Project Description

Many companies are hard-pressed to maintain regulatory compliance while also staying abreast of new regulations and updates. When last counted, more than 21,584 ISO standards (International Organization for Standardization) had been published. Industry-specific standards are also on the rise, including life sciences, a highly regulated sector. This segment is significantly impacted because of new, technologically advanced medical devices requiring strict oversight.

Regulations are being updated to align with new technology

Regulating bodies, including two well-known standards-setting organizations, the Federal Drug Administration (FDA) and its close European Union (EU) counterpart, EudraLex, continue to update hundreds of existing requirements and add new ones to incorporate changing technology. One of the most significant updates enables industries to transition from paper to electronic documentation, including signature sign-offs and records storage using a computerized maintenance management system (CMMS) such as eMaint.

This change helps global companies swiftly and efficiently document, store, and access regulatory compliance information and submit it electronically to regulators to demonstrate compliance with quality, environmental, energy, or food safety requirements and an ever-growing string of new ISO standards.

eMaint CMMS software facilitates ISO compliance

A CMMS enables organizations to simplify the audit process and feel confident when facing an inspection or audit. Whether seeking OSHA, EPA, GMP, FDA, EudraLex, or ISO compliance, organizations can leverage eMaint CMMS software to stay current with the many differing regulations.

ISO standards are particularly critical to manufacturers and maintenance operations. They help establish and ensure maintenance best practices, including compliance, asset management, and risk management. Here’s a shortlist of essential ISO standards.

  • ISO 9001 Quality Management: Establishes the criteria for a quality management system and is the only standard in the ISO 9000 family that can be certified. Being ISO-certified shows customers your commitment to product consistency and quality.
  • ISO 19011 Guidelines for Managing Audit Systems: Provides guidance on external audits, including certification and supplier, which support the implementation of the management system standards (MSS).
  • ISO 55000 Asset Management: Presents an overview of asset management, its principles and terminology, and the expected benefits from adopting asset management.
  • ISO 22000 Food Safety Management: Addresses food safety management and helps organizations identify and control food safety hazards.
  • ISO 31000 Risk Management: Guides organizations in managing risks and performing well in an environment of uncertainty.

5 tactics for achieving audit success with a CMMS

Maintenance professionals leverage eMaint’s adaptable features and functions to ensure audit readiness and pass audits, including ISO audits. Organizations can create, record, and store regulatory proof of compliance in a single place and use the data to generate reports instantly to show auditors.

  1. Track work order historyView asset records and work order history and charges related to each asset, including work order type, status, due date, and description. Auditors want to know that the appropriate SOPs and interpretation of those standards are being complied with daily.How it Helps Pass Audits – Store and document PM work order completions and show how long a work order took to complete. Auditors often ask organizations to show documented work order completions.
  2. Ensure spare parts availabilityUse CMMS inventory tools to accurately catalog parts, track parts usage and histories, associate parts with PMs, and record and view in-stock supplies. Ensure your inventory stays up-to-date, including removing obsolete parts so that critical components remain organized, in stock, and ready for emergency asset maintenance repairs.How it Helps Pass Audits – Auditors will recognize that the organization controls inventory and spare parts for performing PMs to ensure availability and worker safety.
  3. Auto-generate PMsCMMS software enables you to establish and auto-generate an unlimited number of calendar and/or meter-based PMs for each asset. Within the PM task record, you can include detailed procedures, guidelines, and other essential details.How it Helps Pass Audits – eMaint stores all scheduled and completed PMs for each asset and demonstrates a commitment to documenting work and developing comprehensive procedures. An audit starts off right when auditors discover that an organization uses a CMMS.
  4. Generate reports and dashboardsPersonalized reporting and dashboard tools within a CMMS enable you to create and modify reports, add them to dashboards, and automatically generate and email them to specified maintenance team members.How it Helps Pass Audits – Easily run reports to show data required for upcoming inspections and audits and generate key performance indicator (KPI) reports for management to show current regulatory compliance status.

    EXAMPLE: Burris Logistics established calendar-based PMs for inspections of ammonia detectors based on asset type. The organization also set up automated emails to remind a maintenance manager to schedule an OSHA-related PM.

  5. Track calibrationOrganizations can configure eMaint to fit calibration regulatory compliance requirements and manage, schedule, track calibration, and set calibration reminders on equipment and instruments.How it Helps Pass Audits – Provides documentation of equipment calibration schedules and procedures, and tracks completion and on-time performance.

    Excelsior Medical, LLC, a Medline medical device manufacturer, configured eMaint to align with its calibration data needs and reflect regulatory compliance adherence and optimized calibration quality control and accountability.

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