DOC-1.0-009 (Customer Matrix).xlsx

Top Customer Requirements Matrix

DOC-1.0-009 Rev 1

Effective Date: 10/11/23

Customer Name

Industry

Record Retention

Quality Agreement Signed

Quality Assurance Clauses, Manual, Terms

Purchase Order
T & C's

AS9100

ISO 9001

ISO 13485

21-CFR-820
QMS standards

21-CFR part 11

SFDCL

Change Notification

Criteria for Change

Change Notification Timeline

GCM Notes/Comments

Abbott (Thoratec)

Medical

10 years

by PSP in 2021

N/A

Mar-23

Approval/Validation Required

Material substance change/% composition change,
Change in process and/or sampling methods,
Inspection methods,
Location,
ISO/Regulatory status,
Significant QMS change,
QMS/Management Change that affects component,
Change in suppliers,
Change in process that can affect Environment,
Component availability/obsolescence

10 days or 180 days. Email into VN to request clarification.

Customer requires validation of product in order to manufacture in the new facility. Customer did not state that manufacturing at the new facility without our iso 13485 cert there was unacceptable.

Ad-Tech

Medical

15 years or (end of life of product)

Both in 2013

N/A

Approval/Validation Required

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Aerojet Rocketdyne (L3Harris)

Aerospace

6 years

N/A

QA-01.1

Email Notification of Change

The Supplier is required to have a change management system to manage any changes in material, items, services, and processes. The Supplier and its suppliers and subcontractors are prohibited from making any design, manufacturing, or location changes during or between purchase order changes or incorporating any alterations without written notification and approval from L3Harris’ procurement representative. Design or manufacturing changes are defined as anything that alters or may alter form, fit, function, safety, reliability, maintainability, or weight of the item or processes (processes include but not limited to design, fabrication, assembling, machining, finishes, testing, marking, storage, firmware, software, programming, packaging, or delivery).
2.2.2 Prior to manufacturing or delivering any items incorporating a change as defined above, the Supplier shall provide advance notice to L3Harris in sufficient time to reasonably evaluate the proposed change and, if necessary, to place an end-of-life order for the unchanged items. The Supplier shall provide a notice a minimum of 30 calendar days prior to the change.

Supplier shall notify L3Harris in writing promptly, if there are any changes in the Supplier’s quality management system. These are inclusive of the following:
2.2.4.1 Quality System: Changes in Supplier’s registration and/or quality system status resulting from update, loss, suspension, probation, disapproval, withdrawal of 3rd party registrar’s certification from actions resulting from the Government, Federal or Civil Aviation, Defense, or any other regulatory agencies.
2.2.4.2 Relocation: A change in Supplier’s name, ownership, transfer of manufacturing operation or facility location may subject the supplier’s system and processes to reevaluation by L3Harris. If required by L3Harris, Supplier shall submit a validation and contingency plan inclusive of open orders, open POs, items, material on hand, etc. for all items affecting all L3Harris’s item and facilities. The Supplier shall provide the procurement representative with the change plan in writing at a minimum of 60 days prior to the change occurring.
2.2.4.3 Work Transfer: A work transfer risk mitigation plan must be submitted via SCR by the Supplier for approval by L3Harris a minimum of 60 days prior to the change. Supplier shall not proceed with work transition without written approval from L3Harris. In the event of a relocation and/or work transition, requalification may be required.
Supplier shall notify L3Harris in writing promptly, if there are any changes in the Supplier’s quality management system. These are inclusive of the following:
2.2.4.1 Quality System: Changes in Supplier’s registration and/or quality system status resulting from update, loss, suspension, probation, disapproval, withdrawal of 3rd party registrar’s certification from actions resulting from the Government, Federal or Civil Aviation, Defense, or any other regulatory agencies.
2.2.4.2 Relocation: A change in Supplier’s name, ownership, transfer of manufacturing operation or facility location may subject the supplier’s system and processes to reevaluation by L3Harris. If required by L3Harris, Supplier shall submit a validation and contingency plan inclusive of open orders, open POs, items, material on hand, etc. for all items affecting all L3Harris’s item and facilities. The Supplier shall provide the procurement representative with the change plan in writing at a minimum of 60 days prior to the change occurring.
2.2.4.3 Work Transfer: A work transfer risk mitigation plan must be submitted via SCR by the Supplier for approval by L3Harris a minimum of 60 days prior to the change. Supplier shall not proceed with work transition without written approval from L3Harris. In the event of a relocation and/or work transition, requalification may be required.

Alcon

Medical

15 years

N/A

Version 10

Email Notification of Change

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Allvar

Industrial

Currently Allvar does not have any setup

American Machining Solutions

Industrial

Amphenol

Aerospace

10 years

N/A

Rev 34

Rev 14

Email Notification of Change

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Archer

Aerospace

15 years

N/A

Rev C

Art Robbins

Medical

15 years

N/A

Standard

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Arthrex

Medical

• 5 years for hand instruments and components
• 10 years for sterile instruments
• 20 years for metallic and non-metallic implants
• Sterilization Validations: Permanent

Yes

N/A

On POs - No rev

Email Notification of Change

Product / Process Changes For ARTHREX Design Devices manufactured by SUPPLIER to ARTHREX specifications, if changes from approved manufacturing processes, drawing specifications, written specifications and/or purchase order specifications are desired, changes must be submitted to ARTHREX for written approval. This request should be directed to ARTHREX, Inc. Quality Engineering. Changes should be submitted prior to the completion of product to avoid loss of time and possibly scrapping of product. If the SUPPLIER is at any time unsure as to how to proceed, SUPPLIER shall immediately contact the ARTHREX, Inc. Supply Chain Representative and/or Quality Engineer assigned to the product affected prior to proceeding. When contacting Arthrex regarding a proposed change, the following initial information shall be made available to Arthrex:
1. The specific material or process that will not conform.
2. The specification(s) that will not be met and the reason(s) for the nonconformance.
3. The effective dates or batch/serial numbers to which the Deviation applies.
4. The purchase or production order numbers involved.
For product manufactured by SUPPLIER to ARTHREX specifications, no changes in special processes are permitted unless the process has been re-validated and the revalidation approved by ARTHREX, Inc. The efficacy of cleaning validations and the safe performance of ARTHREX products, together with those distributed by ARTHREX, rely heavily on the assurance that materials of construction and materials which come into contact with product and components do not change since the initial product manufacturing and/or cleaning validations were performed and qualified. For product manufactured by SUPPLIER to ARTHREX specifications, ARTHREX is requiring that the SUPPLIER contact and obtain the written consent of ARTHREX prior to implementing any changes affecting the composition, design, performance, cleanliness, bioburden or safety of the supplied component. Such changes include, but are not limited to, changes in materials of construction, cleaning procedures, and chemicals used in production (for example, cleaning fluids, solvents and cutting oils). ARTHREX also requests notification of changes that may not be immediately obvious but may affect the performance of the device. For example, substantial equipment/method changes, cleaning processes, etc. For Design devices manufactured by SUPPLIER to ARTHREX specifications, FORM- 000122063, “Supplier Proposed Process Change (SPPC) Form” is to be used to notify ARTHREX prior to changes in the production process by emailing the aforementioned form to SPPC@Arthrex.com. The change is not to be implemented without prior written approval of ARTHREX. If any change as defined above involves proprietary processes, it does not relieve the SUPPLIER of the obligation to provide prior notification to ARTHREX regarding a proposed change.
Such changes include, but are not limited to, changes in materials of construction, cleaning procedures, and chemicals used in production (for example, cleaning fluids, solvents and cutting oils). ARTHREX also requests notification of changes that may not be immediately obvious but may affect the performance of the device. For example, substantial equipment/method changes, cleaning processes, etc. For Design devices manufactured by SUPPLIER to ARTHREX specifications, FORM- 000122063, “Supplier Proposed Process Change (SPPC) Form” is to be used to notify ARTHREX prior to changes in the production process by emailing the aforementioned form to SPPC@Arthrex.com. The change is not to be implemented without prior written approval of ARTHREX. If any change as defined above involves proprietary processes, it does not relieve the SUPPLIER of the obligation to provide prior notification to ARTHREX regarding a proposed change.

Atec Spine

Medical

15 years

Yes

N/A

No rev

Change Okay

Avanos Medical (Haylard)

Medical

15 years

N/A

Version 1

Email Notification of Change

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Benchmark Electronics

Medical

15 years

N/A

Rev L

2019-0923

Approval/Validation Required

Customer requires validation of product before sending production parts in. Customer did not state that manufacturing at the new facility without our iso 13485 cert there was unacceptable.

Bio-Rad

Medical

5 years

N/A

9/5/2015

Boston Scientfic

Medical

15 years

N/A

On PO's, No Rev

Approval/Validation Required

Customer email for expansion: We will need to onboard any new manufacturing facility and re-qualify material from that location before being able to receive product from that location for production use.

Website is very limited on info

Calmax Technology

Other

15 years

N/A

Supplier Requirements Manual: QP8-002, Rev 3

last updated 07/23/13

Approval/Validation Required

Changes include but in limited to: (Requires a one (1) year notification)
4.8.1. Supplier sub-tier sourcing change
4.8.2. Facility relocation (moving to new physical address Includes: Different Street, City, Country
4.8.3. Facility expansion (new building, expansion of existing building

Must complete the QF8-006 Supplier Notification Request Form

Cardiva Medical

Medical

15 years

N/A

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Celestica

Other

15 years

Only signed by PSP in 2019

QSPECS listed on website https://www.celestica.com/suppliers

On POs: Form # CLSCORP-STDPOT&C (10-21)

Cepheid

Medical

15 years

N/A

On PO's, No Rev

Approval/Validation Required

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Cera-Met

Aerospace

10 years

N/A

On website, no revision

Approval/Validation Required

ConMed

Medical

15 years

8/15/2018

N/A

Rev A

Approval/Validation Required

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.
Quality agreement says meet 21-CFR-820 or ISO 13485. PSP meets both requirements

Coval

Aerospace

Crane Aerospace

Aerospace

10 years

N/A

NEW

Oct-22

Approval/Validation Required

QMS changes, required certfications

Crane will require a list of PN's requesting to be moved, they want FAI's on all those PN's, list of any new vendors being used, and they want to conduct a quality audit.

Website is very limited on info

Dolphin Data Capture

Medical

15 years

N/A

See Cepheid

Donaldson Company

Aerospace

15 years

7/8/2021

May 2021, Rev 24

On PO's, No Rev but dated 2021

Approval/Validation Required

Duqueine

Aerospace

15 years

N/A

On PO's (but in French)

Can't find a way to translate their T&C to English

ECA Medical Instruments

Medical

15 years

Signed by both in 2019

N/A

On PO's

Email Notification of Change

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Edwards Lifesciences

Medical

15 years

by both in 2020

N/A

On PO's, No Rev

Approval/Validation Required

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit. Requested NOC for Inner Nut and Edwards Knobs and that is in process, PSP completing runs and sending to Edwards per their request during conference call for validation of product in NC.
Customer stated in

Embraer Aero Seating Tech.

Aerospace

5 years

N/A

Rev L

On PO's, No Rev

Email Notification of Change

Want to check on their portal and see if there are updated QMS

Emcore Corporation

Aerospace

10 years

N/A

Last updated 04/27/21, Purchasing T&C on PO, Rev L

Approval/Validation Required

Esterline Mason

Aerospace

10 years

N/A

Rev E 02/01/21

10/07/20 Rev D

Approval/Validation Required

Fabrication Specialty

Aerospace

10 years

N/A

Rev H.02

Rev 01/2023

Email Notification of Change

Flextronics Int. Mechanicals

Semi Conductor

7 years

N/A

Rev D

On PO's Rev P

Email Notification of Change

Flir Systems Inc

Industrial

15 years

N/A

Rev E

Approval/Validation Required

General Dynamics

Aerospace

7 years

N/A

General Dynamics Mission System Quality Codes- 04-17-23

2023

Email Notification of Change

Reference QA019, QA 020, QA021 in Quality Codes manual

Inficon AG

Semi Conductor

15 years

N/A

Rev 08/03

Approval/Validation Required

For non critical parts, you can make the change without approvals.

Arben responded to email sent for notification of new site with "all good". From my understanding this means no validation required but we will want to see what Lam's process is as it would most likely be the same.

Intuitive Surgical

Medical

N/A

Rev 6

Email Notification of Change

Henry Servin (Hsands)

Semi Conductor

N/A

Rev B

On file, no rev

Email Notification of Change

Jabil

Semi Conductor

10 years

Supplier Manual (RO-RG60-00006, Rev P)

Rev 05/2018

Email Notification of Change

Joby Aviation

Aerospace

10 years

N/A

Quality Ts&Cs Rev G

Rev 8/15/22

Email Notification of Change

Defined in Quality Terms

36 hours

Kapstone

Medical

15 years

Signed by PSP 09/18/23

N/A

Email Notification of Change

Examples requiring notification and FAI resubmission/process validation:
o Material change or new material supplier
o Special process change including heat treatment: cleaning, coating, etc.
o New or modified production tooling
o Relocating equipment within a site
o MFG location change
o New sub-supplier or sub-supplier process change

Must use FORM-2033 and submit to Kapstone supply chain management

Karl Storz Imaging, Inc.

Medical

15 years

Signed by both in 2020

M528 Rev I

On PO, No Rev

Email Notification of Change

Email the notifiation of change and document in correspondence folder

KLA

Semi Conductor

15 years

N/A

Email Notification of Change

Lam Research Corporation

Semi Conductor

15 years

N/A

2013 Rev 4

Apr 2024

Approval/Validation Required

For non critical parts, you can make the change without approvals.

9 months

Magnetic Component Eng. Inc.

Aerospace

7 years

N/A

SPOCs Rev 20

Approval/Validation Required

Not defined on T&C

90 days in the event of relocation.

Medical Instrument Dev. Lab (MidLabs)

Medical

15 years

Signed by PSP 12/16/19

N/A

On PO, Rev D

Approval/Validation Required

Midlabs said they would need and audit to evaluation the new location.

Medshape, Inc

Medical

7 years

Signed by both in 2017

N/A

Approval/Validation Required

Medtronic

Medical

15 years

On PO, Quality Clauses version B
Supplier Quality Manual 019-G034 Rev C
Supplier Quality Agreement Doc# D01095330 Rev A

D00006149 Version D

Approval/Validation Required

Quality clauses are listed on T&C but there is also a Quality Manual

Meggitt Sensing Systems

Aerospace

15 years

N/A

Rev AD

Dated 10/07/2020

Approval/Validation Required

Microsoft HoloLens

Semi Conductor

4 years

N/A

Dated 01/2020

Email Notification of Change

MPS Microsystems

Medical

20 years

N/A

No date

Change Okay

OEM Systems Co., Ltd

Medical

15 years

N/A

Approval/Validation Required

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.
No T&C, no qaulity statement, they also don't have a website

Pacific Aerospace & Electronics

Aerospace

10 years

N/A

Rev NC

Rev B

Approval/Validation Required

PAC Initiated Changes: The Supplier shall incorporate, at the specified and agreed upon effectivity points, all changes initiated by PAC and communicated to the Supplier through a formal Contract change and/or amendment. Such changes may be in the form of revised drawings, specifications, tests, inspection or machining methods, etc., and may apply to products as well as to the Supplier's management and administrative systems. The Supplier's business management system shall include appropriate controls and records, including controls at the Supplier's sub-tier sources, which provide objective evidence that changes were incorporated as required by the Contract. Objective evidence may be in the form of date, lot, serial number, revision letter, or other positive identification. Such records are subject to on-site verification by PAC at the Supplier's facilities or the facilities of the Supplier's sub-tier sources.

Supplier Initiated Changes: The Supplier may not make any changes in product design, drawings, performance specifications, materials or processes without specific approval by PAC in writing prior to making such changes in products or data. When applicable, the Supplier shall flow-down this requirement to the Supplier's sub-tier sources. The Supplier shall furnish a copy of the change prior to the initial delivery of products to PAC, so that PAC can verify that the change does not violate the above requirements.

Pacific Scientific

Aerospace

7 years

N/A

842BJ 12/21

Listed on POs

Approval/Validation Required

A change is identified as any changes in company ownership, materials, configuration, process, sub-tier suppliers, inspection testing methods, techniques and/ or facility changes prior to the start of fabrication (notification is defined as a minimum of ninety (90) calendar days prior to change). Such changes or events may negate all previous PacSci EMC supplier qualifications, certifications, approval status, and may require re-qualification or re-submittal of a First Article. Supplier requests are to be submitted on PacSci EMC form #2030, Vendor Information Request (VIR), available on the web at psemc.com.

90 days

Parker Hannafin

Aerospace

15 years

N/A

PH-SQRM Ver. 8/22

Dated 07/23

Email Notification of Change

Suppliers shall not make changes to their processes, location, facilities, equipment, material, product
design ( or any change which may affect productdesign orfunction )withoutwritten approval from the
Parker Buyer for:
• Correction of a discrepancy on a previously submitted part;
• Product modified by an engineering change to design records, specifications, or materials; or
• Any planned changes bythe Suppliertothedesign, process, or manufacturing location, such as:
o Use of other material than was used in previously approved part or product
o Production from new, additional, replacement or modified tools, dies, molds, patterns,
etc.
o Production following upgrade or rearrangement of existing tooling or equipment
o Production from tooling and equipmenttransferred to a different plant site or from an
additional plant
o Change of sub-tier Supplierfor parts, nonequivalent materials, or services ( e.g. heat
treating, plating, etc.)
o Product produced after tooling has been inactive for production for 12 months or more
o Change to test/inspection method-new technique (no effect on acceptance criteria)
o For bulk materials: new source of raw material from new or existing Supplier, or change
in product appearance attributes, etc.
o Use of any non-conventional manufacturing methods such as electro-discharge
machining (EDM), electro-chemical machining (ECM), laserorabrasivewaterjet metal
cutting, flame spray coatings, etc.
Before submitting to Parker a requestfora permanent change to a Supplier-controlled design, the
Supplier shall review the FM EA and Control Plan, as applicable, to ensure that all process-related issues
have been addressed and resolved. Parker may require the Supplierto su bmitan updated FM EA and
Control Plan prior to approval of such permanent changes. Parker may also require other portions, or all,
ofthe related qualification process to be repeated. In some cases, Parker may electto review Supplier
proposed permanent changes at the Supplier's facility.

Pentax

Medical

On file, not signed by anyone

No Rev, on website

Customer informed us they are not required to provide us any information such as ISO certs, Quality Agreements, T&C, etc. for our files

Polymicro/Molex

Industrial

15 years

N/A

Rev D

Email Notification of Change

Molex acquired Polymicro

Porvair Filtration Group

Aerospace

15 years

N/A

On PO, No Rev

Approval/Validation Required

Propel Orthodontics

Medical

15 years

N/A

Change Okay

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Protonex LLC (PNI Corp)

Aerospace

15 years

N/A

Can't find their customer folder in the O: Drive

Quallion

Aerospace

10 years

N/A

Rev E

20-May

Approval/Validation Required

A Material Safety Data Sheet as specified in 29 C.F.R. 1910.1200 must accompany each

Redwire (Deployable Space Systems)

Aerospace

7 years

N/A

QA-049 Rev U

N/A

RH USA, Inc.

Aerospace/
Industrial

10 years

8/25/2021

N/A

Change Okay

shipment or be available online.

Richard Johnson Manufacturing

Industrial

15 years

N/A

We have zero info on this company. No T&C, no qaulity statement, no webiste. Are they still in business? 10/03/22 - web search shows they are premanently closed.

Sanmina Corporation

Medical

3 years

N/A

Rev V

Rev 05.10.18

Approval/Validation Required

Supplier shall notify Sanmina of all proposed changes that impact the form, fit, function, quality, reliability,
process, product, services or status of the Material with regard to environmental legislation such as (by
way of example and not limitation) the EU Directive 2011/65/EC on the restriction of the use of certain
hazardous substances (collectively all environmental legislation to be referred to herein as “ROHS”).
Notification shall be provided via an engineering and/or process change request per J-STD-046.
Changes affecting a significant amount of parts defined as greater than fifteen part numbers shall be
accompanied with an Excel file listing those affected part numbers. All Supplier notifications shall be sent
to Sanmina via email to the following Sanmina address: pcn.eol@sanmina.com. The types of changes,
as an example, requiring notification include, but are not limited to:
 Changes in components (die shrink, etc.)
 Reduced inspection and/or testing
 Manufacture site changes
 Deviations from the MT&Q plan
 Changes in packing, shipping and labeling of Product or containers
 Product discontinuance
 Changes in Supplier or Manufacturer part number or name
 Changes to software or firmware
 Work transfer from the organization to an external provider, or from an external provider to another
external provider

90 Days prior to any changes

Alerted customer of the expansion. No response or no issues noted with manufacturing prior to ISO 13485 extended scope audit.

Semi Mechatronics (Refer to Lam requirements)

Industrial

Senior Aerospace Metal Bellows

Aerospace

7 years

N/A

Rev Y

On PO, Rev C

Approval/Validation Required

They only had ISO 14001 and 18001 cert on their website

Talus (Refer to Lam requirements)

Therm-X

Semi Conductor

7 years

N/A

Rev 1

On PO, No Rev

Approval/Validation Required

I just found that "Machine Shop" was an interesting work code industry in E2.

ThermOmegaTech

Aerospace

10 years

N/A

R6.5 Rev: 004

Email Notification of Change

True Digital Surgery

Medical

Trust Automation

Aerospace

7 years

N/A

No Rev, date is 05/08/22

Email Notification of Change

Vacuum Process Engineering, Inc.

Aerospace

7 years

N/A

Rev M

Rev C

Approval/Validation Required

Viper Northwest

Semi Conductor

7 years

N/A

Rev 7.00

9/3/2019

Email Notification of Change

Worth Products

Industrial

Zoetis

Medical

15 years

N/A

Version 2

N/A

Website has very limited information

Zoll Circulation

Medical

2 years

N/A

On PO, No Rev

Approval/Validation Required

Per quality agreement, PSP must meet the requirements of ISO 13485, ISO 9001 or 21 CFR 820

100