Free ISO 9001:2015 Gap Analysis Tool

You need to determine the external and internal issues that are relevant to your organization.

You need to determine the interested parties for your QMS and their relevant requirements.

You need to determine and document the boundaries and applicability of your QMS by considering external and internal issues, requirements of interested parties and your products and services. 

A quality policy must be established that is appropriate for the organization, provides a framework for quality objectives and shows commitment to satisfying requirements and continual improvement. 

You need to plan for the QMS and consider issues and requirements that determine the risks and opportunities to be addressed.

Planning must take place to address the risks and opportunities identified and integrate these into the QMS.

You need to establish quality objectives for the QMS that are measurable, monitored, communicated, updated and documented.

You need to determine the necessary competence required of persons who will perform functions within the QMS processes.

You need to 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.

You need to implement processes for customer communication, determining requirements for products and services, reviewing requirements of products and services and updating documents when changes occur.

You need to establish, implement and maintain a design and development process for your products and services that addresses design and development planning, inputs, controls, outputs and changes.

You need to take steps to ensure externally provided processes meet requirements by determining the type and extent of control needed and the information needed for external providers.

You need to implement 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.

You need to implement planned arrangements to verify that requirements have been met before release of products and services.

You need to implement a process to identify and control nonconforming outputs of your processes so that they are not unintentionally used until a disposition has been made and you must maintain documented information for this process.

You need to determine the monitoring and measurement needs, how they will be done and when they shall be performed for the processes of the QMS and customer satisfaction. You must also analyze and evaluate the data and information arising from monitoring and measurement.

You need to have audit procedures to evaluate the QMS against the planned arrangements (including effectiveness, proper implementation and maintenance) at planned intervals and results must be reported to management.

Top management must review the data from the QMS to assess the need for change in the QMS, resource adequacy and the effectiveness of the QMS.

When a nonconformity occurs you must 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.