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ZQA-001Zetec Quality Assurance ManualRevision MQUALITY ASSURANCE MANUALZQA-001Revision MSuccessful implementation of the requirements defined in this Quality Assurance Manual requiresthe concerted effort of all Zetec employees since everyone contributes to the quality of our productsand services. We are committed to this quality program and to improving its effectivenesswhenever possible.Reviewed By:Electronic approval on fileElectronic approval on fileElectronic approval on fileShane CampbellFrédéric LapriseSteve KingmaVice President, Supply Chain &OperationsUT Business Unit and GeneralManager – CanadaVice President, FinanceElectronic approval on fileElectronic approval on fileElectronic approval on fileTravis Ness,Marissa BusbyKevin NewellDirector, After Market ServicesDirector, Human ResourcesPrincipal NDT Level IIIElectronic approval on fileElectronic approval on fileElectronic approval on fileDiane LawsonGhislain CournoyerRey TaningcoVice President, VP, ET AdjacentBusiness, QualityManager, Quality Assurance –QuébecQuality System Manager,SnoqualmieApproved By:Electronic approval on fileWayne WilkinsonPresidentThis Manual Expires 5 Years from Last Approved By DatePage 1 of 30

ZQA-001Zetec Quality Assurance ManualRevision MREVISION 019J21-Dec-2016H19-Jul-2016G9-Sep-2014Description Removed calibration standards and services from scope of safety-relatedproducts (table 2.1) Added NQA-1 to table 2.3 Removed NQA-1 and 10 CFR 50 from 2.3.4. Removed references to QAS-0023-PR-Z from 4.2.2 Removed portions related to safety-related procurement (4.3, 7.3.2) Specified versions of ISO 9001:2015, ISO/IEC 17025:2017 and NQA-1-2015in all sections Clarified 1.3.4.b and 1.4.1 Updated site activities in table 2.1.1 and replaced “ProfessionalDevelopment” with “Technical Training” Specified version of NQA-1 used by Zetec, i.e., 2015 (sections 2.3 and 18.4) Removed examples from 7.3.1 Changed “Product Support inspection” to “in-plant audit” in 18.1 and 18.3. Updated section 28 (High-level Process Diagram) so that group labels arebetter aligned with Zetec’s organization structure. Replaced SCM-1001-PR-Q with SCM-1019-PR-Q Removed reference to HRS-1006-PR-Q Added reference to COP-0010-PR-Z To modified section Changed the sentence which states that Zetec'squality system is based on CAN-N299.2/.3 to Zetec's quality system is basedon ISO 9001 and ISO/IEC 17025. Manufacturing according to CAN N299.2/.3is available upon request. Added 19.4 (new section on I&TP) Added column to table 2.1.1 to identify safety-related products/servicesprovided by each site. Modified 4.2.2 to include a reference to QAS-0023-PR-Z (CommercialGrade Dedication for Calibration and Testing Labs). Modified process map to account for change to ISO 9001 structure. Replaced reference to N45 with NQA-1 General updates to comply with the 2015 edition of ISO 9001. This includesthe addition of sections 1.1, 1.2, 2.1.2 and 2.2.1. Replaced reference to Reg Guide 1.83 with NEI 97-06 (in section 2.3.2). Updated 25.1.1 to be consistent with TRN-101. Added Principal NDE Level III responsibilities to section 25.1. Clarified 3.2 Update references to related documents. Streamlined manual to reduce duplication of information available inprocedures. Updated section 6.3 to remove the requirement for distribution ofcontrolled copies of the Quality Manual. Removed quality records table from section 17.3 and replaced it withreference to QAP-105. Updated all referenced documents.Page 2 of 30Updated byRey TaningcoRey utzmanNancyStutzmanNancyStutzman

ZQA-001Zetec Quality Assurance ManualRevision Nov-2008Description Added Mission and changed Vision (page 5) Modifications in functions throughout the manualoAdded Quality Assurance ManageroVP of Engineering replaced by VP of each business unitoCalibration Laboratory changed to After Market ServicesoField Service and Field Applications to Product Support Updated to reflect Internal group interactions (section 2.2.4) Added compliance to RCC-M standard (, 25.1.13) Added compliance to ACCP standard (, 24) Organizational updates (2.2.3, 21.1.3) Updated procedure referencesoPDP to COP-006oSHP-023 to OPP-10200 Updated external release statement (6.2.2) Updated Table 17-1 Records Retention Modification of paragraphs in sections (8.1, 16.1, 17.1) Zetec Quality Policy – updated to support ISO/IEC 17025 reqmts Added Table 2.1-1 to support CAN3-Z299.2 requirements Updated to reference CAN3-Z299.2/.3 Section – changed FSP-301-QA to FAP-008 Sections 4.3.9, 7.3.5 – changed PUR-001 to OPP-10205 Sections 5.1.4, 5.3.1 – updated references to QAP-020 Section 5.3.3 – corrected COP-002 reference Section 10.2.2 – changed ESCOP-1004 to QAP-013 Added Section 25, Referenced Documents (Internal, External) Section 12.1.1- added ref to 01-1005 “Zetec General Mfg WorkmanshipStds” in lieu of defining equipment cal ID reqmts (CAR 805). Updated 1.1.1to ref Quality Mgmt Rep (CAR 864). Section – deleted statement about NDT/NDE program conformingto ISO/IEC 17025 requirements. Zetec’s ISO/IEC 17025 registration coverscalibration laboratory activities only. Section 2.7 (Procedures) – moved to 5.1.4, 5.1.5 Section 2.8 (Maint of the Quality Manual) – moved to 6.3.1 Section 5.2 – updated to reflect current organization Sections 5.3.2, 5.3.3 – added Section 5.2.6 moved to 5.2.2; 5.2.7 moved to 5.2.3; 5.2.8 moved to 5.2.2;5.2.9 moved to 5.2.4 Changed Field Services to Field Applications Replaced references to QAP-051 (Document Control) with COP-001; 011006 (Zetec General Drafting Standards) replaced with COP-002; CCS-013(Calibration Standard Raw Matl Receipt Acceptance) replaced with ESCOP1004. Changed to alphabetic revision to accommodate IFS Updated Zetec Vision Added “PDP Lite” to section 3.3.1 Updated document refs in sections 3.4.1, 10.2.3, 13.2.4 (note), 15.2.1,16.3.3, 16.4.2, 16.4.3, 18.3.4, 18.5.1,, 19.2.2 General wording clarifications in sections 5.3.5, 12.1.1, 18.5.1, 23.1.3,23.1.4 Added section 16.1.5 Section 17.3.3 and Table 17-1 – updated employee file retention period tomatch Roper guidelines Added Section 23 Note.Page 3 of 30Updated byR. Kelso &K.BolducD. WoodD. WoodDiane Wood

ZQA-001Zetec Quality Assurance ManualRevision MRevisionDate130-Nov-2006031-Mar2006Description Clarified the Quality Policy re ISO/IEC 17025:1999 requirements Section 2.1.1 -- clarified inclusion of Zetec sites, U.S. & Intl Updated org assignments per current Zetec org. Changed use of“department”, “team” and “group” to “Organization”. Added sections 4.3.9 and 7.3.5 -- PO wording for nuclear safety relatedproducts and services Added section 16.3.1 -- ref Triage and RCA processes Added section 18.4.3 – ref to supplier approval & audit processes Sections 9.2.3 and 23.2.1 -- consolidated references to personnelqualification processes Added Section 24 (Acronyms)Supersedes Snoqualmie Quality Manual Z-QA Rev. 22, Quebec Quality ManualRev. E and Deep River Quality Manual Rev. 3. Updated to document QualityManagement System processes for all 3 sites.Page 4 of 30Updated byDiane WoodDiane Wood


ZQA-001Zetec Quality Assurance ManualRevision MZETEC VISIONZetec is the company that customers and industry rely upon for complex, high-criticalityengineered NDT solutions.ZETEC MISSION STATEMENTDeliver effective high-value innovative NDT solutions that enhance safety in mission-criticalenvironments.ZETEC QUALITY POLICY Zetec is committed to The Inspection Advantage by providing products and services that meetor exceed customer expectation of quality, reliability and value. Zetec strives to continually improve the effectiveness of the Quality Management System andcomply with industry standards. Zetec provides its employees with the resources necessary to achieve superior quality andexpertise; including training to ensure successful implementation of policies and procedures.This quality policy has been issued under the authority of Top Management and is supported byQuality Objectives. The overall Quality objectives established are reviewed during managementreviews.Everyone at ZETEC recognizes their responsibilities to the Quality Management System; including theapplication of good professional practices, familiarizing themselves with quality documentation andimplementing policies/procedures in their work.DEFINITIONSNote: Quality terms used in this manual are defined in ISO 9001:2015 and 10CFR50 Appendix B. Quality AssuranceRefers to the Zetec organization responsible for overseeing theZetec Quality Management System. Quality Control/InspectorQuality Control or Quality Inspectors are those persons taskedwith conducting formal inspections to ensure compliance withproduct specifications on incoming or Zetec-built products. Quality Management SystemRefers to the collective set of quality related processes used atZetec. Also sometimes referred to as the “Quality AssuranceProgram”.Unique terms used in this manual are defined as follows. A complete acronym list is included inSection 26. Eddy Current, UltrasoundSpecifically applies to the NDT applications.Page 6 of 30

ZQA-001Zetec Quality Assurance ManualRevision M Product SupportServices which are performed by Zetec Product Support personnelprimarily involving acquisition and/or analysis of eddy current orultrasound data. Additionally, Product Support may involvetraining or calibration/repair of Zetec manufactured equipment.Product Support activities are typically performed at thecustomer's facility although analysis of eddy current data may beperformed at Zetec. Nuclear Safety RelatedNuclear Safety Related includes a structure, system or componentthat affects the safety function necessary to assure: the integrity of the reactor coolant pressure boundary; the capability to shut down the reactor and maintain it in asafe shutdown condition; the capability to prevent or mitigate the consequences ofaccidents which could result in offsite exposures.1.ORGANIZATION1.1.Zetec has processes in place to assess and plan the business strategically and tactically.1.1.1.The president, the leadership team and key stakeholders perform a strategicreview of all aspects of the business once a year to assess operationalstrengths, weaknesses, opportunities and threats.Risk assessments are performed throughout the exercise to assess risks relatedto competition, product lifetime, NDT product market share, etc. Riskassessments also identify what is needed to counter these potential threats toensure Zetec’s ability to satisfy interested parties and most importantly toidentify factors that may adversely affect the stability of the QualityManagement System.1.1.2.Once the review and assessments are done and needs and expectationsunderstood, strategies and tactics are defined. Strategies and tactics mayapply, but are not limited to, products, markets, and productivity.Outcomes of this exercise are used to plan the evolution of the company byidentifying internal needs such as human resources, material resources,infrastructure requirements, processes, markets and regulatory/statutoryrequirements. All objectives are separated into each applicable department andare then managed by the associated department directors and managers.Review of these objectives is performed at planned intervals.1.2.Zetec understands the needs and expectations of relevant parties.1.2.1.Zetec will identify relevant interested parties and monitor their satisfaction.This is done to ensure Zetec meets or exceeds their expectations and preventconditions that could negatively impact both internal and external customers.Page 7 of 30

ZQA-001Zetec Quality Assurance ManualRevision MInterested partyNeeds and expectationsExternal customersHigh quality, on-time delivery, quickresponses and support, reasonable pricingCustomer surveys, warrantyrequests, complaintsSuppliersReasonable payment terms, partnerrelationships, clear and complete RFQs andPOsComplaints, contracts,partnershipsShareholdersMeet operating profit and gross margingoals, provide inventory controlsFinancial reviews, inventoryreviewsEmployeesProfessional development, professionalworking relationships and clean and safework environmentQuality objectives, performancereviews, training plansLegal entitiesISO standards, environmental standards,regional standardsCertifications, declarations1.3.Monitoring, reviewingResponsibility1.3.1.The President has primary responsibility for all facets of the operation of Zetec,Inc., including quality assurance. The President has delegated theimplementation of the quality assurance program to the Quality AssuranceManagers. Any change or revision to the plan requires the written approvaland acceptance of the President.The Quality Managers also act as the Zetec Quality ManagementRepresentatives, and are responsible for: that processes needed for the Quality Management System(QMS) are established, implemented and maintained, to top management on the performance of the QMS andany need for improvement, the promotion of awareness of customer requirementsthroughout Zetec, and1.3.1.4.Acting as liaison with external parties on matters related to the ZetecQMS.NOTE: The President is responsible for noncompliance notification applicableunder 10 CFR Part 21. Refer to COP-0108-PL-Z (Reporting of Nuclear RelatedSafety Hazards) for additional information.1.3.2.The Quality Assurance Organization is responsible for implementing Zetec’sQuality Management System and ensuring continued compliance of the systemwith applicable standards and requirements.Page 8 of 30

ZQA-001Zetec Quality Assurance ManualRevision M1.3.3.The responsibilities of employees whose work affects quality are defined intheir job descriptions which are maintained by the Human ResourceOrganization. All employees are responsible to meet the quality practices andgoals of the department(s) they support. employees have complete authority to:a. Immediately stop practices which are unsafe or outside of approvedprocedural limits.b. Notify their supervisor and/or any Quality Assurance representative of anynonconforming/questionable item.c. Halt shipments of products known to be defective or known to have beenproduced without using the proper Zetec procedures.Organization Details1.4.1.2.The company organizational charts are maintained by Human Resources.QUALITY MANAGEMENT SYSTEM2.1.Scope and Application2.1.1.The scope of the Quality Management System includes all Zetec facilitiesinvolved in the design, production, delivery and/or calibration and repair ofNDT products and services. See Tables 2.1-1 and 2.1-2 for details.2.1.2.The goal of the Quality Management System is to ensure all strategic activitiesare designed and implemented to meet or exceed requirements of all parties,eliminate nonconformances, and foster continuous improvement.2.1.3.Measures are to be taken to ensure that services, equipment and other itemssupplied to or performed for customers by Zetec shall conform to the specifiedquality levels of applicable codes, standards, regulatory criteria and purchaseorder specifications. Monitoring, measurement and analysis are used,whenever practical, to demonstrate conformity and quality managementsystem effectiveness.Page 9 of 30

ZQA-001Zetec Quality Assurance ManualRevision MTable 2.1 Activities by SiteSiteSite Main ActivitiesNuclear safety relatedactivitiesSnoqualmie, WA, USADesign, Manufacturing, Purchasing,Sales, Human Resources, Quality,Service, Product Support, EngineeringApplications, Technical TrainingNDT personnel servicesQuebec City, Quebec,CanadaDesign, Manufacturing, Purchasing,Sales, Human Resources, Quality,Service, Engineering Applications,Technical TrainingNoneParis, FranceSales, ServiceNoneSeoul, KoreaSales, ServiceNoneShanghai, ChinaSales, ServiceNoneHouston, TX, USASalesNone2.2.Responsibility2.2.1.Zetec management (President, Vice presidents, Directors and Managers) isresponsible for the following: responsibility for the effectiveness of the quality managementprocess. the quality policy is aligned with the company’s strategicdirection. quality objectives align with the quality policy, theorganization and its context, and needs of interested parties. the quality policy is established, communicated andunderstood. quality activities achieve planned results. the integration of all applicable standards and requirementsin their processes. the use of the process approach and risk-based thinking2.2.1.8.Ensuring the availability of resources needed for the qualitymanagement system2.2.1.9.Communicating the importance of complying with qualitymanagement system requirements. Promoting quality processes by engaging, directing and supportingtheir employees2.2.1.11. Promoting improvementPage 10 of 30

ZQA-001Zetec Quality Assurance ManualRevision M2.2.2.The Quality Assurance Organization is responsible for:a. Ensuring the processes needed for the Quality Management System areestablished, implemented and maintained.b. Reporting to the President and other managers on the performance of theQuality Management System and any need for improvement.c. Updating quality controls as necessary and ensuring that personnel assignedto “quality” functions are trained in the assigned function.d. Ensuring that inspectors, when performing an inspection function, shall notinspect their own work.2.2.3.Each manager is responsible for identification and acquisition of the personnel,technology, and material resources needed to meet or exceed Zetec’s qualitystandards.2.2.4.Each Vice President, Manager and Supervisor shall ensure that appropriatecommunication processes are established within Zetec and thatcommunications include quality issues and customer expectations. Theapplicable Vice President of each Business Unit is responsible for the evaluationof requests for new products.2.2.5.Each department within the organization is responsible to create and maintainprocedures and/or work instructions that describe department activities andreference interactions with other departments (where applicable). Business Unit shall monitor customer perceptions related to whetherZetec products and services meet their requirements. Product Management,along with Sales, will determine the best methods for obtaining thisinformation.References/Standards2.3.1.Quality Management System2.3.1.1.The Quality Management System is certified to ISO 9001:2015 andaccredited to ISO/IEC 17025:20172.3.1.2.The quality system also complies with Federal Regulation 10 CFR Part50 Appendix B, 10 CFR Part 21 and applicable sections of NQA-12015. quality system includes provisions to comply with applicableportions of N299.3-19Page 11 of 30

ZQA-001Zetec Quality Assurance ManualRevision MTable 2.3 Quality Standard Applicability by SiteSiteApplicable Quality StandardSnoqualmie, WA, USA10 CFR 50 Appendix B, ISO 9001:2015, ISO/IEC 17025:2017, 10 CFR21, NQA-1-2015, N299.3-19Quebec, Quebec, CanadaISO 9001:2015, ISO/IEC 17025:2017, N299.3-19Paris, FranceISO 9001:2015, ISO/IEC 17025:2017Seoul, KoreaISO/IEC 17025:2017Shanghai, ChinaNoneHouston, TX, USANone2. Testing2. Quality Plans may be initiated if needed to satisfy uniquecustomer requirements.Non-destructive testing procedure requirements are based onSection XI of the ASME Boiler and Pressure Vessel Code and/or therequirements of the NEI 97-06 and/or other particular specifications(i.e., ASNT/ACCP, CGSB, etc.). Acceptance standards shall be thoseapplicable to a given project.NDT Personnel Certification2.3.3.1.Certification of nondestructive testing personnel is based on theguidelines of the American Society for Nondestructive Testing“Recommended Practices for Nondestructive PersonnelQualifications and Certification”, SNT-TC-1A. certification program also satisfies the requirements ofANSI/ASNT CP-189, except that ASNT certification is not required forZetec Level III personnel. safety and protection is based on Federal Regulation 10CFRPart 20 and US NRC RG Division 8 (8.7). performing nondestructive testing shall comply with thequality requirements defined in procedure APM-3008-PR-S, FieldApplications Quality Assurance Requirements.Equipment Calibration2.3.4.1.The Zetec calibration program is committed to meeting therequirements of ISO/IEC 17025:2017. calibration program guidance is further described inprocedure SLP-0001-PR-Z, General Requirements for Service andCalibration.Page 12 of 30

ZQA-001Zetec Quality Assurance ManualRevision M2.4.Resource Management2.4.1.General Resources2.4.1.1.Resources must be provided to implement, maintain and continuallyimprove the Quality Management System. Also, resources must beprovided to enhance customer satisfaction by meeting theirrequirements. infrastructure needed to achieve product and servicerequirements shall be provided. Infrastructure includes buildings,workspace, process equipment and supporting services (IT, safety,security and maintenance). work environment needed to achieve product and servicerequirements shall be provided.Work environment applies to facilities (temperature, humidity,lighting, etc.) and human conditions (social, psychological andphysical aspects). The human resources department and the healthand safety committee ensure that these latter aspects are addressed. should be aware of the relevance and importance of theiractivities and how they contribute to the Quality ManagementSystem. descriptions should be documented and revised as necessary todefine necessary personnel competence. must be competent to perform assigned work based oneducation, training, skills and experience. Note: Effectiveness oftraining is verified as necessary. records shall be maintained. This includes informationsuch as education, training, skills and experience. Refer to COP-0010PR-Z (Training Records Procedure).Continuous Improvement2.5.1.Continuous improvement shall be a goal of the Quality Management System.2.5.2.Management Review of the Quality Management System shall typically beperformed annually. The goal of the Management Review is to assessopportunities for improvement by analyzing data collected though keyperformance indicators, non-conformance, suppliers monitoring and customerssatisfaction surveys. Other goals like the need for changes to the system,including the quality policy and quality objectives are also take intoconsideration. The review shall be performed in accordance with QAS-0049-PRZ (Quality Management System Management Review).Page 13 of 30

ZQA-001Zetec Quality Assurance ManualRevision M2.6.Customer Interface2. Communications -- Effective customer communications must beestablished as follows: Business Unit leader provides product information and obtainscustomer feedback. Refer to SLS-0001-PR-Z (Customer SatisfactionFeedback Procedure) Customer Service Organization handles customer inquiries. Customer service team manages the customer complaint. Whenapplicable, the corrective and preventive action process is engagedwith the Quality Management team to ensure customer issues areaddressed and corrected. Refer to COP-0111-PR-Z (CustomerComplaint Triage Process).Customer Review/Audits2.6.2.1.Zetec shall afford customers or their representatives the opportunityto clarify the customer’s request and monitor work performed. access will be provided to all relevant areas of Zetecfacilities. Confidentiality of other customers’ information shall bemaintained.DESIGN CONTROL3.1.Design control shall apply to all Zetec-designed or modified products provided by Zetec toan external customer.3.2.Responsibility3.2.1.The product managers are responsible for defining product requirements(Voice of the Customer, functional, regulatory, statutory, etc.)3.2.2.The Leader of each Business Unit is responsible for approval of new productproposals.3.2.3.Engineering is responsible for developing products that meet requirementsidentified by the product managers and approved by Business Unit leaders. is responsible for selecting product components that meetregulatory requirement like CE, RoHS, CSA and other country specificrequirements.New Product Design Control3. of the design of a new Zetec product is defined in COP-0006-PR-Z(Product Development Procedure).Established Design Change Control3.4.1.Control of changes to established electrical and mechanical, software andfirmware designs are defined in ENG-3003-PR-S (Configuration and ChangeManagement) and ENG-1000-PR-Q (Request and approval of a technical changePage 14 of 30

ZQA-001Zetec Quality Assurance ManualRevision M(CR) which establishes change identification, documentation, review andapproval requirements.4.PROCUREMENT/PURCHASING DOCUMENT CONTROL4.1.Purchase of parts and materials used in the manufacture of Zetec products are controlled.Zetec services, including services used in the manufacture of Zetec products (e.g.,calibration services, EDM services, etc.) are also controlled.4.2.Responsibility4.2.1.The Procurement/Purchasing Department has primary responsibility forestablishing and implemen

Sep 02, 2020 · Zetec Quality Assurance Manual Revision M Page 1 of 30 QUALITY ASSURANCE MANUAL ZQA-001 Revision M Successful implementation of the requirements defined in this Quality Assurance Manual requires the concerted effort of all Zetec employees since everyone contributes to the quality of our products and services.

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