iAuditor Mobile App Preview

4 Context of the organization

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.

Verify how these issues affect the ability to achieve the intended result of the QMS.

Verify how the organization monitors and reviews information about these internal and external issues.

4.2 Understanding the needs and expectations of interested parties

Verify how organization determined relevant interested parties to QMS.

Verify how the organization has determined the relevant needs and expectations of interested parties.

Verify how the organization has determined the impact or potential impact of the interested parties.

Verify how the organization monitors and reviews information about interested parties and their relevant requirements.

4.3 Determining the scope of the quality management system

Verify the QMS scope considers the following:

External and internal issues.

The requirements of relevant interested parties.

The products and services of the organization.

Verify how the organization has determined how the ISO 9001:2015 standard is applied within the organization.

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.

Verify QMS scope is documented.

Verify scope states what products and services are covered by the QMS and how it justifies instances where requirements cannot be applied.

4.3.1 Determining the scope of the quality management system - supplemental

Verify support functions included in scope

If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design.

4.3.2 Customer-specific requirements

Verify customer-specific requirements evaluated and included in scope

4.4 Quality management system and its processes

Show me how the processes have been determined and how they interact.

Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.

Verify the sequence and interaction of of the processes.

Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.

Verify how resources are determined and allocated.

Verify how responsibilities and authorities are determined.

Verify how risks and opportunities are considered and what actions are taken to address them.

Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.

Verify how opportunities for improvement for the QMS and its processes are determined.

Reviewed documented information created to support the operation of its processes.

4.4.1.1 Conformance of products and processes

Verify conformance to all applicable customer, statutory and regulatory requirements

4.4.1.2 Product Safety

Verify documented process

Where applicable, shall include:

identification of statutory and regulatory product-safety requirements and customer notification

special approvals for design FMEA, process FMEAs and control plans

identification and controls of product safety-related characteristics (including at the point of manufacture)

reaction plans

definition of responsibilities, escalation process and flow of information, including top management and customer notification

training required

changes of product or process shall be approved prior to implementation

transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources

product traceability by manufactured lot (at a minimum) throughout the supply chain

lessons learned for new product introductions

5 Leadership

5.1 Leadership and commitment

Top management is identified

Verify top management demonstrates leadership and commitment by

Taking accountability for QMS effectiveness

Ensuring the QMS policy and objectives are established and are compatible with strategic direction and context of organization

Ensuring the QMS is integrated into organization's business processes

Promoting the use of the process approach and risk-based thinking

Ensuring resources are available

Communicating the importance of effective QMS and of conforming to its requirements

Ensuring intended outcomes

Engaging, directing and supporting persons to contribute to the effectiveness of the QMS

Promoting continuous improvement

Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of respsonsibility

Verify how top management demonstrates leadership and commitment with respect to customer focus by ensuring that

customer and applicable statutory and regulatory requirements are determined, understood and consistently met.

the risks and opportunities that affect product and service conformity and the ability to enhance customer satisfaction are determined and addressed.

the focus of enhancing customer satisfaction is maintained.

Verify corporate responsibility policies are defined and implemented

Anti-bribery policy

Employee code of conduct

Ethics escalation policy ("whistle-blowing policy")

Verify top management reviews the product realization process for effectiveness and efficiency and is input to Management Review

Verify top management has identified process owners and that the process owners understand their roles and are competent to perform those roles

5.2 Policy

Verify the quality policy ...

is appropriate to the purpose and context of the organization and supports its strategic direction.

provides a framework for setting quality objectives.

includes a commitment to satisfy applicable requirements.

includes a commitment to continual improvement of the QMS.

Verify QMS Policy is maintained as documented information.

Verify QMS Policy is communicated, understood and applied within the organization.

Verify QMS Policy is available to relevant interested parties.

5.3 Organizational roles, responsibilities and authorities

Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization

Verify top management assigns responsibility and authority for..

ensuring the QMS conforms to the ISO 9001:2015 and IATF 16949:2016 standards.

ensuring that processes are delivering their intended outputs.

reporting on the performance of the QMS and on opportunities for improvement, in particular to top management.

ensuring the promotion of customer focus throughout the organization.

ensuring the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

Verify personnel are assigned responsibility and authority to ensure that customer requirements are met and these assignments are documented.

Verify personnel responsible for conformity have the authority to stop shipment and stop production to correct quality problems.

Verify personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform

Verify that personnel across all shifts have responsibility for ensuring conformity to product requirements.

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?

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

Verify how actions are planned to address risks and opportunities.

Verify how actions are integrated and implemented into the QMS processes.

Verify how the organization evaluates the effectiveness of the actions.

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.

Verify risk analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.

Verify retained documented information

Verify preventive action process

Verify contingency plans are documented

Verify contingency plans are prepared for continuity of supply in the event of:

key equipment failures

interruption from externally provided products, processes and services

recurring natural disasters

fire

utility interruptions

labour shortages

infrastructure disruptions

Verify validation of manufactured product after re-start

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.

Verify the quality objectives are..

consistent with the quality policy.

measurable.

taking into account applicable requirements.

relevant to the conformity of products and services and to the enhancement of customer satisfaction.

moinitored.

communicated.

updated as appropriate.

Verify objectives are documented.

Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives.

Verify annual quality objectives and related performance targets (internal and external) are established

6.3 Planning of changes

Verify how QMS changes are planned systematically.

Verify how the organization demonstrates the purpose and potential consequences of changes.

Verify how the organization considers the integrity of the QMS.

Verify how resources are made available.

Verify how responsibility and authority is allocated and reallocated.

7 Support

7.1 Resources
7.1.1 General - 7.1.3 Infrastructure

Verify how resources are determined for the organization.

Show me how the capabilities and constraints on internal resources are considered.

Show me how needs from external providers are considered.

Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.

Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.

Verify design layout optimizes material flow, material handling and value-added use of floor space

Verify assessments of manufacturing feasibility and evaluation of capacity planning as inputs into Management Review

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.

Verify premises are in a state of order, cleanliness and repair

7.1.5 Monitoring and measuring resources

Verify how resources are determined to ensure valid and reliable monitoring and measuring results.

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.

Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.

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.

Show me how measurement instruments are identified.

Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.

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.

Verify MSA

Verify criteria used conforms to those in reference manuals on MSA

Verify documented process for managing calibration/verification records

Verify calibration/verification activities and records shall include:

revisions following engineering changes that impact measurement systems

any out-of-spec readings as received for calibration/verification

risk assessment caused by out-of-spec condition

documented information on the validity of previous measurement results when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use

customer notification if product or material has been shipped

statements of conformity to spec after calibration/verification

verification of software version

records of the calibration and maintenance activities for all gauging, including employee-owned, customer-owned or on-site supplier-owned equipment

production-related software verification used for product and process control

Verify defined scope for internal laboratory is documented

Verify laboratory requirements for:

adequacy of the laboratory technical procedures

competency of laboratory personnel

testing of the product

traceability to relevant process standard (such as ASTM, EN, etc.) or when no national standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability

customer requirements, if any

review of related records

Verify external laboratories are accredited to ISO/IEC 17025 or national equivalent and or is acceptable to the customer

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

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.

Verify how knowledge is maintained and made available to the extent necessary.

Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.

7.2 Competence

Show me how you determine the necessary competence of people doing work under your control that affects quality performance.

Show me how you determine competence on the basis of appropriate education, training or experience.

Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.

Verify documented information as evidence of competence where appropriate.

Verify documented process(es) for identifying training needs including awareness and achieving competence

Verify on-the-job training process

Verify documented process(es) to verify internal and second-party auditors are competent and can demonstrate

understanding of the automotive process approach for auditing, including risk-based thinking

understanding of applicable customer and organization specific requirements

understanding of applicable ISO 9001 and IATF 16949 requirements

applicable manufacturing process(es) to be audited, including PFMEA and control plan (second-party auditor only)

understanding of the applicable core tool requirements

understanding how to plan, conduct, report and close out audit findings

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

Verify product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity

Verify maintenance of and improvement in internal auditor competence by

executing minimum number of audits per year, as defined by organization

maintaining knowledge of relevant requirements based on internal or external changes

7.3 Awareness

Verify people doing work under the organization's control are aware of

the quality policy.

the relevant quality objectives.

their contribution to the effectiveness of the QMS, including the benefits of improved performance.

the implications of not conforming with the QMS requirements.

7.4 Communication

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

7.5 Documented information

Verify documented information required by the ISO 9001:2015 standard.

Verify documented information that shows the effectiveness of the QMS.

Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).

Show me how the documented information is reviewed and approved for suitability and adequacy.

Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.

Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.

Verify documented information of external origin is identified, as appropriate, and controlled.

Verify quality manual and it includes, at a minimum:

Scope of the QMS, including details of and justification for any exclusions

documented processes established for the QMS or reference to them

the organization's processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes

a document indicating where within the QMS their customer-specific requirements are addressed

Verify record retention policy

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

Verify documented process describing the review, distribution and implementation of all customer engineering standards/specifications and related revisions

Verify records of dates engineering standard/spec change implemented in production (implementation shall included updated documents)

Verify review is completed within 10 working days of receipt of notification of engineering standards/spec changes

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.

Verify how requirements for products and services are determined.

Verify how criteria for processes and acceptance for products and services are determined.

Verify how resources are determined.

Verify how process control is implemented.

Show me documented information that demonstrates processes have been carried out as planned and can demonstrate conformity of products and services.

Determine how output from the planning process is suitable for operations.

Verify how planned changes are controlled. Verify how unintended changes are reviewed and what actions are taken to mitigate any adverse effects, as necessary.

Verify how outsourced processes are controlled.

Verify topics shall be included in planning for product realization:

customer product requirements and technical specifications

logistics requirements

manufacturing feasibility

project planning

acceptance criteria

Verify organization ensures confidentiality

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.

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.

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.

Verify how the organization reviews..

customer requirements for delivery and post-delivery.

requirements necessary for customer's specified or intended use, where known.

statutory and regulatory requirements applicable to the products and services.

other contract or order requirements.

Verify retained documented evidence of customer-authorized waiver of above requirements for a formal review

Verify organization's manufacturing processes are capable (capability analysis, Cp, Cpk, Pp, Ppk)

Show me that the review is conducted prior to the organization's commitment to supply products and services to the customer.

Verify how the organization resolves differences in the contract or order requirements from those previously defined.

Verify how the organization confirms customer requirements where the customer doesn't provide a documented statement.

Verify documented information of reviews describing new or changed requirements to products and services.

Verify documented information of amended reviews and how relevant personnel are made aware of those changes.

Verify written or verbal communication is in language agreed to with the customer

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.

Verify product and manufacturing design is focused on error prevention rather than detection

8.3.2 Design and development planning

In determining the stages and control for design and development, verify the organization considers..

the nature, duration and complexity of the activities.

the requirements that specify particular process stages including applicable reviews.

required verification and validation.

responsibilities and authorities.

how interfaces are controlled between individuals and parties.

the need for involvement of customer and user groups.

Verify documented information that confirms design and development requirements have been met.

Verify design and development planning includes a multidisciplinary approach of all affected stakeholders within its organization and its supply chain (as appropriate).

Verify product design personnel are competent to achieve design requirements and are skilled in applicable product design tools and techniques.

Verify process for quality assurance for their products with internally developed embedded software.

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..

functional and performance requirements.

information derived from previous similar design and development activities.

statutory and regulatory requirements.

standard or codes of practice that the organization has committed to implement.

potential consequences of failure due to the nature of the products and services.

Verify that the inputs are complete and unambiguous.

Verify documented information on design and development inputs are retained.

Verify design input requirements as a result of contract review

product specs including but not limited to special characteristics

boundary and interface requirements

identification, traceability and packaging

consideration of design alternatives

assessment of risks with the input requirements and the organization's ability to mitigate/manage the risks, including from the feasibility analysis

targets for conformity to product requirements

applicable statutory and regulatory requirements

embedded software requirements

Verify manufacturing process design inputs

product design output data including special characteristics

targets for productivity, process capability, timing and cost

manufacturing technology alternatives

customer requirements

experience from previous developments

new materials

product handling and ergonomic requirements

design for manufacturing and design for assembly

Verify error-proofing included in manufacturing process design as appropriate

Verify multi-disciplinary approach to identify special characteristics

documentation of all special characteristics in the drawings, risk analysis (FMEA), control plans and standard work/instructions

verify special characteristics are identified with specific markings and are cascaded through each of the documents

development of control and monitoring strategies

customer-specified approvals

compliance with customer-specified definitions and symbols (can be organization's equivalent as defined by conversion table)

8.3.4 Design and development controls

Verify the organization applies controls to the design and development process to ensure that..

the results to be achieved are defined.

reviews are conducted to evaluate the ability of the results of design and development to meet requirements.

verification activities are conducted to ensure that the resulting products and services meet the requirements for the specified application or intended use.

validation activities are conducted to ensure that the resulting products and services meet the requirements of the specified application or intended use.

any necessary actions are taken on problems determined during the reviews, or verification and validation activities.

Verify documented information of these activities are retained.

Verify measurement results summary are an input to management review

Verify measurements are reported to customer, if required

Verify validation performed in accordance to customer requirements, including industry and government regulation standards.

Verify interaction of organization's product, including embedded software, within the system of the final customer's product (if contractually agreed with customer)

Verify prototype program and control plan (if required)

Verify prototype performance testing is monitored for timely completion

Verify product and manufacturing approval process conforming to customer requirements

Verify approval of external provided parts and services prior to submission of part approval to customer

Verify product approval is documented prior to shipment (if required) and retained.

8.3.5 Design and development outputs

Verify the organization ensures the design and development outputs..

meet the input requirements.

are adequate for the subsequent processes for the provision of products and services.

include or reference monitoring and measuring requirements, as appropriate , and acceptance criteria.

specify the characteristics of the products and services that are essential for their intended purpose and their safe and proper provision.

design risk analysis (FMEA)

reliability study results

product special characteristics

results of product design error-proofing, such as DFSS, DFMA and FTA

product definition including 3D models, technical data packages, product manufacturing information and geometric dimensioning & tolerancing (GD&T)

product design review results

service diagnostic guidelines and repair and serviceability instructions

service part requirements

packaging and labeling requirements for shipping

Verify documented information on design and development outputs are retained.

Verify manufacturing process design output is documented

Verify manufacturing process design output versus input

Verify manufacturing process design output includes..

specifications and drawings

special characteristics for product and manufacturing process

identification of process input variables that impact characteristics

tooling and equipment for production and control, including capability studies of equipment and process(es)

manufacturing process flow charts/layout, including linkage of product, process and tooling

capacity analysis

manufacturing process FMEA

maintenance plans and instructions

control plan

standard work and work instructions

process approval acceptance criteria

data for quality, reliability, maintainability and measurability

results of error-proofing identification and verification, as appropriate

methods of rapid detection, feedback and correction of product/manufacturing process nonconformities

8.3.6 Design and development changes

Verify the organization identifies, reviews and controls changes made during, or subsequent to, the design and development of products and services, to the extent necessary to ensure that there is no adverse impact on conformity to requirements.

Verify documented information on design and development changes, the result of reviews, the authorization of changes and the actions taken to prevent adverse impacts are retained.

Verify organization evaluates design changes after initial product approval

Verify documented approval or waiver from the customer prior to production implementation (if required)

Verify revision level of embedded software and hardware

8.4 Control of externally provided processes, products and services

Verify the organization has a documented supplier selection process and it includes..

an assessment of the selected supplier's risk to product conformity and uninterrupted supply of the organization's product to their customers

relevant quality and delivery performance

an evaluation of the supplier's QMS

multidisciplinary decision making

an assessment of software development capabilities (if applicable)

Verify "Directed-Buy" external providers meet all requirement

Verify how the organization ensures externally provided processes, products and services conform to specified requirements.

Verify controls applied to externally provided processes, products and services when products and services are intended for incorporation into the organization's own products and services, products and services are provided directly to the customer or a process, or part of a process, is provided by an external provider as a result of a decision by the organization.

Verify how the organization determines and applies criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers.

Verify documented information of activities and actions arising from the evaluations.

Verify how the organization determines controls applied to the external provision of processes, products and services and the resulting output.

Verify how the organization considers the potential impact of the external provided processes, products and services on its ability to meet customer and applicable statutory and regulatory requirements.

Verify the effectiveness of the controls applied by the external provider.

Verify how the organization determines the verification, or other activities, necessary to ensure the externally provided processes, products and services meet requirements.

Verify the organization has a documented process to identify outsourced processes and to select the types and extent of controls used to verify conformity ( shall include criteria and actions to escalate or reduce controls based on supplier performance and assessment of product, material or service risk

Verify the organization has a documented process that purchased products, processes and services conform to the current applicable statutory and regulatory requirements

Verify the organization ensures special controls defined by the customer are implemented and maintained, including at suppliers

Verify supplier's QMS is certified to ISO 9001 with the ultimate objective of becoming certified to IATF 16949

Verify process for software quality assurance for suppliers of automotive product-related software or automotive products with embedded software

Verify organization has documented process and criteria to evaluate supplier performance

Verify organization monitors the following supplier performance indicators

delivered product conformity to requirements

customer disruptions at the receiving plant, including yard holds and stop ships

delivery schedule performance

number of occurrences of premium freight

special status customer notifications related to quality or delivery issues (if provided by customer)

dealer returns, warranty, field actions and recalls (if provided by customer)

Verify the organization has documented the criteria for determining the need, type, frequency and scope of second-party audit

Verify second-party audit reports are retained

Verify inputs to supplier development includes..

performance issues

second-party audit findings

third-part quality management system certification status

risk analysis

Verify the organization communicates to external providers its requirements for..

the processes, products and services to be provided.

the approval of product and services; methods, processes and equipment; and the release of products and services.

competence, including any required qualification of persons.

the external providers' interactions with the organization.

control and monitoring of the external providers' performance to be applied by the organization.

verification or validation activities that the organization, or its customer, intends to perform at the external providers' premises.

Verify all applicable statutory and regulatory requirements and special product and process characteristics are passed down to suppliers

8.5 Production and service provision
8.5.1 Control of production and service provision

Verify the organization has documented information that defines the characteristics of the products to be produced, the services to be provided or the activities to be performed and the results to be achieved.

Verify the availability and use of suitable monitoring and measuring resources.

Verify the implementation of monitoring and measuring activities at appropriate stages to verify that criteria for control of processes or outputs, and acceptance criteria for products and services, have been met.

Verify the use of suitable infrastructure and environment for the operation of processes.

Verify the appointment of competent persons, including any required qualification.

Verify the validation, and periodic revalidation, of the ability to achieve planned results of the processes for production and service provision, where the resulting output cannot be verified by subsequent monitoring or measurement.

Verify the implementation of actions to prevent human error (i.e. poke yoke, visual locations, checklist, emergency stops, templates, document control, ...)

Verify the implementation of release, delivery and post-delivery activities.

8.5.1.1 Control Plan

Verify control plans (in accordance with Annex A) include..

controls used for the manufacturing process control, including verification of job set-ups

first-off/last-off part validation (as applicable)

methods for monitoring of control exercised over special characteristics defined by both the customer and the organization

the customer-required information (if any)

specified reaction plan (see Annex A)

Verify the control plans shall be reviewed and updated..

if the organization determines it has shipped nonconforming product to the customer

when any change occurs affecting product, manufacturing process, measurement, logistics, supply sources, production volume changes or risk analysis (FMEA) (see Annex A)

after a customer complaint and implementation of the associated corrective action (as applicable)

at a set frequency based on a risk analysis

Verify if the customer requires approval of Control Plan after review or revision

8.5.1.2 Standardized work - operator instructions and visual standards

Verify standardized work documents are..

communicated to and understood by the employees who are responsible for performing the work

legible

presented in language(s) understood by personnel who follow them

accessible for use at the designated work area(s)

Verify standardized work documents include rules for operator safety

8.5.1.3 Verification of job set-ups / 8.5.1.4 Verification after shutdown

Verify organization verifies job setups

Verify documentation is maintained for set-up personnel

Verify organization uses statistical methods of verification, where applicable

Verify first-off/last-off part validation

Verify records are retained for process and product approval following set-up and first-off/last-off validations

Verify organization ensure compliance with requirements after a planned or unplanned production shutdown period

8.5.1.5 Total productive maintenance

Verify total productive maintenance system is documented and includes..

identification of process equipment

availability of replacement parts

provision of resource for machine, equipment and facility maintenance

packaging and preservation of equipment, tooling and gauging

applicable customer-specfic requirements

documented maintenance objectives (i.e. OEE, MTBF, MTTR and preventive maintenance compliance metrics)

regular review of maintenance plan and objectives and documented action plan to address corrective actions where objectives are not met

use of preventive maintenance methods

use of predictive maintenance methods (as applicable)

periodic overhaul

8.5.1.6 Management of production tooling and manufacturing, test, inspection tooling and equipment

Verify production tooling management system (customer-owned or organization-owned) includes..

maintenance and repair facilities and personnel

storage and recovery

set-up

tool-change programs for perishable tools

tool design modification documentation, including engineering change level of the product

tool modification and revision to documentation

tool identification, such as serial or asset number; the status, such as production, repair or disposal; ownership; and location

Verify customer-owned tools and equipment are permanently marked in a visible location

Verify system implemented to monitors these activities

8.5.1.7 Production scheduling

Verify production is scheduled to meet customer orders/demands such as JIT

Verify production scheduling is supported by an information system

8.5.2 Identification and traceability

Verify how organization identifies outputs from the process to ensure conformity.

How does the organization identify the status of process outputs.

Verify how the organization controls the unique identification of process outputs when traceability is required. Verify documented information of traceability, where required.

Verify traceability plans..

enable the organization to identify nonconforming and/or suspect product

enable the organization to segregate nonconforming and/or suspect product

ensure the ability to meet the customer and/or regulatory response time requirements

ensure documented information is retained in the format (electronic, hardcopy, archive) that enables the organization to meet the response time requirements

ensure serialized identification of individual products, if specified by the customer or regulatory standards

ensure the identification and traceability requirements are extended to externally provided products with safety/regulatory characteristics

8.5.3 Property belonging to customers or external providers

What care is provided to customers' or external providers' property?

Verify how the organization identifies, verifies, protects and safeguards customers' or external providers' property which is provided for use or incorporation into the organization's products or services.

Verify retained documented information for property that is damaged or otherwise found to be unsuitable for use.

8.5.4 Preservation

Verify how the organization ensures preservation of the process outputs to ensure conformity to requirements.

Verify organization assesses product in stock, the place/type of storage container and the storage environment at planned intervals

Verify organization uses inventory management system to optimize inventory turns over time and ensure stock rotation (i.e. FIFO)

Verify obsolete product is controlled similar to that of nonconforming product

Verify organization complies with customer requirements for preservation, packaging, shipping and labeling

8.5.5 Post-delivery activities

Verify the organization considers the following to meet post-delivery activities.

statutory and regulatory requirements

potential undesired consequences associated with its products and services

the nature, use and intended lifetime of its products and services

customer requirements

customer feedback

Verify organization has process for communication of information on service concerns to manufacturing, material handling, logistics, engineering and design

Verify the following if a service agreement with the customer exists:

relevant service centers comply with applicable requirements

effectiveness of any special purpose tools or measurement equipment

service personnel are trained in applicable requirements

8.5.6 Control of changes

Verify how the organization reviews and controls changes for production or service provision.

Verify retained documented information describing the results of the review of changes, the person(s) authorizing the change and any necessary actions arising from the review.

8.5.6.1 Control of changes - supplemental

Verify documented process

Verify organization...

defines verification and validation activities

validates changes before implementation

documents evidence of related risk analysis

retains records of verification and validation

notifies the customer of any planned product realization changes after the most recent product approval (if required)

obtains documented approval, prior to implementation of the change (if required)

completes additional verification or identification requirements, such as production trial run and new product validation (if required)

Verify production trial run for verification of changes made a supplier

8.5.6.1.1 Temporary change of process controls

Verify organization has a list of primary and approved back-up/alternate process controls

Verify alternate method is documented

Verify alternate control method is approved internally prior to production implementation and by the customer (if required)

Verify alternative control methods are identified in the Control Plan and are reviewed periodically

Verify standard work instructions are created for alternative control methods

Verify alternative process controls are reviewed on a daily basis (at a minimum)

Verify restart verification is documented for a defined period

Verify traceability of all product produced with alternative process control devices or processes

8.6 Release of products and services

Verify at appropriate stages product and service requirements have been met.

Verify products and services are not released to the customer until the planned arrangements have been satisfactorily completed, unless otherwise approved by relevant authority and, as applicable, by the customer.

Verify retained documented information that shows evidence of conformity with acceptance criteria and traceability to person(s) authorizing the release.

Verify verification of product and service requirements are documented as specified in the Control Plan

Verify a layout inspection and functional inspection is performed per the Control Plan and are available for customer review

For appearance items, verify the organizations provides..

appropriate resources, including lighting, for evaluation

masters for color, grain, gloss, metallic brilliance, texture, distinctness of image (DOI) and haptic technology, as appropriate

maintenance and control of appearance masters and evaluation equipment

verification that personnel making appearance evaluations are competent and qualified

For externally provided processes, products, services, verify the organization utilizes one or more of the following methds

receipt and evaluation of statistical data

receiving inspection and/or testing, such as sampling based on performance

second-party or third-party assessments or audits of supplier sites when coupled with records of acceptable delivered product conformance to requirements

part evaluation by a designated laboratory

another method agreed with the customer

Verify organization confirms and is able to provide evidence that externally provided processes, products and services conform to the latest applicable statutory, regulatory and other requirements in the countries where they are manufactured and in the customer-identified countries of destination, if provided

Verify acceptance criteria defined by organization

8.7 Control of nonconforming outputs

Verify that outputs that do not conform to requirements are identified and controlled.

Verify appropriate action is taken for nonconforming products and services (also include after delivery of product or during/after the provision of services).

Correction

Segregation, containment, return or suspension of provision of products and services

Informing the customer

Obtaining authorization for acceptance under concession

Verify conformity to the requirements when nonconforming outputs are corrected.

Verify retained documented information that describes the nonconformity, describes actions taken, describes any concessions obtained and identifies the authority deciding the action in respect of the nonconformity.

8.7.1.1 Customer authorization for concession - 8.7.1.3 Control of suspect product

Verify concession or deviation permit approved by customer prior to further processing from what is currently approved

Verify organization obtains customer authorization prior to further processing for "use as is" and rework dispositions of nonconforming product (including sub-components)

Verify records are maintained of expiration date and quantity authorized under concession

Verify material shipped under concession is appropriately identified

Verify product with unidentified or suspect status is classified and controlled as nonconforming product

Verify appropriate manufacturing personnel are trained for containment of suspect and nonconforming product

8.7.1.4 Control of reworked product - 8.7.1.5 Control of repaired product

Verify documented process for rework confirmation

Verify instructions for disassembly or rework, including re-inspection and traceability requirements

Verify documented process for repair confirmation

Verify instructions for disassembly or repair, including re-inspection and traceability requirements

Verify documented customer authorization for concession for the product to be repaired

Verify retained documentation on the disposition of rework including quantity, disposition, disposition date and applicable traceability information

8.7.1.6 Customer notification - 8.7.1.7 Nonconforming product disposition

Verify customer is immediately notified if nonconforming product is shipped

Verify detailed documentation of the event followed initial communication

Verify documented process for disposition of nonconforming product not subject to rework or repair

Verify nonconforming product is rendered unusable prior to disposal

9 Performance evaluation

9.1 Monitoring, measurement, analysis and evaluation

Verify the organization has determined what needs to be monitored and measured, the methods to be used, when it will be performed, analyzed and evaluated.

Verify the organization evaluates the performance and effectiveness of its QMS.

Review retained appropriate documented information

Verify the organization performs process studies on all new manufacturing processes to verify process capability

Verify adherence to..

measurement techniques

sampling plans

acceptance criteria

records of actual measurement values and/or test results for variable data

reaction plans and escalation process when acceptance criterial are not met

Verify significant process events (i.e. tool change, machine repair) are retained documented information

Verify reaction plans created for processes that are either not statistically capable or are unstable. Reaction plans shall include containment of product and 100% inspection (as appropriate)

Verify records of effective dates of process changes

Verify that organization has determined the appropriate use of statistical tools

Verify statistical concepts are understood and used by employees involved in the collection, analysis and management of statistical data

Verify the organization monitors customers' perceptions and satisfaction based on performance indicators that include but not limited to ..

delivered part quality performance

customer disruptions

field returns, recalls and warranty (where applicable)

delivery schedule performance (including incidents of premium freight)

customer notifications related to quality or delivery issues, including special status

Verify organization monitors customer portals and customer scorecards (where provided)

Verify the organization analyzes and evaluates:

conformity of products and services.

the degree of customer satisfaction.

the performance and effectiveness of the QMS.

if planning has been implemented effectively.

the effectiveness of actions taken to address risks and opportunities.

the performance of external providers.

the need for improvements the the QMS.

Verify organization compares trends in quality and operational performance with progress toward objectives and leads to improving customer satisfaction

9.2 Internal audit

Verify internal audit process is documented

Verify audits are conducted at planned intervals

Verify organization has established, implemented, and maintains an internal audit program

Verify the importance of the process, changes affecting the organization and the results of previous audits are considered

Verify audit criteria and scope are created for each audit

Auditors are objective and impartial

Audit results reported to relevant management

Verify appropriate correction and corrective actions are taken without delay

Review retained documented information

Verify QMS processes are audited over three-year calendar period

Verify manufacturing processes are audited over three-year calendar period

Verify all shifts are audited

Verify products are audited using customer-specific required approaches

9.3 Management review (go through entire standard and add to inputs)

Verify management reviews QMS at least annually

Verify inputs to management review includes:

status of actions from previous management reviews

changes in external and internal issues relevant to the QMS

customer satisfaction and feedback from relevant interested parties

the extent to which quality objectives have been met

process performance and conformity of products and services

nonconformities and corrective actions

monitoring and measurement results

audit results

effectiveness of the audit program

the performance of external providers

adequacy of resources

effectiveness of actions taken to address risks and opportunities

opportunities for improvement

cost of poor quality (cost of internal and external nonconformance)

measures of process effectiveness

measures of process efficiency

product conformity

assessments of manufacturing feasibility made for changes to existing operations and for new facilities or new product

review of performance against maintenance objectives

warranty performance (where applicable)

review of customer scorecards (where applicable)

identification of potential field failures identified through risk analysis (such as FMEA)

actual field failures and their impact on safety or the environment

Verify outputs to management review includes:

opportunities for improvement

any need for changes to the QMS

resource needs

action plan when customer performance targets are not met

Verify retained documented information

10 Improvement

10.1 General

Verify the organization determines and selects opportunities for improvement to improve products and services, corrects, prevents or reduces undesired effects and improves the performance and effectiveness of the QMS.

10.2 Nonconformity and corrective action

Verify how organization reacts to nonconformity, including complaints, by evaluating how its takes action to control and correct it and how it deals with the consequences.

Verify how the organization evaluates the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere.

Verify how organization implements necessary actions.

Verify how organization evaluates the effectiveness of actions taken.

Verify the organization updates risks and opportunities determined during planning, if necessary.

Verify any changes made to the QMS, if necessary.

Verify retained documented information that provides evidence of the nature of the nonconformity and any subsequent actions taken and the results of any corrective actions

10.2.3 Problem solving

Verify document process that includes..

defined approaches for various types and scales of problems

containment, interim actions and related activities necessary for controlling nonconforming outputs

root cause analysis, methodology used, analysis and results

implementation of systemic corrective actions, including consideration of the impact on similar processes and products

verification of the effectiveness of implemented corrective actions

reviewing and updating appropriate documented information (where necessary)

10.2.4 Error-proofing

Verify documented process to determine the use of appropriate error-proofing methodologies

Verify details of error-proofing method used is documented in the process risk analysis (PFMEA) and test frequencies documented in the Control Plan

Verify records of testing of error-proofing devices

Verify challenge parts are identified, controlled, verified and calibrated (where feasible)

Verify reaction plans for error-proofing device failures

10.2.5 Warranty management systems - 10.2.6 Customer complaints and field failure test analysis

Verify warranty management process (if required)

Verify method for warranty part analysis, including NTF (no trouble found)

Verify that the organization has performed analysis on customer complaints and field failures (include embedded software

Verify problem solving and corrective action initiated

Verify the organization communicates the results of testing/analysis to the customer and also within the organization

10.3 Continual improvement

Verify how the organization continually improves. Does it consider the results of analysis and evaluation and the outputs from management review to determine if there are needs or opportunities that shall be addressed as part of continual improvement?

Verify documented process for continual improvement includes..

identification of methodology used, objectives, measurement, effectiveness and documented information

a manufacturing process improvement action plan with emphasis on the reduction of process variation and waste

risk analysis (such as FMEA)

IATF 16949:2016 Checklist

Created by: Mark Thompson | Industry: Manufacturing | Downloads: 426

IATF 16949:2016

Signup for a free iAuditor account to download and edit this checklist. It will be added to your free account and you will be able to conduct inspections from your mobile device.

Download and edit this free checklist

Browse for other checklists


iauditor logo

The World's #1 Cloud-Based Inspection Software and App

chevron logo
coles logo
emirates logo
overground logo
tesla logo
toyota logo

4 Context of the organization

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.

Verify how these issues affect the ability to achieve the intended result of the QMS.

Verify how the organization monitors and reviews information about these internal and external issues.

4.2 Understanding the needs and expectations of interested parties

Verify how organization determined relevant interested parties to QMS.

Verify how the organization has determined the relevant needs and expectations of interested parties.

Verify how the organization has determined the impact or potential impact of the interested parties.

Verify how the organization monitors and reviews information about interested parties and their relevant requirements.

4.3 Determining the scope of the quality management system

Verify the QMS scope considers the following:

External and internal issues.

The requirements of relevant interested parties.

The products and services of the organization.

Verify how the organization has determined how the ISO 9001:2015 standard is applied within the organization.

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.

Verify QMS scope is documented.

Verify scope states what products and services are covered by the QMS and how it justifies instances where requirements cannot be applied.

4.3.1 Determining the scope of the quality management system - supplemental

Verify support functions included in scope

If exemption taken, verify that it is for ISO 9001, Section 8.3. Also verify that permitted exclusion does not include manufacturing process design.

4.3.2 Customer-specific requirements

Verify customer-specific requirements evaluated and included in scope

4.4 Quality management system and its processes

Show me how the processes have been determined and how they interact.

Verify how the processes for the QMS were determine. Verify the inputs and outputs to the processes.

Verify the sequence and interaction of of the processes.

Verify the criteria, methods, measurement and related performance indicators needed to operate and control the processes.

Verify how resources are determined and allocated.

Verify how responsibilities and authorities are determined.

Verify how risks and opportunities are considered and what actions are taken to address them.

Verify what methods are used to monitor, measure and evaluate processes. Verify changes, if needed, are implemented to achieve intended results.

Verify how opportunities for improvement for the QMS and its processes are determined.

Reviewed documented information created to support the operation of its processes.

4.4.1.1 Conformance of products and processes

Verify conformance to all applicable customer, statutory and regulatory requirements

4.4.1.2 Product Safety

Verify documented process

Where applicable, shall include:

identification of statutory and regulatory product-safety requirements and customer notification

special approvals for design FMEA, process FMEAs and control plans

identification and controls of product safety-related characteristics (including at the point of manufacture)

reaction plans

definition of responsibilities, escalation process and flow of information, including top management and customer notification

training required

changes of product or process shall be approved prior to implementation

transfer of requirements with regard to product safety throughout the supply chain, including customer-designated sources

product traceability by manufactured lot (at a minimum) throughout the supply chain

lessons learned for new product introductions

5 Leadership

5.1 Leadership and commitment

Top management is identified

Verify top management demonstrates leadership and commitment by

Taking accountability for QMS effectiveness

Ensuring the QMS policy and objectives are established and are compatible with strategic direction and context of organization

Ensuring the QMS is integrated into organization's business processes

Promoting the use of the process approach and risk-based thinking

Ensuring resources are available

Communicating the importance of effective QMS and of conforming to its requirements

Ensuring intended outcomes

Engaging, directing and supporting persons to contribute to the effectiveness of the QMS

Promoting continuous improvement

Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of respsonsibility

Verify how top management demonstrates leadership and commitment with respect to customer focus by ensuring that

customer and applicable statutory and regulatory requirements are determined, understood and consistently met.

the risks and opportunities that affect product and service conformity and the ability to enhance customer satisfaction are determined and addressed.

the focus of enhancing customer satisfaction is maintained.

Verify corporate responsibility policies are defined and implemented

Anti-bribery policy

Employee code of conduct

Ethics escalation policy ("whistle-blowing policy")

Verify top management reviews the product realization process for effectiveness and efficiency and is input to Management Review

Verify top management has identified process owners and that the process owners understand their roles and are competent to perform those roles

5.2 Policy

Verify the quality policy ...

is appropriate to the purpose and context of the organization and supports its strategic direction.

provides a framework for setting quality objectives.

includes a commitment to satisfy applicable requirements.

includes a commitment to continual improvement of the QMS.

Verify QMS Policy is maintained as documented information.

Verify QMS Policy is communicated, understood and applied within the organization.

Verify QMS Policy is available to relevant interested parties.

5.3 Organizational roles, responsibilities and authorities

Verify responsibilities and authorities for relevant roles are assigned and communicated within the organization

Verify top management assigns responsibility and authority for..

ensuring the QMS conforms to the ISO 9001:2015 and IATF 16949:2016 standards.

ensuring that processes are delivering their intended outputs.

reporting on the performance of the QMS and on opportunities for improvement, in particular to top management.

ensuring the promotion of customer focus throughout the organization.

ensuring the integrity of the QMS is maintained when changes to the QMS are planned and implemented.

Verify personnel are assigned responsibility and authority to ensure that customer requirements are met and these assignments are documented.

Verify personnel responsible for conformity have the authority to stop shipment and stop production to correct quality problems.

Verify personnel with authority and responsibility for corrective action are promptly informed of products or processes that do not conform

Verify that personnel across all shifts have responsibility for ensuring conformity to product requirements.

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?

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

Verify how actions are planned to address risks and opportunities.

Verify how actions are integrated and implemented into the QMS processes.

Verify how the organization evaluates the effectiveness of the actions.

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.

Verify risk analysis includes, at a minimum, lessons learned from product recalls, product audits, field returns and repairs, complaints, scrap and rework.

Verify retained documented information

Verify preventive action process

Verify contingency plans are documented

Verify contingency plans are prepared for continuity of supply in the event of:

key equipment failures

interruption from externally provided products, processes and services

recurring natural disasters

fire

utility interruptions

labour shortages

infrastructure disruptions

Verify validation of manufactured product after re-start

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.

Verify the quality objectives are..

consistent with the quality policy.

measurable.

taking into account applicable requirements.

relevant to the conformity of products and services and to the enhancement of customer satisfaction.

moinitored.

communicated.

updated as appropriate.

Verify objectives are documented.

Verify how the organization determines what will be done, with what resources, when completed and how the results will be evaluated for quality objectives.

Verify annual quality objectives and related performance targets (internal and external) are established

6.3 Planning of changes

Verify how QMS changes are planned systematically.

Verify how the organization demonstrates the purpose and potential consequences of changes.

Verify how the organization considers the integrity of the QMS.

Verify how resources are made available.

Verify how responsibility and authority is allocated and reallocated.

7 Support

7.1 Resources
7.1.1 General - 7.1.3 Infrastructure

Verify how resources are determined for the organization.

Show me how the capabilities and constraints on internal resources are considered.

Show me how needs from external providers are considered.

Verify how the organization provides persons necessary to consistently meet customer, applicable statutory and regulatory requirements for the QMS including the necessary processes.

Verify how the organization determines, provides and maintains the infrastructure for the operation of processes to achieve products and services conformity.

Verify design layout optimizes material flow, material handling and value-added use of floor space

Verify assessments of manufacturing feasibility and evaluation of capacity planning as inputs into Management Review

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.

Verify premises are in a state of order, cleanliness and repair

7.1.5 Monitoring and measuring resources

Verify how resources are determined to ensure valid and reliable monitoring and measuring results.

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.

Verify documented information that shows evidence of fitness for purpose of monitoring and measurement resources.

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.

Show me how measurement instruments are identified.

Show me how measurement instruments are safeguarded from adjustments, damage and deterioration.

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.

Verify MSA

Verify criteria used conforms to those in reference manuals on MSA

Verify documented process for managing calibration/verification records

Verify calibration/verification activities and records shall include:

revisions following engineering changes that impact measurement systems

any out-of-spec readings as received for calibration/verification

risk assessment caused by out-of-spec condition

documented information on the validity of previous measurement results when a piece of inspection measurement and test equipment is found to be out of calibration or defective during its planned verification or calibration or during its use

customer notification if product or material has been shipped

statements of conformity to spec after calibration/verification

verification of software version

records of the calibration and maintenance activities for all gauging, including employee-owned, customer-owned or on-site supplier-owned equipment

production-related software verification used for product and process control

Verify defined scope for internal laboratory is documented

Verify laboratory requirements for:

adequacy of the laboratory technical procedures

competency of laboratory personnel

testing of the product

traceability to relevant process standard (such as ASTM, EN, etc.) or when no national standard(s) is available, the organization shall define and implement a methodology to verify measurement system capability

customer requirements, if any

review of related records

Verify external laboratories are accredited to ISO/IEC 17025 or national equivalent and or is acceptable to the customer

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

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.

Verify how knowledge is maintained and made available to the extent necessary.

Verify how the organization determines current knowledge and how its acquires additional knowledge when addressing changing needs and trends.

7.2 Competence

Show me how you determine the necessary competence of people doing work under your control that affects quality performance.

Show me how you determine competence on the basis of appropriate education, training or experience.

Show me how you take actions to acquire necessary competence where applicable and how do you evaluate the effectiveness of those actions.

Verify documented information as evidence of competence where appropriate.

Verify documented process(es) for identifying training needs including awareness and achieving competence

Verify on-the-job training process

Verify documented process(es) to verify internal and second-party auditors are competent and can demonstrate

understanding of the automotive process approach for auditing, including risk-based thinking

understanding of applicable customer and organization specific requirements

understanding of applicable ISO 9001 and IATF 16949 requirements

applicable manufacturing process(es) to be audited, including PFMEA and control plan (second-party auditor only)

understanding of the applicable core tool requirements

understanding how to plan, conduct, report and close out audit findings

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

Verify product auditors demonstrate competence in understanding product requirements and use of relevant measuring and test equipment to verify product conformity

Verify maintenance of and improvement in internal auditor competence by

executing minimum number of audits per year, as defined by organization

maintaining knowledge of relevant requirements based on internal or external changes

7.3 Awareness

Verify people doing work under the organization's control are aware of

the quality policy.

the relevant quality objectives.

their contribution to the effectiveness of the QMS, including the benefits of improved performance.

the implications of not conforming with the QMS requirements.

7.4 Communication

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

7.5 Documented information

Verify documented information required by the ISO 9001:2015 standard.

Verify documented information that shows the effectiveness of the QMS.

Show me that your documented information contains appropriate identification, format (language, software version, graphics, ...) and media (paper, electronic, ...).

Show me how the documented information is reviewed and approved for suitability and adequacy.

Show me how you control documented information and make it available and suitable for use. Tell me how you protect your documented information.

Verify how the organization controls the distribution, access, retrieval, use, storage, preservation, legibility, control of changes, retention and disposition of documented information.

Verify documented information of external origin is identified, as appropriate, and controlled.

Verify quality manual and it includes, at a minimum:

Scope of the QMS, including details of and justification for any exclusions

documented processes established for the QMS or reference to them

the organization's processes and their sequence and interactions (inputs and outputs), including type and extent of control of any outsourced processes