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ISO 9001 Gap Analysis [Free Tool]

Find out your level of compliance with ISO 9001

Instructions: The questions below cover all relevant ISO 9001 requirements - by filling out the answers, this tool will automatically calculate your company's level of compliance with ISO 9001.

When answering questions, the following scale needs to be used: 
  • 1 — Not implemented: No process or activity implemented, or little/no evidence of any systematic achievement
  • 2 — Planned: Activity or process is planned but is not implemented, or the implementation just started
  • 3 — In progress: Activity or process is partially implemented, so that its full effects cannot be expected
  • 4 — Mostly implemented: Activity or process is fully or mostly implemented, documented, and relevant people are trained, but monitoring, measurement, and improvement are not systematic
  • 5 — Optimized: Activity or process is fully implemented, documented, and is continuously supervised, measured, and improved; relevant people are trained

4 CONTEXT OF THE ORGANIZATION

4.1 UNDERSTANDING THE ORGANIZATION AND ITS CONTEXT


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

Click here to see an example Procedure for Determining Context of the Organization and Interested Parties.   See Preview

Tip
You need to monitor and review information on internal and external issues.

4.2 UNDERSTANDING THE NEEDS AND EXPECTATIONS OF INTERESTED PARTIES


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

Click here to see an example List of Interested parties.   See Preview

4.3 DETERMINING THE SCOPE OF THE QUALITY MANAGEMENT SYSTEM


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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.

Click here to see an example Scope of the Quality Management System.   See Preview

4.4 QUALITY MANAGEMENT SYSTEM AND ITS PROCESSES


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You need to establish, implement, maintain and continually improve a QMS including all processes needed; including interactions and sequences of processes and assigning resources.

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You need to maintain necessary documented information to support the processes and have confidence they are being carried out to plan.

5 LEADERSHIP

5.1 LEADERSHIP AND COMMITMENT


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Top management needs to demonstrate leadership of the QMS by accounting for the efficiency of the QMS, promoting QMS principles, promoting improvement and ensuring resources are available.

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Top management must show leadership with respect to customer focus, customer and statutory requirements, risks and opportunities and enhancing customer satisfaction.

5.2 POLICY


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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.

Click here to see an example Quality Policy.   See Preview

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The quality policy needs to be available, maintained, communicated and understood by relevant interested parties.

5.3 ORGANIZATIONAL ROLES, RESPONSIBILITIES AND AUTHORITIES


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Top management must assign responsibilities and relevant roles for the QMS development, reporting and maintenance so that it meets the intended goals.

6 PLANNING

6.1 ACTIONS TO ADDRESS RISKS AND OPPORTUNITIES


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

Click here to see an example Procedure for Addressing Risks and Opportunities.   See Preview

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

Click here to see an example Registry of Key Risks and Opportunities.   See Preview

6.2 QUALITY OBJECTIVES AND PLANNING TO ACHIEVE THEM


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

Click here to see example Quality Objectives.   See Preview

6.3 PLANNING OF CHANGES


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When QMS changes are needed they must be carried out in a planned manner.

7 SUPPORT

7.1 RESOURCES


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You need to determine the resources needed for the QMS including internal and external resources, people, infrastructure and the environment necessary for the QMS.

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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.

7.2 COMPETENCE


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

Click here to see an example Procedure for Competence, Training and Awareness.   See Preview

7.3 AWARENESS


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You need to take 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.

7.4 COMMUNICATION


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You need to determine the what, when, with whom, how and who of QMS communication for both internal and external communications relevant to the QMS.

7.5 DOCUMENTED INFORMATION


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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.

Click here to see an example Procedure for Document and Record Control.   See Preview

8 OPERATION

8.1 OPERATIONAL PLANNING AND CONTROL


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You need to 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.

8.2 REQUIREMENTS FOR PRODUCTS AND SERVICES


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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.

Click here to see an example Sales Procedure.   See Preview

8.3 DESIGN AND DEVELOPMENT


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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.

Click here to see an example Procedure for Design and Development.   See Preview

8.4 CONTROL OF EXTERNALLY PROVIDED PROCESSES, PRODUCTS AND SERVICES


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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.

Click here to see an example Procedure for Purchasing and Evaluation of Suppliers.   See Preview

8.5 PRODUCTION AND SERVICE PROVISION


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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.

Click here to see an example Procedure for Production and Service Provision.   See Preview

8.6 RELEASE OF PRODUCTS AND SERVICES


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

Click here to see an example Record of Product/Service Conformance.   See Preview

8.7 CONTROL OF NONCONFORMING OUTPUTS


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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.

Click here to see an example Procedure for the Management of Nonconformities and Corrective Actions.   See Preview

9 PERFORMANCE EVALUATION

9.1 MONITORING, MEASUREMENT, ANALYSIS AND EVALUATION


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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.

Click here to see an example Procedure for Measuring Customer Satisfaction.   See Preview

9.2 INTERNAL AUDIT


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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.

Click here to see an example Procedure for Internal Audit.   See Preview

9.3 MANAGEMENT REVIEW


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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.

Click here to see an example Procedure for Management Review.   See Preview

10 IMPROVEMENT

10.1 GENERAL


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You need to identify opportunities for improvement and implement action to meet requirements and enhance customer satisfaction.

10.2 NONCONFORMITY AND CORRECTIVE ACTION


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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.

Click here to see an example Procedure for the Management of Nonconformities and Corrective Actions.   See Preview

Tip
After action is taken you need to update any risks and opportunities found during the corrective action and update the QMS if necessary.

10.3 CONTINUAL IMPROVEMENT


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You need to continually improve the suitability, adequacy and effectiveness of the QMS.
Here's the percentage of your compliance with ISO 9001:
%

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