IATF 16949:2016 Audit
Manufacturing
This IATF audit checklist can be used by Quality Managers to assess if the company’s QMS is aligned with the IATF 16949:2016 standard. It helps ensure that an automotive supplier or manufacturer’s QMS promotes continuous improvement, defect prevention, and waste reduction in the automotive supply chain. Use all sections of this checklist to make an internal assessment of compliance with the IATF 16949:2016 standard.
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4 Context of the organization

Introduction

4.1 Understanding the organization and its context

Verify how the organization has determined external and internal issues relevant to its purpose and strategic direction.
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Verify how these issues affect the ability to achieve the intended result of the QMS.
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Verify how the organization monitors and reviews information about these internal and external issues.
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4.2 Understanding the needs and expectations of interested parties

Verify how organization determined relevant interested parties to QMS.
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Verify how the organization has determined the relevant needs and expectations of interested parties.
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Verify how the organization has determined the impact or potential impact of the interested parties.
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Verify how the organization monitors and reviews information about interested parties and their relevant requirements.
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4.3 Determining the scope of the quality management system

Verify the QMS scope considers the following:
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Verify how the organization has determined how the ISO 9001:2015 standard is applied within the organization.
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If the organization has determined any of the requirements of the ISO 9001:2015 standard not to be applicable, show me how conformity of products and services are not affected by this.
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Verify QMS scope is documented.
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Verify scope states what products and services are covered by the QMS and how it justifies instances where requirements cannot be applied.
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4.3.1 Determining the scope of the quality management system - supplemental

Verify support functions included in scope
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If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design.
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4.3.2 Customer-specific requirements

Verify customer-specific requirements evaluated and included in scope
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4.4 Quality management system and its processes

Show me how the processes have been determined and how they interact.
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Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.
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Verify the sequence and interaction of of the processes.
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Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.
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Verify how resources are determined and allocated.
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Verify how responsibilities and authorities are determined.
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Verify how risks and opportunities are considered and what actions are taken to address them.
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Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.
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Verify how opportunities for improvement for the QMS and its processes are determined.
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Reviewed documented information created to support the operation of its processes.
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4.4.1.1 Conformance of products and processes

Verify conformance to all applicable customer, statutory and regulatory requirements
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4.4.1.2 Product Safety

Verify documented process
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Where applicable, shall include:
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5 Leadership

5.1 Leadership and commitment

Top management is identified
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Verify top management demonstrates leadership and commitment by:
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Verify how top management demonstrates leadership and commitment with respect to customer focus by ensuring that:
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Verify corporate responsibility policies are defined and implemented:
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Verify top management reviews the product realization process for effectiveness and efficiency and is input to Management Review
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Verify top management has identified process owners and that the process owners understand their roles and are competent to perform those roles
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5.2 Policy

Verify the quality policy:
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Verify QMS Policy is maintained as documented information.
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Verify QMS Policy is communicated, understood and applied within the organization.
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Verify QMS Policy is available to relevant interested parties.
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5.3 Organizational roles, responsibilities and authorities

Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization
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Verify top management assigns responsibility and authority for:
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Verify personnel are assigned responsibility and authority to ensure that customer requirements are met and these assignments are documented.
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Verify personnel responsible for conformity have the authority to stop shipment and stop production to correct quality problems.
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Verify personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform
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Verify that personnel across all shifts have responsibility for ensuring conformity to product requirements.
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6 Planning

6.1 Actions to address risks and opportunities

Verify how the internal and external issues and interested parties are considered when planning for the QMS?
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Verify how risks and opportunities are determined and addressed so the QMS can achieve its intended results, prevent and reduce undesired effects and achieve continual improvement
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Verify how actions are planned to address risks and opportunities.
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Verify how actions are integrated and implemented into the QMS processes.
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Verify how the organization evaluates the effectiveness of the actions.
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Verify how actions are taken to address risks and opportunities determined as being appropriate to the potential impact on the conformity of products and services.
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Verify risk analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.
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Verify retained documented information
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Verify preventive action process
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Verify contingency plans are documented
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Verify contingency plans are prepared for continuity of supply in the event of:
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Verify validation of manufactured product after re-start
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6.2 Quality objectives and planning to achieve them

Verify top management ensures that quality objectives are defined, established and maintained at relevant functions, levels and processes.
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Verify the quality objectives are:
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Verify objectives are documented.
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Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives.
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Verify annual quality objectives and related performance targets (internal and external) are established
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6.3 Planning of changes

Verify how QMS changes are planned systematically.
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Verify how the organization demonstrates the purpose and potential consequences of changes.
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Verify how the organization considers the integrity of the QMS.
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Verify how resources are made available.
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Verify how responsibility and authority is allocated and reallocated.
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7 Support

7.1 Resources

7.1.1 General - 7.1.3 Infrastructure

Verify how resources are determined for the organization.
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Show me how the capabilities and constraints on internal resources are considered.
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Show me how needs from external providers are considered.
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Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.
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Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.
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Verify design layout optimizes material flow, material handling and value-added use of floor space
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Verify assessments of manufacturing feasibility and evaluation of capacity planning as inputs into Management Review
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7.1.4 Environment for the operation of processes

Verify how the organization determines, provides and maintains the environment for the operation of processes to achieve products and service conformity.
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Verify premises are in a state of order, cleanliness and repair
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7.1.5 Monitoring and measuring resources

Verify how resources are determined to ensure valid and reliable monitoring and measuring results.
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Verify how the organization ensures that the resources provided are suitable for the specific type of monitoring and measurement activities being undertaken and that they are maintained to ensure continued fitness of purpose.
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Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.
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Show me how measurement instruments are verified or calibrated at specific intervals against national or international standards. If no standards, show me documented information which is used as the basis for calibration or verification.
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Show me how measurement instruments are identified.
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Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.
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Verify how the organization determines the validity of previous measurements if you find an instrument to be defective during verification or calibration. Verify any actions taken.
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Verify MSA
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Verify criteria used conforms to those in reference manuals on MSA
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Verify documented process for managing calibration/verification records
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Verify calibration/verification activities and records shall include:
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Verify defined scope for internal laboratory is documented
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Verify laboratory requirements for:
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Verify external laboratories are accredited to ISO/IEC 17025 or national equivalent and or is acceptable to the customer
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Verify scope incudes relevant inspection, test or calibration service and the certificate of calibration or test report includes the mark of a national accreditation body
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7.1.6 Organizational knowledge

Verify how the organization determines the necessary knowledge for the operation of processes and achieves conformity of products and services.
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Verify how knowledge is maintained and made available to the extent necessary.
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Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.
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7.2 Competence

Show me how you determine the necessary competence of people doing work under your control that affects quality performance.
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Show me how you determine competence on the basis of appropriate education, training or experience.
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Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.
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Verify documented information as evidence of competence where appropriate.
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Verify documented process(es) for identifying training needs including awareness and achieving competence
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Verify on-the-job training process
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Verify documented process(es) to verify internal and second-party auditors are competent and can demonstrate:
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Verify how manufacturing process auditors demonstrate technical understanding of the relevant manufacturing process(es) to be audited, including process risk analysis (PFMEA) and control plan
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Verify product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity
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Verify maintenance of and improvement in internal auditor competence by:
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7.3 Awareness

Verify people doing work under the organization's control are aware of:
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Verify that the organization documents process for employee motivation and empowerment:
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Verify that the organization promotes quality and technological awareness in the whole organization
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7.4 Communication

Verify internal and external communication process (what, when, with whom and how to communicate).
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7.5 Documented information

Verify documented information required by the ISO 9001:2015 standard.
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Verify documented information that shows the effectiveness of the QMS.
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Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).
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Show me how the documented information is reviewed and approved for suitability and adequacy.
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Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.
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Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.
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Verify documented information of external origin is identified, as appropriate, and controlled.
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Verify quality manual and it includes, at a minimum:
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Verify record retention policy
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Verify production part approvals, tooling records, product and process design records, purchase orders (if applicable) or contracts and amendments are maintained for the length of time that the product is active for production/service plus one calendar year
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Verify documented process describing the review, distribution and implementation of all customer engineering standards/specifications and related revisions
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Verify records of dates engineering standard/spec change implemented in production (implementation shall included updated documents)
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Verify review is completed within 10 working days of receipt of notification of engineering standards/spec changes
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8 Operation

8.1 Operational planning and control

Verify how the organization has planned, implemented and controlled processes needed to meet the requirements of products and services.
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Verify how requirements for products and services are determined.
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Verify how criteria for processes and acceptance for products and services are determined.
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Verify how resources are determined.
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Verify how process control is implemented.
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Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.
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Determine how output from the planning process is suitable for operations.
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Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.
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Verify how outsourced processes are controlled.
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Verify topics shall be included in planning for product realization:
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Verify organization ensures confidentiality
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8.2 Determination of requirements for products and services

Verify processes created for communicating with customers on information relating to products, services, enquiries, contracts, order handling, customer views, perceptions and complaints, handling or treatment of customer property and specific requirements for contingency actions.
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Verify process to determine the requirements for products and services to be offered to potential customers and how the process is established, implemented and maintained.
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Verify how product and service requirements including statutory and regulatory requirements are defined. Verify that the organization has the ability to meet the defined requirements and substantiate any claims for its products and services.
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Verify how the organization reviews:
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Verify retained documented evidence of customer-authorized waiver of above requirements for a formal review
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Verify organization's manufacturing processes are capable (capability analysis, Cp, Cpk, Pp, Ppk)
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Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer.
Meets requirement
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Verify how the organization resolves differences in the contract or order requirements from those previously defined.
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Verify how the organization confirms customer requirements where the customer doesn't provide a documented statement.
Meets requirement
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Verify documented information of reviews describing new or changed requirements to products and services.
Non-conformance
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Verify documented information of amended reviews and how relevant personnel are made aware of those changes.
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Verify written or verbal communication is in language agreed to with the customer
Meets requirement
Non-conformance
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N/A
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8.3 Design and development of products and services

8.3.1 General

Verify how the design and development process is established, implemented and maintained.
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Verify product and manufacturing design is focused on error prevention rather than detection
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Verify that the organization documents the design and development process
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8.3.2 Design and development planning

In determining the stages and control for design and development, verify the organization considers:
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Verify documented information that confirms design and development requirements have been met.
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Verify design and development planning includes a multidisciplinary approach of all affected stakeholders within its organization and its supply chain (as appropriate).
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Verify product design personnel are competent to achieve design requirements and are skilled in applicable product design tools and techniques.
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Verify process for quality assurance for their products with internally developed embedded software.
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Non-conformance
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8.3.3 Design and development inputs

In determining requirements essential for the type of products and services being designed and developed, the organization shall consider:
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Verify that the inputs are complete and unambiguous.
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Verify documented information on design and development inputs are retained.
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Verify design input requirements as a result of contract review:
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Verify manufacturing process design inputs include (but not limited to):
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Verify error-proofing included in manufacturing process design as appropriate
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Non-conformance
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Verify multi-disciplinary approach to identify special characteristics:
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8.3.4 Design and development controls

Verify the organization includes all products and services that affect customer requirements such as sub- assembly, sequencing, sorting, rework, and calibration services in the scope of their definition of externally provided products, processes, and services
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Non-conformance
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Verify the organization applies controls to the design and development process to ensure that:
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