ISO 9001 Readiness Checklist

How ready is your organisation for ISO 9001 certification? Fill out our free self-assessment checklist to find out more. It should only take 5 minutes.

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Clause 4 = Context of the organisation

The 'context of the organisation' refers to the combination of internal and external factors and conditions that can have impacts on your business.

Have you considered the external and internal context issues?

Have you considered the products and services of your organization?

Have you considered the boundaries and/or limits on the applicability of your QMS?

Have you considered identifying, monitoring and reviewing the relevant internal and external issues of your organization to establish whether the impact of any changes to them will affect your QMS?

Have you considered identifying the ‘interested parties that are relevant to your QMS?

Have you considered identifying what requirements these interested parties themselves have, which are relevant to your organization’s QMS?

Have you considered continually monitoring and reviewing these interested parties?

Have you considered adopting a process approach when developing, implementing and improving the effectiveness of your QMS?

Have you considered establishing the scope of your QMS?

Clause 5 = Leadership

The Top management is required to demonstrate a direct involvement in the organisation's QMS.

Is top management involved in the QMS preparation and continued review?

Do they ensure that the Quality Policy is communicated within your organization and to relevant parties?

Are responsibilities and authorities assigned and communicated by top management?

Are these understood within your organization?

Can top management demonstrate that they have taken responsibility for emphasising the importance of conforming to the requirements of your QMS?

Can top management demonstrate that they ensure that the QMS is achieving its intended results?

Can top management demonstrate that they drive continual improvement within your organization?

Can top management demonstrate that they promote the use of risk- based thinking and customer focus?

Clause 6 = Planning

When planning for the quality management system, the organisation shall consider both its context and interested parties. Although risks and opportunities must be determined and addressed.

Have you established measurable quality objectives at relevant functions and levels?

Are they consistent with your organization’s quality policy?

Are they established for relevant processes and are they relevant to the enhancement of customer satisfaction?

Is your organization’s QMS maintained when any changes to it are planned and implemented?

When carrying out the changes, is consideration taken into account of why the change is being made and any potential consequence of those changes?

Have you identified that there are resources necessary to carry out the changes?

Clause 7 = Support

The organisation shall determine and provide the resources needed for the establishment, implementation, maintenance and continual improvement of the quality management system.

Have you determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS?

Have you determined and maintained the knowledge obtained by your organization?

Have you retained documented information to demonstrate that all personnel under your control are competent?

Are all personnel under your control aware both of your organization’s quality objectives as well as the consequences of nonconformance with your QMS requirements?

Has the organization ensured that people doing work under their control are aware of the quality policy and objectives, their contribution to these and the implications of not conforming?

Has the organization determined internal and external communications relevant to the QMS?

Has the documented information required by the standard and necessary for the effective implementation and operation of the QMS been established?

Clause 8 = Operations

The organisation shall plan, implement and control the processes needed to meet the requirements for the provision of products and services, and to implement action plans.

Can you demonstrate that you have specific processes in place for establishing the requirements for the products and services you intend to offer to customers?

Can you substantiate any claims you make in respect to the products and services you offer?

Can you show a designed process where requirements for your products and services have not been established or defined, to the extent that enables product/service provision to take place?

Have you taken a risk-based approach when determining the type and extent of controls to apply to your external providers of processes, products and service?

Do you communicate to your external providers any ‘competence requirements which will apply to their personnel?

Can you identify, verify, protect and safeguard property belonging to any customer and/or external providers used by your organization?

Do you retain documented information on the release of products and services, verifying that they have met customer requirements and are traceable to the person(s) authorising the release?

Clause 9 = Performance Evaluation

The organisation should determine what needs to be monitored and measured. It must also determine the methods for monitoring, measurement, analysis, and evaluation needed to ensure valid results.

Can you demonstrate that you have sought out information relating to how customers view your organization, as well as your products and services?

Clause 10 = Continuous Improvement

The organisation shall determine and select opportunities for improvement and implement any necessary actions to meet customer requirements and enhance customer satisfaction.

Can you demonstrate that you are actively looking for opportunities to improve the performance of your QMS?

Can you identify whether any non- conformity could also exist elsewhere within your facilities, equipment, systems and processes or whether they could potentially happen elsewhere?

Can you demonstrate that you are continually improving the adequacy, suitability and effectiveness of your QMS?