NELAP / ISO 17025 | Approved | 2027-03-01 |
> | Subcontractor | EMSL Analytical (Houston) | NVLAP / ISO 17025 | Approved | 2027-03-01 |
>
> Three items need immediate attention: verify Austin Metrology Services' A2LA accreditation, confirm the calibration scopes for Agilent and Thermo field service, and implement the customer notification process for subcontracted work.

## Sample Output Excerpt

Below is a representative excerpt from the generated Externally Provided Services Procedure showing the evaluation criteria and subcontracting policy.

---

### Supplier Evaluation Criteria

| Provider Type | Evaluation Criteria | Required Evidence | Re-evaluation Frequency |
|--------------|-------------------|------------------|----------------------|
| **Calibration laboratory** | ISO/IEC 17025 accreditation covering required parameters and ranges; accreditation scope review; quality of certificates | Current accreditation certificate with scope; calibration certificates meeting ISO/IEC 17025 requirements | Annual — verify accreditation status and scope |
| **Reference material producer** | ISO 17034 accreditation; traceability to NMI/SI; certificate of analysis with stated uncertainty | ISO 17034 accreditation certificate; certificates of analysis per lot | Annual — verify accreditation status |
| **PT provider** | ISO/IEC 17043 accreditation; relevant matrix and analyte coverage | Accreditation certificate; program documentation | Annual — review PT program suitability |
| **Chemical/consumable supplier** | Certificate of analysis availability; lot traceability; consistent quality history; technical support | Sample certificate of analysis; supplier quality statement | Annual — review CoA quality and delivery performance |
| **Subcontracted testing laboratory** | ISO/IEC 17025 accreditation for subcontracted methods; NELAP or state equivalence where required; quality history | Current accreditation certificate with scope covering subcontracted methods; sample test reports | Annual — review accreditation, turnaround, and quality of results |

### Initial Evaluation Process

| Step | Action | Responsible | Documentation |
|------|--------|------------|---------------|
| 1 | Identify need for new supplier and define requirements | Requesting analyst or Lab Director | Purchase request form |
| 2 | Obtain supplier quality documentation (accreditation, quality system, CoA samples) | Quality Manager | Supplier evaluation file |
| 3 | For critical suppliers (calibration, subcontractors): verify accreditation status via accreditation body directory | Quality Manager | Screenshot or printout of accreditation body listing |
| 4 | Evaluate against criteria for provider type (see table above) | Quality Manager | Supplier evaluation record (Form F-EPS-001) |
| 5 | Approve or reject; add approved suppliers to Approved Supplier List | Quality Manager, approved by Lab Director | Approved Supplier List update |
| 6 | For subcontractors: establish formal agreement including confidentiality, reporting, and notification requirements | Lab Director | Subcontracting agreement |

### Subcontracting Policy

#### Customer Notification (Clause 6.6.2)

LabTech Analytical will inform the customer in writing when laboratory activities will be performed by a subcontractor:

1. **At proposal/quotation stage**: If subcontracting is anticipated, the quotation identifies the subcontracted analytes and the subcontracting laboratory
2. **When subcontracting becomes necessary after acceptance**: The customer is notified in writing before samples are sent to the subcontractor and given the opportunity to approve or decline
3. **Customer approval**: Where the customer or regulatory authority requires it, written customer approval is obtained before subcontracting proceeds
4. **Emergency subcontracting**: In cases of equipment breakdown or capacity overflow, the customer is notified as soon as practicable, and retrospective approval is documented

#### Responsibility

The laboratory retains full responsibility for all subcontracted work. Subcontracted results are reviewed by a qualified LabTech analyst before inclusion in reports. Any subcontractor nonconformance is handled under LabTech's nonconforming work procedure.

#### Reporting of Subcontracted Results

Subcontracted test results are clearly identified in LabTech test reports with:
- The name and accreditation number of the subcontracting laboratory
- The specific tests performed by the subcontractor
- A statement that the laboratory remains responsible for the subcontracted results

<!-- /excerpt -->

## Extension Tools

### `supplier_evaluation_validator`

Validates the externally provided services procedure for complete supplier evaluation documentation including approved supplier list, evaluation criteria, and supplier categorization.

| Check | What It Validates | Severity if Missing |
|-------|------------------|:-------------------:|
| Approved supplier list | Reference to a maintained list of evaluated suppliers | ERROR |
| Evaluation criteria | Defined criteria for evaluating external providers | ERROR |
| Initial evaluation process | Process for qualifying new suppliers before first use | ERROR |
| Periodic re-evaluation | Annual or periodic review process for approved suppliers | ERROR |
| Critical supplier criteria | Enhanced criteria for calibration labs and subcontractors (accreditation) | ERROR |
| Evaluation records | Requirement to maintain records of supplier evaluations | ERROR |
| Supplier categories | Types of providers identified (calibration, PT, consumables, subcontractors) | ERROR |

### `subcontracting_compliance_checker`

Validates subcontracting procedures for ISO 17025 Clause 6.6.2 compliance including customer notification, responsibility, and reporting requirements.

| Check | What It Validates | Severity if Missing |
|-------|------------------|:-------------------:|
| Customer notification | Process to inform and obtain approval from customers before subcontracting | ERROR |
| Subcontractor selection criteria | How subcontractors are selected and qualified | ERROR |
| Accredited subcontractor preference | Stated preference for ISO 17025 accredited subcontractors | ERROR |
| Subcontractor monitoring | Ongoing oversight of subcontractor performance | ERROR |
| Responsibility statement | Laboratory retains responsibility for subcontracted work | ERROR |
| Subcontracted results reporting | Subcontracted work identified in test reports | ERROR |

## Getting Started

Activate the *ISO 17025 Externally Provided Products & Services* skill. This skill addresses Clause 6.6 and is relevant to every laboratory — even labs that do not subcontract testing still rely on external providers for calibration, chemicals, and proficiency testing.

Have this information ready:

- **Vendor list** — all suppliers you purchase from: calibration labs, chemical suppliers, consumable vendors, gas suppliers, reference material producers
- **Subcontracting arrangements** — any tests you send to other laboratories, who performs them, and current customer communication practices
- **Accreditation certificates** — copies of accreditation certificates for your calibration providers and subcontractors (or at minimum their accreditation body and certificate numbers)
- **Supplier quality documentation** — any existing quality statements, ISO certifications, or certificates of analysis from your suppliers
- **Service contracts** — instrument service contracts that include calibration services
- **Proficiency testing** — PT program provider names and accreditation status

The agent interviews you about each provider category, defines appropriate evaluation criteria, builds the approved supplier list with evaluation status, and documents the subcontracting policy with customer notification procedures. Both tools validate completeness — the supplier evaluation validator checks the procedure and the subcontracting compliance checker verifies all Clause 6.6.2 requirements are met.



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