Free ISO 9001:2015 Gap Analysis Tool

Find out your level of compliance with ISO 9001. Please reach out to us with the details and we will provide you the solution.

Context of the organization and Leadership

Find out your level of compliance with ISO 9001. Please reach out to us with the details and we will provide you the solution.

Planning and Support

Find out your level of compliance with ISO 9001. Please reach out to us with the details and we will provide you the solution.

Operation

Find out your level of compliance with ISO 9001. Please reach out to us with the details and we will provide you the solution.

Performance and Improvement

Find out your level of compliance with ISO 9001. Please reach out to us with the details and we will provide you the solution.

Contact
Organization
Planning & Support
Operation
Performance

Contact Information

Company Name

Full Name

Email

Telephone

Context of the Organization

Have you determined the external and internal issues that are relevant to your organization?

Yes No

Do you monitor and review information on these issues?

Yes No

Have you determined the interested parties for your QMS and their relevant requirements?

Yes No

Have you determined and documented the boundaries and applicability of your QMS by considering external and internal issues, requirements of interested parties and your products and services?

Yes No

Have you established, implemented, maintained and continually improved a QMS including all processes needed; including interactions and sequences of processes and assigning resources?

Yes No

Do you maintain necessary documented information to support the processes and have confidence they are being carried out to plan?

Yes No

Leadership

Does top management demonstrate leadership of the QMS by accounting for the efficiency of the QMS, promoting QMS principles, promoting improvement and ensuring resources are available?

Yes No

Does top management show leadership with respect to customer focus, customer and statutory requirements, risks and opportunities and enhancing customer satisfaction?

Yes No

Is a quality policy established that is appropriate for the organization, provides a framework for quality objectives and shows commitment to satisfying requirements and continual improvement?

Yes No

Is the quality policy available, maintained, communicated and understood by relevant interested parties?

Yes No

Has top management assigned responsibilities and relevant roles for the QMS development, reporting and maintenance so that it meets the intended goals?

Yes No

Planning

Has planning for the QMS considered issues and requirements that determine the risks and opportunities to be addressed?

Yes No

Has planning taken place to address the risks and opportunities identified and integrate these into the QMS?

Yes No

Have you established quality objectives for the QMS that are measurable, monitored, communicated, updated and documented?

Yes No

When QMS changes are needed are they carried out in a planned manner?

Yes No

Support

Have you determined the resources needed for the QMS including internal and external resources, people, infrastructure and the environment necessary for the QMS?

Yes No

Have you identified the resources needed for valid monitoring and measurement results for product and service conformity including measurement traceability , safeguards for measurement and organizational knowledge necessary for operations?

Yes No

Have you determined the necessary competence required of persons who will perform functions within the QMS processes?

Yes No

Have you taken actions to ensure persons doing work within the QMS know the quality policy, quality objectives and how they contribute to the QMS including the implications of non-conformance?

Yes No

Have you determined the what, when, with whom, how and who communicates for both internal and external communications relevant to the QMS?

Yes No

Have you set up a process to control documented information of the QMS including creating and updating, control of use, adequate protection, control of distribution and changes?

Yes No

Operation

Do you plan and control processes needed for your product or service including criteria for acceptance, resources needed, control necessary and what documented information is needed, including control of planned changes?

Yes No

Have you implemented processes for customer communication, determining requirements for products and services, reviewing requirements of products and services and updating documents when changes occur?

Yes No

Have you established, implemented and maintained a design and development process for your products and services that addresses design and development planning, inputs, controls, outputs and changes?

Yes No

Have you taken steps to ensure externally provided processes meet requirements by determining the type and extent of control needed and the information needed for external providers?

Yes No

Have you implemented the controlled conditions necessary for your production and service provision including; necessary documented information, monitoring and measurement, identification and traceability (if necessary), property belonging to customers or external parties, preservation of product or service, control of changes and post delivery activities associated with your product and service?

Yes No

Have you implemented planned arrangements to verify that requirements have been met before release of products and services?

Yes No

Have you implemented a process to identify and control nonconforming outputs of your processes so that they are not unintentionally used until a disposition has been made? Is documented information maintained for this process?

Yes No

Performance Evaluation

Have you determined the monitoring and measurement needs, how it will be done and when it shall be performed for the processes of the QMS and customer satisfaction? Is analysis and evaluation done on the data and information arising from monitoring and measurement?

Yes No

Are there audit procedures to evaluate the QMS against the planned arrangements (including effectiveness, proper implementation and maintenance) at planned intervals? Are results reported to management?

Yes No

Does top management review the data from the QMS to assess the need for change in the QMS, resource adequacy and the effectiveness of the QMS?

Yes No

Improvement

Do you identify opportunities for improvement and implement action to meet requirements and enhance customer satisfaction?

Yes No

When a nonconformity occurs do you take action to deal with the nonconformity and deal with the consequences, evaluate the need to eliminate the root cause of the nonconformity and review the effectiveness of the corrective action taken?

Yes No

After action is taken do you update any risks and opportunities found during the corrective action and update the QMS if necessary?

Yes No

Do you continually improve the suitability, adequacy and effectiveness of the QMS?

Yes No

Some required Fields are empty
Please check the highlighted fields.

HEALTHCARE

QUALITY ASSURANCE

ISO

Mark Approval / Licensing / Compliance

Medical Device and Diagnostics

Drugs / Biologics / Pharmacovigilance

Free ISO 9001:2015 Gap Analysis Tool