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Free ISO 9001 GAP Analysis


To your best ability, answer yes or no. 
If you are not sure, answer no; for a some guidance and suggestions.

You will be emailed the report with suggested courses of action for each clause.
4.1 Have you determined the external and internal issues that are relative to your organization that are related to your intended results of your quality system?
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4.2 Does your management team all understand your organization’s interested parties and their needs and expectations?
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4.3 Have you determined the specific scope that your quality management system is to be certified for?
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4.4.1 (1) Do you have a documented quality manual and / or related procedures / documented processes that cover the different areas of your quality system and the requirements of ISO 9001?
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4.4.1 (2) Do your documented processes / procedures include inputs, outputs, metrics and risks?
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5.1.1 Is the organization's management highly involved and committed to the quality management system?
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Clause 5.1.2 Is there good evidence of understanding customer and any applicable regulatory requirements and the focus on processes to ensure customer satisfaction is maintained?
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5.2.1 & 5.2.2 Has the organization established an overall quality policy that fits the organizations vision, requirements and includes a commitment to continual improvement?
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5.3 Has the organization established roles responsibilities and authorities around the quality management system including assigning responsibilities for those in charge of different aspects of the quality management system?
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6.1.1 Does the organization have evidence that risks relating to interested party expectations and internal and external issues had been addressed by the quality management system?
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6.2.1 Does the organization have documented quality objectives including plans to ensure they are met?
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6.3 Does the organization handle changes to the quality management system effectively?
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7.1.1 Are of the internal capabilities of the organization clearly understood as well as any resources need from external providers (e.g., outside design house used)?
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7.1.2, 7.1.3. 7.1.4 Does the organization clearly have the people resources, the buildings equipment, transportation, and it resources as well as the necessary environment for its processes?
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7.1.5.1 Does the organization have the necessary equipment to verify that conformity of products and services to agreed upon requirements?
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7.1.5.2 Is measuring equipment managed through a calibration process that ensures traceability for equipment used for inspection and measurement?
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7.1.6 Does the organization ensure that knowledge that is necessary for the operation of its processes is maintained and made available?
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7.2 Does the organization have an established training program that ensures that staff is competent in the areas they are working?
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7.3 Does the organization ensure that staff is aware of quality policy, quality objectives, and their contribution?
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7.4 Does the organization have a solid method for communication internally and externally relevant to the quality management system? This would include handling quoting, project management, customer complaints, etc?
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7.5 Does the organization have he defined document and control, approval, and revision process for all quality management system documents?
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8.1 Does the organization have work instructions for processes where the work needs to be carried out consistently, including inspections and records to demonstrate the conformity of products and services to the agreed upon requirements?
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8.2 does the organization have strong processes for determining the requirements for products and services, customer communication, and the quote and contract review process as well as handling changes?
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8.3 This section only applies to organizations that are design responsible. Does the organization have a well-established design process with records of design and development inputs and outputs?
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8.4 Does the organization have a well-established process that ensures that processes and products and services provided externally conform to all internal requirements? This may include steps such as receiving inspection or other certification verification?
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8.5 Does the organization have work instructions, training, monitoring and measurement, and inspection processes that ensure the tight control of the production and service provision process?
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8.5.2 Our process and product outputs identified by suitable means to ensure that the status is identified (in process or inspected and passing) …?
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8.5.3 Are there internal processes to identify, verify, protect and safeguard customers property that's provided for use or incorporation into the products or services?
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8.5.4 Does the organization have good methods for preserving any production outputs or service outputs to ensure conformity to the customer requirements?
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8.5.5 If the organization has post-delivery activities such as servicing, is this process well established?
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8.6 Does the organization have planned arrangements, at appropriate stages of development and service delivery to verify that the requirements have been met and ensure that products and services are not released until all plan arrangements have been satisfactorily completed?
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8.7 Does the organization have a well-established process to control any non-conforming outputs including non-conforming product or services, dealing with the outputs, and retaining the proper records?
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9.1.1 With a focus on evaluating the performance and effectiveness of the quality management system, does the organization have well established monitoring, measurement, analysis, and evaluation processes?
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9.1.2 Does the organization monitor customers satisfaction with the organization and use this information to improve the effectiveness of its quality management systems?
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9.1.3 Does the organization actively analyze and evaluate the data captured in the monitoring and measurement activities?
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9.2 Does the organization have a well-established internal audit process?
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9.3 Does the organization have an established management review process?
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10.2 Does the organization have a well-established corrective action process?
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10.3 Does the organization have a well-established continual improvement process?
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