For supplier-qualification, quality & sourcing engineers

Quality, Inspection & Validation

Missing image: First-article inspection bench at H-O Products in Winsted, Connecticut, with calibrated gauges, a ballooned customer drawing, and die-cut parts staged for dimensional verification (1140 × 420)

The quality system at H-O Products Corp. as it operates on the shop floor in Winsted, Connecticut: ISO 9001:2015 certified by Amtivo (USA) Inc., an ANAB-accredited registrar, covering the development and manufacturing of standard and custom tapes, pads, and gaskets.

On contract, H-O supports customers in aerospace, defense, automotive, EV, medical, and other regulated industries with First Article Inspection documentation aligned with AS9102, PPAP packages aligned with AIAG, IQ/OQ/PQ supplier records for medical device validation, 100% inspection where required, and full lot, batch, and material traceability.

Built for: design and quality engineers writing supplier-qualification packages, and supplier-development engineers evaluating H-O for converted-part subassemblies under their own program-level certifications.

01
ISO 9001:2015
Certificate of Registration
Issued by Amtivo (USA) Inc., an ANAB-accredited registrar. Certificate #263587, maintained under annual surveillance assessments.
02
2-way traceability
Raw roll to shipped lot
Forward and backward lot traceability; per-piece resolution available on contract with a customer-specified identification scheme.
03
100% on contract
Inspection when the drawing calls for it
Default sampling per ANSI/ASQ Z1.4 at the specified AQL; 100% inspection on critical characteristics, new tools, and contract requirements.
04
1971 family-owned
Winsted, Connecticut
Manufacturing and inspection under one roof and one certified quality management system since 1971.
Made in Winsted, Connecticut // 50+ Years of American Manufacturing // H-O is ISO 9001:2015 Certified
The 30-second version

H-O Products Corp. is an ISO 9001:2015 certified engineered-materials converter in Winsted, Connecticut, certified by Amtivo (USA) Inc. (Certificate #263587) for the development and manufacturing of standard and custom tapes, pads, and gaskets.

The quality system delivers First Article Inspection documentation aligned with AS9102, 100% inspection when a drawing or contract calls for it, calibrated dimensional and optical measurement, PPAP packages aligned with AIAG, IQ/OQ/PQ supplier-side records for medical device validation, and full lot, batch, and raw material traceability in both directions.

Where a customer requires a registration H-O does not currently hold — AS9100D, NADCAP, IATF 16949, or active ITAR — this document names it directly so fit can be evaluated at qualification. Request the quality package →

QMS, FAI & Inspection Models

The quality system, the First Article package, and when a lot moves to 100%.

Three things a supplier-qualification engineer needs to confirm first: that the quality management system is certified and current, that First Article Inspection can be delivered to a recognizable structure, and that the inspection model is defined rather than improvised. Here is each.

Missing image: H-O quality-inspection-validation operation overview, small custom image (640 × 420)
01 · QMS

ISO 9001:2015 Certificate of Registration — Amtivo (USA) Inc.

H-O Products Corp. holds a current Certificate of Registration to ISO 9001:2015, issued by Amtivo (USA) Inc., an ANAB-accredited registrar and IAF MLA member. Certificate #263587, current cycle issued August 14, 2026, valid through September 13, 2029, subject to annual surveillance assessments. Single-site registration covering the Winsted, Connecticut facility (12 Munro Street). Download the current certificate (PDF).

The registered scope, verbatim from the certificate: "The Development and Manufacturing of Standard and Custom Tapes, Pads and Gaskets for Various Industries including Construction, Energy, Fenestration, Window and Door, Appliance Manufacturers, HVAC, Acoustics, and Medical." The QMS (document control, change control, calibration, training, internal audit, management review, nonconformance, corrective action, and supplier control) is the set of defined procedures and retained records that maintain that registration.

02 · FAI

First Article Inspection on contract — aligned with AS9102 form structure.

When a customer specifies First Article Inspection, H-O produces an FAI package using documentation aligned with the AS9102 form structure — part identification (drawing rev, material spec, supplier and lot), product accountability (raw material certs and process flow-down where applicable), and characteristic accountability with the actual measurement, the inspection method, and the gauge calibration ID for each ballooned dimension on the customer drawing.

FAI triggers (new tool, tool revision affecting form/fit/function, drawing or material revision, production lapse beyond a customer-specified interval) are confirmed at qualification rather than assumed; the AS9102 default trigger set is used when the customer has not specified its own. The FAI package is a program-level deliverable, not a per-shipment record.

03 · Inspection model

Sampling per ANSI/ASQ Z1.4 — 100% on contract.

The default in-process and final inspection model is statistical sampling per ANSI/ASQ Z1.4 at the AQL specified by the customer drawing or PO; when no AQL is given, H-O's standard procedure applies. 100% inspection: every piece in the lot inspected against the specified characteristics — is performed when the drawing or PO requires it, when a characteristic is flagged critical or major, when first-piece production from a new tool is being qualified, when a deviation is being investigated, or when the customer's quality agreement specifies it.

By default, inspection records resolve to the lot, not the individual piece. Per-piece records require customer-specified post-process identification (serialized trays, individually-bagged parts, laser-marked features) and are scoped at quote.

When sampling stops being enough

The five conditions that move a lot to 100% inspection.

Sampling per ANSI/ASQ Z1.4 is the right tool for stable production of a known geometry on a qualified tool. It stops being the right tool the moment any of the conditions below is true. Each one shifts the inspection model from a probability statement (an AQL says "the lot probably contains less than X% defective") to a coverage statement ("every piece in this lot was inspected against the specified characteristics"). The trigger is whichever fires first.

  1. Customer drawing or PO calls for it. When a print or contract specifies 100% inspection on a feature or on the part, sampling is not optional. The PO carries.
  2. Critical or major characteristic flagged. Per the customer's classification of characteristics, the flagged feature is inspected on every piece regardless of the AQL on the rest of the part.
  3. First-piece production from a new tool. Until the new die or fixture has been verified to hold tolerance over a representative run, every piece is inspected. After tool qualification, sampling resumes.
  4. Deviation under investigation. When a process change, material lot change, or trend in inspection data triggers an investigation, affected lots are inspected 100% until root cause is closed.
  5. Customer quality agreement specifies it. Standing 100%-inspection requirements written into a long-term supply agreement override the default sampling plan for the contract's duration.
What 100% inspection does and does not establish

100% inspection establishes that every piece in the lot was inspected against the specified characteristics. It does not, by itself, produce a per-piece record tying a specific shipped part to a specific inspection event — that requires post-process individual identification (serialization, individual bagging, laser-marked features), scoped and quoted separately.

Multi-cavity tooling cavities are not numbered on the parts themselves, so cavity-of-origin is not recoverable from a finished piece. Customers whose protocols require per-piece resolution should specify the identification scheme at PPAP or qualification kickoff so the routing is built around it.

Optical & Dimensional Inspection

How parts are actually measured on the floor.

Inspection is only as good as the gauge that produced the number, and only as defensible as the calibration record behind that gauge. H-O's inspection toolset is built around three principles: every measurement carries a calibration ID, every gauge is calibrated through an accredited source on a documented interval, and the method used is recorded on the inspection sheet so it can be reproduced.

Method 01 · Dimensional

Calibrated hand gauges against the drawing.

Calipers, micrometers, pin gauges, and thickness gauges measure the dimensional characteristics on the customer drawing. Each gauge carries a calibration ID; the specific gauge used for a given characteristic is recorded on the inspection record so the measurement can be traced to the instrument that produced it.

Missing image: Calibrated calipers, micrometers, and pin gauges on the inspection bench at H-O Products, with a ballooned customer drawing (640 × 360)
Method 02 · Optical

Vision-based measurement for tight-tolerance profiles.

For tight-tolerance die-cut and laser-cut profiles where contact gauging is impractical, optical and vision-based measurement captures edge geometry and feature position without deforming the part. Applied where the drawing tolerance or the part geometry calls for it.

Vision-based optical measurement of a tight-tolerance die-cut profile at H-O Products
Method 03 · Visual

Visual inspection against defined acceptance criteria.

Surface, edge, and cosmetic characteristics are inspected against criteria defined on the drawing or in the customer's quality agreement — not against an undefined "looks acceptable" judgment. Critical and major visual characteristics follow the same 100%-inspection triggers as dimensional characteristics.

Missing image: Visual inspection of die-cut parts against defined acceptance criteria at H-O Products (640 × 360)
Method 04 · Calibration

Calibration discipline — certified gauges, recorded on the sheet.

Every gauge is calibrated on a documented interval against a source whose own standards are traceable through the U.S. national measurement system (NIST), performed either by an accredited external calibration laboratory or against a standard calibrated by one. The certificate, the standard used, the interval, and the next-due date are held in the QMS calibration log. A measurement without an instrument ID is not a measurement; it is a number.

Missing image: Calibrated gauge with calibration ID label and the QMS calibration log at H-O Products (640 × 360)
What makes a measurement defensible

The instrument-ID linkage.

When a customer audit challenges a recorded measurement months after a lot shipped, the question is not "was the part good" — it is "can you show me the gauge that produced this number, its calibration status on the day of inspection, and the method used." That chain is what the inspection record carries: characteristic, measured value, method, gauge calibration ID. The calibration log resolves the gauge ID to its certificate and interval. The result is an inspection record that can be defended on its own terms, not re-litigated.

Reference · ISO 9001:2015 Clause 7.1.5

ISO 9001:2015 Clause 7.1.5 requires that monitoring and measuring resources be suitable, maintained, and — where measurement traceability is a requirement — calibrated or verified against measurement standards traceable to international or national measurement standards, with the basis of calibration retained as documented information.

— Summary of ISO 9001:2015 Clause 7.1.5.1 / 7.1.5.2 requirements. Refer to the published standard for normative text.

Materials & performance testing

The test bench behind the inspection bench

Beyond dimensional and visual inspection, H-O runs materials and performance testing in-house in Winsted, CT. It is used to verify a material against its data sheet, support a customer qualification, or investigate a deviation, with each method run with reference to the named standard. H-O is not an accredited third-party test laboratory; results are reported for engineering and supplier-qualification use, and the vendor TDS remains the controlling document for published material properties.

Test 01 · Dielectric

Dielectric breakdown and withstand.

Dielectric breakdown and withstand testing of insulating materials and die-cut insulators, with reference to ASTM D149. Used to confirm that a dielectric barrier or insulator construction supports the requirement on the drawing, at qualification and when a lot is in question.

Dielectric breakdown tester at H-O Products in Winsted, Connecticut, with a die-cut insulator sample staged between the electrodes
Test 02 · Tensile & peel

Tensile, elongation & peel on the Instron.

Universal-tester measurement of tensile strength and elongation with reference to ASTM D412 for elastomers, and peel adhesion with reference to ASTM D3330 for pressure-sensitive constructions. Run at qualification, on customer request, and when incoming material behavior does not match the TDS.

Instron universal tester at H-O Products with an elastomer specimen in the grips for a tensile and elongation test
Test 03 · UV chamber

UV-chamber accelerated weathering.

Fluorescent-UV exposure with reference to ASTM G154, for comparative screening of how a material or converted construction holds up under UV. Results rank materials against each other under the defined cycle; they are not a service-life prediction.

UV exposure chamber at H-O Products loaded with material samples for comparative accelerated-weathering screening
Test 04 · Spectrometer

Spectrometer material verification.

Spectrometer-based material identification to confirm that an incoming material matches the specified chemistry. An additional check on the raw-material end of the traceability chain, alongside the supplier certificate of analysis.

Missing image: Spectrometer at H-O Products used to verify that an incoming material lot matches the specified chemistry (640 × 360)
Validation Support & PPAP

The documentation packages H-O supplies into customer qualification efforts.

Two structured submission frameworks come up repeatedly in supplier qualification: IQ/OQ/PQ for medical device manufacturers validating equipment, and PPAP for customers running a defined production part approval. H-O does not own either process — the customer does — but it produces the supplier-side records that drop into them.

IQ / OQ / PQ · Medical device validation

Supplier-side records that drop into the customer's protocol.

For medical device manufacturers performing Installation, Operational, and Performance Qualification on equipment that uses H-O converted components, H-O provides the supplier-side documentation the customer's validation team needs — certificate of conformance, certificate of analysis, raw material lot traceability, dimensional inspection data with calibration references, process control records for the converting operation, and change-control notification on any material or process change that could affect the validated state.

Missing image: Supplier-side validation records at H-O Products: certificate of conformance, certificate of analysis, and lot-traceability documentation staged with die-cut parts (640 × 360)

H-O does not perform IQ/OQ/PQ on customer equipment — that work is owned by the customer's validation team. The boundary matters: H-O supplies records; the customer validates. The records are structured to drop into the customer's protocol rather than sit alongside it.

PPAP · Production Part Approval

PPAP package on contract — aligned with AIAG PPAP 4th Edition.

When a customer requires a Production Part Approval Process submission, H-O produces a PPAP package using documentation aligned with the AIAG PPAP 4th Edition manual. The methodology originates in automotive and EV launches, but PPAP-style submissions are now requested by medical, defense, industrial, and consumer-electronics programs that want a structured, evidence-backed supplier launch qualification. The submission level — 1 (warrant only) through 5 (full submission held at supplier) — and the element list are confirmed at PPAP kickoff.

Elements H-O routinely produces from the QMS
  • Design Records — customer drawing, latest rev, with H-O internal reference
  • Process Flow Diagram & Control Plan for the converting operation
  • Dimensional & Material Results — per the control plan, with upstream CoAs
  • Sample Production Parts, Master Sample & PSW — the signed warrant
Elements scoped at kickoff (customer flow-down / collaborative)
  • DFMEA / PFMEA — flow-down from customer; H-O references rather than authors
  • MSA (gauge R&R) and Cpk / Ppk studies — when the customer's PPAP level requires
Scope boundary

Both frameworks are on-contract documentation deliverables, scoped at kickoff — not standing certifications of the QMS. H-O references AS9102, AIAG PPAP, and the customer's IQ/OQ/PQ protocol structure; it is not certified or accredited to any of them. The certification H-O holds is ISO 9001:2015. On a program whose own QMS carries AS9100, IATF 16949, or ISO 13485, the H-O records sit underneath that program-level certification at the converted-part subassembly level.

Lot, Batch & Material Traceability

From the raw roll to the shipped lot — one identifier chain, both directions.

When a field issue surfaces, the question is rarely "was the part good when it left the supplier" in the abstract — it is "which other parts came from the same material lot, and where are they now." The chain below is what makes that question answerable. Resolution is to the lot by default. Per-piece resolution is available when the customer specifies a part-identification scheme at qualification, and is scoped at quote.

01
Raw material receipt

Incoming silicone, fluorosilicone, foil, foam, or graphite is logged against the supplier's lot number and certificate of analysis. The supplier lot is the upstream anchor of the chain.

02
Converting work order

The work order records which raw material receipt was consumed, the operator, the equipment, and the converting parameters. This is where the supplier lot becomes an H-O production run.

03
Inspection records

In-process and final inspection records produced during the run — characteristics, measured values, methods, gauge calibration IDs — are tied to the work order.

04
H-O lot identifier · shipped

Each shipped lot carries the H-O internal lot number, which resolves through the QMS to all of the records above. Packing list, CoC (when specified), and CoA (when specified) reference the same lot number. The lot is the default resolution unit; per-piece identification requires a customer-specified scheme.

Figure 4.1 — Read: all records resolve from a single H-O lot number. The forward direction (supplier-lot → customers) uses the same chain, indexed from the other end. Per-piece resolution requires a customer-specified identification scheme arranged at qualification.

What the chain is for

Forward and backward, not just one direction.

  1. Backward (failure investigation). Customer reports a field issue and provides the H-O lot number from the carton or shipment paperwork. From that lot number, the QMS resolves to the work order, operator and equipment, inspection records, raw material receipt, and supplier CoA. Resolution is to the lot — not the individual piece — unless a per-piece identification scheme was in place for that program.
  2. Forward (raw material recall). An upstream supplier issues a recall or CoA correction on a specific lot. From that supplier lot number, the QMS resolves to every H-O receipt that consumed it, every work order built from those receipts, every shipped lot, and every customer who received them. Customer notification is initiated within the timeframe specified in the quality agreement.
The cavity question

Multi-cavity tooling produces parts that are dimensionally identical by design but are not individually marked with their cavity of origin. Cavity-of-origin is not recoverable from a finished piece.

Customer protocols requiring per-cavity or per-piece resolution should specify the identification scheme at PPAP or qualification kickoff. Some H-O customers handle this by writing protocol language that explicitly acknowledges cavities are not numbered and treats the lot as the resolution unit; others specify a serialized tray, individual bagging, or post-mold marking. Both are routine — but they are arrangements made in advance, not retrofitted to a shipped lot.

Compliance & Documentation Support

What ships with the order, what is produced on contract, and what H-O does not certify.

The matrix below is the single reference for a supplier-qualification engineer building an approved-vendor file: every document H-O can supply, when it is provided, and what it covers. The not-currently-held rows are stated as plainly as the rest — naming a gap is more useful to an auditor than hiding it.

DocumentWhen providedWhat it covers
Packing listEvery shipmentCustomer PO, line item, part number, quantity shipped, H-O lot number. The lot-level identifier that resolves to all internal records.
Certificate of Conformance (CoC)Default for aerospace, defense, medical · on request elsewhereStatement that the lot meets the agreed specification, signed by H-O quality. References the customer PO, drawing rev, and H-O lot number.
Certificate of Analysis (CoA)When specified on PO or in QAActual inspection measurements with gauge calibration references for the lot. Typically supplied for medical, automotive, EV, and selected aerospace programs.
Upstream material certificationsOn requestPass-through of the silicone, fluorosilicone, foam, foil, or graphite supplier's CoA. Always retained on file regardless of whether shipped with the order.
FAI package (AS9102-aligned)Program-level deliverableForm 1 / 2 / 3 documentation per § 01. Provided at first-piece, tool change, drawing rev, customer-specified production lapse, or as the customer specifies.
PPAP package (AIAG-aligned)Program-level deliverableLevels 1–5 to customer spec per § 03. Resubmission triggered by AIAG-defined conditions or customer request.
IQ/OQ/PQ supplier recordsProgram-level · into customer protocolCoC, CoA, raw material traceability, process control records, change-control notification per § 03. Not a customer validation deliverable on its own.
ISO 9001:2015 Certificate of RegistrationOn request · supplier qualificationIssued by Amtivo (USA) Inc. (ANAB-accredited · IAF MLA). Cert #263587, valid through September 13, 2029, subject to annual surveillance. Single-site registration: 12 Munro Street, Winsted, CT 06098. Registered scope: "The Development and Manufacturing of Standard and Custom Tapes, Pads and Gaskets for Various Industries including Construction, Energy, Fenestration, Window and Door, Appliance Manufacturers, HVAC, Acoustics, and Medical."
Customer quality agreementAt qualification or first POCustomer-specific quality manuals, supplier flow-downs, change-control thresholds, retention periods, and key-characteristic flagging are reviewed and accepted at qualification.
NCR & CAR recordsOn request · on customer auditNonconformance and corrective-action records relevant to the customer's parts, made available during supplier audits or on specific request.
ITAR registrationNot currently heldH-O is not currently registered with the U.S. Department of State DDTC under ITAR. (H-O has held an active ITAR registration in the past but does not at present.) Programs requiring an actively-registered ITAR supplier should confirm registration status at qualification and route accordingly.
AS9100D certificateNot provided · H-O does not hold AS9100DH-O is registered to ISO 9001:2015 and supplies AS9102-aligned FAI. Customers requiring AS9100-certified suppliers in their flow-down should evaluate whether the ISO 9001 + AS9102 FAI arrangement meets the requirement at the converted-part level.
NADCAP accreditationNot provided · H-O does not hold NADCAPNADCAP is special-process-specific accreditation. H-O's converting operations are not within NADCAP scope; programs requiring NADCAP-accredited special processes should source those processes from accredited suppliers.
IATF 16949 registrationNot provided · H-O does not hold IATF 16949IATF 16949 is the automotive-specific QMS standard built on ISO 9001:2015. H-O is registered to ISO 9001:2015 but not IATF 16949. Automotive and EV programs requiring an IATF-certified supplier should evaluate whether an ISO 9001 supplier with PPAP-aligned documentation meets the requirement at the converted-part subassembly level.
Registrations H-O does not currently hold

Stated plainly, so a supplier-qualification engineer can evaluate fit before investing time:

  • AS9100D — aerospace QMS registration. Not held.
  • NADCAP — special-process accreditation. Not held; H-O's converting operations are out of NADCAP scope.
  • IATF 16949 — automotive QMS registration. Not held.
  • Active ITAR registration — H-O has held active ITAR registration in the past but does not at present.

On programs that flow down these requirements, the common arrangement is that the customer's own QMS carries the program-level certification and H-O supplies converted-part subassemblies underneath it, with ISO 9001 plus on-contract documentation aligned with the program's reference standard. Whether that arrangement satisfies a given flow-down is the customer's call to make at qualification.

Building a supplier-qualification file?

Request the quality package

Send the part, the program, and the records you need. A supplier-development contact responds with the certificate, the capability statement, and a quote, with any registration H-O does not hold named up front.

Supplier Qualification FAQ

The eight questions a supplier-qualification engineer actually asks.

Direct answers to the questions that come up when H-O is being evaluated for an approved-vendor list — what is certified, what is on contract, and what is not held.

8 questions

Is H-O Products certified to ISO 9001:2015?

Yes. H-O Products Corp. holds a current Certificate of Registration to ISO 9001:2015, issued by Amtivo (USA) Inc., an ANAB-accredited registrar and IAF MLA member. Certificate #263587, current cycle issued August 14, 2026, valid through September 13, 2029, subject to annual surveillance assessments. Single-site registration covering the Winsted, Connecticut facility (12 Munro Street). Download the current certificate (PDF).

The registered scope, verbatim from the certificate: "The Development and Manufacturing of Standard and Custom Tapes, Pads and Gaskets for Various Industries including Construction, Energy, Fenestration, Window and Door, Appliance Manufacturers, HVAC, Acoustics, and Medical." A copy of the current certificate is provided to customers as part of supplier qualification packages on request.

Is H-O Products ITAR registered?

No. H-O Products is not currently registered with the U.S. Department of State Directorate of Defense Trade Controls under ITAR. (H-O has held an active ITAR registration in the past but does not at present.) For programs that require an actively ITAR-registered supplier, customers should confirm registration status at the time of supplier qualification and route accordingly. ITAR-controlled technical data and articles must be handled within the bounds of the regulation by an actively-registered party.

Is H-O Products AS9100 certified?

No. H-O is registered to ISO 9001:2015 (Certificate #263587, Amtivo / ANAB), not AS9100D. When a customer specifies First Article Inspection, H-O produces an FAI package using documentation aligned with the AS9102 form structure. Customers needing an AS9100-certified supplier in their flow-down should confirm whether ISO 9001 with AS9102-aligned FAI documentation is acceptable at the converted-part subassembly level — which is the common arrangement when the customer's own QMS carries the program-level AS9100 certification.

Can H-O perform First Article Inspection per AS9102?

Yes. When a customer specifies First Article Inspection, H-O produces an FAI package using documentation aligned with the AS9102 Form 1 / Form 2 / Form 3 structure — part identification, product accountability, and characteristic accountability. Each dimensional and material characteristic on the customer drawing is identified, ballooned, and recorded with the actual measurement, the inspection method used, and the calibration ID of the gauge or instrument.

FAI triggers — new tool, tool revision affecting form/fit/function, drawing or material revision, production lapse beyond a customer-specified interval — are confirmed at qualification rather than assumed; the AS9102 default trigger set is used when the customer has not specified its own.

Does H-O do 100% inspection?

On contract, yes. The default inspection model is statistical sampling per ANSI/ASQ Z1.4 with the AQL specified by the customer or by H-O's standard procedure when none is given. 100% inspection — every piece in the lot inspected against the specified characteristics — is performed when the customer drawing or PO requires it, when a critical or major characteristic is so designated, when first-piece production from a new tool is being qualified, or when a deviation from print is being investigated.

By default, inspection records are kept at the lot level; tying a specific shipped piece back to a specific inspection event requires a customer-specified per-piece identification scheme (serialization, individual bagging, or laser-marked features) and is scoped at quote. The cost differential between sampling and 100% inspection is captured at the quote stage.

Can H-O support a PPAP submission?

Yes. H-O supplies PPAP documentation packages aligned with the AIAG PPAP 4th Edition manual at the level required by the customer (Level 1 through Level 5). The methodology applies wherever a customer requires a defined production part approval submission — most commonly automotive and EV programs, but also used by medical, defense, industrial, and consumer-electronics customers who want a structured supplier-side launch qualification.

Elements H-O routinely produces from the QMS include design records, process flow diagram, control plan, dimensional and material results, sample parts, master sample, and the part submission warrant. Elements such as DFMEA/PFMEA, MSA gauge R&R, and Cpk/Ppk capability studies are scoped at kickoff as customer flow-down or collaborative work. The specific deliverable list is confirmed at PPAP kickoff so the package matches the customer's launch-qualification gating.

What documentation does H-O provide for medical device IQ/OQ/PQ?

For medical device manufacturers performing IQ/OQ/PQ on equipment that uses H-O converted components, H-O provides the supplier-side documentation needed to support the customer's validation. This typically includes the certificate of conformance, certificate of analysis, raw material lot traceability records, dimensional inspection data with calibration references, process control records for the converting operation, and change-control notification on any material or process change that could affect the validated state.

H-O does not perform IQ/OQ/PQ on customer equipment — that work is owned by the customer's validation team — but the supplier records H-O provides are structured to drop into the customer's protocol.

What is included in lot and material traceability records?

Each shipped lot is identified by an internal H-O lot number that ties back to: the specific raw material lot or roll consumed (with the material supplier's lot number and certificate of analysis), the converting work order, the operator and equipment used, the inspection records produced during that run, and the customer purchase order and shipment date. Resolution is to the lot — that is the default unit.

Per-piece resolution (a specific shipped piece tied to a specific inspection event) is available when a customer-specified identification scheme is in place: serialized tray, individual bagging, or laser-marked features arranged at qualification or PPAP kickoff. Records are retained per the ISO 9001:2015 documented retention period, and longer when contractually required for aerospace, defense, or medical programs.

Forward and backward traceability — from a customer-reported field issue back to a raw material lot, or from a raw material recall forward to every customer who received affected lots — is supported.

Standards & References

The standards and bodies referenced in this document.

H-O is certified to ISO 9001:2015. The other standards below are methodologies H-O references on contract, or the registrar and bodies behind the certification — not registrations H-O holds.

ISO 9001:2015

ISO 9001:2015, Quality management systems — Requirements. International Organization for Standardization. The standard H-O Products Corp. is certified to; Clauses 7.1.5 (monitoring and measuring resources), 7.5 (documented information), 8.5.2 (identification and traceability), 8.7 (control of nonconforming outputs), and 10.2 (nonconformity and corrective action) are referenced on this page.

SAE AS9102

SAE AS9102, Aerospace First Article Inspection Requirement. SAE International. Defines the First Article Inspection process and the Form 1 / Form 2 / Form 3 documentation structure that H-O references when producing FAI packages on contract.

AIAG PPAP 4th Edition

Production Part Approval Process (PPAP), 4th Edition. Automotive Industry Action Group (AIAG). Defines the PPAP element set and submission levels that H-O references when producing PPAP packages on contract.

ANSI/ASQ Z1.4

ANSI/ASQ Z1.4, Sampling Procedures and Tables for Inspection by Attributes. American Society for Quality. The acceptance-sampling standard H-O's default inspection model is referenced to, at the AQL specified by the customer.

Amtivo (USA) Inc.

Amtivo (USA) Inc., 7502 W. 80th Avenue, Suite 225, Arvada, CO 80003-2128. The ANAB-accredited certification body that issued H-O Products Corp.'s ISO 9001:2015 Certificate of Registration #263587. Certificate validity may be confirmed directly with the registrar.

Request the quality package

Send the part, the program, and the records you need. A supplier-development contact will respond with the certificate, the capability statement, and a quote.

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A supplier-development contact at H-O Products Corp. in Winsted, CT typically responds within one business day.

H-O Products Corp. · 12 Munro Street, Winsted, CT 06098, USA · ISO 9001:2015 certified by Amtivo (USA) Inc. (Cert #263587). Operating since 1971.

Document CAP-QV-01 Rev 1.0 · Quality, Inspection & Validation capabilities. Certification statements are accurate as of the document revision date and are maintained against the registrar's certificate cycle (current cycle valid through September 13, 2029). H-O Products Corp. is an ISO 9001:2015 certified organization; this document describes the quality system and the records produced under it.

Where a customer requires a registration H-O does not currently hold — AS9100D, NADCAP, IATF 16949, or active ITAR registration — it is named explicitly rather than implied. © 2026 H-O Products Corp.

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