The new version of 9001 ISO certification has validated the current paperless document maintenance trends. Softening the requirements of the previous version, ISO has eliminated the distinction between records and documents, categorizing both as “documented information.” What does it mean for organizations that want to get ISO 9001 certified?

They don’t need to implement complex document management processes to create documentation for their quality management systems. Any kind of mandatory information can be kept electronically. No need to worry about bulky filing cabinets, controlling document retention periods, and other issues. You only need to find the right document management system and follow some rules.

To help you with that, in our article, we will discuss the 9001 ISO certification requirements and explain how electronic document management simplifies compliance. Keep reading to find these and other tips about the certification process.

The Latest Version of 9001 ISO Certification

ISO 9001 certification is an international standard that lists requirements for quality management systems. It provides organizations with proof that they invest in continuous improvement of their product or service and meet regulatory requirements. Organizations must be able to provide supporting documentation to achieve compliance.

As a rule, ISO reviews all international standards every five years to check if any changes are necessary. In 2015, the International Organization for Standardization reviewed the requirements for the documentation kept by quality management system users. In September 2015, it introduced the updated version of 9001 ISO certification requiring all the affected entities to end the transition by 15 September 2018.

Key 9001 ISO Provisions

The updated 9001 version doesn’t significantly affect the types of documents stored, document retention period, or other timelines. It simplifies compliance by merging documents and records into the single “document information” category and sets out some additional requirements:

• “The organization shall maintain documented information to the extent necessary to support the operation of processes and retain documented information to the extent necessary to have confidence that the processes are being carried out as planned (ISO 9001:2015 clause 4.4).”
• Quality management system (QMS) documentation shall include: “documented information required by this International standard and determined by the organization as being necessary for the effectiveness of the quality management system (ISO 9001:2015 clause 7.5.1).”
• “When creating and updating documented information the organization must ensure appropriate identification and description (e.g., a title, date, author, or reference number); format (e.g., language, software version, graphics), and media (e.g., paper/electronic); review and approval for suitability and adequacy (ISO 9001:2015 clause 7.5.1).”
  

These are the core requirements reflecting the key 9001 ISO certification provisions. The main point is that electronic document management is enough to meet all of them. For more detailed information on the new version of 9001 ISO certification, you can check the highlights here.

Why Organizations Get ISO Certified

9001 ISO certification is not mandatory, and you can keep operating for many years without it. Yet, it’s a sign of quality that shows your customers and partners you care about quality assurance. This way, you boost customer satisfaction and engagement rates.

Besides, by adopting an effective ISO 9001 quality management system, you can increase your business’s efficiency, profitability, and productivity. During the ISO 9001 certification process, you detect flaws in your quality assurance systems and documentation. After fixing them, your business processes will become smoother and better coordinated.

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Why Electronic Document Management Facilitates 9001 ISO Certification Compliance

To show how electronic document management enables 9001 ISO compliance, we need to explain quality management systems. A QMS is a combination of business processes established to meet customer requirements and provide high-quality services. Among other things, it is based on document maintenance.

Even though QMSs include many elements, document management is one of the core things. Any organization aiming for 9001 ISO compliance needs to store copies of all critical internal documents and ensure access to them at any time.

This makes organizations applying for 9001 ISO compliance look for document management software. Whereas previously tons of physical copies were necessary to manage documents, now, a decent electronic document management system (EDMS) can do the trick.

Electronic document management software replaces print documents with electronic files convenient for meeting 9001 ISO certification provisions. Since both print and offline media are allowed, you are free to choose the most suitable format.

Most progressive businesses opt for electronic document management, as it is more efficient for the following reasons:

• Electronic document management systems are designed with compliance in mind. EDMS vendors know their software is intended to help users achieve different certifications and regulatory norms, so they already provide the necessary record-keeping and security capabilities.
• Electronic document management offers automation. EMDSs automate document storage, filtering, and maintenance, saving organizations a lot of time and effort.
• Electronic document management systems may support document rendering. If you adopt an EDMS with automated document rendering, the software will generate custom documents based on real-time triggers and events.
• Electronic document management systems allow customizing document retention periods and deletion. Since every organization has a different quality management approach, the documentation and the required document retention period differ. With EDMSs, you can easily specify how long you want to keep each document and when to delete it automatically.
• Electronic document management systems save storage space. Filing cabinets cluster your office and increase rent. Hence, if you reduce their number of entirely go paperless, you can significantly cut expenses or enjoy a more spacious office.
  

After all, electronic document management is something you cannot avoid as digital transformation gains traction. In a decade, it may even be mandatory to become ISO compliant. So you’d better start digitization beforehand.

Read About Using Paperless Process Management to Reduce Paper Trail

Steps to Get ISO 9001 Certified with Electronic Document Management

Compliance with 9001 ISO certification is a comprehensive process that may be challenging. Even though electronic document management helps to get certified painlessly, you will need to take many steps, including:

1. Analyze the current documentation in your quality management system.
2. Compare what you have to what you need to detect gaps.
3. Convert mandatory physical copies into digital documents.
4. Integrate an electronic document management system with your quality management software and database.
5. Set up automated document rendering and cloud-based storage in the electronic document management solution.
6. Make sure you meet all the listed ISO certification requirements.
7. Contact certification bodies operating by ISO/IEC standards to initiate an audit.
   

Note that the ISO doesn’t provide compliance certificates itself. It only reviews the standards and updates them for quality assurance. Hence, you will need to cooperate with independent certification bodies.

Inkit for Electronic Document Management

Inkit is a reach enablement platform (REP) that supports electronic document management and helps organizations achieve ISO certification. Among other features, it provides an automated document rendering API called Render. Render converts custom documents to PDF based on automated real-time requests and stores them in the cloud. Thanks to this, you can fully automate document generation and maintenance for 9001 ISO compliance.

Ready to meet ISO requirements with Inkit? Contact us to access the platform now.