/** * ISO 9001:2015 seed for clause_library. * Generated from the QRS Form 04-2a Word reports (Stage 1 readiness list and * Stage 2 / Surveillance / Recertification clause table). * Readiness rows whose Word label is "General" are stored as GEN-1..GEN-4 with title="General" (codes must be unique). * default_evidence = the ORIGINAL objective-evidence wording from those reports (company-specific names, document numbers and * non-conformity text removed). It is what the report shows when an auditor marks a checkpoint C. * Format: lines starting with "• " are bullets, **text** is bold (same as the Word reports). * Re-seeding is safe: existing rows are never overwritten; an empty default_evidence is filled in. */ export interface SeedRow { group_key: 'clause' | 'performance' | 'risk' | 'feedback' | 'statutory'; code: string; heading: string; title: string; requirement: string; default_evidence?: string; } export const ISO9001_FULL_CLAUSES: SeedRow[] = [ { "group_key": "clause", "code": "4.1", "heading": "Clause 4. Context of the Organization", "title": "", "requirement": "Understanding the organization and its context — external and internal issues relevant to purpose and affecting ability to achieve intended QMS outcomes.", "default_evidence": "During the audit, the Understanding the Context of the organization procedure was developed within the company and communicated at relevant levels.\n\nUnderstanding Context of Organization" }, { "group_key": "clause", "code": "4.2", "heading": "Clause 4. Context of the Organization", "title": "", "requirement": "Understanding the needs and expectations of interested parties, incl. applicable legal requirements and other requirements the organization subscribes to.", "default_evidence": "During the audit, it was noted that the organization had identified its interested parties and the corresponding needs and expectations of each party.\n\nNeeds & Expectations of Interested Parties" }, { "group_key": "clause", "code": "4.3", "heading": "Clause 4. Context of the Organization", "title": "", "requirement": "Determining the scope and boundaries of the quality management system (products, services, sites, activities included/excluded) and the basis on which the scope is determined.", "default_evidence": "During the audit, the organization has identified the scope of its Quality Management System.\n\nCompany Profile" }, { "group_key": "clause", "code": "4.4", "heading": "Clause 4. Context of the Organization", "title": "", "requirement": "Quality management system, including the processes needed and their interactions, established, implemented, maintained, and continually improved in accordance with the requirements of ISO 9001:2015.", "default_evidence": "During the audit, the organization demonstrated that the processes needed for the Quality Management System, together with their sequence and interaction, have been identified, documented, implemented and maintained, and are continually improved in accordance with the requirements of ISO 9001:2015." }, { "group_key": "clause", "code": "5.1", "heading": "Clause 5. Leadership", "title": "", "requirement": "Leadership and commitment — top management demonstrates leadership and commitment to the QMS, promotes customer focus and risk-based thinking, integrates QMS requirements into business processes, and provides resources.", "default_evidence": "During the audit, it was observed that top management demonstrated leadership and commitment to the implementation of the Quality Management System (QMS), promoted customer focus and risk-based thinking, integrated QMS requirements into the organization’s business processes, and provided the necessary resources for the effective implementation of the QMS." }, { "group_key": "clause", "code": "5.2", "heading": "Clause 5. Leadership", "title": "", "requirement": "Quality policy — established, documented, communicated, appropriate to purpose and context, includes commitment to satisfy applicable requirements and to continual improvement, available as documented information.", "default_evidence": "Top management has established and maintained various policies and procedures, including the Quality Policy and operational controls relevant to the company’s activities." }, { "group_key": "clause", "code": "5.3", "heading": "Clause 5. Leadership", "title": "", "requirement": "Organizational roles, responsibilities and authorities assigned and communicated, incl. management representative/quality management function, and responsibility for reporting on QMS performance.", "default_evidence": "During the audit, it was verified that the organizational chart and job descriptions are established and communicated, and that the responsibilities and authorities for relevant roles within the Quality Management System are assigned and understood." }, { "group_key": "clause", "code": "6.1", "heading": "Clause 6. Planning", "title": "", "requirement": "Actions to address risks and opportunities — determined with regard to context (4.1) and interested party requirements (4.2); integrated into QMS processes; effectiveness of actions evaluated.", "default_evidence": "During the audit, Risk Assessment records were made available for verification. The organization has established criteria for assessing risk levels based on probability and impact/severity ratings. The identified risks were assessed in accordance with the established criteria, with appropriate controls and mitigation measures identified in response to the risks and their potential impact on the organization’s operations and service delivery." }, { "group_key": "clause", "code": "6.2", "heading": "Clause 6. Planning", "title": "", "requirement": "Quality objectives established at relevant functions, levels and processes, and planning to achieve them — consistent with quality policy, measurable, monitored, communicated, updated as appropriate.", "default_evidence": "During the audit, the Quality objectives were established, and planning actions for achieving these objectives were available." }, { "group_key": "clause", "code": "6.3", "heading": "Clause 6. Planning", "title": "", "requirement": "Planning of changes — when the organization determines the need for changes to the QMS, changes are carried out in a planned manner, considering the purpose and potential consequences, the integrity of the QMS, resource availability, and allocation/reallocation of responsibilities and authorities.", "default_evidence": "During the audit, the organization demonstrated that arrangements for planning changes to the QMS have been established through the Management of Change Procedure. The procedure addresses the planning and control of changes, including consideration of their potential impact, QMS integrity, resources, and responsibilities and authorities.\n\nNo significant QMS changes requiring implementation under the procedure were identified during the audit period; therefore, no implementation records were applicable for verification." }, { "group_key": "clause", "code": "7.1", "heading": "Clause 7. Support", "title": "", "requirement": "Resources — determination and provision of resources needed for establishment, implementation, maintenance and improvement of the QMS.", "default_evidence": "The organization determines and provides the resources needed to implement and maintain the Quality Management System and continually improves its effectiveness and enhances customer satisfaction by meeting customer requirements." }, { "group_key": "clause", "code": "7.2", "heading": "Clause 7. Support", "title": "", "requirement": "Competence — determination of necessary competence of persons affecting the performance and effectiveness of the QMS; training or other action taken; records retained.", "default_evidence": "During the audit, competence records for the personnel affecting the performance and effectiveness of the Quality Management System were reviewed. Training records, qualifications and evidence of competence were available and confirm that the necessary competence is determined and maintained." }, { "group_key": "clause", "code": "7.3", "heading": "Clause 7. Support", "title": "", "requirement": "Awareness — persons doing work under the organization's control are aware of the quality policy, relevant quality objectives, their contribution to QMS effectiveness (incl. benefits of improved performance), and implications of not conforming.", "default_evidence": "During the audit, the organization provided a competency matrix demonstrating that awareness sessions had been conducted for employees in specific designations. The available records provided evidence of employee awareness activities related to the Quality Management System." }, { "group_key": "clause", "code": "7.4", "heading": "Clause 7. Support", "title": "", "requirement": "Communication — internal and external communications relevant to the QMS determined (what, when, with whom, how, who communicates).", "default_evidence": "During the audit, it was observed that the organization has established arrangements for communicating QMS-related information across all levels of the organization. Communication is carried out through documented information relevant to employees’ areas of responsibility, with department heads responsible for communicating relevant information to their respective personnel. Technical and commercial information is communicated to the relevant functions through documented information, while additional communication is facilitated through meetings, memos, intercom services, and mobile communication, as applicable." }, { "group_key": "clause", "code": "7.5", "heading": "Clause 7. Support", "title": "", "requirement": "Documented information — creation, updating and control (identification/description, format, review/approval, distribution, access, storage, retention, disposition, control of external origin documents).", "default_evidence": "During the audit, the organization demonstrated that arrangements for the control of documented information have been established and maintained in accordance with the requirements of ISO 9001:2015." }, { "group_key": "clause", "code": "8.1", "heading": "Clause 8. Operation", "title": "", "requirement": "Operational planning and control — criteria for the processes needed to meet requirements for the provision of products and services established and implemented; controlled/planned changes implemented; consequences of unintended changes reviewed and mitigated; outsourced processes controlled.", "default_evidence": "During the audit, the organization demonstrated that operational planning and control arrangements have been established through the Quality Assurance & Quality Control Procedure. Sampled operational records, including customer quotations, Local Purchase Orders (LPOs) received from clients, and invoices, were made available for verification." }, { "group_key": "clause", "code": "8.2", "heading": "Clause 8. Operation", "title": "", "requirement": "Requirements for products and services — communication with customers established (incl. handling enquiries, contracts, orders, feedback); requirements related to products and services determined and reviewed before commitment to supply; changes to requirements communicated to relevant persons.", "default_evidence": "During the audit, the requirements for products and services were verified through sampled operational records, including customer quotations, Local Purchase Orders (LPOs) received from clients, invoices, and delivery notes. The records provided evidence of customer communication, determination and fulfilment of specified requirements, and order processing before delivery." }, { "group_key": "clause", "code": "8.3", "heading": "Clause 8. Operation", "title": "", "requirement": "Design and development of products and services (where applicable) — planning, design and development inputs, controls applied during the process, outputs, and changes documented; design outputs verified/validated against input requirements prior to release.", "default_evidence": "During the audit, documented information demonstrating the planning, inputs, controls, outputs and changes of design and development was reviewed and found consistent with the applicable customer, statutory and regulatory requirements." }, { "group_key": "clause", "code": "8.4", "heading": "Clause 8. Operation", "title": "", "requirement": "Control of externally provided processes, products and services — criteria for evaluation, selection, monitoring of performance, and re-evaluation of external providers established; type/extent of control applied and verification activities defined.", "default_evidence": "During the audit, the organization presented the list of its suppliers and documented evidence of supplier evaluations to demonstrate how it manages externally provided processes, products, and services. This includes controls related to the selection, monitoring, and evaluation of external providers." }, { "group_key": "clause", "code": "8.5", "heading": "Clause 8. Operation", "title": "", "requirement": "Production and service provision — carried out under controlled conditions (incl. availability of documented information, suitable monitoring/measuring resources, identification & traceability where required, preservation, post-delivery activities, control of changes).", "default_evidence": "During the audit, production/work instructions and operational controls for the key activities were made available and verified, confirming that production and service provision are carried out under controlled conditions." }, { "group_key": "clause", "code": "8.6", "heading": "Clause 8. Operation", "title": "", "requirement": "Release of products and services — planned arrangements verified at appropriate stages; evidence of conformity with acceptance criteria maintained; release not proceeding until requirements satisfactorily completed (unless otherwise approved by a relevant authority and, as applicable, the customer).", "default_evidence": "Release of products and services was verified through sampled delivery receipts. The records provided evidence of completed deliveries to customers following fulfilment of the applicable order requirements. The sampled records were found to be acceptable, and no nonconformity was identified." }, { "group_key": "clause", "code": "8.7", "heading": "Clause 8. Operation", "title": "", "requirement": "Control of nonconforming outputs — outputs not conforming to requirements identified and controlled to prevent unintended use or delivery; actions taken (correction, segregation, containment, return, suspension) documented; conformity verified after correction.", "default_evidence": "Control of nonconforming outputs was verified through the reviewed records. Nonconforming products and services are identified and controlled to prevent their unintended use or delivery, and the actions taken are documented." }, { "group_key": "clause", "code": "9.1.1", "heading": "Clause 9. Performance Evaluation", "title": "", "requirement": "Monitoring, measurement, analysis and evaluation — what needs to be monitored and measured, and the methods, timing and analysis/evaluation required, determined; QMS performance and effectiveness evaluated.", "default_evidence": "The organization has established monitoring, measurement, analysis and evaluation of its quality performance. Records reviewed during the audit confirm that the results are analysed and used to evaluate the performance and effectiveness of the Quality Management System." }, { "group_key": "clause", "code": "9.1.2", "heading": "Clause 9. Performance Evaluation", "title": "", "requirement": "Customer satisfaction — monitoring of customer perceptions of the degree to which their needs and expectations have been fulfilled; methods for obtaining, monitoring and reviewing this information determined.", "default_evidence": "Customer satisfaction was monitored through the Customer Feedback/Complaints Register, which provided evidence of customer perceptions, feedback, and complaints being recorded and reviewed. The records demonstrated that customer feedback was considered as an input for evaluating the fulfilment of customer needs and expectations." }, { "group_key": "clause", "code": "9.1.3", "heading": "Clause 9. Performance Evaluation", "title": "", "requirement": "Analysis and evaluation — appropriate data and information arising from monitoring and measurement analysed and evaluated, incl. conformity of products/services, customer satisfaction, performance and effectiveness of the QMS, effectiveness of planning, effectiveness of actions to address risks/opportunities, performance of external providers, and need for improvements.", "default_evidence": "The organization has recently adopted ISO 9001:2015 requirements into its processes. Available operational and customer-related records were reviewed as evidence of monitoring and measurement activities. The organization has initiated the collection and review of relevant information, including customer feedback and complaints, to support evaluation of its processes and performance. The analysis and evaluation process is at an early stage of implementation and is expected to be further developed as sufficient performance data becomes available. No additional nonconformity was identified under this clause, with specific deficiencies noted during the audit addressed separately under the respective applicable clauses." }, { "group_key": "clause", "code": "9.2", "heading": "Clause 9. Performance Evaluation", "title": "", "requirement": "Internal audit — conducted at planned intervals to provide information on whether the QMS conforms to the organization's own requirements and ISO 9001:2015, and is effectively implemented and maintained.", "default_evidence": "During the audit, the internal audit programme and the internal audit reports were reviewed. Audits are planned and conducted at defined intervals by competent auditors, and the results are reported to the relevant management, confirming the implementation and effectiveness of the Quality Management System." }, { "group_key": "clause", "code": "9.3", "heading": "Clause 9. Performance Evaluation", "title": "", "requirement": "Management review — top management reviews the QMS at planned intervals to ensure continuing suitability, adequacy and effectiveness; inputs and outputs as required by the standard.", "default_evidence": "During the audit, the Management Review Meeting records were reviewed. The review covers the required inputs, and the outputs include decisions and actions related to improvement opportunities, changes and resource needs of the Quality Management System." }, { "group_key": "clause", "code": "10.1", "heading": "Clause 10. Improvement", "title": "", "requirement": "General — improvement opportunities determined and selected; necessary actions implemented to meet customer requirements and enhance customer satisfaction, incl. addressing changing needs/expectations, correcting/preventing/reducing undesired effects, and improving QMS performance and effectiveness.", "default_evidence": "The organization has determined and selected opportunities for improvement through operational activities, the review of customer feedback and the results of analysis, to enhance customer satisfaction. Records reviewed during the audit confirm the improvement actions taken." }, { "group_key": "clause", "code": "10.2", "heading": "Clause 10. Improvement", "title": "", "requirement": "Nonconformity and corrective action — reaction to nonconformity, evaluation of need for action to eliminate cause(s), review of effectiveness, updates to risks/opportunities as needed.", "default_evidence": "The organization has established a process for addressing nonconformities and customer complaints, as evidenced by the reviewed Customer Feedback/Complaints Register. Sampled records demonstrated that identified issues were recorded, causes were considered, corrective actions were assigned to responsible personnel, and closure status was monitored. The organization has recently adopted ISO 9001:2015, and the corrective action process is at an early stage of implementation." }, { "group_key": "clause", "code": "10.3", "heading": "Clause 10. Improvement", "title": "", "requirement": "Continual improvement — suitability, adequacy and effectiveness of the QMS continually improved, considering results of analysis and evaluation and the outputs of management review.", "default_evidence": "The organization continually improves the suitability, adequacy and effectiveness of the Quality Management System, as evidenced by the review of audit results, customer feedback and management review outputs." } ]; export const ISO9001_READINESS_ITEMS: SeedRow[] = [ { "group_key": "clause", "code": "4.1/4.2", "heading": "Document Review & Readiness", "title": "", "requirement": "Are the organization's context and needs/expectations of interested parties (incl. legal & other requirements) documented?", "default_evidence": "• Understanding Context of Organization\n• Needs & Expectations of Interested Parties" }, { "group_key": "clause", "code": "4.3", "heading": "Document Review & Readiness", "title": "", "requirement": "Are the scope and boundaries of the QMS clearly defined and available in documented form (QMS manual/scope statement), including the products, services and processes covered?", "default_evidence": "• YES – Reference: Quality Management System Manual" }, { "group_key": "clause", "code": "5.2", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the quality policy documented, dated, and signed/approved by top management, and appropriate to the purpose and context of the organization?", "default_evidence": "• YES: – Reference: Quality Policy, signed by MD" }, { "group_key": "clause", "code": "5.3", "heading": "Document Review & Readiness", "title": "", "requirement": "Are QMS roles, responsibilities, and authorities documented (org chart/responsibility matrix)?", "default_evidence": "• YES – Reference: Organization chart and job descriptions" }, { "group_key": "clause", "code": "6.1/6.2", "heading": "Document Review & Readiness", "title": "", "requirement": "Are actions to address risks and opportunities, and quality objectives with plans to achieve them, documented?", "default_evidence": "• YES – Reference: Risk Registry / Risk Management Procedure / Quality Objectives" }, { "group_key": "clause", "code": "6.3", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the planning for changes to the QMS documented (purpose of the change, potential consequences, resource allocation, responsibilities)?", "default_evidence": "• YES – Reference: Management of Change" }, { "group_key": "clause", "code": "7.1", "heading": "Document Review & Readiness", "title": "", "requirement": "Are resources needed for the QMS determined and documented (people, infrastructure, work environment, monitoring & measuring resources, organizational knowledge)?", "default_evidence": "• YES – Reference: Tools list, Company Photos, List of Employees" }, { "group_key": "clause", "code": "7.2/7.3", "heading": "Document Review & Readiness", "title": "", "requirement": "Are competence and awareness/training records or plans available?", "default_evidence": "• YES – Reference: Resource Management" }, { "group_key": "clause", "code": "7.5", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the documented information control procedure (creation, approval, retention, version control) available?", "default_evidence": "• YES – Reference: Documented Information Procedure" }, { "group_key": "clause", "code": "8.2", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the process for determining and reviewing requirements for products and services (incl. customer communication) documented?", "default_evidence": "• YES – Reference: Operations Procedure" }, { "group_key": "clause", "code": "8.1, 8.3–8.4", "heading": "Document Review & Readiness", "title": "", "requirement": "Are operational planning and control, design & development (where applicable), and control of externally provided processes/products/services documented?", "default_evidence": "• Quality Assurance & Quality Control Procedure\n• Purchase Procedure" }, { "group_key": "clause", "code": "9.2", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the internal audit programme/procedure documented, and has at least one internal audit cycle been completed covering the QMS?", "default_evidence": "• Internal Quality Audit Procedure" }, { "group_key": "clause", "code": "9.3", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the management review procedure documented, and has at least one management review been conducted?", "default_evidence": "• Management Responsibility Procedure" }, { "group_key": "clause", "code": "10.1", "heading": "Document Review & Readiness", "title": "", "requirement": "Is the nonconformity and corrective action procedure documented?", "default_evidence": "• Control of Non-Conformance & Corrective Action" }, { "group_key": "clause", "code": "GEN-1", "heading": "Document Review & Readiness", "title": "General", "requirement": "Has a discussion been held with client personnel confirming organizational readiness for the Stage 2 (Implementation Verification) audit?", "default_evidence": "• During the audit, the Stage 2 Audit objectives and criteria were discussed with the client" }, { "group_key": "clause", "code": "GEN-2", "heading": "Document Review & Readiness", "title": "General", "requirement": "Have the client's site-specific conditions relevant to the QMS been evaluated?", "default_evidence": "• YES" }, { "group_key": "clause", "code": "GEN-3", "heading": "Document Review & Readiness", "title": "General", "requirement": "If the client is multi-site, has the level of control/sampling approach been established?" }, { "group_key": "clause", "code": "GEN-4", "heading": "Document Review & Readiness", "title": "General", "requirement": "Are resources (time, competence, information) adequate for the Stage 2 audit?" } ]; export const ISO9001_EXTRA_ELEMENTS: SeedRow[] = [ { "group_key": "performance", "code": "PERF-1", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Customer & Product/Service Requirements Review", "requirement": "", "default_evidence": "The process for determining and reviewing requirements for products and services was reviewed and confirms that customer requirements (incl. those not stated but necessary for intended use), statutory and regulatory requirements, and the organization's own requirements have been determined, reviewed before commitment, and are consistently met." }, { "group_key": "performance", "code": "PERF-2", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Design and Development Controls", "requirement": "", "default_evidence": "Design and development records (where applicable) were reviewed and confirm that planning, inputs, design and development controls, outputs, and changes are documented and that design outputs meet input requirements prior to release." }, { "group_key": "performance", "code": "PERF-3", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Control of Externally Provided Processes, Products & Services", "requirement": "", "default_evidence": "The organization's approved supplier / external provider list and evaluation records were reviewed and confirm that criteria for evaluation, selection, monitoring of performance, and re-evaluation of external providers have been established and applied, with the type and extent of control proportionate to the impact on the organization's ability to consistently meet requirements." }, { "group_key": "performance", "code": "PERF-4", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Quality Objectives and Performance Indicators", "requirement": "", "default_evidence": "Quality objectives and associated performance indicators were reviewed and confirm that suitable, measurable indicators have been established and monitored to evaluate QMS performance and progress towards the organization's quality objectives." }, { "group_key": "performance", "code": "PERF-5", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Production and Service Provision Records", "requirement": "", "default_evidence": "Records of production and service provision were reviewed and confirm that products and services are provided under controlled conditions, incl. identification and traceability where required, and that records demonstrating conformity to requirements are retained." }, { "group_key": "performance", "code": "PERF-6", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Quality Objectives and Action Plan", "requirement": "", "default_evidence": "The Quality Objectives and Action Plan were reviewed and confirm that measurable objectives, responsibilities, timeframes, and planned actions have been established, monitored, and periodically reviewed to support continual improvement of the QMS." }, { "group_key": "performance", "code": "PERF-7", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Control of Nonconforming Outputs", "requirement": "", "default_evidence": "The nonconforming output control procedure and related records were reviewed and confirmed that outputs not conforming to requirements are identified and controlled to prevent unintended use or delivery, with corrective action and re-verification recorded where applicable." }, { "group_key": "performance", "code": "PERF-8", "heading": "Management System Effectiveness — Quality Performance Verification", "title": "Monitoring and Measuring Resources / Calibration", "requirement": "", "default_evidence": "Monitoring and measuring equipment records were reviewed and confirm that resources needed for valid and reliable monitoring and measurement results are determined, suitable for the specific type of activities, calibrated/verified at specified intervals, and safeguarded from adjustments, damage or deterioration." }, { "group_key": "risk", "code": "RISK-9", "heading": "Risk Management", "title": "Risk & Opportunity Management", "requirement": "", "default_evidence": "The organization's Risk & Opportunity Management Procedure / Register was reviewed and confirms that internal and external issues, interested parties, and compliance obligations relevant to the QMS have been identified, assessed, and are being addressed to support achievement of intended QMS outcomes." }, { "group_key": "feedback", "code": "FEED-10", "heading": "Customer Feedback and Complaints", "title": "Customer Feedback / Complaints Monitoring", "requirement": "", "default_evidence": "The organization's system for monitoring customer perception and satisfaction was reviewed, including the mechanism for receiving, recording, and responding to customer feedback and complaints. Evidence of feedback collection was verified, demonstrating a systematic approach to monitoring customer satisfaction.\n\nNumber of complaints received during the audit period: 1 Open: 0 Closed: 1" }, { "group_key": "statutory", "code": "STAT-11", "heading": "Statutory / Regulatory Compliance", "title": "Domestic / Local Legal Requirements", "requirement": "", "default_evidence": "Compliance with applicable domestic/local statutory and regulatory requirements (municipality, civil defense, labour law, etc.) was reviewed and found to be identified and monitored via the organization's Legal & Other Requirements Register." }, { "group_key": "statutory", "code": "STAT-12", "heading": "Statutory / Regulatory Compliance", "title": "International Requirements", "requirement": "", "default_evidence": "Applicable international requirements relevant to the organization's scope of operations were reviewed and found to be identified within the Legal & Other Requirements Register." }, { "group_key": "statutory", "code": "STAT-13", "heading": "Statutory / Regulatory Compliance", "title": "Product / Service Certification Standards", "requirement": "", "default_evidence": "Certification(s) or standards applicable to the organization's products / services were reviewed for validity and relevance to the scope of the QMS." }, { "group_key": "statutory", "code": "STAT-14", "heading": "Statutory / Regulatory Compliance", "title": "Insurance", "requirement": "", "default_evidence": "The organization's insurance coverage relevant to its operations was reviewed for validity." }, { "group_key": "statutory", "code": "STAT-15", "heading": "Statutory / Regulatory Compliance", "title": "International Registration(s)", "requirement": "", "default_evidence": "Applicable international registrations (if any) relevant to the organization's operations were reviewed." }, { "group_key": "statutory", "code": "STAT-16", "heading": "Statutory / Regulatory Compliance", "title": "Others", "requirement": "", "default_evidence": "(Specify any other applicable statutory, regulatory, or contractual requirement reviewed.)" } ];