ISO 13485:2016
Medical Devices
Quality Management System

WHAT IS ISO 13485

When it comes to patient care, the medical field is quite delicate. The medical devices sector has its own set of standards, laws, and certifications that it must adhere to. Each step was taken to ensure quality, safety, and, most importantly, legal conformity.

The particular steps that medical device manufacturers must take are not spelled out in the ISO 13485 certification. Nonetheless, the certification ensures the public that rigorous standards are maintained throughout the production of medical equipment.

There are several advantages to adopting ISO 13485 for your company. Maintaining an ISO 13485 quality management system will require some more work up front, but the payoff is greater efficiency and happier clients.

HISTORY OF ISO 13485:2016

ISO 13485, the standard for quality management in the medical device industry, was released to the public in 1996. ISO 13485 was developed for the original makers of medical equipment, whereas ISO 13488 was created for the suppliers and contract manufacturers of such products because of the time commitment involved. In 2003, the version underwent change, and the papers were integrated into a single quality standard that could be applied anywhere. The year 2016 saw the last update before it was finalised.

The latest version of 13485:2016

ISO 13485:2016 is compliant with the requirements of ISO 9001:2008. This is due to the fact that the most recent version of ISO 9001 does not follow the high-level structure (Annex L) (which is 9001:2015). ISO 9001:2015 focuses on customer satisfaction and continual improvement, whereas ISO 13485:2016 prioritises the documentation and safety of a product.

More attention has been paid to risk in the latest version of ISO 13485, and the facility requirements, design and development requirements, supplier control, complaint management, etc., have all been improved. In addition, it lays down the standards for product cleanliness, facility upgrades, and the allocation of responsibility for training employees.

The Intent of ISO 13485:2016

Organizations that are involved in the conception, manufacturing, installation, and servicing of medical devices and services linked to them are the intended users of the ISO 13485 standard.

Moreover, both internal and external parties, such as certification organisations, can utilise it as a tool to assist them in the conduct of their auditing procedures. It guarantees the safe design, development, manufacture, installation, and delivery of medical equipment at every stage of the process, from the beginning to the conclusion of their useful lives. The importance of ISO 13485 lies not only in its implementation, but also in the fact that it provides a mechanism for conducting in-depth audits in order to determine whether or not the system is working effectively. It instills a greater level of trust in the manufacturer’s capacity to continuously achieve and maintain compliance with regulatory standards. It can also assist to avoid surprises and failures, both of which have the potential to have a negative impact on patient safety as well as the reputation of the manufacturer. Manufacturers may show their dedication to medical device safety and quality by adopting ISO 13485, which offers a realistic basis for addressing the EU Medical Device Directive (MDD) and the EU Medical Device Regulation (MDR), among other requirements.

ISO 13485:2016 Structure

1. Scope

The goals of a cutting-edge QMS for medical devices are laid forth in the scope, along with the system’s emphasis on process-based thinking and ongoing enhancements.

2. Normative References

Identifies the appropriate reference standards and documents, such as ISO 9001:2015.

3. Terms & Definitions

Related terms such as Active Medical Device, Advisory Notice, Customer Complaint and Sterile Medical Device with their definitions that are applicable to the standard.

4. General requirements

Describes the fundamentals of a well-documented ISO 13485 QMS, such as
• A comprehensive quality handbook with a defined quality management system scope
• Methods for Maintaining Records
• Documentation, logs, and standard operating procedures

5. Management responsibility

The role of ‘top management’: the top management team who are responsible for running the show. Leaders are responsible for ensuring the happiness and well-being of their clients and patients by using the following measures:
• Defined roles and obligations
• Management should conduct regular evaluations.
• Quality goals and policies that are easy to understand

6. Resource management

Methods through which your staff, equipment, and training must be managed and deployed in order to achieve your quality goals.

7. Product realization

Details the pre- and post-production steps needed to bring a medical equipment to market, including as
• Production and manufacture • Feedback collection and implementation
• Planning
• Design
• Purchasing
• Traceability

8. Measurement, analysis and improvement

Describes how to keep track of and evaluate your operations so that you may tweak and enhance them over time. Principal things to think about are:
• Auditing
• CAPAs
• Non-conformance control
• Measuring and maximizing customer satisfaction and patient/product safety

Requirements of ISO 13485

Medical equipment and services must be manufactured in accordance with ISO 13485:2016, which details the standards for a Quality Management System to ensure that these needs are always met. Unless where otherwise noted, the requirements of ISO 13485:2016 are universal and can be applied to organisations of any size or kind. Whenever a condition is stated to apply to medical equipment, it also applies to any related services provided by the company.

The ISO 13485 structure is split into eight sections, with the first three being introductory, and the last five containing the mandatory requirements for the Quality Management System. Here is what the five main sections are about:

Clause 4 – Quality Management System (“Intersection”)

In Clause 4, we focus on two subsets of a Quality Management System: General Requirements and Documentation Requirements.

General Requirements: The creation and execution of a Quality Management System is motivated by a small number of consistent requirements that may be applied to any ISO standard. ISO 13485 has its own set of criteria, which are as follows:
1. Honour the norm.
2. Record the pertinent information.
3. Keep doing what’s necessary.
4. Make sure the system you implement works and that you have written processes in place.
5. Think about the potential dangers of whatever you do.
6. Identify potential dangers and take measures to reduce them as much as possible, so as to avoid catastrophe.
7. Get a handle on the proper procedures for making your medical device, and keep to them.
8. Find a mechanism to monitor your progress, fix any problems you find, and produce documentation to prove everything is being done.
9. Identify the obligations to which you are subject by law, and abide by them.
10. Keep control of the job even if you have to outsource some of it.
11. Confirming the functionality of all systems utilised in your production processes is essential to ensuring that they do not disrupt operations in any way.

Documentation Requirements: A Quality Manual is an essential part of most quality systems. A company should decide what it will guarantee beyond the Quality Manual in order to create a setting and culture that is consistent with quality being prioritised in all they do. A policy or an aim statement can encapsulate this dedication. The standard has stringent standards that must be met in regards to both processes and documentation:

1. The development of a medical device must be supported by documentation detailing the item’s features and its recommended application.
2. Create a strategy for managing records.
3. Create a strategy for managing documentation.

Clause 5 – Management Responsibility (“Highway”)

Organizational leadership has to prove they care by proving they can be held responsible for day-to-day decisions. Manufacturers must respect all applicable regulations and prioritise the demands of their customers at all times. The quality policy must have the full backing of management, who must ensure it complies with applicable regulations in the nation of employment and disseminate the policy’s goals to staff. They need to be able to organise, give out responsibilities, and talk to others clearly. The Management Review is a regular audit of company operations and progress towards goals.

Clause 6 – Resource Management (“Roadway”)

The Quality Management System must be run in accordance with ISO 13485 and local regulations, and it is the responsibility of upper management to make this happen. ISO 13485 stipulates that upper management shall provide sufficient resources to carry out the organization’s promised job. The term “resources” is broadly defined to include things like “people,” “infrastructure,” “consumables,” “equipment,” “succession planning,” and ” This might be as narrow as managing the daily process to cut down on pollutants, or as broad as anticipating future retirements to guarantee uninterrupted operations. This may seem like a little commitment on the part of management, but it is mandated by Clause 6 and is essential to the company’s success in the medical device manufacturing industry.

Clause 7 – Product Realization (“Overpass”)

Each step along the way from ideation to actualization requires careful planning. In order to meet the standards of ISO 13485, Clause 7, it may be necessary to establish a system for recording the genesis of ideas, the validation of concepts, the design and development of goods, and their verification and validation. The device’s design and development can’t happen without open lines of communication.

The secret is to stick to the sequence: strategy, resources, output, review, verification, validation. It is essential for the execution of a product that ideas be transferred, the design be managed, revisions be documented, and all relevant information be kept. A system should define and keep tabs on supply, save vital information about each product, and provide a method for verifying the authenticity of these items.

Maintaining a clean environment, keeping tabs on installations, supplying the required maintenance, and meeting regulations unique to medical equipment are all part of a thorough quality assurance plan. Achieving product realisation also includes doing things like keeping track of machinery, fixing any problems that arise, and labelling each item correctly. Ultimately, maintaining ISO 13485 compliance may be aided by keeping an eye on things like product traceability, customer property management, and product storage.

Clause 8 – Measurement, Analysis and Improvement (“Bridge”)

You now have a responsibility to provide the consumers what they want since your product has been made and made available to the public. How do you get there then? The solution is straightforward: just ask for comments. In order to successfully monitor and measure product success, the following steps are required per Clause 8:

• Resolving Customer Complaints
• Notifying the proper authorities of what has happened
• being subjected to audits for in-house quality control
• Internal examination of processes and outcomes is ongoing
• identifying and managing items that fall short of the intended standard (nonconforming product)
• examining collected data to find ways to enhance the procedure

QUALITY PRINCIPLES OF ISO 13485:2016

To adopt process approach

Each member of staff is responsible for ensuring that all of the tasks they are assigned are completed in line with the standard’s procedures, job descriptions, workflows, and application instructions. In terms of making the most of limited means, this is crucial information to have. As a result of early detection of potential threats, prompt action may be done in the face of actual dangers, and unanticipated events can be avoided.

Customer-oriented

Companies that make the client their primary focus can never be caught off guard. Hence, it’s crucial to supply what the buyers want. Customers must be given priority in order to generate satisfaction and dependence, to rise to a higher position in the market, and to acquire an edge over rivals.

Promoting Involvement of Employees

One of the most important ideas is ensuring employee morale, and its base is engaging and raising the consciousness of all people. This theory is universally recognised as a fundamental tenet of effective management practises. If employees can’t work together, no one will feel responsible for resolving problems or take pride in solving them as their own. Those in the professional world, on the other hand, have to be accountable for their own results. Workforce are more productive and invested in their work when they feel they are making a difference for the organisation.

To embrace a method of continual improvement

To ensure the long-term success of the business, this guiding philosophy is crucial. Each worker is expected to contribute to the company-wide effort to constantly enhance the quality of products, procedures, and infrastructure. The company’s inability to be adaptable and quick to seize opportunities is a direct result. The ISO 13845 Medical Devices Quality Management System standard is based on this fundamental idea, which is shared by various quality management frameworks.

Approaching decision making with realism

Businesses are held to a higher standard in which decisions are expected to be grounded in facts and logic. Avoiding this course of action may prevent an undesirable outcome. Hence, using and analysing all data generated from the operations is vital for an organisation to make proper and effective judgements.

Know all about ISO 13485

  • Advisory Notice – notice issued by the organization, subsequent to delivery of the medical device, to provide supplementary information or to advise on action to be taken in the use of a medical device, modification of a medical device, return of the medical device to the organization that supplied it, or destruction of a medical device.

Note: Issuance of an advisory notice can be required to comply with applicable regulatory requirements.

  • Medical Device – An article, instrument, apparatus or machine that is used in the prevention, diagnosis or treatment of illness or disease, or for detecting, measuring, restoring, correcting or modifying the structure or function of the body for some health purpose. Typically, the purpose of a medical device is not achieved by pharmacological, immunological or metabolic means*.
  • Active Medical Device – An active medical device is a device that-to operate-uses and converts energy in a significant way. For a device to be an active device, the form of energy does not include gravitational or directly provided human energies.
  • Medical Equipment – Medical equipment means equipment used in a patient care environment to support patient treatment and diagnosis. Medical equipment manufacturers range from businesses that produce basic supplies like bandages, forceps, scalpels, and gloves to those that do cutting-edge research and create sophisticated apparatus like surgical robots, CAT scans and MRI machines.

Mandatory Documentations for ISO 13485:2016

Download PDF For Complete Documentation

  • 1. Functions performed by the entity to satisfy relevant legislation
  • 2. Documentation and process for verifying software use claims
  • 3. Guide to Excellence in Quality
  • 4. Registration of a Medical Device
  • 5. Methodology for Keeping Tabs on Paperwork
  • 6. Methodology for Maintaining Records
  • 7. Strategic Approach to Quality Assurance
  • 8. Aims for Quality
  • 9. Authorizations and Duties
  • 10. Management review process documentation
  • 11. Instructional Methods
  • 12. Prerequisites for building upkeep and repair
  • 13. Prerequisites for the Office Setting
  • 14. Plans for the management of potentially hazardous materials
  • 15. Methodology for Managing Dangers During Product Development
  • 16. outcomes of product realisation planning
  • 17. Documentation of the Customer Requirements Review and Any Further Actions
  • 18. Planning for interaction with clients
  • 19. The Design and Development Process
  • 20. Preliminary Design and Development Scheduling

The QMS documentation is there to make sure that the most important procedures are well-understood and can be carried out exactly the same way every time. For this to succeed, the requisite procedures should be as straightforward and straightforwardly explained as feasible. In many cases, a graphic flow chart is all that’s needed to clearly and concisely convey the necessary details. Having straightforward documentation for procedures makes it simpler to train and test workers to consistently provide high-quality results.

ISO 13485:2016 Standard Process

Steps To Obtaining ISO 13485 Certification

It is a simple process to have yourself certify as ISO 13485 certified. To initiate, follow these steps:

1. Quality plan – For certification to be achieved, you must initially create a quality plan that conforms to the standard’s specifications. Arrange the workflow of your quality system, identify the necessary responsibilities, and assign people to them.

2. Target markets and compliance – locate the markets where you intend to sell your medical devices and ensure that they are in line with local laws.

3. design controls execution- Establishing and documenting design controls at the earliest feasible stage in product development is essential.

4. Control over documents – In order to keep the QMS up-to-date and in accordance with ISO 13485 standards, your team should be trained to adhere to a unified and consistent procedure.

5. CAPA system – The CAPA process, along with Design Controls, is the backbone of your QMS. Make sure you have well-defined and effective CAPA processes in place.

6. Arrange for Notified Bodies to Conduct Audits – Notified Bodies are responsible for conducting audits of medical device manufacturers to ensure they are in line with ISO 13485. Audits for certification are performed in two phases, with the second phase requiring producers to demonstrate complete compliance with the standard.

Benefits of ISO 13485

The ability to enter new markets is the certification’s most obvious practical value. Without this accreditation, the firm cannot legally sell its goods or even function in the medical device industry in most countries. The biggest obstacle to entering a market is generally something like this.

Besides the most apparent advantage, firms having ISO 13485 certification can also:

1. Enhance the credibility of an organization and identity

In terms of quality control in the medical device sector, the ISO 13485 certification is the gold standard. Customers can be certain that they are receiving a product of the highest quality thanks to this certification, which also notifies them that the company has a quality assurance standard in place.

ISO 13485 certification is vital for medical device makers to demonstrate quality and safety, and it also serves as a potent marketing tool for any business.

2. Decision-making based on evidence

The company’s dedication to quality has been validated by ISO 13485 accreditation. Management receives data on a consistent basis, which they may utilise to make choices that are more in line with the company’s long-term objectives.

There will be consequences if management notices a lag in attaining the targets.

3. Continual improvement

One of the tenets of ISO quality management systems is the continual improvement. The adoption of a QMS causes a shift in perspective amongst an organization’s leadership and workforce, who now actively seek for ways to enhance operations.

High performance, strategic leadership, and employee engagement may all result from the implementation of systematic procedures that are designed to limit the occurrence of errors and the volume of labour required. It in turn means better final results for consumers.

4. Boost involvement of employees

Employees are better equipped to play their part in ISO 13485 implementation when processes are well-documented and controlled. Employees are overjoyed when they are given the opportunity to contribute to the company’s success by looking new ways to improve existing procedures.

Employees are more invested in the company when they feel they have a meaningful role to play. Because of this, productivity and efficiency are improved.

5. Satisfaction of customers

The pursuit of 100% customer satisfaction is key to the ISO 13485 implementation process. Customers have more trust in businesses that have earned the ISO 13485 standard certification. Customers have high expectations since they know the organisation has a solid quality management system.

Relevant Industries For ISO 13485

Medical device developers, factories, and retailers can all benefit from ISO 13485 certification. Moreover, certification can increase a company’s marketability because more and more manufacturers are insisting on it as a prerequisite for doing business with a supplier or service provider.

ISO 13485 is the worldwide standard for quality management systems (QMS) in the medical device industry. It specifies the minimum standards for a QMS in these fields.

The MDR 2017/745 mandates that all businesses operating inside the European Union have a Quality Management System (QMS) that is ISO 13485:2016 certified. Companies that fall under this category include:

  • Manufacturers of Medical Devices– producers of all devices specified under Annex XVI of the MDR, which includes both in vitro diagnostic and medicinal devices.
  • Developers of healthcare technology, especially software used in medicine
  • Manufacturers of medical equipment
  • Parts and component makers for medical devices, as per Article 23 of the MDR and Article 20 of the In Vitro Diagnostic Medical Device Regulation
  • Installers, repairmen, and maintainers of medical equipment
  • Distributors and importers in the European Union who perform similar tasks to manufacturers

FUTURE of ISO 13485

Predicting what the future version of ISO 13485 will entail is always challenging. This relates to the Quality System’s emphasis on preventative measures. The current placement of preventative activities in ISO 13485’s last chapter is, to be frank, a little unusual, given that these actions are fundamentally connected to the QMS risk-based approach that serves as a foundation of ISO 13485:2016.

Take ISO 9001:2015 as an example, where preventative activity has been all but eliminated. Each and every quality management system should use a risk-based approach, and preventative measures are an integral element of this strategy.

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