ISO 13485 MEDICAL DEVICES MANAGEMENT STANDARD

ISO 13485 is the Medical Devices’ Quality Management Standard. It meets customer and applicable regulatory requirements in the medical devices industry. The development of this specification was driven by a need for a harmonised ISO Standard for medical devices by the EU. It follows the principles set out in ISO 9001 but not the top-level index. Unlike ISO 9001, the primary emphasis is on conformance to regulatory requirements. As a result of this regulatory focus, there are more explicit requirements in order to meet the demands of a rigorous regulatory framework.

WHAT IS ISO 13485?

ISO 13485 is the international Standard for the design and manufacture of Medical Devices. The standard is a part of the requirements for the Medical Devices CE Mark conformance and UKCA Logo approvals.

To achieve ISO 13485 Certification, organisations must commit to a focused and systematic approach to business. This means decision making must be fact-based. Thus, the organisation must demonstrate internally, and to the external Assessor, the following:

• Focus on demonstrating compliance to applicable regulatory and legal requirements.
• A clear focus on, and understanding of, Customer requirements.
• Management commitment to comply with the requirements and quality effectiveness in all aspects of the business as well as evidence of that commitment.
• Risk Management.
• Design, including characteristics for safe and proper use.
• Involvement of trained, qualified and competent employees.
• Properly monitored and controlled work processes that comply with the requirements of the Standard.
• Facilities and resources provided throughout the organisation meet the needs of the documented work and maintenance processes .
• Mutually beneficial Supplier relationships that promote clear management of supplies and services.
• Where problems arise, employees can quickly identify, investigate and correct them and prevent any recurrence.
• Management must ensure monitoring of all aspects of the business and that this monitoring meets the ISO 13485 Standard and leads to improved processes. Therefore, appropriate records must evidence proof of that improvement
• External independent UKAS accreditation. Alternatively, if required by MDR then independent assessment by a Notified Body (EU) or Approved Body (UK), including on-going Surveillance visits at least annually.

UPDATES

Recently, updates of Management Standards have harmonised with a common top-level Index. This clarity assists the integration of systems when an organisation goes through certification for two or more Management Standards. However, ISO 13485 is an exception. This is because of the specific focus on “Requirements for regulatory purposes” and the demands that those requirements place on an organisation.

Additionally, any ISO 13485 Quality System needs to be flexible. The System must enable the business to successfully respond to modern volatile and competitive business environments. Of course, this is a common requirement with ISO 9001. However, the regulatory framework for this industry places rigorous legal and risk management demands on the organisation to conform and to retain appropriate evidence of regulated operations.

BENEFITS OF ISO 13485

The ISO 13485 Medical Devices Management Standard is a critical component of the modern medical devices business. The good news is that Certification confers considerable benefit and on the organisation…

1. COMPETITIVE ADVANTAGE

   The standard enables your organisation to meet the Medical Device requirement for CE Mark or UKCA Logo. The use of the appropriate Mark or Logo affords the organisation access to National, Regional and International markets where sales are not possible without them.
   ISO 13485 gives an externally checked confidence that your business is using a documented system to fulfil Customer requirements and which meet regulations. In addition, the Standard shows your organisation has a commitment to improve. It also provides assurance to Customers that they can depend on consistent Product and Service quality as well as the management commitment to maintain that Standard.

2. OPERATIONAL CONTROL

   ISO 13485 provides a systematic and integrated approach to managing risks and to business processes. It provides a clear structure of operating processes. Furthermore, that structured approach emphasises continual improvement of working systems. Consequently, your business decisions will be more fact-based, leading to the reduction of errors, duplication, complaints and problems./li

3. LEGALLY ROBUST

   The ISO 13485 Standard ensures that your organisation meets the appropriate legal and regulatory controls in a consistent and controlled manner. Lost records and poor documentation can easily lead to expensive proceedings. With ISO 13485 your organisation gains fine control in critical areas of document control and record keeping.  Consequently, your management are legally risk aware and properly prepared for legal challenges in this increasingly litigious business.

4. CUSTOMER ORIENTATION:

   Your customers soon recognise that their requirements are met in an orderly and consistent way. Such assurance positively impacts customer relations. Appropriate records and communication, and effective operations, will lead to better business outcomes for the customer and the business itself.

The evidence shows that ISO 13485 implementation costs are an investment for your business. Cost advantages and other improvements gained through better methods lead to improved productivity, reduction of waste and better management control. Consequently, achieving successful Assessment and Certification also assists in retaining existing Customers, and in gaining new ones.

YOU NEED ISO 13485 certification

Your business faces an increasingly competitive business environment. Tougher regulatory controls and legal challenges are also growing in scope and the organisation needs evidential defence on a regional and international scale.  ISO 13485 provides a robust response to these demands. The CE Mark and UKCA Logo in the Medical Devices Industry are, therefore, a keystone of your organisational success. In a tough regulatory environment, Certification to this Standard represents a significant investment in your business.

All the requirements of this International Standard are generic. Intentionally, they apply to all Medical Device organisations, regardless of type, size and location. So, you will establish parity with your competitors and at the same time cover your Medical Devices Management responsibilities. The ISO 13485 Standard ensures you meet all the legal and regulatory demands your business faces as well as defending your organisation against legal challenge.

WHEN TO START?

Start now and gain the benefit sooner. We have a tailored programme to assist you to gain the Standard. While this is an important point, we also have a principle that sets us aside from our competition. We specifically work to ensure that you, “Improve your business, rather than just comply to the standard”. Many companies just use Management Standards to add another award. We believe that you can go beyond simply meeting your regulatory obligations. Our emphasis is on making your investment pay. That is, we will work toward improving your business and getting a return on your investment in the system.

If you would like to know more about how we can help you invest in your business future, simply press one of the buttons below to contact CHARTER 4.