What Is ISO Compliance?

The International Organization for Standardization (ISO) is an international organization composed of representatives from various national standards organizations.

Together, ISO is considered the authority for setting worldwide proprietary, commercial and industry standards for effective risk management strategies for processes, policies and procedures so that they align with ISO specifications.

All told, the ISO has issued more than 21,000 standards encompassing a range of industries, including technology, healthcare, food safety and manufacturing. “ISO compliance” refers to meeting the requirements of ISO standards, although specific requirements will depend on which ISO standard your organization is achieving compliance for.

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Types of ISO Compliance Standards

The following are several examples of the most common ISO standards that Reciprocity can support:

ISO 9000 and 9001

Guidelines for quality management systems (QMS) and quality assurance created to enable companies to document requirements for a quality management system

ISO 27001

Guidelines for how to manage information security

ISO 13485

Guidelines for quality management for medical device

ISO 14001

Guidelines on corporate environmental management created to help organizations limit their negative impact on the environment
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Our checklist will guide you to success
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Why Is ISO Compliance Important?

Businesses and industries are affected by ISO compliance to various degrees, depending on the specific ISO standard in question. For example, industries that must take quality standards seriously — construction, manufacturing, healthcare and technology — have a strong incentive to comply with ISO standards such as ISO 9000, 9001, or 13485.

While there are no direct penalties for ISO non-compliance, there are several indirect repercussions, such as the cost of re-applying for lapsed ISO certification.

Moreover, organizations that ignore ISO compliance might suffer reputational damage, lose potential customers who prefer ISO-compliant vendors or spend more resources on mitigation of compliance issues that ISO might have prevented.

For example, ISO 27001 certification can cost upwards of $80,000. If an organization were to fail its certification, the business might lose customer contracts that depend on such certification, in addition to paying for another certification once nonconformance with any regulatory requirements has been corrected.

Read how ZenGRC increases audit efficiencies for Beeline.

ISO Requirements at a Glance

For the most current version of a particular ISO standard, please refer to the ISO official updates page.

As a general guide to ISO compliance, we’ve included this ISO compliance checklist to help your organization get started preparing for your ISO certification.

ISO Compliance Audit Checklist

1

Plan, implement and maintain a compliance audit program.
You will first need to establish a team responsible for planning, implementing and monitoring your audit management and compliance management program overall. This team will perform a risk assessment, take any corrective action to mitigate risks and implement a management process for monitoring and maintaining compliance.

2

Define the criteria and scope of your ISO audit.
Your organization is not only responsible for creating and maintaining a compliance program, it must also understand the scope of any ISO audit for which you’re preparing to assure that all requirements have been met. Ignoring audit requirements can result in costly re-certifications.

3

Conduct an internal audit first to assure all requirements have been met.
To assure that you can be confident about the results of a formal audit, it’s a good idea to conduct an internal audit before that formal one. An internal audit will allow you to gather valuable data around your ISO compliance and indicate any areas that still require remediation.
Furthermore, your organization should conduct routine internal audits to achieve continuous improvement over time.

4

Take corrective action for any vulnerabilities uncovered during auditing.
Whether that corrective action is a system that requires calibration, sensitive document controls that need to be implemented or business processes that must be adapted to incorporate stronger security controls — it’s important to remediate all potential indicators that your organization may not pass certification.

5

Document all risk management, controls and remediation efforts.
Compliance certifications depend heavily on documentation of management systems and the controls that are implemented within them. Therefore, any steps you take to assess vulnerabilities, facilitate risk management, or implement security and quality standards should be documented and saved for your compliance audit.

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Reciprocity Has Your ISO Compliance Solution

Achieving compliance certification for any ISO standard or standards requires considerable investment in time and financial resources, particularly for any organization still using legacy tools and spreadsheets to achieve and maintain compliance workflows.

Also, remember: initial compliance certification is only half the battle. After certification is achieved, your organization must keep up compliance management to assure that the new systems, processes and controls don’t degrade over time and are updated as your organization grows and your risks change.

This is far too great a responsibility for a large organization to achieve manually. Instead, adopt a compliance tool that will automate your enterprise’s ISO compliance and certification. That will save you time, money and a lot of headaches.

At Reciprocity, our compliance experts can help you to prepare your ISO compliance and certification program, expedite the process and minimize the burden on your team.

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ZenGRC ISO Capabilities

Our fully integrated and automated ZenGRC platform equips you witha strong foundation for ISO compliance, enabling you to monitor your program over time to ensure you remain compliant and avoid non-compliance penalties. Our platform capabilities include:

  • Automation to streamline compliance workflows
  • Monitoring of the entire compliance lifecycle
  • User-friendly dashboard with real-time metrics on prioritized ISO audit tasks
  • Pre-built templates to help you prepare for auditing
  • A central document management repository to organize audit-ready documentation
  • Universal control mapping functionality to fulfill multiple requirements with a single control
  • Tracking of training management for team members and outstanding ISO tasks

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Frequently Asked Questions

Your need for ISO certification depends on your industry and its compliance requirements. Industries required to meet ISO compliance standards, however, include engineering, manufacturing, healthcare, IT, construction and more.

ISO certification is usually not legally required for most industries. Rather, certain sectors have strong business incentives to embrace ISO standards, as a demonstration of an organization’s commitment to high standards of quality and performance.

The seven quality management principles are:

  1. Customer focus
  2. Leadership
  3. Engagement
  4. Process
  5. Improvement
  6. Evidence-based decision making
  7. Relationship management

ISO 9000 is the whole family of QMS standards; ISO 9001 is one specific standard within that family, which provides the regulations for gap analysis and internal auditing that must be conducted while creating and maintaining a quality management system.