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A checklist for organizations seeking to claim conformity to the ISO 9001:2015 International Standard. The checklist covers various aspects of the standard, including infrastructure, operational planning, requirements for products and services, design and development, control of externally provided processes, and post-delivery activities. It helps organizations ensure they have addressed all necessary requirements for conformity and customer satisfaction.
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internal issues that are relevant to its purpose, strategic direction and that affect its ability to achieve the intended result(s) of its quality management system?
information about these external and internal issues?
a) Determined the interested parties that are relevant to the quality management system? b) Determined the requirements of these interested parties that are relevant to the quality management system?
information about these interested parties and their relevant requirements?
and the applicability of the quality management system in order to establish its scope?
taken into consideration: a) The external and internal issues referred to in 4.1?
b) The requirements of relevant interested parties referred to in 4.2?
c) The products and services of the organization?
requirements of the ISO 9001:2015 International Standard (if applicable) within the determined scope of its quality management system?
management system available and maintained as documented information?
products and services covered?
a) Maintained documented information to support the operation of its processes? b) Retained documented information to have confidence that the processes are being carried out as planned?
5.1.1 General
and commitment with respect to the quality management system by: a) Taking accountability for the effectiveness of the quality management system? b) Ensuring that the quality policy and quality objectives are established for the quality management system and are compatible with the context and strategic direction of the organization? c) Ensuring the integration of the quality management system requirements into the organization’s business processes? d) Promoting the use of the process approach and risk-based thinking? e) Ensuring that the resources needed for the quality system are available? f) Communicating the importance of effective quality management and of conforming to the quality management system requirements?
system achieves its intended results? h) Engaging, directing and supporting persons to contribute to the effectiveness of the quality management system? i) Promoting improvement?
j) Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility?
5.1.2 Customer Focus
and commitment with respect to customer focus by: a) Ensuring that customer and applicable statutory and regulatory requirements are
determined, understood and consistently met? b) Ensuring that the risks and opportunities that can affect conformity of products and services along with the ability to enhance customer satisfaction are determined and addressed? c) Ensuring that the focus on enhancing customer satisfaction is maintained?
5.2.1 Establishing the quality policy
and maintained a quality policy that: a) Is appropriate to the purpose and context of the organization and supports its strategic direction? b) Can provide a framework for setting quality objectives? c) Includes a commitment to continual improvement to satisfy applicable requirements? d) Includes a commitment to continual improvement of the quality management system? 5.2.2 Communicating the Quality Policy
a) Available and maintained as documented information? b) Communicated, understood and applied within the organization? c) Available to relevant interested parties, as appropriate?
responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?
and authority by: a) Ensuring that the quality management system conforms to the requirements of the ISO 9001:2015 International Standard? b) Ensuring that the processes are delivering their intended outputs? c) Reporting on the performance of the quality management system and on
processes needed for the quality management system?
that: a) Are consistent with the quality policy? b) Are Measurable?
c) Take into account applicable requirements? d) Are relevant to conformity of products and services and to enhancement of customer satisfaction? e) Are monitored?
f) Are communicated?
g) Are updated as appropriate?
information on the quality objectives? 6.2.
has the organization determined: a) What will be done?
b) What resources will be required?
c) Who will be responsible?
d) When it will be completed?
e) How the results will be evaluated?
changes to the quality management system and carried those changes out in a planned manner (see 4.4)?
considered: a) The purpose of the changes and their potential consequences?
b) The integrity of the quality management system? c) The availability of resources?
d) The allocation or reallocation of responsibilities and authorities?
7.1.1 General
the resources necessary for the establishment, implementation, maintenance and continual improvement of the quality management system?
considered: a) The capabilities of, and constraints on, existing internal resources? b) What needs to be obtained from external providers? 7.1.2 People
the persons necessary for the effective implementation of its quality management system and for the operation and control of its processes? 7.1.3 Infrastructure
maintained the infrastructure necessary for the operation of its processes and to achieve conformity of products and services? 7.1.4 Environment for the operation of processes
maintained the environment necessary for the operation of its processes and to achieve conformity of products and services?
7.1.5 Monitoring and measuring resources
7.1.5.1 General
the resources needed to ensure valid and reliable results when monitoring and measuring is used to verify the conformity of products and services to requirements?
provided: a) Are suitable for the specific type of monitoring and measurement activities being undertaken? b) Are maintained to ensure their continuing fitness for their purpose?
training, or experience?
c) Ensured where applicable taken actions to acquire the necessary competence, and evaluate the effectiveness of the actions taken? d) Retained appropriate documented information as evidence of competence?
doing work under the organization’s control are aware of: a) The quality policy?
b) Relevant quality objectives?
c) Their contribution to the effectiveness of the quality management system, including benefits of improved performance? d) The implications of not conforming with the quality management system requirements?
external communications relevant to the quality management system including: a) What it will communicate?
b) When to communicate?
c) With whom to communicate?
d) How to communicate?
e) Who communicates?
7.5.1 General
system included documented information that: a) Is required by the ISO 9001: International Standard? b) Is documented information determined by the organization as being necessary for the effectiveness of the quality management system? 7.5.2 Creating and updating
information has the organization ensured:
a) The documented information has an appropriate identification and description? b) The documented information has an appropriate format? c) The documented information has been reviewed and approved for suitability and adequacy? 7.5.3 Control of documented information
7.5.3.
information required by the quality management system and by the ISO 9001:2015 standard is controlled to ensure: a) That is available and suitable for use, where and when it is needed? b) That it is adequately protected (from loss of confidentiality, improper use, or loss of integrity)? 7.5.3.
documented information, addressed: a) Its distribution, access, retrieval and use?
b) Its storage and preservation, including preservation of legibility? c) Its control of changes (e.g. version control)? d) Its retention and disposition?
information of external origin necessary for the planning and operation of the quality management system be identified as appropriate, and be controlled?
information as evidence of conformity and protected it from unintended alterations?
controlled the processes (see 4.4) needed to meet the requirements for the provision of
customers ensured that: a) The requirements for the products and services are defined including: applicable statutory and regulatory requirements along with those considered necessary by the organization? b) The organization can meet the claims for the products and services it offers? 8.2.3 Review of the requirements for products and services
8.2.3.
to meet the requirements for products and services to be offered to customers?
committing to supply products and services to a customer that includes: a) Requirements specified by the customer, including requirements for delivery and post-delivery activities? b) Requirements not stated by the customer, but necessary for the specified or intended use, when known? c) Requirements specified by the organization? d) Statutory and regulatory requirements applicable to the products and services? e) Contract or order requirements differing from those previously expressed?
order requirements differing from those previously defined are resolved?
requirements are confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements? 8.2.3.
information as applicable: a) On the results of the review?
b) On any new requirements for the products and services? 8.2.4 Changes to requirements for products and services
documented information is amended, and that relevant persons are made aware of the changed
requirements, when the requirements for products and services are changed?
8.3.1 General
and maintained a design and development process that is appropriate to ensure the subsequent provision of products and services? 8.3.2 Design and development planning
and controls for design and development, considered: a) The nature, duration and complexity of the design and development activities? b) The required process stages, including applicable design and development reviews? c) The required design and development verification and validation activities? d) The responsibilities and authorities involved in design and development process? e) The internal and external resource needs for the design and development of products and services? f) The need to control interfaces between persons involved in the design and development process? g) The need for involvement of customers and users in the design and development process? h) The requirements for subsequent provision of products and services? i) The level of control expected for the design and development process by customers and other relevant interested parties? j) The documented information needed to demonstrate that the design and development requirements have been met? 8.3.3 Design and development inputs
requirements essential for the specific types of products and services to be designed and developed by considering: a) Functional and Performance requirements?
information on design and development outputs? 8.3.6 Design and development changes
controlled changes made during, or subsequently to the design and development of products and services, to ensure that there is no adverse impact on conformity to requirements?
information on: a) The design and development changes?
b) The results of reviews?
c) The authorization of the changes?
d) The actions taken to prevent adverse impacts?
8.4.1 General
provided processes, products and services conform to requirements?
be applied to externally provided processes, products and services when: a) The products and services from external providers are intended for incorporation into the organization’s own products and services? b) The products and services are provided directly to the customer(s) by external providers on behalf of the organization? c) A process, or part of a process, is provided by an external provider as a result of a decision by the organization?
criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers, based on their ability to provide processes or products and services in accordance with requirements?
information of these activities and any necessary actions arising from the evaluations? 8.4.2 Type and extent of control
provided processes, products and services do not adversely affect the organization’s ability to
consistently deliver conforming products and services to its customers?
a) Ensured that externally provided processes remain within the control of its quality management system? b) Ensured that it has defined both the controls it intends to apply to an external provider and those it intends to apply to the resulting output? c) Taken into consideration the potential impact of the externally provided processes, products and services on the organization’s ability to consistently meet customer requirements along with applicable statutory and regulatory requirements? d) Taken into consideration the effectiveness of the controls applied by the external provider? e) Determined the verification, or other activities, necessary to ensure that externally provided processes, products and services meet requirements? 8.4.3 Information for external providers
requirements prior to their communication to the external provider?
providers its requirements for: a) The processes, products and services to be provided? b) The approval of products and services, methods, processes, equipment and the release of products and services? c) Competence, including any required qualification of persons? d) The external provider’s interactions with the organization? e) The controlling and monitoring of external providers’ performance applied by the organization? f) Verification or validation activities that the organization, or its customer, intends to perform at the external providers’ premises?
8.5.1 Control of production and service provision
protected and safeguarded customer or external providers’ property provided for use or incorporation into the products and services?
is lost, damaged or found to be unsuitable for use, has the organization reported this to the customer or external provider and retained documented information on what has occurred? 8.5.4 Preservation
during production and service provision, to the extent necessary to ensure conformity to requirements? 8.5.5 Post-delivery activities
post-delivery activities associated with the products and services?
activities that are required has the organization considered: a) Statutory and Regulatory requirements?
b) The potential undesired consequences associated with its products and services? c) The nature, use and intended lifetime of its products and services? d) Customer requirements?
e) Customer feedback?
8.5.6 Control of changes
changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?
information describing the results of the review of changes, the person(s) authorizing the change, and any necessary actions arising from the review?
arrangements, at appropriate stages, to verify that the product and service requirements have been met?
products and services to the customer not proceed until the planned arrangements have been satisfactorily completed, unless otherwise
approved by a relevant authority and as applicable, by the customer?
information on the release of products and services which includes: a) Evidence of conformity with the acceptance criteria? b) Traceability to the person(s) authorizing the release?
not conform to their requirements are identified and controlled to prevent their unintended use or delivery?
outputs based on the nature of the nonconformity and its effect on the conformity of products and services?
nonconforming products and services detected after the delivery of products and during or after the provision of services?
outputs in one or more of the following ways by: a) Correction?
b) Segregation, containment, return or suspension or provision of products and services? c) Informing the customer?
d) Obtaining authorization for acceptance under concession?
requirements when nonconforming outputs are corrected? 8.7.
information that: a) Describes the nonconformity?
b) Describes the actions taken?
c) Describes any concessions obtained?
d) Identifies the authority deciding the action in respect of the nonconformity?