AS9100, ISO 13485 & ISO 27001 Services

The same principle that guides our ISO 9001 work applies to other management system standards: the system should fit the organization – not force the organization into unnecessary bureaucracy.

We provide certification, consulting and internal audit services for AS9100, ISO 13485 and ISO 27001. We start with the processes, controls and systems already in place, keep what works, and add only what the applicable standard genuinely requires or what improves control.

Certification

If you need certification, we can manage the implementation from the current starting point through certification readiness. We build the management system around the way your organization already works, reuse effective processes and controls, and keep the documentation as lean as the standard allows.

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Consultancy

If you already have a management system in place, bring us the specific problem you need solved. We can help interpret a difficult requirement, resolve an implementation roadblock, simplify an overcomplicated process, address audit findings, or improve a control that is not working well in practice.

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Auditing

We also provide outsourced internal audits for AS9100, ISO 13485 and ISO 27001. Our auditors follow the way work actually happens, test whether controls are implemented and effective, and distinguish formal audit findings from practical improvement opportunities.

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Training

Our sister company, StandardsCourses, provides online management system training from introductory courses through auditor, implementer and lead auditor programs for supported standards.

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ISO 9001 Quality Management Standard

ISO 9001

ISO 9001 provides the foundation for a quality management system focused on consistent processes, customer requirements and continual improvement. Learn more about ISO 9001.

AS9100 Aerospace Industry Standard

AS9100

AS9100 builds on ISO 9001 with additional requirements for aviation, space and defense organizations, including stronger controls for product safety, risk, configuration and supply-chain quality. See how AS9100 compares with ISO 9001.

ISO 13485 Medical Devices Standard

ISO 13485

ISO 13485 provides quality management requirements for organizations involved in medical devices, with particular emphasis on regulatory requirements, risk controls, traceability and controlled processes. See how ISO 13485 compares with ISO 9001.

ISO/IEC 27001 Information Security Management

ISO 27001

ISO/IEC 27001 provides the framework for an information security management system (ISMS), using risk-based controls to protect information and manage security systematically. Find out how ISO 27001 compares with ISO 9001.

Integrated Management Systems

If your organization needs more than one management system standard, we can integrate the common requirements instead of building separate systems that duplicate the same work. ISO 9001, AS9100, ISO 13485 and ISO 27001 can share suitable processes such as document control, internal audit, management review, corrective action and other common management-system controls.

The objective is simple: one practical management system where possible, with standard-specific controls added only where they are genuinely needed.

We can develop, simplify and audit integrated systems. During implementation, we reuse effective common processes rather than duplicating procedures for each standard. During internal audits, we can evaluate shared processes once while still checking the requirements that are unique to each standard.

A good integrated management system should feel like one way of running the organization – not several ISO systems competing for the same people, records and processes.

We offer Certification Services, Consultancy and Internal Audit Services for organizations that need an integrated approach.

Whether we are building the system, solving a specific problem or auditing it, the approach stays the same: understand how the organization actually works, preserve effective controls, and avoid duplicate or unnecessary bureaucracy.

If you already operate one certified management system, that existing structure can often become the starting point for the next standard rather than beginning again from scratch. That can reduce implementation effort and make the resulting system easier for employees to use.

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