The International Organization for Standardization (ISO) is responsible for creating international standards for products, services, and systems. These regulations help to ensure quality, safety, and efficiency at businesses around the world. Today, we’ll specifically cover ISO 9000 standards as they relate to cannabis organizations. Of these, ISO 9001 is the standard that outlines the requirements that an organization’s quality management system (QMS) must meet or exceed to be certified. The requirements are generic, as the standard is designed to be used by companies of any size in any industry. Over a million organizations in more than 170 countries currently hold this certification. To be certified, these companies define their own objectives and then work to improve their processes to meet them.
ISO 9001 is just one part of the family of ISO 9000 standards. However, it is the only standard that lists actual requirements and is also the only one that organizations need to certify. The other standards in the ISO 9000 family are important to provide supporting guidelines and information.
So, what are the rest of the ISO 9000 standards? They include ISO 9000, ISO 9002, ISO 9003, and ISO 9004. Of these, ISO 9000 is the most important because it’s the foundation for all of the other ISO 9000 standards and provides the guidelines that cover the concepts that make up a QMS. It contains two sections: fundamentals, which lays out the basic principles of quality management, and vocabulary, which is a dictionary of QMS terminology. The ISO 9000 standard is based on quality management principles:
- A customer focus
- Leadership from top management
- Internal engagement
- A process approach
- Continuous improvement
- Evidence-based decision making
- Relationship management
The key takeaway to remember is that ISO 9000 is only a guideline. You cannot become ISO 9000 certified but you can achieve an ISO 9001 certification.
Certifying your QMS with ISO 9001
While ISO is related to the standards, a QMS refers to the implementation of policies, processes, documented procedures, and records in an organization. A QMS defines how the company can meet the requirements of their customers and other stakeholders who are affected by their work. The ISO 9001 standard provides management practices for a company’s QMS to ensure high levels of quality and efficiency.
The requirements for ISO 9001 are pretty generic. Regardless, a certified QMS still needs to do the following:
- Ensure that employees receive training outlining the quality requirements
- Meet the requirements of other stakeholders. For example, customer requirements and regulatory standards
- Be able to produce records to prove that system requirements have been met
- Determine and document the processes, their interactions, and their results
- Constantly monitor the QMS’ performance
- Perform internal audits and correct any issues
- Address any risks that could result from changes
- Continuously improve the QMS
Exploring cloud QMS benefits
A cloud-based QMS is an organization’s best bet to get up and running quickly. Additionally, the cloud makes implementation much easier. Its workflows and permissions allow it to be easily accessed by everyone regardless of whether they’re working in an office or at the production site. Here are some of the additional benefits of using a cloud QMS:
- Easily find documents – No one likes sorting through hundreds of paper files or clicking through thousands of online folders. Cloud-based QMS platform should have powerful search options based on metadata, repository name, and content. Metadata allows you to add extra information to documents so you can categorize and filter for a simplified experience.
- Utilize advanced user permissions – Security is crucial when it comes to company policies. Many potential security issues can be solved with user permissions. With advanced permissions, QMS software is able to automatically assign the proper view, edit, and approval rights that help to eliminate the potential for human error.
- Incorporate central file ownership – Having a single document owner also helps to minimize potential issues. By having all documents owned and managed by the company in a cloud QMS, you’ll never need to worry about losing files or having key documents accidentally deleted. It also limits the damage that can be done by malicious third-parties or disgruntled employees.
- Automate document lifecycles – From creation to disposal, the document lifecycle plays a big part in ISO 9001 requirements. Many important QMS documents need to be properly reviewed and approved and only the most recent versions of those approved documents should be accessible. QMS software workflows automate the review and approval processes by automatically sharing documents with the right reviewers. Then, after the document has been approved, the changes are automatically applied to the new master document while the obsolete version is archived.
- Monitor activity history – To pass any ISO 9001 audit (or internal audit, for that matter), you need to produce a complete audit trail of documents’ activity history. That doesn’t only apply to active documents but also to the earlier versions of those documentsCloud QMS software makes this simple by tracking changes to both the current and past versions of documents.
ISO 9001 helps cannabis startups evaluate their processes and, as a result, identify areas for improvement. Essentially, ISO 9001 helps companies who are making excellent cannabis products most of the time, make an excellent product every time., A cloud QMS system can simplify your cannabis startup’s process to achieve the ISO 9001 certification m while also providing you with a number of other business and cost-saving benefits.
Mike Hansen is a product solutions manager at AODocs.