ML23222A086

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QSA Global, Inc., 24 Month Report for QA Program Approval Number 0040
ML23222A086
Person / Time
Site: 07100040
Issue date: 08/03/2023
From: Hieber J
QSA Global
To:
Document Control Desk, Office of Nuclear Material Safety and Safeguards
References
Download: ML23222A086 (1)
v • d • e


Text

QSA GLOBAL ATTN: Document Control Desk 3 August 2023 Director, Division of Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852 Regarding: 24 Month Report for QA Program Approval Number 0040

Dear Sir or Madam,

Pursuant to the reporting requirements of 10 CFR 71.106(b), QSA Global, Inc. advises that our QA Program, as described under Quality System Manual QSM-1 Revision 11 on file with your office, has been changed as allowed under 10 CFR 71.106(b) in the following manner:

  • Revision 12 changes have previously been reported in QSA Global, Inc. letter dated 16 June 2017.
  • Revisions 13 and 14 changes have previously been reported in QSA Global, Inc. letter dated 28 August 2019.
  • Revision 15 changes as follows:

o Updated formatting throughout the manual to incorporate new branding.

o Corrected grammatical errors throughout the manual.

o Updated phrasing in the following sections:

3.3, 6.1, 8.1, 9.3, 9.4, 9.6, 10.2, 11.2, 12.2, 13.2, 13.3, 14.1, 14.2, 14.5, 20.3 &

22.2. These phrasing revisions involve replacing a few select words within the noted sections, are minor in nature, and either correct grammatical errors, flow more naturally, define acronyms or better describe the point.

o Title of section 1. 1, "Quality Policy" changed to "Quality Policy & Quality System Objectives" to more accurately described section contents. Title change also reflected within the Table of Contents.

o Title of section 11.0, "Inspection and Testing" changed to "Inspection Test and Operating Status". Title change also reflected within the Table of Contents.

o Title of section 20.0, "Process Monitoring & Continual Improvement" changed to "Process Monitoring, Measurement & Continual Improvement:. Title change also reflected within the Table of Contents.

o Removed"[ ... ] that all employees working as a team and individually will [ ... ]"

phrasing from section 1.2.

o Added bullet in section 1.2 to define that, "Quality is doing the right thing ethically and with integrity".

o Updated the commitment statement and added quality objectives in section 1.2.

o Section 1.5 changed "ISO 13485:2016 Paragraph 5.6." to "ISO 13485:2016 Paragraph 5.6.2" to better identify the location of the standard requirement.

o Removed "sterilization" from list of special processes under section 8.3.

o Added "certifications" as an example of documents that may be provided to end users under section 14.6.

o Expanded that references are periodically reviewed to identify new regulations for clarification under section 22.2.

Page 1 of 2 QSA Global Inc.* 40 North Avenue Burlington, MA 01803

  • 888.272.2242
  • 781.272.2000
  • F: 781.359.9179
  • qsa-global.com

QSAGLOBALa o Removed references to Reg Guide 6.9 under Appendices A and B, as it is no longer applicable.

o Added QMP-3700 to Appendix B for the description of managing risk under the quality system.

These changes did not reduce any prior commitments in QSA Global, lnc.'s NRC approved quality assurance program. As such, these changes were allowed under 10 CFR 71.106(b) and are notified as required under that same section. Enclosed is the Quality System Manual, QSM-1, Revision 15, to be kept on file. Should you have any questions or wish to discuss this notification further, please feel free to contact me.

Sincerely, E-SIGNED by John Hieber I I '

on 2023-08-08 12:02:10 GMT John Hieber Quality Assurance Manager iohn.hieber@gsa-global.com (781) 505-8256

Enclosures:

QSA Global, Inc. letter dated 16 June 2017 QSA Global, Inc. letter dated 28 August 2019 QSM-1, Rev. 15 Page2 of 2 QSA Global Inc.

  • 40 North Avenue Burlington, MA 01803
  • 888.272.2242
  • 781.272.2000
  • F: 781.359.9179
  • qsa-global.com

t)E'j QSA GLOBAL QSA Global, Inc.

kif ttf*I 40 North Avenue Burlington, MAO 1803 Telephone: (78 l) 272-2000 Toll Free: (800) 815-1383 Facsimile: (781) 359-9191 16 June 2017 ATTN: Document Control Desk Director, Division of Spent Fuel Management Office ofNuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852 Regarding: 24 Month Repoti for QA Program 0400

Dear Sir or Madam,

Pursuant to the repotiing requirements of IO CFR 7 l .106(b ), QSA Global, Inc. advises that our QA Program, as described under Quality System Manual QSM-1 Revision 11 on file with your office, has been changed as allowed under 10 CFR 71.106(b) in the following manner:

  • Text clarifications in section 1.2 expanding the scope by adding "security, and other applications",

and by adding applicable international regulatory requirements incorporated into our program.

  • Section 1.4 was clarified to specify clearly both the Quality Assurance and the Quality Control aspects of the quality system support processes.
  • Section 1.6.1 was clarified to reference a competency requirement for staff performing work affecting quality.
  • Section 3.0, Design control requirements was clarified to indicate that the requirements of ISO 13485 section 7.3 do apply to medical device manufacture unless otherwise specified under contract.
  • Section I 7.1, under the Awareness training definition, replaced "affect" with "effect". Also under the Verification definition, replaced "is" with "are". Both changes were made for grammatical correctness.
  • Appendix C, updated the Key Process Model chart to include Quality Assurance along with Quality Control under the Support Processes section.

These changes did not reduce any prior commitments in QSA Global, Inc.'s NRC approved quality assurance program. As such, these changes were allowed under 10 CFR 71.106(b) and are notified as required under that same section. Should you have any questions or wish to discuss this notification futiher, please feel free to contact me.

Page 2 Sincerely, e-Signed by Lori Podolak on 2017-06-14 17:23:20 GMT e-Signed by Michael Fuller June 14, 2017 Lori Podolak on 2017-06-1419:03:42 GMT Senior RA/QA Specialist RA/QA Director Date Ph: (781) 505-8241 Fax: (781) 359-9191 Email: Lori.Podolak(@qsa-global.com

Enclosure:

QSM-1 Revision 12

\*, ' ,I " 1..) 111

ATTN: Document Control Desk 28 August 2019 Director, Division of Spent Fuel Management Office of Nuclear Material Safety and Safeguards U.S. Nuclear Regulatory Commission 11555 Rockville Pike Rockville, MD 20852 Regarding: 24 Month Report for QA Program 0400

Dear Sir or Madam,

Pursuant to the reporting requirements of 10 CFR 71.106(b), QSA Global, Inc. advises that our QA Program, as described under Quality System Manual QSM-1 Revision 11 on file with your office, has been changed as allowed under 10 CFR 71.106(b) in the following manner:

Revision 12 (previously reported in our letter dated 16 June 2017):

  • Text clarifications in section 1.2 expanding the scope by adding "security, and other applications",

and by adding applicable international regulatory requirements incorporated into our program.

  • Section 1.4 was clarified to specify clearly both the Quality Assurance and the Quality Control aspects of the quality system support processes.
  • Section 1.6.1 was clarified to reference a competency requirement for staff performing work affecting quality.
  • Section 3.0, Design control requirements was clarified to indicate that the requirements of ISO 13485 section 7.3 do apply to medical device manufacture unless otherwise specified under contract.
  • Section 17 .1, under the Awareness training definition, replaced "affect" with "effect. Also under the Verification definition, replaced "is" with "are". Both changes were made for grammatical correctness.
  • Appendix C, updated the Key Process Model chart to include Quality Assurance along with Quality Control under the Support Processes section.

Page 1of2 QSA Global Inc.* 40 North Avenue Burlington, MA 01803

  • 888.272.2242
  • 781.272.2000
  • F: 781.359.9179
  • qsa-global.com I

_J

Revision 13:

  • Revised Quality Policy signatory in section 1.1 to new VP/GM.
  • Section 1.2 added reference to our holding company, Illinois Tool Works (ITW), simplified list of regulatory references.

" Revised language in section 1.3 to better reflect Leadership engagement in the Quality System.

11 Section 1.4, Expanded Quality System description to specifically include addressing opportunities and risks.

  • Section 1.5, expanded description of Management Review to better comply with ISO 9001:2015.
  • Section 1.6, expanded description of Resource Management to better align with ISO 9001:2015.

(ii Added section 1.7 to address Risk Management and Identification of Opportunities

  • Appendix A, revised ISO 9001 column to adjust clause references to the 2015 standard.
  • Appendix B, created additional top-level procedure entries.
  • Changed "President to "Vice President/General Manager or "VP/GM" throughout document.

Revision 14:

11 Updated ISO 13485 reference in section 1.2 to ISO 13485:2016.

o Added reference to ISO 13485:2016 in section 1.5 for management review minimum content requirements.

  • Updated ISO 13485 references in section 18 to exclude Cleanliness, Installation & Servicing applicability to medical devices manufactured by QSA Global, Inc.

CJ Updated ISO 13485 section references in Appendix A to reflect the 2016 standard.

These changes did not reduce any prior commitments in QSA Global, lnc.'s NRC approved quality assurance program. As such, these changes were allowed under 10 CFR 71.106(b) and are notified as required under that same section. Should you have any questions or wish to discuss this notification further, please feel free to contact me.

Sincerely, Michael Fuller Director, Regulatory Affairs/ Quality Assurance mike.fuller@gsa-global.com

+1 781 505-8231 Page 2 of2 QSA Global Inc,

  • 40 North.Avenue Burlington, MA 01803
  • 888.272.2242
  • 781.272.2000
  • F: 781.359.9179
  • qsa-global.com

Document Number Revision

  • Q;SA *GLOBAL~ QSM-1 15 Effective Date: December 7, 2022

Subject:

. Quality System Manual Reviews & A rovals Name Title Date Michael Fuller Director, Regulatory E- by Michael Fuller December 06, 2022 Affair Assurance -06 20:35:53 GMT Lori Podolak Senior Regulatory Affairs /

December 07, 202 ecialist JasonBoum Vice President/ General December 07, 2022 Man SA Global Inc.

QSM-1 Rev. 15

Table of Contents 1.0 Management Responsibility ............................................................................................. 1 1.1 Quality Policy & Quality System Objectives ................................................ 1 1.2 Introduction to QSA Global, Inc ................................................................... 2 1.3 Responsibilities/Organization ......................................................................... 3 1.4 Quality Systen1................................................................................................ 4 1.5 Management Review ..................................................................................... 5 1.6 Resource Management .................................................................................. 6

1. 7 Risk Management and Identification of Opp01tunities .................................. 6 2.0 Contract Review ................................................................................................................ 7 3.0 Design Control ................................................................................................................... 7 3.1 General .......................................................................................................... 7 3 .2 Design Inputs and Reviews ........................................................................... 7 3.3 Design Verification and Validation ................................................................ 8 3.4 Design Transfer ............................................................................................. 8 4.0 Document and Data Control ............................................................................................ 9 4.1 Document Review and Approval .................................................................. 9 4.2 Distribution ..................................................................................................... 9 5.0 Purchasing ......................................................................................................................... 9 5 .1 Evaluation of Suppliers, Contractors and Consultants ................................... 9 5 .2 Procurement Documents ............................................................................. 10 5 .3 Verification of Purchased Product .............................................................. I 0 6.0 Control of Customer Supplied Product ........................................................................ 10 6.1 Minimum Requirements ............................................................................... 11 6.2 Protection of Customer Property .................................................................. 11 7.0 Product Identification and Traceability ....................................................................... 11 7.1 Product Identification .................................................................................. 11 7 .2 Product Traceability .................................................................................... 11 7.3 Records ......................................................................................................... 11 8.0 Process Control ............................................................................................................... 12 8.1 General ........................................................................................................ 12 8.2 Special Processes .......................................................................................... 12 9.0 Inspection and Testing .................................................................................................... 12 9.1 General ........................................................................................................ 12 9.2 Incoming Inspection and Testing ................................................................. 13 9.3 In-process Inspection and Testing ................................................................ 13 9.4 Final Inspection and Testing ......................................................................... 13 9.5 Inspection & Test Records ........................................................................... 13 10.0 Control of Measuring and Test Equipment .................................................................... 14 10.1 General ........................................................................................................ 14 10.2 Calibration of Measuring & Test Equipment.. ............................................. 14 10.3 Control of Key Process Equipment. ............................................................. 14 10.4 Damaged or Out of Calibration Equipment Control ................................... 15 11.0 Inspection Test and Operating Status ........................................................................... 15 11.1 General ...................................................................................................................... 15 QSM-1 Rev. 15

12.0 Control of Nonconforming Material ................................................................................ 15 12.1 General ..................................................................................................................... 15 13.0 Corrective and Preventive Action..................................................................................... 16 13.1 General ..................................................................................................................... 16 13.2 Process ........................................................................................................................ 16 14.0 Handling, Storage, Preservation and Delivery ............................................................. 17 14 .1 Handling ...................................................................................................................... 17 14.2 Storage and Preservation.......................................................................................... 17 14.3 Labeling ...................................................................................................................... 17 14.4 Packaging .................................................................................................................... 17 14.5 Delivery.................................................................................................................... 17 15.0 Control of Quality Records ............................................................................................. 17 15.1 General ..................................................................................................................... 18 15.2 Medical Device Records .......................................................................................... 18 16.0 Internal Audits ................................................................................................................ 18 16.1 Process* ........................................................................................................................ 18 17.0 Training ........................................................................................................................... 18 17.1 General ..................................................................................................................... 19 18.0 Servicing and Installation....................*.......................................................................... 19 18.1 Servicing ..................................................................................................................... 19 18 .2 Installation................................................................................................................ 20 19.0 Statistical Techniques ..................................................................................................... 20 20.0 Process Monitoring, Measurement & Continual Improvement .................................. 20 20.1 Customer Satisfaction................................................................................................. 20 20.2 Analysis of Data ....................................................................................................... 20 21.0 Project Management .......................................................................................................... 21 22.1 Safety Programs ........................................................................................................................ 21 22.1 General ..................................................................................................................... 21 Appendices A. Requirements Cross Reference of OMS to Standards & Regulations B. Quality Management System Implementing Procedures C. Key Process Model D. Summary of Changes to Prior Revision ii QSM-1 Rev. 15

1.1 Management Responsihilitf 1.2 Quality Policy & Quality System Objectives QSA Global commits to ensure that all products, processes and services are manufactured/performed in a controlled, reliable and safe manner to meet customer, applicable statutory and regulatory requirements.

o Quality is determined by our customers.

  • Quality is continuously measured and evaluated.
  • Quality is every individual's responsibility.
  • Quality is a team effort.
  • Quality is doing it right the first time.
  • Quality is doing the right thing ethically and with integrity
  • Quality Is a continuously improving process.

With the commitment to these principles as well as our policies and standards, QSA will lead the industry with:

  • Guaranteed product safety and full compliance
  • Performance metrics that will drive differentiation and maximum customer satisfaction.

o Fulfillment across our complete value chain and at all levels of our organization To define and focus QSA activities and effectively implement the Quality Policy, quality objectives are established by QSA management. These objectives are monitored and periodically reviewed by management to assess the scope, applicability, implementation, and effectiveness of the quality system. The quality objectives and status are documented and communicated to the QSA staff.

The responsibility for the maintenance of the quality system and monitoring the implementation of the quality system provisions is delegated to the Director of Regulatory Affairs and Quality Assurance.

Signed. _.A---,1.Z:~c..-_-=;;..;l:::;..-'::,,J='-Q::::;...'.L___,;;;=-----Date:8/5/2022

~akeBourn Vice PresidenUGeneral Manager Page 1 of30 QSM-1, Rev.15

1.2 Introduction to QSA Global, Inc QSA Global, Inc. is a wholly owned division of Illinois Tool Works (ITW) and is part of the Test & Measurement business segment. QSA Global, Inc. manufactures, distributes and redistributes radioactive material in the form of sealed sources, devices and transport packages for use in indush*ial and medical applications throughout the world. Additionally, QSA Global, Inc. manufactures indush*ial X-ray equipment and other accessories for use in non-destructive testing, security and other applications, and perfom1s contract manufacturing of customer designed sources for industrial and medical applications. These sources, devices and transpmi packages are authorized for use through the following certifications:

  • Type B approvals
  • Special form approvals
  • Sealed Source and Device Registrations
  • Type A analyses
  • FDA approvals
  • Licenses & Approvals Issued by Regulatory Authorities The design, testing, manufacture and distribution of these products are covered under the following Quality System and/or regulatory requirements as applicable:
  • 21 CFR 820
  • 49 CFR Part 173
  • Applicable Czech Republic Acts & Decrees
  • Applicable Canadian Transport, Device, and Medical Device Regulations
  • Applicable European Union Transport, Device, and Medical Device Directives QSA Global, Inc's primary manufacturing location is in Burlington, MA. QSA also has distribution and servicing facilities in Baton Rouge, LA, Dobrany, Czech Republic and other locations and performs services throughout the world. As needed, these other facilities would be added to the ISO 9001 accreditation scope.

Due to the diverse nature of the stakeholders and regulatory entities associated with QSA business activities, the Quality Management System (QMS) has been developed to include measures designed to satisfy the varied requirements identified above. To facilitate identification of specific requirements, and where they are addressed by the QMS, a cross reference matrix is provided in Appendix A.

The QSA Quality Management System does not apply to "Traded Product" purchased and resold by QSA for the convenience of our customers. Traded Products are commercial items that are not designed or manufactured by QSA Global, and for which QSA has no responsibility for or control over the quality of the product.

Page 2 of30 QSM-1, Rev.IS

1.3 Responsibilities/Organization The management team has the overall responsibility for the Quality System program, including ensuring effective implementation by the various functional areas (such as Engineering, Quality Assurance/Quality Control, Operations, Regulatory, Commercial, Finance, Human Resources and Information Technology). The management team ensures the integration of the Quality System through a process approach and risk-based thinking.

The current organizational structure is documented and implements the responsibilities given in this section.

Vice President/General Manager The Vice President/General Manager of QSA Global, Inc is responsible for establishing and implementing a Quality System that complies with the requirements of this Quality System Manual. The VP/GM will communicate to all staff the Quality Policy and Quality Objectives, and ensure that systems are in place to meet statutory, regulatory and customer requirements.

Management Representative The VP/GM appoints the Director of Regulatory Affairs/Quality Assurance (RA/QA) as the Management representative. This position is independent from production schedules and reports directly to the VP/GM. The Management Representative should have a BS degree in a scientific discipline, either formal or on the job training in quality systems and experience in QA programs established for compliance to regulatory requirements.

This position is responsible for monitoring the implementation of the Quality System. This includes providing guidance and direction for the other functional activities to achieve the effective implementation of the Quality System. This position has the authority and freedom to stop unsatisfactory work. The Management Representative serves as liaison with representatives of external parties on matters relating to the quality system such as the State of Massachusetts, Nuclear Regulatory Commission, Food and Drug Administration, Department of Transportation, and competent authorities of other jurisdictions.

Functional Managers The functional managers are responsible for the quality program activities described in this manual and ensuring that appropriate systems and procedures are in place. Management is responsible for ensuring that noncompliance and improvement opportunities are addressed in a timely manner and that personnel are indoctrinated and trained in the applicable Quality System requirements.

Functional Managers are responsible for appointing Subject Matter Experts (SMEs). The SMEs are individuals, that by virtue of training and/or experience and an assessment by the manager indicates the individual is an expert for a particular subject. The SMEs are responsible for writing, reviewing and assisting in training in Quality Management Procedures (QMP) and Work Instructions (WI) and associated documentation.

Page 3 of30 QSM-1, Rev.15

Staff All staff are trained in the Quality System Manual (QSM) and are responsible for understanding, adhering to and maintaining the stated requirements of the QSM.

All staff have the authority to stop unsatisfactory work. All staff have the responsibility to report any defects or noncompliance which could result in a substantial safety hazard or any other condition that could lead to a noncompliant condition.

1.4 Quality System A Quality System is established, maintained and implemented that ensures processes are identified and documented and that appropriate procedures are in place. The system ensures that the product conforms to specified requirements, that opportunities are identified as available, and that risks (business, safety, supply, etc.) are identified, assessed and addressed.

Quality planning is accomplished through the use of design review and process planning.

Risk assessment/management is performed as required at all levels of the organization.

The Quality System is integrated into the key processes necessaiy for the enterprise to achieve its quality objectives. These key processes and process elements are defined as follows:

Management -

  • Strategic Planning
  • Resource Management
  • Performance Management
  • Management Review Product Realization -
  • Customer Service & Order Management
  • Product Design & Development
  • Procurement of Goods & Services
  • Manufacturing & Assembly
  • Distribution Support Processes -
  • Financial Control
  • Facility & Equipment Maintenance
  • Information & Data Management
  • Regulatory & Licensing
  • Quality Assurance
  • Quality Control Verification and Measurement
  • Health & Safety The functional relationship of these key process elements are described and depicted in the process model of Appendix C.

Page4 of30 QSM-1, Rev.15

The Quality System is based on a graded approach. Items that are critical to product safety or product quality are identified and appropriate control, traceability and inspection criteria established. The Quality System is implemented using the documents listed below.

The Quality System Manual The Quality System Manual is the master document (Level 1) that implements and requires that all the applicable quality standards, as described in section 1.2 are met. The manual includes the Quality Policy listed in Section 1.1, which is endorsed by the VP/GM of the company.

Quality Management Procedures The Quality Management Procedures (QMP) are the second level (Level 2) of documents and implement the requirements of the Quality System Manual. The QMPs describe the following:

  • Minimum requirements for legal and business needs
  • How to meet commitments in the quality manual
  • Cover the core elements under the relevant QA standards
  • Process and responsibilities The Quality Management Procedures that implement those elements of the quality system defined in 10 CFR 71, subpart H and described in NRC Regulatory Guides 7.10 and 6.9 are tabulated in Appendix B.

Work Instructions Work Instructions are the Level 3 documents and provide step by step guidance on how to implement requirements in the QMPs. Work instructions provide:

  • Instructions to complete a task or operation including applicable inspection and acceptance criteria
  • References to records or equipment as needed for task
  • Descriptions of a process and may not be department specific Work Instrnctions may utilize drawings, and/or specification sheets to cover adequate level of detail.

Records Records are Level 4 documents and provide evidence of implementation of the quality program and associated processes. Quality records are maintained and retained in accordance with applicable laws, regulations, and license requirements.

1.5 Management Review To assess the effectiveness of the Quality System, a systematic management review of the Quality System is performed at least annually.

The Management Review includes the VP/GM of the company, RA/QA Director and appropriate functional management staff. Measurable quality objectives will be established and reviewed during the management review. The Management Review Page 5 of30 QSM-1, Rev.15

consists of a review of at a minimum the elements of ISO 9001:2015 Paragraph 9.3 .2 and ISO 13485:2016 Paragraph 5.6.2.

The outputs of the management review will include decisions and actions related to identified opportunities, suitability and effectiveness of the quality program, resources, and potential changes to the quality system.

Records are maintained of the Management Review indicating results and actions.

The VP/GM is responsible to ensure that actions are completed as required.

1.6 Resource Management Executive management of QSA Global determines and provides the resources necessary for the establishment, implementation, maintenance and continual improvement of the quality system in a manner that meets regulatory, business, and customer requirements.

1.6.1 A system is established to recruit and train an adequate staff of competent personnel for performing work affecting quality.

1.6.2 Facilities and equipment including supporting services are provided suitable to the production requirements, and to deliver product that conforms to requirements. A preventive maintenance program is established to ensure critical equipment and facilities are available to support operations.

1.6.3 A system of procedures, reviews, and controls are implemented to establish an appropriate work environment to conduct operations safely and in conformance with regulations. These reviews and controls are applied to any new process or significant changes to existing processes and facilities as applicable. Procedures and controls are established as appropriate to:

  • Provide for the safety of personnel
  • Establish and maintain the integrity and cleanliness of product 1.7 Risk Management and Identification of Opportunities Risk assessment and mitigation is an inherent component of the industry in which QSA Global operates. Many processes, from equipment design and development to international sales, involve analysis of relative risk to the company with follow-on mitigation actions as required. Additionally, QSA Global, Inc. employs the ITW Business Strategies, including the 80/20 Front to Back process, Customer-Back Innovation, use and monitoring of Customer-Facing Metrics, and various proprietary business analysis tools to identify and maximize opportunities both for business and for continuous product and process improvements.

Formalized risk assessment is performed during new product development, as well as during contract reviews. Informal assessments are performed regularly as part of all processes at QSA Global, Inc.

Page6of30 QSM-1, Rev.IS

2.0 Contract Review Procedures are established to ensure that contract and order requirements are adequately defined, coordinated and documented. Customer requirements differing from those provided in a quotation are resolved prior to the acceptance of a contract/order. A review of the contract also ensures that QSA Global is capable of meeting the contract requirements prior to the acceptance of the contract/order.

Contract/order review is perfonned by appropriate personnel prior to the issuance of a quotation and/or acceptance of any contract or order.

The individual performing contract review identifies and addresses any areas of concern and/or non-compliance until resolution. This includes involving any pertinent personnel as needed, i.e.: QA, Engineering, Regulatory, Finance, etc. Evidence of contract/order review is documented.

Amendments or modifications to a contract or order, by either QSA Global, or the customer, is documented and the customer notified of the changes.

3.1 Design Control Procedures are established describing the method to control and verify the design of new products or changes to existing products to ensure the specified requirements are met. Unless otherwise specified under contract, the provisions of design and development contained in ISO 13485 section 7.3 apply to the medical devices being manufactured by QSA Global.

3.2 General Development of concepts for new products or changes to existing products and processes may begin before a full design effort begins. Such concepts must be documented on prototype drawings and/or processes controlled by engineering. A risk analysis is performed as part of the product and process design.

A design history file is established once a project is initiated. All information regarding the design, testing, verification, and release of the product or process is documented in the design history file. This file is controlled and maintained for the life of the product or process.

3.3 Design Inputs and Reviews The designer obtains the design inputs, which will include as a minimum any regulat01y requirements, contract requirements, customer input, technical and/or performance requirements. Consideration of safety related functions are included during the design, as well as potential consequences of device/process failures. The Design Engineer ensures the design inputs are addressed by the intended design output.

This assessment is reviewed by a qualified individual other than the originator for adequacy. Any incomplete infonnation, ambiguous or conflicting requirements are addressed.

Design Reviews are held as needed during the development process. These will involve individuals as needed from other functional areas for applicable input and review.

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Where necessary, there will be a clear assignment of responsibility between the interfaces of the functional groups.

Once the design is complete it is checked by someone other than the originator of the document. The Design Checker ensures the design outputs matches the design inputs as intended, and this review is documented before release.

3.4 Design Verification and Validation The design is verified. Design verification may follow one or a combination of the following:

  • Testing - All testing is performed in accordance with established procedures that identify the testing requirements, is documented and reviewed as appropriate to the requirements of the design inputs.
  • Analysis - Alternate calculations, analysis or assessments may be used to provide evidence that a design output will satisfy the inputs.
  • Independent analysis - Submittal to outside agencies for verification. This is either for testing of actual prototypes or calculative analysis.

After verification, it is confirmed that the design outputs meet the design inputs, that inspections and tests are identified and a Final Design Review is conducted to present all testing, design and evaluation results. This design review includes all the necessary functional groups.

The Design Engineer and/or the Project Manager monitor the initial production run for validation of manufacturing processes to ensure the product confonns to the intended user needs and specifications. Any changes required to the design become design revision inputs and are evaluated with the same level of control and review as the original.

Ifrequired, units from the initial production run may be used to validate the design.

Validation is achieved through monitoring of initial units in the field, additional testing, or other methods to ensure that the units conform to users' needs and intended uses.

Validation is documented in the design history file.

Changes to an approved design are reviewed, verified and validated as appropriate, and approved before implementation. The review of design changes includes an evaluation of the effect of the change on constituent parts and product already delivered. Records of the design change review are maintained in the design history file.

3.5 Design Transfer The final design is translated into instructions and drawings to ensure production conforms to the design basis. These instmctions and drawings include measures for quality verification and are reviewed prior to issue to verify conformance to the design requirements.

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4.1 Document and Data Control Procedures are established for the control of documents and data pertinent to the Quality System. The establishment and changes to the Quality Policy, Quality System Manual, Quality Management Procedures, and Work hlstructions are procedurally controlled.

Controlled documents such as engineering drawings, marketing literature, product manuals and documents of external origin, i.e., standards and customer drawings are processed in accordance with the responsible departmenfs work instructions.

Computer software is validated and controlled as needed.

Documents and data can be in any form, i.e., hard copy or electronic media.

Documents and data are reviewed and approved for adequacy by authorized personnel prior to issue and have the approval date and the effective date indicated.

4.2 Document Review and Approval The document originator obtains reviews and approvals from appropriate functional groups.

Document and data changes will be reviewed and approved by the same functions that performed the original review and approval. The functions will have access to pertinent background information to base their review and approval.

Changes will be visibly highlighted in the document. Approved changes will be communicated to appropriate personnel in a timely manner.

4.3 Distribution All personnel have access to all QA documents and instructions as needed for their activities. A master list of controlled documents is kept and identifies current revision status of documents. Invalid/obsolete documents will be promptly removed to ensure against unintended use.

5.1 Purchasing Procedures are established for ensuring the quality of procured materials and/or services confonn to specified requirements.

5.2 Evaluation of Suppliers, Contractors and Consultants Purchasing will evaluate and select suppliers based on their ability to meet contract requirements including the quality system and any specific requirements. Quality Assurance will assist in the assessment of suppliers. The extent of the assessment is dependent on the quality class of product provided by the supplier and may include evaluations and/or audits as applicable. One or more of the following methods may be utilized in evaluating the qualifications of a vendor:

  • Audits and/or coordinated review by multiple functional groups (e.g.

Engineering, Purchasing, and Quality);

Page 9 of30 QSM-1, Rev.15 L

  • Accreditation by a recognized independent authority (e.g. NVLAP, A2LA, NADCAP, NMAS, ASME );
  • Audits and/or evaluations by other Illinois Tool Works (ITW) companies;
  • Source inspection / surveillance.

Considerations to be taken into account when selecting a supplier include technical capability, quality assurance system, and ability to meet schedules, price and financial stability of the supplier.

The performance of key suppliers is monitored, and periodically reviewed. The criteria for evaluation and periodic re-evaluation of performance is documented, and records of the reviews are maintained. In cases of contract manufacturing that does not involve NRC certified devices and packages, suppliers specified by the customer may be used in lieu of those on QSA Global's approved supplier listing, without evaluation by QSA.

5.3 Procurement Documents Purchasing documentation contains data clearly describing the products ordered including (with revision levels as appropriate):

  • Specifications, drawings, process requirements, inspection instructions and other relevant technical data, including requirements for approval or qualifications of product, material certifications, certificate of conformances, test rep01is, procedures, process equipment and personnel
  • The applicable quality system
  • The review and approval of purchasing documents for adequacy of the specified requirements prior to release
  • Any changes to the procurement document will be reviewed and approved to the same level of control as the original document
  • As applicable, supplier must notify of any significant changes in process of producing requested product 5.4 Verification of Purchased Product All materials and/or services contracted must comply with the applicable contractual requirements and identified specifications on the purchase order which may include:
  • Inspection at supplier site
  • Inspection upon receipt at QSA site
  • Objective evidence of the quality of the product from suppliers, such as material certification, certificate of conformances or test reports
  • Notifications of any changes in the process or component
  • Notification of any nonconforming material 6.1 Control of Customer Supplied Product Procedures are established for ensuring that customer supplied product will be handled and stored properly. These are items that will be incorporated into or used with QSA Global products.

Page 10 of30 QSM-1, Rev.IS

6.2 Minimum Requirements The customer is responsible to provide acceptable product and to specify any special requirements. Customer supplied product may be verified as to fitness for use, based on customer needs.

Items will be received, identified and stored in a controlled and traceable manner. Items will be maintained according to original manufacturer's guidance. Items lost or damaged will be documented and reported back to the customer.

6.3 Protection of Customer Property Customer supplied property including intellectua1 property and personal data are protected from damage, loss, or use by unauthorized persons.

7.1 Product Identification and Traceability Procedures are established for identification, traceability and control of materials, parts, and subassemblies and product.

7.2 Product Identification Where required, material, parts, subassemblies and product are identified by suitable means from receipt through all stages of production and delivery. Identification of items is maintained by part number, heat number, or other suitable means.

7.3 Product Traceability Where and to the extent that traceability is a specified requirement, individual products, lots, or batches will be assigned a unique identification. Identification will be maintained on the product or on records traceable to the product.

Materials, parts, and components fmmd to be nonconforming will be appropriately marked, removed from use and placed in an isolated hold area.

7.4 Records According to the level of traceability required by contract, regulatory, or other established requirement, the system will provide that:

  • Identification will be maintained throughout the life of the product
  • The quality records of a product, including design, production, results of inspections and tests including acceptability can be retrieved
  • Appropriate retention periods are specified Page 11 of30 QSM-1, Rev.15

8.1 Process Control Procedures are established to control and document production processes.

8.2 General Production activities will be adequately documented through controlled procedures, instrnctions or drawings appropriate to the quality and safety significance. These may include process flow, routings and hold points. Qualification of personnel for the process will be indicated as needed.

Critical features, acceptance criteria and workmanship standards will be clearly described and monitored.

Production activities will be performed in accordance with these documents and applicable regulations, codes, standards or Process Plans.

Evidence of operations and inspections perfonned will be maintained. The current status of operations and/or inspections of a product will be clearly identified, either by documentation, labeling, production location or other easily. identified means.

Appropriate production equipment that meets specified requirements wi11 be used in suitable work environments. This equipment will be inspected and maintained to ensure process capability. Where applicable any limitations of the equipment will be documented and made available to the operator.

Where applicable, processes and equipment including software will be approved and validated. Medical product manufacturing processes and associated software is validated in cases where the result cannot be velified by subsequent monitoring or measurement. The extent of validation is based on the process risk analysis. Changes or process deviations to these systems will require reassessment and approval.

8.3 Special Processes Special processes, including welding, heat treating, etc on safety critical components will be controlled through the use of qualified people and procedures to meet the relevant standards or industry codes.

9.1 Jnspectiop and Testin2 Procedures are established to control the inspection and testing activities for products, materials and services, verifying that they meet the specified requirements.

9.2 General Parameters, features and characteristics that require inspection or testing are documented. Inspection and testing is perfonned in accordance with written and approved instructions or plans.

Inspection and test instructions identify the acceptance standards / criteria that items must meet. Test instructions identify the test conditions, including prerequisites, and measuring or test equipment required.

Page 12 of30 QSM-1, Rev.15

Personnel perfonning inspection and testing are qualified to the applicable standard.

Inspection of items important to safety is performed by qualified personnel other than those who perfom1ed the activity being inspected.

9.3 Incoming Inspection and Testing Incoming items are verified to the specifications used to obtain those items. This may be done by physical verification, comparison against Certificates of Compliance (CoC), or other appropriate method.

The level of inspection is commensurate with the control required for the incoming units with respect to safety, supplier performance and complexity.

The level and results of inspection is documented and trended.

Items not in confonnance with the specifications used to inspect them will be identified, segregated and not used without approval by authorized personnel.

9.4 In-process Inspection and Testing Where direct inspection is not practical, indirect verification of quality may be used through process monitoring and/or process control. When necessary, hold points are implemented to check product quality.

Items in process do not progress in the production process until inspected and/or tested as required. Inspection hold points are identified in the processing documents.

Items not in conformance with the specifications used to inspect/test them will be identified, segregated and not used without specific approval by authorized personnel.

9.5 Final Inspection and Testing Final inspection provides evidence of confo1mance of the items to the design specifications, verifies that all required operations have been performed, and ensures the overall quality of the product. Final inspections provide for:

  • Resolution of nonconforming conditions identified during processing,
  • Verification of identification and traceability of item(s) to specific records, and
  • Ensuring adequate protection from damage.

Items are not to be released for sale or use until all inspection documentation has been reviewed and authorized as applicable.

9.6 Inspection & Test Records Records of inspections and tests clearly show the results and identify the inspecting and authorizing entities.

The evaluation of test results to ensure the test requirements have been met is documented.

Page 13 of30 QSM-1, Rev.15

10.1 Control o{ Measurin& and Test Eqpjpment Procedures are established for the control of measuring and test equipment, and key process equipment.

10.2 General Procedures are established for administration and control of calibrated measuring and test equipment, and key process equipment.

All personnel using measuring and test equipment are responsible for ensuring current calibration and performing visual verification for any damage or wear prior to each use and that the equipment is capable of providing the required measurement. Equipment used must be suitable for its intended purpose.

Measuring and Test Equipment and Key Process Equipment will be uniquely identified to facilitate tracking and control.

10.3 Calibration of Measuring & Test Equipment Measuring and test equipment will be labeled such that its calibration status is readily determined when in use. Labeling will indicate the planned date the next calibration is due.

Measuring and Test equipment will be calibrated at prescribed intervals consistent with the device's use and calibration history, or prior to use.

Calibration procedures will include directions on accuracy and precision as needed.

Records of calibration will be maintained of the device's calibration status and demonstrate traceability to nationally recognized standards. Where no known standard exists, the basis of calibration will be documented.

When applicable, a manufacturer's certificate of accuracy may be used in lieu of calibration by an approved supplier for newly purchased items based on a suitable evaluation and approval.

Calibration services for measuring and test equipment will be perfonned by approved suppliers.

10.4 Control of Key Process Equipment Key process equipment will be labeled such that its inspection status is readily determined when in use. Labeling wm indicate the planned date the next inspection is due.

Critical characteristics of key rrocess equipment will be verified by inspection or approved acceptance tests ai periodic intervals based on the equipment's use and wear history.

Inspections of key process equipment will be performed using calibrated measuring devices and will be documented on records traceable to the device.

Page 14 of30 QSM-1, Rev.15

10.5 Damaged or Out of Calibration Equipment Control Measuring and test equipment and key process equipment found to be damaged or out of calibration will be identified, removed from service, and segregated if practical to prevent further use.

A review of the use of the device since the last verifiable acceptable calibration or inspection will be performed, and the impact of the device's deviation evaluated and documented.

Potentially impacted product will be identified and evaluated as nonconforming product and appropriate corrective actions taken.

11.1 Inspection Jest and Operatina Status Procedures are established to ensure the inspection, test, and operating status of materials, parts, and products is identified and maintained.

11.2 General Work instructions are in place to ensure that the identification and status of materials are maintained throughout manufacturing, installation, and service processing. This includes the rework/repair of all non-conformances.

Where necessary to ensure compliance to engineering/regulatory specifications quality control hold points are planned and implemented in processing documents to require determination of quality status prior to continued processing.

Processing, inspection and acceptance status may be accomplished through the use of a combination of stamps, labels, route cards, fonns and service check sheets.

Acceptance status of goods is indicated by suitable non-damaging identification or otherwise by means of a signature on the documentation identifiable to the goods.

12.1 Control of Nonconforming Material Procedures are established that document the methods to control materials, parts, and components that do not conform to specified requirements in order to prevent use.

12.2 General An item that is, or is suspected to be, unacceptable, will be identified and documented as to its status and type of nonconformance.

Nonconforming items will be quarantined or placed in controlled hold areas, when practical, until proper disposition is completed.

The review and disposition of nonconforming items will be conducted and approved by a Material Review Board or other approved personnel.

Acceptance of reworked or repaired nonconforming items will be verified by re-inspecting or re-testing to the original requirements, or approved alternative instructions.

Page 15 of30 QSM-1, Rev.15

Final disposition of non-conformances will be identified and documented including justification.

Any affected functions will be notified of the nonconfonnance and agreed corrective/preventive action. In the event nonconfonning product is identified subsequent to delivery, the receiving party will be notified of the condition and recall or corrective action taken as applicable.

Nonconformance reports will be analyzed to determine quality trends for appropriate management review and assessment 13.1 Corrective and Preventive Action Systems are established for documenting, investigating and implementing Corrective and Preventive Actions.

13.2 General A Condition Report (CR) or equivalent is used to document the need for a co1Tective action to fix and prevent recurrence of a nonconformance, an internal or external customer dissatisfaction or a finding resulting from program audits. A CR can also be issued as a preventive action or improvement item when a program weakness or an enhancement opportunity is found.

A CR can be generated as a result of any of the following activities:

  • Internal or external audit
  • Customer feedback/customer complaint
  • Product non-conformance
  • Supplier audit
  • Observations during routine or non-routine events 13.3 Process The CR is evaluated to determine the need for an investigation as to the cause and proposed co1Tective action(s) based on the condition's potential or actual significance in tenns of impact or consequences. This evaluation includes considerations of impact on safety, quality, and public confidence. CRs are classified as Major or Minor based on the evaluation.

Condition Reports evaluated as Major are assigned to a qualified person for investigation and the determination of appropriate corrective or preventive action(s). A root cause determination is perfonned for CRs classified as Major. The results of the investigation are disseminated to affected functions, QA conducts follow-up of Major CRs to assess implementation and effectiveness of corrective action. A log is kept of CRs which is periodically reviewed for trends.

Trends are evaluated during the periodic management review meeting.

Page 16 of30 QSM-1, Rev.15

Any required 10 CFR.Part 21, Medical Device Reporting or other applicable regulatory reporting requirements made will be documented and notifications made in accordance with regulatory requirements.

14.1 Handling. Storage. Preservation and Delivery Procedures are established for ensuring that product throughout the business process is handled and stored in ways that preserve the product quality.

14.2 Handling Personnel handling product will work to prevent damage or degradation of the quality of the product during processing. This includes:

  • Maintaining identity and traceability as required
  • Cleaning
  • Preventing, detecting and removing of foreign objects or contamination
  • Special handling as appropriate for the product 14.3 Storage and Preservation Designated stock areas will be maintained for the storage of product. Control will be maintained of:
  • Inspection prior to stocking
  • Receipts to stock
  • Identity and traceability as required
  • Prevention of damage or degrading of quality
  • Suitable environment for storage
  • Release from stock Product that may degrade from age will be rotated and assessed as appropriate.

14.4 Labeling As applicable, labeling activities will be controlled and inspected for accuracy prior to release. Labeling for medical products is subjected to an inter-disciplinary review to verify technical accuracy and suitability for use.

14.5 Packaging Items are placed in suitable packaging for the product. The packaging will protect the item from damage or alteration during normal transport. All packaging will conform to appropriate regulatory requirements for the product.

14.6 Delivery Products will be delivered to the end user with all appropriate documentation, eg.

manuals, certifications, etc. Delivery will be accomplished using appropriate transportation to ensure integrity of the product and to ensure compliance with established regulatory requirements. Records are maintained of the distribution.

1s.1 Control of ouality Records Procedures are established for identification, specifying retention periods, collection, indexing, access, filing, storage, maintenance and disposition of quality records.

Page 17 of30 QSM-1, Rev.15 L

15.2 General Quality records are maintained to demonstrate conformance to requirements and effective operation of the quality system. Records may be any type, such as hard copy or electronic media.

Records include pertinent quality records from suppliers. Quality records will be retained such that records are readily retrievable and readily accessible to authorized personnel and auditors. Where contractually required, records are available for customer evaluation for an agreed period.

Retention times of records are established and recorded. Records will be retained in a suitable environment to prevent damage, deterioration and loss.

15.3 Medical Device Records A quality system record, device master record and device history file will be established and maintained as applicable.

16.1 InteruaJ Audits Procedures are established for planning and implementing internal quality audits. Audits are carried out to verify whether activities and related results comply with planned arrangements and to determine the effectiveness of the quality system.

Quality Assurance is responsible for:

  • Planning and scheduling internal audits
  • Assignment of lead auditors
  • Review and approval of audit plans, checklists and reports
  • Determination of follow-up actions
  • Reporting internal audit results for management review 16.2 Process Audits will be scheduled on the basis of status and importance. Personnel, independent of those having direct responsibility for the activity being audited will cany out the audits.

The results of the audit will be recorded and reviewed with personnel having responsibility in the area audited. The responsible manager will determine and initiate corrective actions in a timely fashion.

Follow-up audit activities will be conducted as required to verify and record the implementation and effectiveness of the corrective actions.

Internal audit results will be presented and reviewed at management review.

11.1 Training Procedures are established to identify training needs, control training requirements, verification of training and qualifications. Training activities are developed and implemented to ensure individuals have the requisite knowledge and skills to perform their assigned tasks competently.

Page 18 of30 QSM-1, Rev.IS

17.2 General Training of staff is operations (task) based. An operation may encompass a number of procedures and may span disciplines.

Training required for the operation is determined and documented by an SME (Subject Matter Expert) and functional managers, and usually is of two types:

  • Awareness. Familiarization with procedures that do not have a direct effect on the operation but provide information and guidance. Testing is usually not required to satisfy the training.
  • Verification. Training that has a direct effect on performing the operation.

Testing or other methods of evaluation are required to verify satisfactory completion of the training.

When applicable as required by license, standards, or regulations, qualification for a specific task is provided in accordance with the governing standard to ensure competency (e.g. welding, non-destructive examination, etc.).

Functional managers are responsible to ensure that irn;lividuals they are responsible for are trained for the operations assigned.

Training will be documented and become part of the employee's training record.

SME's may provide training. When used, manner and method of testing is under the control of the SME and functional managers.

All individuals involved in operations will be trained before performing that operation (task) independently. Individuals will be made aware of the relevance and importance of the activity in meeting the quality objectives. Individuals will be made aware of potential defects tliat could result from improper performance of process.

18.1 Servicing and Installation Procedures are established for servicing and installing equipment manufactured or distributed by QSA Global, Inc. The Cleanliness, Installation, and Servicing provisions ofISO 13485, section 7.5.2, 7.5.3, and 7.5.4 do not apply to medical devices manufactured under contract by QSA Global.

18.2 Servicing Service activities will be adequately documented through controlled procedures, instructions or drawings appropriate to the quality and safety significance of the product.

Required service inspections will be identified with their frequency. Inspection results will be documented.

Findings which are not due to normal wear or clear accident conditions should be reported to Engineering for evaluation and trending.

Page 19 of30 QSM-1, Rev.15

18.3 Installation Where required, installation of product will be controlled by instructions or specifications. Any required testing is performed and documented to demonstrate proper installation.

19.0 Statistical Techniques Procedures are established as needed for controlling statistical techniques.

The use and extent of statistics will be determined by the process and/or item under study. This determination will be made by qualified personnel. Detennination of specific methods and their application will be documented. All documentation will be checked by a competent individual other than the author.

Analysis derived from application of said statistics will be used to detem1ine actions taken as detennined by the SME (subject matter expert).

20.1 Process Monitorine;, Measurement & Continual Improvement Procedures are established for managing Continual Improvement of the quality of QSA Global products, and/or the efficiency and effectiveness of our processes.

20.2 Customer Satisfaction Measures are established to collect and analyze information relative to meeting customer expectations. These measures are documented, and records of analysis maintained.

20.3 Analysis of Data Key quality indicators will be identified and measured. Input may be obtained from, but not limited to:

  • Non-confommnce reports
  • Customer feedback, internal or external
  • Quality records
  • Internal and external audit reports
  • Corrective and preventive action reports.
  • Design reviews & design change requests
  • Management r~views
  • Any other sources of information relating to the quality of products, or process efficiency and effectiveness.

Page 20 of30 QSM-1, Rev.15

Trends of agreed upon indicators or objectives will be analyzed and documented.

Results of trend analyses will be reported to management for review. The selection of indicators is designed to provide information relative to:

  • Conformance of product to requirements
  • Supplier performance
  • Process trends including opportunities for preventive action
  • Assessment of customer satisfaction
  • Progress towards meeting quality system objectives Management reviews make use of these analyses to identify and recommend actions to be taken to improve quality system performance.

21.0 Project Management Procedures are established to describe the methods for Project Management.

A determination will be made as to whether a new process will be managed as a project or whether it can be managed in accordance with standard business processes and procedures (e.g. Process Plans).

Once it has been determined that the process will be managed as a project, a Project Manager will be assigned. The Project Manager will establish a project tean1 with specific functions assigned to the team members. Key activities, tasks, and deliverables will be established. The project schedule and costing will be compiled.

Periodic project review meetings will be held with key members of the project team.

Minutes of these meetings will be published to record key actions, status, and decisions.

The Project Manager is responsible for the project schedule and costs.

22.1

  • sareo: Pro~rams Programs are implemented to develop, maintain, review and improve safety at QSA Global. The safety programs include Radiation Protection and Occupational Safety.

22.2 General Operational risks and requirements with respect to health and safety are identified and documented and will provide the basis for program design. Safety programs are designed to control the hazards identified, and incorporate policies, procedures, and standards to ensure compliance.

Roles and responsibilities of functional groups and individuals with respect to safety programs are identified in the programs. Workers are trained in the content of safety programs, including policies, procedures and standards, with specific training commensurate with individuals' tasks.

Audits are periodically conducted to evaluate whether safety policies and procedures are being followed. Safety reviews are applied to the design of new or modified facilities or equipment to include all necessary safety features.

Page21 of30

Information systems are established to provide documentation and demonstrate compliance and allow for tracking and trending to measure performance. Appropriate references are periodically reviewed to identify new regulations or proposed changes to existing regulations; safety programs are updated in a timely manner to reflect such changes.

Page 22 of30 QSM-1, Rev.IS

Appendix A - Requirements Cross Reference of OMS to Standards & Be2ulations

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Quality Policy 1.1 5.2 1.2 -- 5.3 -- All 3.2(a)

Responsibilities / Organization 1.3 5.3 71.103 1.1 I 820.20 5.5.1 -- All 3.2(b)

Quality System 1.4 4.4 71.105 2 II&V 820.20 4 &4.1 32 AII&V Instructions, Procedures & Drawings 4.0 7.5 71.111 5 V 820.20 4.2 32 All 3.2 Management Review 1.5 9.3 71.105 -- 11 820.20 5.6 32 AII 3.2(b)

Contract Review 2.0 8.2.3, -- -- -- 7.2.2 26 --

8.2.4 Design Control 3.0 8.3 71.107 3 III 820.30 7.3 9-20&34 Atticle 9 AIi 3.2(c) &

4 Document & Data Control 4.0 7.5.2, 71.113 6 V&VI 820.40 4.2.4, 32 --

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7.5 Purchasing 5.0 8.4 71.109 4&7 IV &VII 820.50 7.4 9 AII 3.2(d) 71.115 Control of Customer Supplied 6.0 8.5.3 -- -- -- -- 7.5.10 -- --

Product Product Identification & Traceability 7.0 8.5.2 71.117 8 VIII 820.60, 65, 7.5.8& 52-56 AII 3.2(d)

& 120 7.5.9 Process Control 8.0 8.5.1 71.119 9 IX 820.25 & 70 7.5.6 17 All 3.2(d)

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Page23 of30 QSM-1, Rev.15

Appendix A - Regyirements Cross Reference of OMS to Standards & Regylations

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& 11 71.123 Control of Measuring & Test 10.0 7.1.5 71.125 12 XII 820.72 7.6 32 AII 3.2(b)

Equipment Inspection and Test Status 11.0 8.5.2, 71.129 14 XIV 820.86 7.4.3 & 32 AIi 3.2(b) 8.6 7.5.9 Control ofNonconforming Material 12.0 8.7 71.131 15 xv 820.90 8.3 32 AU 3.2(b)

Co1Tective & Preventive Action 13.0 10.2 71.133 16 XVI 820.100 8.5.2 57, 59, 63- Article 10 &

65 19 All 3.1 Handling, Preservation, Storage, and 14.0 8.5.4 71.127 13 XIII 820.130 to 7.5.11 14, 52-56 --

Delivery 820.160 Conh*ol of Quality Records 15.0 7.5.3 71.135 17 XVII 820.180 4.2.3, 55 AU 3.2 &

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7.3.10 Internal Audits 16.0 9.2 71.137 18 XVIII 820.22 8.2.4 32 --

Training 17.0 7.3 71.105 2 II 820.25 6.2 32 --

Servicing & Installation 18.0 8.5.1 -- -- -- 820.200 7.5.3 & 32 --

7.5.4 Statistical Techniques 19.0 9.1.1 -- -- -- 820.250 8.2.5 & -- --

8.2.6 Page24 of30 QSM-l,Rev.15

Appendix A - Requirements Cross Reference of OMS to Standards & Regulations TypeB Sources Transport Packages Medical Devices Reactor QMS Element Description

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Appendix B - Quality Management System Implementing Procedures NRC Position Procedure Title Description RG7.10 1 QSM-1 Quality System Manual Overall description of business, functional organization, and quality assurance program.

QMP-1000 Management Review Describes the process for periodic management assessment of the effectiveness of the quality system.

QMP-2900 Continual Improvement Describes the management oversight of the systems and processes affecting the effectiveness of quality system implementation.

2 QMP-2600 Training Establishes the framework for training and qualification of persom1el involved in activities affecting quality.

.) QMP-1200 Design Control Establishes and maintains the method to conh*ol and verify the design of new products to ensure the specified requirements are met.

4 QMP-1400 Purchasing Describes the requirements for ensuring the quality of procured materials and/or services conform to specified requirements.

5&6 QMP-1300 Document & Data Control Describes the requirements for the control of documents and data pertinent to the quality management system.

7 QMP-1400 Purchasing Describes the requirements for ensuring the quality of procured materials and/or services conform to specified requirements.

8 QMP-1600 Product Identification and Describes the requirements for identification and control of materials, parts, and Traceability components.

9 QMP-1700 Process Control Desc1i.bes the methods for production process control.

QMP-1500 Customer Supplied Product Establishes controls for handling and processing customer owned products and components.

QMP-2700 Servicing Establishes the requirements for servicing and maintenance of product subsequent to manufacture and delivery.

Page 26 of30 QSM-1, Rev.15

A;guendix B Oualitv Management S;fstem Im,glementing Procedures NRC Position Procedure Title Description RG7.10 10& 11 QMP-1800 Inspection & Testing Describes the inspection and testing activities for products, materials and services (units) verifying that they meet the specified requirements.

12 QMP-1900 Control of Measw-ing & Test Describes the method for control of measuring and test equipment, and key process Equipment equipment.

13 QMP-2300 Handling, Storage, Packaging, & Describes the requirements for assuring that product throughout the business process Delivery will be handled and stored in ways that preserve the product quality.

14 QMP-2000 Inspection & Test Status Descnbes the methods used to assure the Inspection, Test, and Operating Status of materials, parts, and products is identified and maintained.

15 QMP-2100 Control ofNonconf01ming Material Describes the methods to control materials, parts, and components that do not conform to specified requirements in order to prevent use.

16 QMP-2200 Corrective and Preventive Actions Describes the requirements of a system for documenting, investigating and implementing Corrective and Preventive Actions.

17 QMP-2400 Control of Quality Records Describes the requirements for identification, collection, indexing, access, filing, storage, maintenance and disposition of quality records.

18 QMP-2500 Internal Quality Audits Describes the requirements for planning and implementing internal quality audits.

-- QMP-1100 Quotation Managem.ent & Contract Establishes the process for identifying the product requirements and transfer into the Review production processes.

-- QMP-2800 Statistical Techniques Applies to the use and documentation of statistical techniques used in production, design and service.

-- QMP-3000 Project Management Describes the methods for project management at QSA Global, Inc.

Page27 of30 QSM-1, Rev.15

A1212endix B-Oualit:f Mana2ement Svstem Im12Iementin!! Procedures NRC Position Procedure Title Description RG7.10

-- QMP-3100 Safety Programs Describes the method for developing, maintaining, reviewing and improving safety programs at QSA Global, Inc.

-- QMP-3200 Contract Manufacturing Desciibes the requirements for executing contract manufacturing activities.

QMP-3700 Risk Management Describes the process for managing Iisk under the quality management system (QMS)

Page 28 of30 QSM-1, Rev.IS

ALluemlix c - Key Process Model Management Pnx:esses (Pl1111n1na - Fac:llltlas - ,"!urri~n R!sources -Goats g* o~Jiiictiv~,,- llonltomg'J

.Product *oelive*ry- Sub.-Proc:989GB Sentinel lndustt1&1 QSA Global Satisfy Customer Sources Quality Product Realization Needs Medical Produms Ragulafmy Quality Control Heallh &Safely ApPfQWll&I Quality Assurance Services Page 29 of30 QSM-1, Rev.IS

A1mendix D- Summary of Changes to Prior Revision Section I Paragraph Description of Change Cover page Updated company logo, updated VPGM name Table of Contents Updated to create linked entries Section 1.1, page 1 Updated Quality Policy statement Appendix A Removed reference to Reg Guide 6.9 (no longer applicable)

AppendixB Removed reference to Reg Guide 6.9 (no longer applicable)

Appendix B, page 28 Added Risk Management QMP-3700 to table Throughout Various grammatical and clerical corrections Page 30 of30 QSM-1, Rev.JS

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