ISO 9001 CHECKLIST

ARE YOU PREPARED FOR ISO 9001?

This questionnaire has been prepared by Bureau Veritas’ experts to enable you to self-assess your
organisation’s readiness for certification to the ISO 9001:2015 Quality Management System (QMS) standard.
Completing the document will give you a better understanding of your QMS in relation to the requirements
of ISO 9001 and establish any gaps that you may need to address prior to certification.

QMS AND YOUR ORGANISATION

Establishing a QMS within the context of your organisation and organisational structure.

Have you identified the external and internal factors that could impact what you’re currently doing and
your strategic direction (what you are aiming to do differently in the future), as well as those that impact
your ability to achieve the desired outcomes of your QMS?

Do you have a mechanism in place to regularly review and monitor these factors?

Have you identified the needs and expectations of all stakeholders / interested parties that could impact
how you set out your QMS and do you review them on a regular basis?

Have you established the scope and boundaries of your QMS, taking into account the external and internal
factors, relevant stakeholders, and the requirements for your products and/or services?

Has your QMS been established, including the necessary processes with consideration of the sequence of
those processes?

Have you defined the methods of managing these processes with responsibilities, methods,
measurements and relevant performance indicators to make sure they are effectively followed
and controlled?

ORGANISATIONAL LEADERSHIP
Has your QMS been linked to business leadership?

Does your senior management team take accountability for ensuring the effectiveness of your QMS?

Have policies and objectives been established and communicated for your QMS that align with your
organisation’s context and strategic direction?

Have you set objectives at appropriate functional, process, departmental, and individual levels within the
organisation?

Have you integrated the QMS requirements into your business processes with consideration of risks?

Has the risk based approach been promoted by management?

Have you determined the customer requirements, met these requirements along with other applicable
statutory and regulatory requirements, and communicated them throughout the organisation?

Have you identified the risks and opportunities that could impact the conformity of your products and
services, with plans to address these where possible, as well as your ability to enhance customer
satisfaction?

Have you determined and communicated authorities and responsibilities for the effective operation of the
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QMS throughout the organisation?

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ISO 9001 CHECKLIST CONT’D
PLANNING FOR THE FUTURE
Putting in place measures for change

Have you identified the risks and opportunities that relate to the success of your QMS and in achieving the
intended results?

Have you planned actions to address these risks and opportunities where possible and integrated them
into your business processes?

Have you established the objectives / measures of success for your product or service within relevant
departments at the required levels and within the processes?

Do you have a plan in place to identify when changes are needed to the QMS and a method to introduce
those changes in a controlled manner?

SUPPORT FOR INTERNAL AND EXTERNAL STAKEHOLDERS

Making sure all parties have the tools to deliver your objectives.

Have you determined and provided the necessary resources that you need in terms of people,
infrastructure and the environment you operate in, for establishing, implementing, maintaining and
continually improving your QMS?

Where monitoring or measuring is used to ensure conformity of products and services to specified
requirements, have you determined and provided the resources necessary to obtain valid and
reliable results?

Have you identified the knowledge that is required to operate processes and achieve conformity of
products and services in line with the QMS?

Have you ensured that the competence required to meet product / service requirements and maintain the
QMS has been provided through appropriate education, training and/or experience?

Have you ensured that individuals working under your control are aware of the quality policy and
objectives, their contribution to the achievement of these and the consequences of not following the
required rules / procedures?

Have you determined the internal and external communication relevant to the QMS?

Have you established the necessary documented information required by the standard to effectively
implement and operate the QMS?

OPERATING YOUR QMS

Processes to ensure quality of products or services.

Have you established procedures for delivering products and services that meet the specified requirements?

Are any changes implemented in a controlled manner and actions taken to mitigate any potential
negative impacts?

Have you defined a process for reviewing and communicating with customers regarding product/service
information, enquiries, contracts and / or order handling?

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ISO 9001 CHECKLIST CONT’D
OPERATING YOUR QMS CONT’D
Can you confirm that this review has been conducted before committing to supply products and services?
If you engage in product / service design and development to meet customers’ needs, are there processes
in place that align with the standard’s requirements?

Do you ensure that externally provided processes, products and services meet the specified requirements?

Do you have appropriate criteria for evaluating and selecting external providers, monitoring their
performance and considering alternative providers if needed?

Is the provision of products and services carried out under controlled conditions, including:
• Documented information about the product/service characteristics and desired outcomes
• Monitoring and measuring activities undertaken at appropriate stages to verify product / service
and / or process conformity and acceptance criteria
• Ensuring that individuals are competent in carrying out the tasks they are required to complete

Do you employ suitable methods to ensure identification and traceability of outputs during production and
service provision?

Is customer and / or externally provided property effectively controlled when used in the provision of
products / services?

If post-delivery activities such as warranty, maintenance services, recycling or final disposal are required,
are they clearly defined and managed?

Are nonconforming outputs managed effectively to prevent unintended use or delivery?

EVALUATING PERFORMANCE
Measurement and evaluation to check performance and identify any issues early.

Has your organisation determined what needs to be monitored and measured to ensure effective outputs
of the processes in relation to the product / service?

Have you established the methods for this monitoring, measurement, analysis and necessary evaluation to
ensure reliable results?

Have you established when monitoring and measurement results will be analysed and evaluated?

Have you implemented methods to monitor customer perceptions regarding the fulfilment of their needs
and expectations?

Have you implemented an internal audit programme for the QMS?

Have you identified the need for improvements within the QMS and determined how they will be
incorporated into management reviews?

Have you established and implemented an approach for conducting management reviews?

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ISO 9001 CHECKLIST CONT’D
CONTINUAL IMPROVEMENT
Ensuring continual improvement of quality within your organisation.

Has your organisation identified and selected improvement opportunities and taken necessary actions
to meet customer requirements and enhance customer satisfaction?

Do you have appropriate processes in place for managing nonconformities and implementing
corrective actions?

Have you determined how you will address the requirement for continual improvement of the QMS in
terms of its suitability, adequacy and effectiveness?

SHAPING A WORLD
OF TRUST
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company, contributing to transforming the world
we live in. A world leader in testing, inspection and
certification, we help clients across all industries
address challenges in quality, health & safety,
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t: 0345 600 1828

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ISO9001 Checklist 10.23_AB