AS9100 Gap Analysis Tool

You need to determine the external and internal issues that are relevant to your organization.Find out more here: Procedure for Determining Context of the Organization and Interested Parties.

You need to determine the interested parties for your QMS and their relevant requirements.Find out more here: Procedure for Determining Context of the Organization and Interested Parties.

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.Find out more here: Scope of the Quality Management System.

Top management must show leadership with respect to customer focus, customer and statutory requirements, risks and opportunities, and enhancing customer satisfaction.Find out more here: Procedure for Measuring Customer Satisfaction.

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.Find out more here: Quality Policy.

You need to plan for the QMS and consider issues and requirements that determine the risks and opportunities to be addressed.Find out more here: Procedure for Addressing Risks and Opportunities.

You need to establish quality objectives for the QMS that are measurable, monitored, communicated, updated, and documented.Find out more here: Quality Objectives.

You need to identify 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. You need to have a register of monitoring and measurement equipment and a process for recall and calibration.Find out more here: Procedure for Equipment Maintenance and Measurement Equipment.

You need to determine the necessary competence required of persons who will perform functions within the QMS processes.Find out more here: Procedure for Competence, Training and Awareness.

You need to take actions to ensure that 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. These persons also need to be aware of relevant QMS documentation, how they contribute to product and service conformity and product safety, and the importance of ethical behavior.Find out more here: Procedure for Competence, Training and Awareness.

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, prevention of use of obsolete documents, and changes. Any electronic document controls must have defined data protection processes.Find out more here: Procedure for Document and Record Control.

You need to implement processes for customer communication, determining requirements for products and services (including special requirements and operational risks), reviewing requirements of products and services, and updating documents when changes occur. When customer requirements cannot be fully met, you need to have a process to negotiate a mutually acceptable change.Find out more here: Sales Procedure.

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 (including the ability to provide, verify, test, and maintain products and services).Find out more here: Procedure for Design and Development.

You need to take steps to ensure that externally provided processes meet requirements by determining the type and extent of control needed and the information needed for external providers. You need processes in place to approve providers, review performance, manage risks, and control documented information created by providers.Find out more here: Procedure for Purchasing and Evaluation of Suppliers.

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. Your processes need to include foreign object prevention, control of equipment, tools and software programs, validation and control of special processes, and production process verification.Find out more here: Procedure for Production and Service Provision.

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. Dispositions of Use-As-Is or Repair can only be used when approved by an authorized design representative and customer authorization.Find out more here: Procedure for Management of Nonconformities and Corrective Actions.

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.Find out more here: Procedure for Internal Audit.

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.Find out more here: Procedure for Management Review.

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 (including human factor causes), and review the effectiveness of the corrective action taken. You need to flow corrective actions to external suppliers when needed and take action when timely responses are not achieved.Find out more here: Procedure for Management of Nonconformities and Corrective Actions.