11 You have managed to convince top management that adopting a QMS based on the ISO 9001:2015 will turn around the company's fortunes and allow it to leapfrog the competition. They have approved your proposal, and since that time, your organization has used the QMS for 2 years and is now attempting to get certification for ISO 9001:2015; hence, management has directed that a first-party audit should be conducted to establish any gaps within the Quality Management System (QMS) being implemented at the organization in preparation for the second-party and third-party audit, which will assess the organization for certification. (1) As the process owner, you are to assess the extent of compliance of the organization's QMS and effect corrective measures to streamline the QMS to acceptable standards for certification. (2) The table below provides key findings after the audit; you are to fill in the missing details, i.e. I) Clause Reference from the ISO Standard 9001:2015, II) Ratings, here you are establishing conformance or non-conformance and its severity, and III) the Audit Evidence available or missing. Rating Keys: A = Minor Non-conformance, B= Major Non-conformance, C = Critical Non-conformance Audit Finding No. Audit Findings 01 02 03 The organization does NOT have a documented quality policy? Customer requirements are NOT determined at every stage of the firm's operations The organization has a quality manual, but it has NOT been communicated to the employees 04 The organization has NOT established documented, implemented and maintained a QMS. 05 The organization does NOT monitor, measure and analyze QMS processes? 06 The organization has NOT established mechanisms to maintain control over outsourced processes? The organization has put in place actions necessary to 07 achieve planned results and continual improvement of 08 09 processes needed for the QMS? Changes and the current revision status of documents are NOT identified? When document changes are made, the relevant parties are NOT informed. In product design and development planning, the 10 organization has NOT established the responsibilities and authorities involved in the design and development process The organization does NOT conduct a review before committing to supply products and services to a customer. Page 4 of 5 Clause Reference Ratings YES NO ABC Audit Evidence