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You, as auditor, are in dialogue with the quality lead and managing director of a small business that supplies specialist laboratory equipment and furniture. You: "I'd like to look at how you manage change in the organisation. What changes have you made as a business, say, over the last 12 months?" Auditee: "We have made some strategic changes, the main one being that we no longer manufacture our own products in house." You: "That sounds like quite a significant change. What has been the impact of that?" Auditee: "We now mainly sell other manufacturers' products, under their brand names, and have outsourced manufacture of our own brand products to one of our suppliers. Unfortunately, we had to make six members of our staff redundant. This represents about 20% of our workforce, so this has been quite a challenging time." This scenario presents a number of audit trails to different ISO 9001 requirements. Which three of the following requirements would be relevant audit trails for this scenario?
Correct Answer: B,C,F
B: Control of externally provided processes, products, and services: This is relevant because the organization has outsourced the manufacture of its own brand products to a supplier. According to ISO 9001, the organization must ensure that externally provided processes remain within the control of its quality management system. C: Design and development of products and services: Even though the organization no longer manufactures in- house, it still needs to control the design and development of its products, especially since they are now being produced by an external provider. F: Organisation roles and responsibilities: The change in strategy has led to a significant reduction in staff, which would have an impact on the roles and responsibilities within the organization. It is important to audit how these changes have been managed and communicated within the organization to ensure continued effectiveness of the quality management system. These audit trails are aligned with the requirements of ISO 9001:2015, which emphasizes the importance of controlling externally provided processes and products, managing design and development, and clearly defining roles and responsibilities within the quality management system.