Organization Management Platform
ins2outs helps organizations define and operate various management systems, e.g., quality, information security, privacy, compliance, etc. The platform offers ins2outs software, ready-to-buy know-how sets, and direct support from consultants and experts.
We help your company address regulatory requirements
Platform elements
Use ins2outs to promptly define a management system, get certified, and meet regulatory requirements.
ins2outs software
An organization works in ins2outs software (SaaS) hosted in a secure cloud environment. ins2outs provides an account where any of its management systems are hosted, like quality, information security, privacy, and others. The organization invites its users to the ins2outs software.
Know-how sets
The platform offers ready-to-buy know-how sets. A know-how set consists of policies, processes, procedures, instructions, document templates, roles, training, regulations, and standards. The organization gets immediate access to the know-how set and starts implementing it.
Consulting
ins2outs platform offers support from both internal and external consultants. The consultants support your organization in the definition, implementation, certification, and operations of your management system as well as placing your products on the market.
Operate any management system
Use ins2outs to define and certify management systems for your organization
ISO 13485/21 CFR 820 Quality Management System
A Quality Management System (QMS) is used by an organization involved in one or more stages of the life cycle of a medical device (MD) or in vitro diagnostics medical device (IVD MD).
ISO 27001 Information Security Management System
An Information Security Management System (ISMS) addresses information security, cybersecurity, and privacy management.
ISO 27701 Privacy Information Management System
A Privacy Information Management System (PIMS) is used to process personally identifiable information in a secure and lawful manner.
Other management systems
Define your management system in 5 steps
Learn how to define and certify a management system
1. Get know-how
Use your know-how to start the definition of the system or buy one of the ready know-how sets
2. Define
Step by step, define your management system by creating/updating system documentation
3. Share and execute
ins2outs will train your organization users on all finalized documentation. The system is used by the organization
4. Certify
Invite a notified body for the certification. Present the system’s documentation in the stage I audit, and execution in stage II
5. Operate
Use your system in daily operations. Benefit from tasks automation on ins2outs
ins2outs Software
Learn about the features ins2outs offers for your organization
Flexible management system
On ins2outs you can easily define and operate any management system. The system structure offers policies, processes, procedures, instructions, document templates (ins/outs), linked to any normative sources (regulations and standards), and then grouped around the organization roles. Add to that training, guidelines and information contexts and you have everything that is needed to define any management system.
Operate integrated management systems
Organizations these days have to fulfill many legal and business requirements just to mention compliance with laws, regulations, and standards. This results in the need to operate under multiple management systems e.g. for regulatory compliance, information security, privacy, quality, environment, or AI. ins2outs allows you to define and manage multiple management systems on the same platform.
Automated execution
Decrease the effort needed to operate your management system by introducing automation. ins2outs offers automatic role-based training, push notifications for users, user compliance KPI, documentation readiness KPI, configurable documentation workflow logic, automatic notifications on tasks, reviews, documentation checkups, mapping your system to any regulation or standard, and many more. That allows you to operate your system to a high standard with minimal effort.
Ready to use know-how sets
Speed up your management system definition by selecting one of the available know-how sets
ISO 13485:2016 / 21 CFR 820 Know-how set
This know-how set defines an ISO 13485:2016, 21 CFR 820, ISO 14971:2019, and ISO 62366-1:2015 compliant Quality Management System (QMS). It can be used by an organization involved in one or more life cycle stages of medical devices.
ISO 27001:2022 Know-how set
This know-how set defines an ISO 27001:2022 and ISO 27002:2022 compliant information security and a cyber security management system. It is used to ensure information security, cybersecurity, and lawful processing of personal information.
IEC 62304:2006 Know-how set
This know-how set defines IEC 62304:2006, ISO 13485:2016, and ISO 14971:2019 compliant Software Development Life Cycle (SDLC). An organization can use it to develop software in a medical device (SiMD) or software as a medical device (SaMD).
ISO 27701:2019 Privacy Information Management
Consulting
Define, certify, and operate your management system definition with the help of our consultants
Quality Manager as a Service (QMaaS)
Quality Manager defines, supervises, and operates your ISO 13485 and 21 CFR 820-compliant Quality Management System (QMS). The consultant will lead your QMS certification and support market approvals of your medical devices.
Information Security Officer as a Service (ISOaaS)
Information Security Officer defines, supervises, and operates your ISO 27001-compliant Information Security Management System (ISMS). The consultant will lead your ISMS certification and manage the information security approach.
Clients
Benefits for organizations
Addressing requirements of any management system or regulation
Implement any management system or prove compliance with any regulation worldwide. Choose the platform that prepares your organization for any incoming change in the regulatory environment on any market your company targets.
Promptly deliver know-how to your organization
Acquire the required know-how set instantly from the ins2outs platform or our consultants’ ecosystem. Let your organization gain new know-how, business processes, and build the necessary competencies.
Shorten your system's implementation time by up to 75%
A management system implementation can be a prompt and effective process. Combine ins2outs software, ready-to-use know-how sets, and our consultants to define and certify any management system in weeks, not years.
Operate integrated management systems
These days organizations have to operate in different domains like regulatory, cyber, privacy, and quality. That usually leads to operating multiple systems like quality and cybersecurity. ins2outs was built to enable such an evolution of your organization.
Get support from consultants and experts
Find a consultant to support you in addressing your regulatory, compliance, or standardization requirements among the ins2outs consultants ecosystem.
ins2outs Pricing
ins2outs Software
- Cloud-hosted
- Requires one active user account
- Standard features package
- Full view and edit rights
Know-how sets
- Defines a management system
- Requires ins2outs account
- One-time net fee
- For organizations of any size
Consulting
- Experienced consultants
- Delivered via ins2outs
- Monthly fixed fee or hourly fee
- For organizations of any size
Set your standards high with ins2outs
Try ins2outs for free for one month to check how you can operate a management system in your organization