Gap Analysis ISO 9001 Checklist

• Client / Site

• Conducted on (Date and Time)

  Date

• Inspected by

• Location
  Address

Context of the Organization

• Have all external and internal issues that are relevant to your organization’s purpose and the achievement of customer satisfaction and the organization’s strategic direction been determined?

  Yes

  No

  N/A

• Are these issues reviewed and monitored on a regular basis?

  Yes

  No

  N/A

• Have the needs and expectations of interested parties that are relevant to the QMS been determined?

  Yes

  No

  N/A

• Was the scope of your QMS determined whilst taking into account all the external and internal issues, the needs of interested parties and the scope your products and services?

  Yes

  No

  N/A

• Is your QMS established, and does it include a description of the processes required and their sequence and interaction?

  Yes

  No

  N/A

• Have the criteria for managing these processes and their interaction been established?

  Yes

  No

  N/A

• Have all responsibilities, methods, measurements and related performance indicators, needed to ensure the effective operation and control, been established?

  Yes

  No

  N/A

Leadership

• Has top management taken accountability for the effectiveness of the QMS?

  Yes

  No

  N/A

• Have the policy and objectives for the QMS, which are compatible with the strategic direction of the organization, been established and communicated?

  Yes

  No

  N/A

• Have the objectives been established at relevant departmental and individual levels with the business?

  Yes

  No

  N/A

• Have the requirements for the QMS been integrated into the business processes and have management promoted awareness of the process approach?

  Yes

  No

  N/A

• Have customer requirements and applicable statutory and regulatory requirements been determined, met and communicated throughout the organization?

  Yes

  No

  N/A

• Have the risks and opportunities that are relevant to the QMS been established?

  Yes

  No

  N/A

• Has the organization established and communicated the responsibilities and authorities for the effective operation of the QMS?

  Yes

  No

  N/A

Planning

• Have the risks and opportunities that need to be addressed to give assurance that the QMS can achieve its intended result(s) been established?

  Yes

  No

  N/A

• Has the organization planned actions to address these risks and opportunities and integrated them into the system processes?

  Yes

  No

  N/A

• Is there a defined process for the determining the need for changes to the QMS and managing their implementation?

  Yes

  No

  N/A

Support

• Has the organization determined and provided the resources needed for the establishment, implementation, maintenance and continual improvement of the QMS (including people, environmental and infrastructure requirements)?

  Yes

  No

  N/A

• Is monitoring or measuring is used for evidence of conformity of products and services to specified requirements?

  Yes

  No

  N/A

• Has the organization determined the resources needed to ensure valid and reliable monitoring and measuring of results?

  Yes

  No

  N/A

• Has the organization determined the knowledge necessary for the operation of its processes and the achievement of conformity of products and services and implemented a lessons learned process?

  Yes

  No

  N/A

• Has the organization ensured that those persons who can affect the performance of the QMS are competent on the basis of appropriate education, training, or experience or taken action to ensure that those persons can acquire the necessary competence?

  Yes

  No

  N/A

• Has the documented information required by the standard and necessary for the effective implementation and operation of the QMS been established?

  Yes

  No

  N/A

Operation

• Is there a defined process for the provision of products and services that meet the requirements defined by the customer?

  Yes

  No

  N/A

• Are there any changes planned?

  Yes

  No

  N/A

• Are they carried out in a controlled way and actions taken to mitigate any adverse effects?

  Yes

  No

  N/A

• Are any outsourced processes managed and controlled?

  Yes

  No

  N/A

• Is there a defined process for reviewing and communicating with customers in relation to information relating to products and services, enquiries, contracts or order handling?

  Yes

  No

  N/A

• Is this review conducted prior to the organisation’s commitment to supply products and services?

  Yes

  No

  N/A

• Do you design and develop products or services?

  Yes

  No

  N/A

• Are these processes established and implemented in line with the requirements of the standard?

  Yes

  No

  N/A

• Do you ensure that externally provided processes, products, and services conform to specified requirements?

  Yes

  No

  N/A

• Do you have criteria for the evaluation, selection, monitoring of performance and re-evaluation of external providers?

  Yes

  No

  N/A

• Is the provision of products and services carried out in controlled conditions which include: <br>• the availability of documented information that defines the characteristics of the products and services? <br>• the availability of documented information that defines the activities to be performed and the results to be achieved? <br>• monitoring and measurement activities at appropriate stages to verify that criteria for control of processes and process outputs, and acceptance criteria for products and services, have been met? <br>• the people carrying out the tasks are competent?

  Yes

  No

  N/A

• Do you have effective methods of ensuring traceability during the operation process?

  Yes

  No

  N/A

• Is property belonging to customers or external providers used in the provision of the product or service?

  Yes

  No

  N/A

• Is this controlled effectively?

  Yes

  No

  N/A

• Is there a requirement for post-delivery activities associated with the products and services such as warranty, maintenance services, recycling or final disposal?

  Yes

  No

  N/A

• Are these defined and managed?

  Yes

  No

  N/A

• Are any nonconforming process outputs managed so as to prevent their unintended use?

  Yes

  No

  N/A

Performance Evaluation

• Has the organisation determined what needs to be monitored and measured and the methods for monitoring, measurement, analysis and evaluation, to ensure valid results?

  Yes

  No

  N/A

• Has it established when the results from monitoring and measurement shall be analyzed and evaluated?

  Yes

  No

  N/A

• Have methods of monitoring customer perceptions of the provision of products and services been established?

  Yes

  No

  N/A

• Has it determined the need or opportunities for improvements within the QMS and how these will be fed into management reviews?

  Yes

  No

  N/A

• Has the organisation established a process for an internal audit of the QMS?

  Yes

  No

  N/A

• Has an approach to perform management reviews been established and implemented?

  Yes

  No

  N/A

Improvement

• Has the organisation determined and selected opportunities for improvement and implemented the necessary actions to meet customer requirements and enhance customer satisfaction?

  Yes

  No

  N/A

• Does the organisation operate appropriate processes for managing nonconformities and the related corrective actions?

  Yes

  No

  N/A

• Has the organisation decided on how it will address the requirement to continually improve the suitability, adequacy, and effectiveness of the QMS?

  Yes

  No

  N/A

Completion

• Recommendations

• Inspector's Full Name and Signature

  Sign