Understand the Management Responsibilities in ISO 13485 Quality Management System for Medical Devices

Medical device manufacturing is one of the most regulated sectors in which important quality systems and product requirements must be fulfilled. The regulatory necessities are intended to confirm that manufacturers constantly design, produce and place onto the market medical devices that are safe and fit for their intended goal. The ISO 13485 standard is an actual solution to meet the complete requirements for a QMS. Implementing ISO 13485 delivers a practical foundation for manufacturers to address the rules and responsibilities as well as demonstrating a commitment to the safety and quality of medical devices.

ISO 13485 is a Quality Management System standard, consequent from the internationally recognized and recognized ISO 9000 quality management standard series. ISO 13485 familiarizes the previous version of ISO 9001, ISO 9000:2008 process-based model for a regulated medical device manufacturing environment. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, Act, it is considered for regulatory obedience; therefore, it is more prescriptive in nature and needs a more thoroughly ISO 13485 documents QMS. ISO 13485 support medical device manufacturers in designing a quality management system that establishes and sustains the effectiveness of their procedures. It confirms the constant design, development, production, installation and distribution through to disposal of medical devices that are safe for their proposed.

There have constantly been requirements regarding management responsibilities in ISO 13485. After all, leadership from top management is part of the foundation of the ISO 13485 standard, along with six other quality management principles. And, this is a good thing—without management’s ongoing support, Quality Management System is destined for problems.

What are the management responsibility requirements in the ISO 13485:2016?

The ISO 13485 standard covers the responsibilities of top management, the majority of which are the same as, the current requirements in the previous version. The first part defines how top management must show leadership through its commitment to the QMS, including:

• Assure adequate resources are available when required.
• Holding accountability for the effectiveness of the Quality Management System.
• Fostering constant enhancement.
• Confirming that the quality objectives and quality policy are aligned with the QMS, and with the company’s strategic goals.

The remaining three parts, discuss the quality policy and its requirements, the requirement to put consumers first, and the roles, responsibilities, and authorities of the company. These requirements only saw slight changes from the last revision; for example, top management’s responsibility to confirm the suitability, adequacy, and efficiency of the QMS remains the same, although a few requirements have been removed—such as those for the QMS representative. The role of top management remains as important as ever.

How can you meet the requirements?

The requirements in the ISO 13485:2016 standard haven’t changed much from the last version, so don’t have to worry about making major changes to the role of top management in Quality Management System. That said, here are some significant things that organization should contain to demonstrate top management’s commitment and involvement in Quality Management System:

• Management is complex in measuring the effectiveness of the Quality Management System.
• Top management provides clear direction for creating the quality policy and quality objectives, communicates this throughout the organization, and tracks their progress.
• Management demonstrates that the QMS is not a side project, but rather a significant part of business processes.
• Management assesses and addresses the necessity for resources.
• Management supports and encourages constant improvement.
• Top management assure that a process is in place to understand and meet appropriate requirements from consumers, as well as local and federal regulations.
• Management attentions on the consumers.
• Roles, responsibilities, and authorities are appropriately assigned, and understood both by the assignees, and by other employees who interact with the assignees.

In addition, it’s significant to remember that management assessment and its necessities remain in the new revision, which contains response to management on QMS efficiency and maintenance. The management review process continues to be a key indicator of management’s ongoing commitment to the Quality Management System, and in fact, the new revision has extended on those requirements. New inputs are essential regarding the handling of complaints and reporting to relevant regulatory authorities. Also, the outputs now have necessities regarding actions and decisions that lead to changes to the QMS, and obedience with regulations. It’s no secret that in order for an ISO 13485 QMS to succeed, it needs support from management. Without such support, other priorities will take center stage, and all that time and money spent executing the Quality Management System are wasted—and the possible benefits lost.

Mandatory Steps for Effective ISO 13485 Certification

ISO 13485:2016 specifies for a quality management system where an organization wants to prove its capability to deliver medical devices and associated services that constantly meet client and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, with design and growth, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities. ISO 13485:2016 can also be used by sellers or external parties that provide product, including quality management system-related services to such organizations.

Who is ISO 13485 for?

ISO 13485 is designed to be used by organizations complex in the design, production, installation and service of medical devices and related services. It can also be used by internal and external parties, such as certification bodies, to help with their auditing processes.

Steps to follow during ISO 13485 Certification

To confirm medical products will pass certification, here are the key steps that organization should follow during the ISO 13485 implementation and certification:

• Conduct a Gap Analysis:

This is an audit that controls the level of compliance versus the standards that are being held.

• Develop a project plan:

After the audit and gap analysis, describe a corrective plan which lists all non-conformities, including how to fix problems to comply with ISO 13485 necessities and related regional standard implementation.

• Develop documentation:

Put together the ISO 13485 documents that includes a Quality Manual, procedures, work instructions and documentation with proof of implementation.

• Develop & conduct training:

This is one of the most significant steps in checklist. Delivery of training to anyone who will be complicated in any stage of the production of the medical device is mandatory. The first training educates the team on appropriate requirements of the ISO 13485 standards, with those relevant to regional and product certifications. The next training is to set in place a Quality Management System that delivers a standard for complying with work instructions and required sanitary procedures, as well as recording of proof of execution on specific documentation.

• System Implementation:

A period of three to six months is specified to implement the new Quality Management System as per ISO 13485 requirements and preparation of documentation to prove compliance.

• Conduct an internal audit:

The dealer should conduct an internal medical device audit to measure agreement and accurate any noted deviations. Internal audit can also be performed by a third-party auditor.

• Conduct a management review:

If the Quality Management System is not executed according to ISO 13485 procedure, and does not meet the well-defined policy and objectives, it must be adjusted to meet the essential requirements.

• Apply for ISO 13485 certification:

An external audit of ISO 13485 is the concluding step. This external audit is typically directed by certification bodies. Based on the willingness of organization, the certification body will issue the ISO 13485 certificate if pass, or issue a non-conformance report that will need corrective actions. Once all non-conformance items are closed, the organization can then re-apply for certification.

ISO 13485 Certifications Supports Medical Device Companies:

The medical device sector is a high-pressure industry where people admiration innovation as long as it doesn’t sacrifice user safety. Moreover, creators must respond to demand spikes, as examples like the flow in ventilator needs during the COVID-19 pandemic showed. Getting an ISO 13485 certification can help a business make positive, permanent quality and process developments. Thus, representatives from certified companies often find that ISO 13485 contributes to organizational flexibility. It’s not right for every association, but the associated advantages make it well worth consideration.

ISO 13485 Requirements for Improvement of Medical Device Management System

ISO 13485 Certified means an organization has implemented an ISO 13485 Quality Management System and has successfully encountered all of the requirements in ISO 13485. ISO 13485 assesses whether Quality Management System is proper and effective while emphasizing the safety and efficacy of medical devices.

These days, many organizations associated with manufacturing of Medical devices decide to implement ISO 13485 system and get registration because it assures customers that the company has a good Quality Management System (QMS). An organization with an effective QMS, as per ISO 13485 requirements will characteristically meet customer expectations and it will be always better than an organization that does not have one.  This is because the Goals and Purposes of the QMS take the customer needs into account.  As goals focus on the customer, the organization spends less time concentrating on individual goals of departments and more time working together to meet customer needs.

ISO 13485:2016 provides the requirements for measurement, analysis and improvements of these processes including:

• General.
• Monitoring and Measurement.
• Control of nonconforming product.
• Analysis of data.
• Improvement.

General:

All organizations are essential to create a plan and then apply to the monitoring, measurement, analysis and improvement processes required in order to meet the conformity needs of the product, to ensure the conformity of the QMS, and maintain the efficiency of the QMS. Today experienced consultancy group sell a readymade ISO 13485 documents on the website that can help such organization in preparing and maintaining the records and documents.

Monitoring and Measurement:

As part of the requirements each organization is essential to monitor and measure a variety of information in order to improve their process and meet customer requirements this includes:

• Customer Feedback.
• Complaint Handling.
• Reporting to Regulatory Authorities.
• Internal Audit.
• Monitor and Measure processes and products.

Control of nonconforming product:

Organizations are essential to react to any product that is not in compliance to product requirements. Organizations want to identify and control these products to confirm that they are not used and distributed further. This process wants to be documented and maintained. Corrective and Preventive Action (CAPA) processes is an important part of the ISO 13485:2016 Quality Management System, it helps to precise non-conformances requires doing something different than the action that caused them.

Analysis of data:

The organization needs to collect and analyze proper data to determine the efficiency of the QMS. The procedures to determine this essential to include data collection and analysis, including statistics to help understand the extent of the QMS productivity. The analysis wants to include at a minimum: feedback; conformity to product requirements, characteristics and trends of processes and products, suppliers, audits, service reports.

Improvement:

Improvements are a critical part of the quality management system. ISO 13485:2016 needs all organizations to focus on continually improving. Overall, the organization wants to identify and implement any changes essential to maintain the effectiveness of the QMS, and the medical device safety and performance. Organizations essential to do this by quality policy, quality objectives, audit results, post-market surveillance, analysis of data, corrective actions, preventive actions, and management review.

5 Key elements of the ISO 13485 Medical devices Quality management system

ISO 13485:2016 specifies requirements for a quality management system where an organization needs to prove its capability to provide medical devices and related services that constantly meet customer and appropriate regulatory requirements. ISO 13485 is intended to help medical device manufacturers create a Quality Management System (QMS) that confirms quality and safety of complete products.

ISO 13485 internal auditor training provide that need to know about the Quality management system and fulfill all the requirements as an ISO 13485:2016 QMS auditor. ISO 13485 auditor training will guide management as well as employees of organization in the field of manufacturing, supply of a medical device or its components for Quality management system based on ISO 13485:2016 standard. The standard delivers a step-by-step framework for creating a QMS and evaluating gaps in current system in terms of monitoring and controlling processes.

5 Key elements of ISO 13485:

1. Quality Management System (QMS):General quality management system requirements, as well as the documentation required to implement and maintain an effective quality management system. According to ISO, organizations need to:
   • Control the processes the quality management system needs and what’s required to apply these processes throughout the organization, taking into account the various roles involved.
   • Apply a risk-based method to the control of the appropriate processes required for the quality management system.
   • Determine the categorization and interaction of these processes.
2. Management Responsibility: The unique roles and responsibilities of management as it pertains to quality management system execution and maintenance. Management should provide evidence of its assurance to the development and maintenance of the quality management system and its efficiency. to do that:
   • Communicate the importance of meeting regulatory requirements.
   • Create high-value quality policy.
   • Confirm that quality objectives are established.
   • Conduct management reviews.
   • Confirm availability of quality management system resources.
3. Resource management: The resources life sciences organizations should oblige to implement the quality management system and maintain system efficiency. It outlines the provisions required to meet major regulatory and customer requirements.
   • The provision of resources.
   • Human resources.
   • Infrastructure.
   • Work environment.
   • Contamination control.
4. Product realization: In a rush to get products into expansion as soon as possible, many organizations often overlook the planning stage. plan realization efforts properly.
   • Launch the quality requirements for products.
   • Describe what essential processes will be and what supporting documentation will be required for those processes
   • Framework the company infrastructure that will essential to be created and what the work environment should be like.
   • Describe employee qualification and training requirements.
   • Establish processes for verification, validation, measurement, monitoring, handling, inspection, storage, supply, and traceability.
5. Measurement, analysis, improvement: The organization shall plan and implement the monitor, measurement, analysis, and development processes, related to the quality management system and products. Organizations need to:
   • Establish conformity of product.
   • Confirm conformity of the quality management system.
   • Maintain the efficiency of the quality management system.

WHAT IS ISO 13485? WHY SHOULD YOU IMPLEMENT IT?

What is a Medical Device? 

A medical device is a product i.e. instrument, machine, implant, or in vitro reagent that is intended for use in the diagnosis, prevention and treatment of diseases, rehabilitation of illness and disease, or other medical conditions.

What is ISO 13485?

ISO 13485 is an effective standard that helps businesses meet the comprehensive quality management requirements of medical devices. The standard provides a strategic framework and practical foundation to adhere to medical device directives, regulations, protocols and responsibilities. The standard essentially enables you to fulfil your commitment to the safety and quality of medical devices. 

ISO 13485 is an individual QMS (Quality Management System) standard derived from the internationally established and recognized ISO 9000 Quality Management Standard series. The standard is designed for the QMS of medical devices with the primary quality levels of the ISO 9000 series. Therefore, it is a complete system that guides businesses in medical device manufacturing and management to adhere to the standard safety and quality protocols in the medical industry. 

How Can ISO 13485 Help you?

ISO 13485 provides a fool proof quality check throughout the process for the excellent quality of medical devices. The standard ensures that the devices are functioning properly and serving as per their intended purposes with utmost safety. The standard will ensure 

• Consistent design
• Competent development 
• Streamlined production 
• Accurate installation 
• Safe delivery and distribution 

Who Should Implement ISO 13485 Standard?

ISO 13485 is primarily created for designers, manufacturers, and distributors of medical devices. In addition, suppliers and service providers can implement the standard and gain a competitive advantage by enhancing the organization’s marketability and recognition. 

• The Standard is Applicable to
• Manufacturing of medical devices (MD) or in vitro diagnostic products (IVD)
• Manufacturing of reagents or substances for use in IVD or MD(for Pharma and diagnostic purpose
• Medical device Traders  

How can you Implement ISO 13485?

Similar to many ISO standards, the ISO 13485 also follows the PDCA framework. After considering the customer requirements and industry standards, you can identify quality objectives and then prepare the quality manual and policy. It will define the scope and give you a direction along with the framework for implementation. The standard ensures that the organization is capable of consistently achieving and maintaining the quality requirements and complies with the internationally recognized quality standards. 

What are the Requirements of ISO 13485? 

The ISO 13485 standard contains specific requirements for manufacture, installation and servicing of medical device, which strongly focuses on the compliance of EU Directives for MD or IVD such as

Documentation requirements

ISO 13485 quality management system – readymade documents is reducing your risk and saving you time and money. Suppliers that comply with your quality and ISO 13485 documents requirements reduce the need for more costly and regulatory inspections. Other helps to reduce your risk are providers who advise you of changes, support your warranty requirements, and take corrective and preventive measures when necessary.

ISO 13485 documentation kit by Global Manager Group consists of the following documents in editable .doc format.

• ISO 13485 Manual
• ISO 13485 Procedures
• Exhibits
• Sample Formats / Templates
• Quality SOP 
• Filled forms
• ISO 13485 Audit Checklist
• Medical Device File

What are the Benefits of ISO 13485 Implementation?

• The ISO 13485 emphasizes risk management, risk-based decision making and changes related to the increased regulatory requirements for organizations in the supply chain. 
• Increase access to more markets worldwide with certification
• Enhance credibility and recognition of your organization 
• Improve decision-making processes 
• Consistently improve your quality and performance 
• Outline how to review and improve processes across your organization
• Increase efficiency, cut costs and monitor supply chain performance
• Demonstrate that you produce safer and more effective medical devices
• Meet regulatory requirements and customer expectations.

ISO 13485: What does it require from Quality manual?

Sometimes organizations go too far with quality manual, creating a huge, unusable book that is pretty much just the ISO 13485 standard and just rewritten it with do some modification. Technically suppose that, this would show written proof that the organization is committed to meeting every single requirement the standard lists for their Quality Management System (QMS) – but a document like this is much too long and difficult to understand to be of any use to employees. Many modern companies like to go with a short with its ISO 13485 manual that’s easy to read and understand.

The actual requirement to include in ISO 13485 quality manual that is mainly understands. So here are the requirements of a quality manual, and the thinking behind each requirement:

(1) The QMS scope:

The QMS scope is a description of what company does for example we can say Distribution of Medical Devices, Software Design for MRI Machines, etc. and the boundaries of your Quality Management System. It requires to be agreed upon with the certification body, as it will be stated on the ISO 13485 certificate.

Now you are capable to understand what’s included in your scope and what’s not, you required to list any exclusions from the standard. Mostly, there won’t be any to list, but a common exclusion is the “Design and Development” clause of the ISO 13485 standard, because many companies manufacture products according to customer specifications, and don’t actually design any products.

(2) ISO 13485 Documented procedures:

There are quite a lot of procedures that ISO 13485 requires an organization to document or require at least reference in the quality manual. Mandatory documented procedures include:

• Control of documents
• Control of records
• Internal audit
• Control of non-conforming products
• Corrective and preventive actions
• Validation of computer software
• Customer specifications such as manufacturing, inspection, packaging, and delivery
• Monitoring and measurement
• Servicing and installation (if applicable)
• Management review
• Work environment and contamination control
• Design and development
• Validation of sterilization and sterile barrier systems (if applicable)
• Identification and traceability
• Preservation of product
• Calibration or verification for measuring equipment
• Feedback and complaint handling
• Reporting to regulatory authorities
• Advisory notices, reworks, data analysis

Additionally to the required documents, there is a requirement for companies to develop ISO 13485 documentation for any procedures that are likely to have non-conformances were they not considered or forgot to write. Basically, if you require a ISO 13485 documented procedure to prevent mistakes from occurring, then you require a good documented procedure.

The Documented Procedures that are shown graphically such as in form of flowcharts can be included right in the quality manual. For longer procedures it requires more written information, it is easy to include references to these documents in the quality manual. In this way, the quality manual can serve as a kind of quick-reference guide to company procedures.

(3) Descriptions of processes and interactions: The easiest way to accomplish descriptions of processes is with a simple, top-level flowchart illustrating the basics of organization’s processes, with arrows determining how they interact. There is no requirement to go into great detail for this in the quality manual.

How to Manage the Quality Manual according to ISO 13485:2016 requirements

For the most part, organizations can create Quality Manual that technically meets the ISO 13485 requirements – but, forget to have this document. As a result, time and effort are wasted creating a huge ISO 13485 document that no one will ever read.

A good short ISO 13485 Manual can bring many benefits to an organization and its QMS:

• It offers a medium for the organization to present its commitment and approach to quality management.
• It is a good place to document other requirements, besides those required in an accessible and easy-to-read format.
• It shows stakeholders that the organization truly knows how to manage the quality of its products and services.
• It helps the auditor do a better and more complete job of QMS auditing, and in turn, to offer suggestions for improving the system.
• Perhaps best of all, it provides a good overhead view of the Quality Management System for the management representative, as well as the process owners.

How to make ISO 13485 Manual?

When creating or updating your ISO 13485 Manual, as with any other requirement of the standard, you need to focus primarily on what the standard actually requires, and try to meet those requirements before going creative. When you apply this approach, it’s really not that difficult to write a good Quality Manual; just make sure you include these elements required standard:

• a definition of the scope of your Quality Management System
• a list of exclusions, if any, and reasoning behind them
• a description of their processes and interactions, preferably in graphical form, like process flowchart
• documented procedures for the QMS or reference to them

All You Need to Know About ISO 13485 Manual

Are you from the healthcare industry? Do you deal with the manufacturing of medical devices? Are you struggling to meet required quality standards? Then, you definitely need to know about ISO 13485 Manual. As you would know, ISO standards are the standards that help you meet and ensure required quality parameters during the manufacturing / production processes.

A brief about ISO 13485 Manual

ISO 13485 deals with the quality standards and requirements pertaining to the design and manufacture of medical devices. These standards help you to establish a full-fledged quality management system (QMS) in the processes of developing, manufacturing and employing medical equipment.

ISO 13485 Manual is a documentation kit that helps a user to follow all standards and requirements. This kit helps a user (medical device manufacturers) to understand what all he needs to do and how to do to get the ISO certification.

Why ISO certification is advisable for medical device manufacturers?

Well, ISO certification is advisable for all manufacturing units. If we talk about medical device manufacturers, they need ISO 13485 certification. Let’s run through the benefits of ISO certification, which you can get by using an ISO 13485 Manual.

• The ISO 13485 certification is recognized and accepted at a global level.
• If your organization is ISO 13485 certified, it can act as a social proof and trust element among your existing customers.
• It also presents your organization as a reputed body and can win new customers since it demonstrates a strong commitment to quality standards.
• The standard ISO 13485 ensures compliance with the regulations of the European market. And, it is a prerequisite for all the organizations operating from the US when it comes to exports’ transactions.
• If you implement the ISO 13485 QMS, your organization, as a whole, will significantly boost both efficiency and effectiveness. In turn, your profit levels will go up.

So, you can get a lot many benefits if your organization is ISO 13485 certified. But, how to proceed with would be your next question. We have a solution for this query as well – it is none other than ISO 13485 Manual!

How can ISO 13485 Manual help medical device manufacturers?

Did you know that the process of getting ISO certified is complex? One definitely needs professional assistance to get through it. And, that’s why; the ISO 13485 Manual is in the place.

As stated about, this manual is a documentation kit. It includes procedures to follow and documents to prepare. The entire quality management system that complies with ISO standards comes with it. You can use this manual for quick ISO certification. Also, it can act as a training material. You can train your organization for ISO certification with the help of this manual.

Closing thoughts…!

Don’t you agree that it is crucial for any manufacturing organization to develop a system that ensures quality? The ISO 13485 Manual exactly does the same for medical device manufacturers. Get ready to show commitment towards your customers by acquiring ISO certification.

How ISO 13485 Manual Satisfy Organizational Need?

The ISO 13485 Manual describes the quality management systems structure which has been implemented to meet the ISO 13485:2003 Medical devices – Quality management systems – Requirements for regulatory purposes.

The purpose of ISO 13485 Manual is to define and describe the quality system, powers and responsibilities of the management to define the operation of the system, and a general description of all processes that provide the quality system. This Manual is also used to present the quality of customers, suppliers, regulators and other external stakeholders, and to inform them about the specific checks that are performed in Services to ensure the quality of their system.

ISO 13485 Manual deals with the Quality System Regulation and the basic Good Manufacturing Practices require that all producers and distributors should consider when they plan to medical devices, including medical devices, kits, trays or packs, for manufacturing and distribution. The Quality System regulation outlines the minimum elements of a system for the design and manufacture of medical devices. Medical device manufacturers often find that their quality needs to be wider than meet these basic elements as a result of the additional need for Quality Company.

ISO 13485 Manual for Medical Devices also governs the creation of quality related documents. It will be revised, as necessary, to reflect the quality system currently in use. It is issued on a controlled copy basis to all internal functions affected by the quality system and on an uncontrolled copy basis to customers and suppliers. It may be issued to customers on a controlled copy basis upon customer request.

The management of any Organization is committed to implementing, and maintaining a documented quality system. This commitment includes: ensuring that customer, regulatory and legal requirements are understood and appropriately addressed, the quality policy is understood and implemented at all levels of the organization, quality objectives and plans are established as necessary and that the responsibilities of all functions affecting quality are clearly defined. In addition of this, the management Organization establishes annual key initiatives, which include quality objectives. The objectives are established via the Management Review Procedure and communicated to all levels of the organization for use in establishing each function’s and employees annual key objectives. Quality objectives are measurable, include business performance indicators reflecting requirements for products/services, and are consistent with the quality policy. Hence, on the basis of these necessary requirements ISO 13485 Quality Manual enables Management that will make provisions for the necessary resources and personnel to maintain the system, including a management representative, who will ensure that the requirements of this manual are met. Management will review the system annually to determine its effectiveness.