ISO 9001:2015 Compliance Checklist: Ensuring Product, Service, and Customer Satisfaction, Exams of Quality Management

Download ISO 9001:2015 Compliance Checklist: Ensuring Product, Service, and Customer Satisfaction and more Exams Quality Management in PDF only on Docsity!

DNV GL

Assessment Checklist

ISO 9001:

Rev 0 - December 2015

4 Context of the Organization

No. Question Proc. Ref. Comments

4.1 Understanding the Organization

and its context

1 Has the organization determined external and

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?

2 Is the organization monitoring and reviewing

information about these external and internal issues?

4.2 Understanding the needs and

expectations of interested parties

3 Has the organization:

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?

4 Is the organization reviewing and monitoring

information about these interested parties and their relevant requirements?

4.3 Determining the scope of the quality

management system

5 Has the organization determined the boundaries

and the applicability of the quality management system in order to establish its scope?

6 When establishing the scope has the organization

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?

7 Has the organization applied all of the

requirements of the ISO 9001:2015 International Standard (if applicable) within the determined scope of its quality management system?

8 Is the scope of the organization’s quality

management system available and maintained as documented information?

9 Does the organization’s scope state the types of

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 Leadership

No. Question Proc. Ref. Comments

5.1 Leadership and commitment

5.1.1 General

1 Has top management demonstrated leadership

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?

g) Ensuring that the quality management

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

2 Has top management demonstrated leadership

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 Policy

5.2.1 Establishing the quality policy

3 Has top management established, implemented

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

4 Is 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?

5.3 Organizational roles, responsibilities

and authorities

5 Has top management ensured that the

responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization?

6 Has top management assigned the responsibility

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?

6 Has the organization developed quality objectives

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?

7 Has the organization maintained documented

information on the quality objectives? 6.2.

8 When planning how to achieve quality objectives

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?

6.3 Planning of changes

9 Has the organization determined the need for

changes to the quality management system and carried those changes out in a planned manner (see 4.4)?

10 When planning for changes has the organization

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 Support

No. Question Proc. Ref. Comments

7.1 Resources

7.1.1 General

1 Has the organization determined and provided

the resources necessary for the establishment, implementation, maintenance and continual improvement of the quality management system?

2 When providing resources has the organization

considered: a) The capabilities of, and constraints on, existing internal resources? b) What needs to be obtained from external providers? 7.1.2 People

3 Has the organization determined and provided

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

4 Has the organization determined, provided and

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

5 Has the organization determined, provided, and

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

6 Has the organization determined and provided

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?

7 Has the organization ensured that the resources

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?

7.3 Awareness

15 Has the organization ensured that the persons

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?

7.4 Communication

16 Has the organization determined the internal and

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 Documented Information

7.5.1 General

17 Has the organization’s quality management

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

18 When creating and updating documented

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.

19 Has the organization ensured that documented

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.

20 Has the organization, in order to control

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?

21 Has the organization determined documented

information of external origin necessary for the planning and operation of the quality management system be identified as appropriate, and be controlled?

22 Has the organization retained documented

information as evidence of conformity and protected it from unintended alterations?

8 Operation

No. Question Proc. Ref. Comments

8.1 Operational planning and control

1 Has the organization planned, implemented and

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.

7 Has the organization ensured that it has the ability

to meet the requirements for products and services to be offered to customers?

8 Has the organization conducted a review before

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?

9 Has the organization ensured that contract or

order requirements differing from those previously defined are resolved?

10 Has the organization ensured that customer

requirements are confirmed by the organization before acceptance, when the customer does not provide a documented statement of their requirements? 8.2.3.

11 Has the organization retained documented

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

12 Has the organization ensured that relevant

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 Design and development of products

and services

8.3.1 General

13 Has the organization established, implemented

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

14 Has the organization in determining the stages

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

15 Has the organization determined the

requirements essential for the specific types of products and services to be designed and developed by considering: a) Functional and Performance requirements?

21 Has the organization retained documented

information on design and development outputs? 8.3.6 Design and development changes

22 Has the organization identified, reviewed, and

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?

23 Has the organization retained documented

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 Control of externally provided

processes, products and services

8.4.1 General

24 Has the organization ensured that the externally

provided processes, products and services conform to requirements?

25 Has the organization determined the controls to

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?

26 Has the organization determined and applied the

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?

27 Has the organization retained documented

information of these activities and any necessary actions arising from the evaluations? 8.4.2 Type and extent of control

28 Has the organization ensured that externally

provided processes, products and services do not adversely affect the organization’s ability to

consistently deliver conforming products and services to its customers?

29 Has the organization:

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

30 Has the organization ensured the adequacy of

requirements prior to their communication to the external provider?

31 Has the organization communicated to external

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 Production and service provision

8.5.1 Control of production and service provision

37 Has the organization identified, verified,

protected and safeguarded customer or external providers’ property provided for use or incorporation into the products and services?

38 When property of a customer of external provider

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

39 Has the organization preserved the outputs

during production and service provision, to the extent necessary to ensure conformity to requirements? 8.5.5 Post-delivery activities

40 Has the organization met the requirements for

post-delivery activities associated with the products and services?

41 In determining the extent of the post-delivery

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

42 Has the organization reviewed and controlled

changes for production or service provision, to the extent necessary to ensure continuing conformity with requirements?

43 Has the organization 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?

8.6 Release of products and services

44 Has the organization implemented planned

arrangements, at appropriate stages, to verify that the product and service requirements have been met?

45 Has the organization ensured that the release of

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?

46 Has the organization retained documented

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?

8.7 Control of nonconforming outputs

47 Has the organization ensured that outputs that do

not conform to their requirements are identified and controlled to prevent their unintended use or delivery?

48 Has the organization taken appropriate action on

outputs based on the nature of the nonconformity and its effect on the conformity of products and services?

49 Has the organization also applied action on

nonconforming products and services detected after the delivery of products and during or after the provision of services?

50 Has the organization dealt with nonconforming

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?

51 Has the organization verified conformity to the

requirements when nonconforming outputs are corrected? 8.7.

52 Has the organization retained documented

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?