Spotlight on Standards: ISO 13485 (Medical Devices) and ISO 14001 (Environmental Management)

“A SCARY NUMBER OF STANDARDS”

One of our clients once asked: “There are a scary number of standards, can you help to clarify some of them?” With this in mind, we have launched Spotlight on Standards to highlight two popular standards in each edition of Quality Insights. The aim is to introduce, outline and remove a lot of uncertainty.

This time, we focus on:

ISO 13485 – MEDICAL DEVICES – QUALITY MANAGEMENT SYSTEMS – REQUIREMENTS FOR REGULATORY PURPOSES

What is ISO 13485?

ISO 13485 is a globally recognized medical device certification standard to help you demonstrate that your management system meets product and regulatory requirements.

The standard specifies requirements for a quality management system (QMS) to help an organization show its ability to provide medical devices and related services that adhere to user and legal standards.

Organizations can be involved in one or more life-cycle stages, including production, storage and distribution, and installation. It can also be involved in servicing, design and development or associated activities like technical support.

The standard can be used by suppliers or external parties that provide products to organizations.

Key benefits

Certification follows successful completion of an audit and enables you to:

• Produce and distribute devices faster
• Enable systematic process improvement
• Discover ways to improve efficiency and add value
• Gain a competitive advantage
• Monitor supply chains for continuous improvement
• Align with UN Sustainable Development Goals 3 and 10
• Homing in on critical areas

From identifying issues to prioritizing ownership and updating processes, ISO 13485 has several key requirements to fulfill.

Key requirement areas:

• Outline your organization’s strategy and engage stakeholders
• Develop an implementation plan
• Meet any new competency requirements and create awareness for all parties that impact your QMS
• Review and confirm leadership roles, responsibilities and accountabilities
• Determine the systems that manage outsourced products and services
• Review and understand the requirements for risks and opportunities
• Ensure that documented information requirements are understood
• Update the existing QMS to meet the new requirements and verify its effectiveness

Cutting to the core

ISO 13485 contains several core concepts that, if implemented correctly, can help to enhance your organization.

Some core requirements:

• The context of your organization
• Interested parties
• Issues, risks and opportunities
• Leaders and risk owners
• Threats and opportunities
• Communications
• Documented information
• Performance evaluation
• Operational planning and control
• Nonconformity and corrections
• Implementing ISO 13485

It is essential that ISO 13485 is implemented correctly to reap all of the rewards. We can support you to achieve this through our various training courses.

Key areas:

• Ensure senior management support and commitment
• Engage the entire organization through internal communications
• Compare your existing systems with the new requirements
• Obtain worker, customer and supplier feedback on current systems
• Create an implementation team
• Define roles, responsibilities and schedules
• Start with the basic principles
• Use training and incentives to encourage employee involvement
• Share knowledge on the standard and consider internal auditor training
• Regularly review the system to ensure continual improvement

ISO 14001 – ENVIRONMENTAL MANAGEMENT SYSTEMS – REQUIREMENTS WITH GUIDANCE FOR USE

What is ISO 14001?

ISO 14001 certification is integral to reducing your environmental impact.

The standard applies to all organizations and the environmental aspects of their activities, products and services that can control or influence from a life-cycle perspective.

ISO 14001 specifies environmental management system (EMS) requirements that enhance your organization’s environmental performance. You can learn to systematically manage the environmental responsibilities that contribute to sustainability.

Key benefits

An ISO 14001 EMS can provide value to the environment, the organization itself and interested parties. Consistent with your environmental policy, EMS outcomes include:

• Environmental performance enhancement
• Fulfillment of compliance obligations
• Risk avoidance
• Achievement of environmental objectives
• Brand growth
• Alignment with UN Sustainable Development Goals 1, 2, 3, 4, 6, 7, 8, 9, 12, 13, 14 and 15

Pinpointing the pain points

Using our vast dataset, we have identified the standard’s key pain points:

• Understanding the standard’s requirements
• Understanding and determining the context, issues, interested parties and relevance
• Identifying aspects, legal requirements and objectives, especially those inconsistent and immeasurable
• Testing and implementation of emergency plans
• Deviations from written procedures
• Monitoring and measurement
• Organizing proper performance evaluation and measurement criteria
• Executing internal audits as planned

Cutting to the core

ISO 14001 contains several core concepts that, if implemented correctly, can help to enhance your organization.

Some core requirements:

• The context of your organization
• Interested parties
• Leadership and commitment
• Address risks and opportunities
• Communications
• Documented information
• Operational planning and control
• Performance evaluation
• Nonconformity and corrections
• Implementing ISO 14001

It is essential that ISO 14001 is implemented correctly to reap all of the rewards.

Key areas:

• Ensure senior management support and commitment
• Engage the entire organization through internal communications
• Compare your existing systems with the new requirements
• Obtain worker, customer and supplier feedback on current systems
• Create an implementation team
• Define roles, responsibilities and schedules
• Start with the basic principles
• Use training and incentives to encourage employee involvement
• Share knowledge on the standard and consider internal auditor training
• Regularly review the system to ensure continual improvement

HOW WE CAN HELP?

With expertise in all major industries, we understand each sector’s pain points and have the technical skills and logistical capabilities to ensure realistic outcomes.

An audit against ISO 13485 and/or ISO 14001 from us will help your organization to stand out from the crowd by supporting you to develop and improve performance, among other things.

Additional ISO 13485 services

We offer a range of complementary services:

• In Vitro Diagnostic Regulation (IVDR) Technical Documentation Training Course
• ISO 13485 Medical Devices QMS Auditor/Lead Auditor Training Course
• ISO 14971 Risk Management for Medical Devices Introduction Training Course
• MDR Clinical Evaluation Training Course
• MDR Implementation Training Course
• MDR Internal Auditor Training Course
• MDR Technical Documentation Transition Training Course
• Medical Devices QMS Software Validation Training Course

Additional ISO 14001 services

We offer a range of complementary services:

• ISO 14001 EMS Auditor/Lead Auditor Training Course
• ISO 14001 EMS eLearning Bundle (Introduction, Internal Auditor and Implementation)
• ISO 14001 EMS Internal Auditor Training Course
• ISO 14001 EMS Introduction and Implementation eLearning Pathway
• ISO 14001 EMS Introduction and Internal Auditor eLearning Pathway
• ISO 14001 EMS Introduction eLearning Training Course
• ISO 14001 EMS Introduction/Foundation Training Course

With a global presence, we have a history of successfully executing large-scale, complex international projects. We speak the language, understand local markets and operate consistently, reliably and effectively globally.

Our services can benefit you, whatever your size or sector. Learn more here.