The International Organization for Standardization (ISO) is an independent global organization made up of various committees and subcommittees. The organization develops a broad range of voluntary standards that apply to nearly every industry. The standards consist of requirements, specifications, and guidelines that businesses follow to:
Historically, ISO was founded on the idea of answering a fundamental question: “What’s the best way of doing this?”1 Probably one of the most recognized standards is ISO 9001. It defines the criteria for quality management systems (QMS), which mostly applies to companies involved with regulated products or services and their efforts to design and manufacture quality into products. Like most standards, ISO 9001 goes through a review and update every five years — 2015 is the latest iteration of the standard.
By definition, a quality management system is a formalized system that documents processes, procedures, and responsibilities for achieving quality policies and objectives.2 Compliance with ISO 9001 indicates a company:
Organizations that apply the ISO 9001 standard in their business practices can give their customers the assurance that their products and services are safe, reliable, and of good quality. However, before a company can proudly tout the ISO 9001 credential, it needs to complete the preparation and audit requirements.
ISO standards are designed to help companies create a roadmap to achieve and maintain the objectives outlined in the specific standard. In addition to ensuring consistent delivery of safe and quality products and services, the standards include measures for companies to pursue continuous improvement. The following sections provide tips on improving your chances for a successful ISO 9001 audit.
Audit preparation is essential. It’s advisable for your organization to maintain an audit-ready state, which means your systems and processes are prepared for an audit at any time. That said, one of the best ways to prepare for a customer or regulatory inspection is to perform an internal audit. It’s always better to find issues yourself and document your resolution than for them to show up during an external audit. Below are a few key areas of audit preparation:
Your documentation processes need to demonstrate how you complete reviews, approvals, and reapprovals. This includes identifying all revisions and changes and preventing the use of obsolete documents. Also, be prepared to make documents available prior to the audit. Some of the documents that might be required in advance include:
Audits are a conversation, not an interrogation. They are an integral part of your continuous improvement efforts, so they can actually serve as a free consultation. In preparing for an audit, it’s important to be up to speed on the latest regulations. Also, know the difference between industry standards, best practices, and what is specifically stated in the regulations. If a standard isn’t specified in the regulations, it is optional.
The more risks you identify and document prior to an audit, the more prepared you will be for the inspection. Risk-based thinking is a systematic approach to monitoring trends and identifying and mitigating risks before they result in costly delays, rework, or product recalls. For example, if other audits have revealed the same issue, create a strategy to resolve it. This involves implementing a change management process, or if you either cannot or will not change it, develop a written justification for your decision.
Request a closing meeting to review all audit findings and to set expectations before the auditor leaves. Ensure you understand the findings. This will help with properly responding to findings once you receive the audit report. Be sure to document all actions, processes, and justifications in resolving findings. It’s important to be transparent in order to demonstrate that you have effectively identified and mitigated the root cause of nonconformances.
Audits don’t need to be arduous and stressful. If you use them as an opportunity to identify your organization’s strengths and weaknesses, you can be more effective in maintaining an audit-ready status. Implementing a digitized, platform-based QMS helps you ensure conformance to the ISO 9001 standards, improving your ability to have a successful audit experience.
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