Regulatory
ISO audits are conducted to verify that your organization’s internal processes align with the relevant ISO standards you’re obligated to satisfy. An ISO audit — and the ISO certification it is aimed toward — helps inspire existing and potential customers’ confidence in your products. Automating your ISO audit processes and activities with ISO audit software can substantively accelerate compliance efforts.
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ISO audits provide on-site verification of compliance-related processes, products and systems. To achieve this verification, three types of ISO audits are conducted: first-party audits, second-party audits and third-party audits. A first-party audit is conducted internally by company staff to measure the effectiveness of ISO-related processes. A second-party, or supplier audit, is commonly spearheaded by a lead auditor within the organization who works to validate that the work that vendors who supply products and/or services to the organization are meeting the requirements of the ISO auditing standard. This type of audit may also include external audits by customers. A third-party audit is conducted by an accredited registrar for certification purposes. Registrars perform two-stage certification audits to verify conformance against the relevant ISO standard before issuing an official certification.
Conduct Regularly Scheduled Internal Performance Audits: Performing rigorous internal audits on a regular basis makes it easier to catch serious nonconformance issues before they become big problems that trigger red flags during external audits.
Implement Appropriate Corrective Actions: When recurring problems are identified, expedient actions should be taken to curtail them. If auditors find that corrective and preventive actions (CAPA) have been inadequately managed according to ISO auditing standards, it will undoubtedly delay certification.
Review Your Entire Quality Management System Annually: At least once a year, high-level managers should thoroughly review quality policies, process changes, ISO audit plans, nonconformance issues, CAPAs, customer feedback, modifications to regulations and the status of internal ISO audits.
Monitor Objectives and Adjust Them Accordingly: Quality objectives are the primary means by which a company can translate quality policy goals into realizable plans for improvement. As such, they should be monitored continuously and modified when appropriate to ensure that ISO auditors can see that progress has been tracked and ISO audit plan objectives have been met over time.
Each ISO standard provides a blueprint that indicates what companies need to do to achieve and maintain compliance. Because an ISO audit provides a snapshot of a company's progress toward meeting regulatory goals, it is the most beneficial tool a company can employ to monitor and document its compliance status.
Examples of standards that most life science or similarly regulated manufacturing companies conduct ISO audits against include ISO 9001:2015 (and other standards in the ISO 9000 family that pertain to quality management) and ISO 13485 (quality systems for medical device manufacturers). ISO audits are invaluable components of assessing adherence to these and other standards such as:
ISO 7218:2007 (food microbiology)
ISO 9241/ISO 10075 (ergonomics)
ISO 14000 (environmental management)
ISO 14971 (risk management)
ISO 15189 (medical laboratories)
ISO 15706-2 (audiovisual)
ISO 17025 (testing/calibration laboratories)
ISO 18416:2007 (cosmetics)
ISO/TC 67 (petroleum/natural gas)
ISO/TR 27809:2007 (health informatics/software)
What are your objectives? Objectives require evidence, so auditors often request to see data and records proving that companies have established and documented ISO audit plans. All employees should know where the organization’s quality objectives can be found.
What is your quality policy? This is the most fundamental question asked in every ISO audit, especially if the same auditor performs them on multiple occasions. Employees should be able to articulate their understanding of the quality policy and how it relates to their work and the overall ISO audit plan.
Where do your procedures originate from? Documentation of standard operating procedures (SOPs) help prove that work processes and practices are properly controlled. When workers can show that they know where documented procedures are located and are able to find them quickly, they are better prepared to answer auditors’ questions.
What do you do if you encounter a nonconformance? A company’s ability to respond to quality events (i.e., nonconformances, deviations, complaints, etc.) is indicative of its commitment to continual improvement, a vital element of ISO compliance. ISO auditors want proof that employees know when to use a nonconformance report and when to initiate CAPA process. A documented and readily accessible ISO audit plan can substantiate that improvement systems are in place.
The unparalleled ISO audit software solutions provided by MasterControl enable companies to streamline ISO audits and allow them to take control of their audit processes, quality, compliance and growth. MasterControl ISO audit software systems are designed to make ISO audits faster, easier and more effective. MasterControl integrates every aspect of the quality system with audit data and tasks while simultaneously simplifying audit scheduling and execution. Users can even use MasterControl’s ISO audit software to launch quality event forms (for CAPAs, nonconformances, etc.) directly from an ISO audit finding, which streamlines audit processes and ensures that issues are thoroughly addressed. With its robust document management, reporting and analytics capabilities, the system provides enhanced visibility into audit activities to both auditors and management.
Regulatory agencies like ISO and FDA encourage manufacturers’ use of effectual audit software applications, provided that the systems are suitably validated in a way that maximizes their capacity to avoid quality problems and product defects. As proof of MasterControl’s ability to facilitate compliance with ISO auditing standards and other regulatory requirements, the FDA’s Office of Regulatory Affairs (ORA), the lead office for FDA field activities, has relied on MasterControl software since 2009 as the primary tool its quality managers use to uniformly apply and monitor work processes and products.
To learn more about accelerating ISO audits with MasterControl, please contact a MasterControl representative.
To learn more about MasterControl's software systems, please contact a MasterControl representative.
