Table of Contents Quality audits consist of system audits, process audits. Audits in a quality assurance system are called quality audits. It is a systematic review of a quality system carried out by an external quality auditor or audit team. The primary objective is to ensure that procedures correctly reflect documented standards. Audits are an important part of a quality assurance system and are a key part of the ISO 9001 quality system standard. Say no to plagiarism. Get a tailor-made essay on “Why Violent Video Games Should Not Be Banned”? Get the original essay Quality audits are increasingly regular in today's pharmaceutical industry due to increasingly complex regulations and increasing globalization. Companies in the pharmaceutical industry often undergo developments and new research cycles for manufactured products and, therefore, these companies need to establish quality assurance departments that ensure that process quality is maintained effectively. Regular quality audits of QA procedures provide an effective way for management to evaluate the effectiveness of these procedures. Quality audits consist of system audits Process audits Product audits Compliance System audits A quality system audit is defined by ISO10011-1 (1990) as a “systematic and independent examination used to determine whether activities related to quality and the corresponding results are in accordance with the planned arrangements and whether these arrangements are implemented effectively and enable the objectives to be achieved. It is “a documented activity carried out to verify, by examination and evaluation of objective evidence, that the applicable quality system evidence is appropriate and has been developed, documented and implemented effectively in accordance with specific requirements. » This is the role of the quality system. audits to ask questions such as: How is the system defined? Who is the party responsible for manufacturing the product? What is the degree of involvement of the managerial department in the daily operation of a quality system? Who is responsible for ensuring that the quality of manufactured products meets customer standards? What types of direct and indirect processes are used in the production of the product(s). What procedures are in place to assist the organization in its production efforts. How are these procedures maintained and updated, and by whom? Where can I find the procedures? Quality system audits tend to focus on the macro nature of a quality management system, that is, the general and broad range rather than the limited scope. Process Audits Process audits are analytical in nature, unlike more general system audits which are much easier to define and refine. The central objective of these audits is that of: people, equipment and machines. He must check how these factors come together to produce a reliable product. It must compare and contrast the active processes in which products are manufactured with those of written procedures. This is basically a guide to the manufacturing process. Keep in mind: this is just a sample. Get a personalized document now from our expert writers. Get a Custom Essay It is also focused on the process itself. He must ask himself if the process is valid and reliable. Does the process produce the expected results consistently? Do processes need to be changed or updated in order to ?.