ISO 9001:2015 Checklist

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(Yes/No)

4 Context of the organization
4.1 Understanding the organization and its context
The organization shall determine external and internal issues that are relevant to its purpose and its strategic direction and that affect its ability to achieve the intended result(s) of its quality management system.  The organization shall monitor and review the information about these external and internal issues

4.2 Understanding the needs and expectations of interested parties
Due to their impact or potential impact on the organizations ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, the organization shall determine:

The interested parties that are relevant to the quality management system

The requirements of these interested parties that are relevant to the quality management system; the organization shall monitor and review the information about these interested parties and their relevant requirements

4.3 Determining the scope of the quality management system
The organization shall determine the boundaries and applicability of the quality management system to establish its scope

4.4 Quality management system
The organization shall establish, implement, maintain and continually improve a quality management system, including the processes needed and their interactions

ISO 9001:2015 Clause

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5 Leadership
5.1 Leadership and commitment
5.1.1 General
Top management shall demonstrate leadership and commitment with respect to the quality management system by:
Taking accountability of the effectiveness of the QMS
Ensuring that the quality policy and objectives are established for the QMS and are compatible with the context and strategic direction of organization
Ensuring the integration of the QMS requirements into the   organization’s business processes
Promoting the use of the process approach and risk based thinking
Ensuring that the resources needed for the QMS are available
Communicating the importance of effective quality management and of conforming to the QMS requirements
Ensuring that the QMS achieves its intended results
Engaging, directing and supporting persons to contribute to the effectiveness of the QMS
Promoting continual improvement
Supporting other relevant management roles to demonstrate their leadership as it applies to their areas of responsibility

5.1.2 Customer Focus
Top management shall demonstrate leadership and commitment with respect to customer focus by ensuring:

1. Customer and applicable statutory and regulatory requirements are determined, understood and consistently met
2. The risks and opportunities that can effect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed
3. The focus on enhancing customer satisfaction is maintained

5.2 – Policy
5.2.1 Developing the Quality Policy
Top management shall establish, review and maintain a quality policy that:
Is appropriate to the purpose and context of the organization.

Provides a framework for setting and reviewing quality objectives
Includes a commitment to satisfy applicable requirements

It should communicated and understood and be available to relevant interested parties as appropriate

5.2.2 Communicating the Quality Policy
The quality policy shall:

1. Be available and be maintained as documented information
2. Be communicated, understood and applied within the organisation
3. Be available to relevant interested parties, as appropriate

5.3 Organizational roles, responsibilities and authorities  
Top management shall ensure that the responsibilities and authorities for relevant roles are assigned, communicated and understood within the organization

6 Planning
6.1 Actions to address risk and opportunities
When planning for the QMS the organization shall consider the issues referred to 4.1 and the requirements referred to in 4.2 and determine the risks and opportunities that need to be addressed to:

a)give assurance that the QMS can achieve the intended results
b) enhance desirable effects
c) prevent or reduce, undesired
effects
d) achieve improvement

6.1.2 The organization shall plan:

a) actions to address these risks and opportunities
b) how to:
1) Integrate and implement the
actions into its QMS
2) Evaluate the effectiveness of
these actions 

6.2 Quality objectives and planning to achieve them

6.2.1 The organisation shall establish quality objectives at relevant functions, levels and processes needed for the QMS

ISO 9001:2015 Clause

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6.2.2 When planning actions to achieve quality objectives the organization shall determine:

What will be done, what resources will be required, who will be responsible, when will it be completed, how will the results be evaluated

6.3 Planning of changes
When the organisation determines the need for changes to the QMS, the changes shall be carried out in a planned manner:
The purpose of the change and any potential consequences, the integrity of the QMS, the availability of resources, the allocation or re-allocation of responsibilities and authorities

7 Support  
7.1 Resources  
The organization shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system

7.2 Competence
The organisation shall:

Determine the necessary competence of persons doing work under its control that affects the performance and effectiveness of the QMS

Ensure that these persons are competent on the basis of appropriate education, training or experience

Where applicable take actions to acquire the necessary competence and evaluate the effectiveness of the actions taken

Retain appropriate documented information as evidence of competence

7. 3 Awareness
Persons doing work under the organization’s control shall be aware of:
The quality policy and 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

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7.4 Communication
The organization shall determine  internal and external communications relevant to the QMS
What it will communicate?
When to communicate?
With whom to communicate?
How to communicate?

7.5 Documented information
7.5.1 General
The organizations QMS shall include:

Documented information required by this international standard and determined by the organization as being necessary for the effectiveness of the QMS

7.5.2 Creating and updating
When creating and updating documented information the organization shall ensure appropriate:
Identification and description (e.g. a title, date, author, or reference number);
format (e.g. language, software version, graphics) and media (e.g. paper, electronic);
review and approval for suitability and adequacy.

7.5.3 Control of documented information
Documented information required by the QMS and by this International Standard shall be controlled to ensure:
it is available and suitable for use, where and when it is needed it is adequately protected

7.5.3.2
For control of documented information the organization shall address the following activities where applicable:
Distribution, access, retrieval and use
Storage and preservation
Control of changes
Retention and disposition

Documented information of external origin shall be identified as appropriate and controlled

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8 Operation
8.1 Operational planning and control
The organization shall plan, implement and control the processes needed to meet   requirements for the provision of products and services, and to implement the actions determined in 6.0 by:

Determining requirements for the products and services

Establishing criteria for the processes and for the acceptance of products and services

Determining the resources needed to achieve conformity to product and service requirements

Implementing control of the processes in accordance with the criteria

Determining and keeping documented information to the extent necessary to have confidence that the processes have been carried out as planned and to demonstrate conformity of products and services to requirements

The organisation shall control planned changes and review the consequences of unintended changes taking action to mitigate any adverse effects as necessary

The organisation shall ensure that outsourced processes are controlled in accordance with 8.4

8.2 Requirements for products and services

8.2.1 Customer communication
Communication with customers shall include:

Providing information relating to products and services

Handling enquiries, contracts or orders including changes

Obtaining customer feedback, including customer complaints

The handling or controlling customer property

Establishing specific requirements for contingency actions when relevant

ISO 9001:2015 Clause

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8.2.2 Determining requirements related to products or services
 

8.2.3 Review of requirements related to products and services

8.2.4 Changes to requirements for products and services No

8.3 Design and development

8.3.1 General
The organisation shall establish, implement and maintain a design and development process that is appropriate to ensure the subsequent provision of products and services

8.3.2 Design and development planning

8.3.3 Design and development inputs

8.3.4 Design and development controls

8.3.5 Design and development outputs

8.3.6 Design and development changes

8.4 Control of externally provided services

8.5 Production and service provision

8.6 Release of products and services

8.7 Control of nonconforming process outputs

9 Performance evaluation
9.1 Monitoring, measurement, analysis and evaluation
9.1.1 General
The organization shall determine:

what needs to be monitored and measured, the methods of monitoring measurement, analysis and evaluation as applicable to ensure valid results

when monitoring and measuring will be performed and when results from monitoring and measurement shall be analysed and evaluated

The organisation shall evaluate the quality performance and effectiveness of the QMS

9.1.2 Customer Satisfaction

9.1.3 Analysis and evaluation

9.2 Internal Audit
9.2.1
The organization shall conduct internal audits at planned intervals to provide information on whether the QMS conforms to the organisations own requirements for its QMS and to this international standard and is effectively implemented and maintained

ISO 9001:2015 Clause

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9.3 Management Review
Top management shall review the organization's QMS, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness

10 Improvement
10.1 General
10.2 Nonconformity and corrective action
When a nonconformity occurs, including those arising from complaints, the organization shall react to the nonconformity

10.3 Continual improvement
The organization shall continually improve the suitability, adequacy and effectiveness of the QMS