Key Advantages of ISO 13485 MDQMS

Medical devices and related service quality management systems are governed by ISO 13485 standards. The International Organization for Standardization is the publisher. ISO 13485 addresses:

• Quality assurance
• Risk Control
• Adherence to the law
• Efficiency in operations
• Capacity to track and retrieve goods and equipment
• Improvement of procedures and goods

Pharmaceutical and medical device companies can obtain ISO 13485, a quality management system certification, which is evolved from ISO 9001. It covers specific requirements that make applying certain of the ISO 9001 requirements challenging. Organizations that manufacture medical products and associated services can benefit greatly from ISO 13485 since it guarantees quality commitment, boosts productivity, and expands clientele. Additionally, certification can lessen production lag, product liability, and impediments to international markets. The most recent revision was released in February 2016.

The Advantages of ISO 13485

Companies that have adopted ISO 13485 report various advantages. Due to the certification’s potential financial benefits, many businesses pursue it. Their dedication to producing high-calibre medical equipment is demonstrated by the certification. As a result, companies can draw in more customers than before.

Among the most desired advantages are the following:

• Agreement with Bigger Businesses: Large medical device companies often have a preference for working with ISO 13485-certified vendors. The 2016 upgrade has increased demand for certification. The changes state that large corporations are now responsible for ensuring that all subcontractors adhere to ISO 13485 standards; subcontractors that currently possess this certification are likely to be given preference.
• Show Your Commitment to Excellence: ISO 9001 and ISO 13485 are regarded as markers of an organization’s dedication to quality. Getting a quality management accreditation shows customers and authorities that your company values quality.
• Increase Possible Market: International medical device standards like ISO 13485 and ISO 9001. The ISO 13485 standard is created to ensure that medical devices in different places demonstrate reality and quality. If you are taking into account the exporting the products the ISO 13485 can give the advantage.
• Win More in Business: Many corporations seek to collaborate with medical device organizations that hold ISO 13485 certification, and some demand that their partners hold this certification as well. This is partly because, as of the most recent version of ISO 13485, corporations have to guarantee that any subcontractors they engage with meet the requirements of ISO 13485. Gaining more business is made possible by ISO 13485 certification due to these preferences and criteria.
• Make It Easier to Obtain ISO 9001 Certification: Numerous companies are certified to both ISO 9001 and ISO 13485 standards. If your business is currently accredited under ISO 13485, the process of becoming certified to ISO 9001 is considerably easier. The requirements of these two standards are largely compatible. While several standards pertaining to business terms are not covered by ISO 13485, you will have previously finished most of the work with ISO 9001.
• Assist Staff in Obtaining Relevant Data: The ISO 13485 documentation requirements are made to make sure that every member of a development team always has access to the data they require, which can cut down on the time and costs involved in developing new products.
• Increase and Strengthen Your Business Knowledge: Additionally, we hear from clients that by recording the procedures related to their medical devices, the company may create a centralised knowledge base. This information can be used to pinpoint issues, enhance the final product, and expedite the production process. It also facilitates the onboarding process for new hires.

Difference Between ISO 9001 and ISO 13485

ISO 13485 and ISO 9001 are both quality management systems for the general industry, with ISO 9001 focusing on customer satisfaction through high standards. However, they differ in their focus on the safety and efficacy of medical devices. ISO 9001 is more focused on customer satisfaction and aligns with regulatory standards, while ISO 13485 is more closely linked to safety and efficacy, requiring more extensive documentation. Companies that manufacture both medical devices and other products may want to maintain both certifications.

Specific requirements and elements of ISO 13485 are as follows:

• Extra precautions to avoid contamination
• Monitoring centred on achieving customer needs as opposed to arbitrary metrics of customer satisfaction
• The Necessity for several documents at every stage of the product development process
  Instead of concentrating on continual improvement as mandated by ISO 9001,
• Concentrate on preserving the effectiveness of the quality management system.
• Managing risks during the design and production phases
• Extra requirements for recalls, advisory notices, and regulatory reporting

ISO 13485: Audit Criteria and Certification Process

ISO 13485 is a globally recognised standard that defines the standards for a quality management system (QMS) in the medical device industry. It specialises in the design, development, production, installation, and maintenance of medical devices and related services. ISO 13485 is based on the ISO 9001 standard; however, it adds some sector-specific features. The standard prioritises regulatory compliance, risk management, and process control for medical device design, production, and distribution.

What is the ISO 13485 Certification?

ISO 13485 certification demonstrates that the certified company has implemented appropriate, independently inspected processes and controls to assure the safety, efficacy, and quality of medical devices throughout their lifecycle. This includes process control from design and development to manufacture, installation, maintenance, and end-of-life. To acquire ISO 13485 certification, an organization must establish an internal QMS process that meets the standard. After implementing the QMS, a recognised certification authority conducts a full audit of the company. The audit evaluates the organization’s compliance with ISO 13485 regulations and the efficacy of its QMS.

What is the ISO 13485 Audit Criteria?

Here are the primary ISO 13485 audit criteria:

• Document Review: The auditor evaluates the organization’s QMS documentation (policies, procedures, work instructions, and records) to determine that it satisfies ISO 13485 requirements.
• On-site Audit: The audit is designed to evaluate the described system’s implementation and effectiveness as a standards-compliant QMS. It assesses processes, procedures, and records, as well as conducts interviews with employees to ensure their comprehension and participation.
• Process Evaluation: All processes must be documented, managed, and ISO 13485 compliant. This comprises all stages, including design and development, risk management methods, supplier management techniques, and other relevant processes.
• Regulatory Conformity: The audit certifies conformity with regulatory requirements, such as those set by the FDA in the United States or the Medical Devices Directive in the European Union.
• Noncompliance and Corrective Actions: Any audit deficiencies must be identified and resolved. The non-compliant components will then have to be re-audited. The organization’s process for addressing these issues may also be evaluated.
• Management Review: Auditors examine top management’s internal QMS evaluation and improvement strategies.

ISO 13485’s Audit and Certification Process

The ISO 13485 auditing and accreditation process typically includes the following steps:

• Preparation: The applicant must create and implement a QMS that meets the standards. This often needs a significant cultural transformation within the firm. This need support from the entire organization.
• Documentation: The applicant team must document how their QMS meets the standard. This necessitates comprehensive policies, processes, work instructions, records, and other documents.
• Internal Audit: This is used to test initial compliance. Members of the applying organization frequently execute this task to assist the complete company in preparing for the certification audit. This internal audit identifies any shortcomings so that the organization can enhance internal processes before to the actual audit.
• Certification Audit: A certified certification organization is invited (and paid for) to audit the company’s quality management system. The first stage of the audit focuses solely on ISO 13485 documentation; auditors analyse the company’s plan and processes to ensure that it conforms with ISO 13485 on documents. This document assessment is supplemented by internal interviews to determine readiness for the stage-two audit and, if necessary, establish a corrective action plan. Stage two audits evaluate the operational effectiveness of the QMS after any initial corrective actions have been undertaken. This comprises additional interviews and, in most cases, an on-site inspection to ensure compliance and check quality records.
• Nonconformity Management: Any feature that auditors identify as lacking is deemed a nonconformity. To acquire certification, the company must take corrective actions.
• Certification Decision: When an organization is found to be in comply, it is granted ISO 13485 certification.   
• Surveillance Audits: A certification authority conducts these on a regular (usually annual) basis to ensure that the organization’s QMS is still operating by ISO 13485 standards.

How to Perform an ISO 13485 Management Review Within the Organization?

The ISO 13485 standard addresses the management review procedure in requirement 5.6. It entails assessing the applicability and efficacy of the quality management system, finding areas for development, and adjusting the system as necessary. Encouraging QMS improvement and preserving standard compliance depend heavily on the ISO 13485 management review procedure.  

The goal of the ISO 13485 management review is to find areas for improvement while assessing the applicability and efficacy of an organization’s quality management system. In this phase, required inputs including audits, regulatory reporting, and customer feedback are reviewed, and the Quality Management System is adjusted as necessary. Organizations can use the supplied data to drive QMS improvement and increase customer satisfaction by appropriately completing an ISO 13485 management review.

A planned interval management review is necessary to guarantee the continued acceptability, sufficiency, and efficacy of a QMS built on ISO 13485. It must also comprise an evaluation of the QMS’s potential for modification and enhancement. Lastly, as proof of compliance, ISO 13485 documents of the management review must be preserved. So here are some of the ISO 13485 management review inputs:

Feedback and compliance management: This is typically a review of data and metrics that are closely tied to product performance, customer experience (e.g., metrics related to customer complaints, customer survey results), and ongoing, product-specific continuous improvement initiatives.

Reporting to regulatory authorities: The organization must examine both the reasons for reporting and the ISO 13485 procedure it uses to submit information to the regulatory bodies.

Audits: Does the management representative of the company go over the ISO 13485 audit reports and make sure they are incorporated into the annual audit plan? If so, a member of management is in charge of examining the audit findings and how they enhance the management system. If the audit reports contain the review data, they are records of the management review as well as the audits.

Monitoring and measurement of processes: Does your organization maintain metrics for its primary processes, also known as key performance indicators (KPIs), which are used to assess how adequate the procedures are? Management review is occurring if these KPIs are set up, examined by upper management, and utilized to decide how best to allocate resources for process enhancements.

Corrective and preventive action: Every corrective action does not need to be reviewed by the upper management. Instead, they should be aware of the patterns in nonconformity incidents and the efficacy of the actions done to specify improvements.

Follow-up from previous management review: If the previously listed steps are followed up on to make sure they were carried out, these criteria are fulfilled. To make sure of this, it is best to go over the minutes of the most recent ISO 13485 management review meeting. Making sure that the records reflect this follow-up examination is crucial.

Changes that could affect the QMS: The company must monitor external factors, such as the latest ISO 13485 standard version, that may have an impact on the system. Reviews of internal data will also cover modifications made within the company, like audits or suggestions for enhancement.

Recommendations for improvement: As mentioned above, some suggestions for enhancement, like those from the internal audit, can be handled as part of that system. Additional suggestions, such as those gleaned from an employee suggestion system, are often documented in a verifiable log.

Applicable new or revised regulatory requirements: Regulation changes that may affect the QMS and/or the business must be communicated to the higher levels of management.

Know the Necessity of Having an ISO 13485 Quality Policy

ISO 13485 Certification is the universal standard for the establishment and maintenance of an archived quality management system in the medical device industry. If a manufacturer has followed the ISO 13485 Standard, it will have a place where it can ensure local medical regulations, such as the EU Medical Device Directive (MDD), the Medical Device Regulation (MDR), the US FDA 21 CFR 820, and other guidelines that demonstrate a commitment to the quality and security of medical devices.

One of the first things a company should create when developing a Quality Management System (QMS) for a medical device manufacturing business is the Quality Policy (requirement 5.3), as per ISO 13485:2016. Many might be wondering what this ISO 13485 Quality Policy entails and why the QMS needs it. The organization’s overall purpose should be defined in the ISO 13485:2016 policy, which is drafted by senior management to guide all staff members about the development and delivery of medical devices to patients.

Important Components of a Quality Policy in ISO 13485:

• Make the policy meet the needs of the company
• Establish a structure for defining organizational quality goals
• Demonstrate a commitment to complying with all requirements
• Determine management commitment
• Implement the Quality Policy
• Maintain a frequent assessment of the Policy

The goal of this high-level policy is to ensure that all employees are aware of it and can follow it, providing a single strategic direction for requirements fulfilment and product development. After that, a company’s commitment to quality can be used across the entire organization to lead its quality objectives—the primary goals for improvement that it intends to accomplish—and to keep an eye on how its processes are carried out.

A manufacturer of medical devices must have a Quality Management System which incorporates the ISO 13485 policy. It outlines the organization’s dedication to quality and adherence to legal obligations and acts as a guide. To comply with ISO 13485, a quality policy must have the following components:

1. Commitment to compliance: Medical device regulations, standards, and guidelines should be emphasized in the policy as well as the organization’s commitment to complying with the standard.
2. Customer focus: The policy should demonstrate how committed the company is to satisfying customers and fulfilling their needs.
3. Risk management: The organization’s dedication to recognizing, evaluating, and controlling risks related to the creation, manufacturing, and distribution of medical devices should be covered by the policy.
4. Continuous improvement: The organization’s dedication to continuously enhancing its processes, products, and Quality Management System via objective measurements and data analysis needs to be highlighted in the policy.
5. Employee competence: The policy should emphasize the value of employee competency and offer a structure for guaranteeing that staff members have the abilities, know-how, and education required to carry out their duties efficiently and effectively.
6. Documented processes: The necessity of documenting processes and procedures to guarantee uniformity, traceability, and efficient internal communication should be addressed in the policy.
7. Monitoring and measurement: The policy should specify how the company plans to track, measure, and examine key performance indicators to assess the QMS’s efficacy and promote ongoing development.
8. Management responsibility: The policy requires to specify precisely what the top management’s tasks, duties, and authority are when it comes to creating, putting into practice, and overseeing the Quality Management System.
9. Supplier management: The organization’s methods for choosing, assessing, and keeping an eye on suppliers to guarantee the quality and safety of goods and services acquired should be covered by the policy.

Through the integration of these components into the ISO 13485 policy, entities can exhibit their dedication to manufacturing secure and efficient medical devices that satisfy both regulatory mandates and patient expectations.

Most Efficient Way to Comply with ISO 13485’s Requirements for Medical Device Infrastructure

Any company cannot operate its operations without an infrastructure, which is required for the production, design, or supply of any good or service. Buildings, offices, utilities, machinery, tools, computer systems, and transportation systems are all examples of infrastructure. Similarly, all businesses engaged in the production or distribution of medical devices are obligated to keep an effective framework in place that guarantees product quality at the level necessary for client satisfaction.

Organizations have to maintain an infrastructure that guarantees product conformance and quality according to ISO 13485:2016. Preventing product mix-ups and maintaining efficient order management of products are two crucial goals of ISO 13485:2016 infrastructure requirements. According to ISO 13485:2016 standard, infrastructure is used “to achieve conformity to product requirements.” According to the standard, infrastructure entails:

• Buildings, workspaces, and associated utilities – The structure that offers space for product manufacturing and, ultimately, storage is included in this. Workspaces are designated places within a building where various operations can be carried out in isolation, and utilities such as electricity, gas, water, sewage, and internet connections are included as accompanying services. Consequently, a medical device company must maintain an infrastructure that includes all utilities, structures (necessary for efficient operations), and workspaces (examples of workspaces in such industries include raw material stores, heat treatment areas, assembly areas, finished goods stores, etc.).
• Process equipment (both hardware and software) – The following comprises the machinery that makes up the process equipment as well as the software that powers it—the programs that control those components. Therefore, medical device manufacturers must keep up with the necessary hardware (for machining the forged component) and G-codes (software saved for all item codes) to satisfy production plans.
• Supporting services (such as transport, communication, or information systems) – The term “supporting services” refers to all of the equipment required for communication, transportation, or information systems. Conveyor belts, forklifts, cargo lifts, and other forms of transportation that are used to move raw materials, finished goods, or in-process goods are referred to as transport services, and they must be kept in working order by medical device makers. Similar to this, they must keep up with services like maintaining ISO 13485 documents, email systems, and message-delivery ERP systems that are necessary for interdepartmental communication.

The most recent standard includes a further requirement that businesses maintain the infrastructure to avoid product mix-ups and guarantee the processing of items in an orderly way. Information systems have also been introduced to the infrastructure’s supporting services division. The requirements can be totalled up as follows:

1. Document infrastructure requirements – To assure product quality, prevent mixing between various lots, batches, and other products, and ensure the efficient handling of customer orders, the organization is necessary to document all infrastructure needs. An efficient ERP system that manages product stocks, client orders, product labelling, and inspection and manufacturing status can help with this. Physically, the production lots are accompanied by an ERP-generated production card. The production operator updates the physical production card at each manufacturing stage, along with the status update in the ERP system, and then the manufacturing lot moves on to the following manufacturing activity.
2. Identify maintenance activities that could affect quality, and maintain records – Any maintenance conducted on processing equipment, whether it be hardware or software, must be identified, documented, and managed at specific intervals.  
3. Provide the infrastructure needed to control the work environment – A controlled work environment is necessary to guarantee the quality of the finished product. Therefore, it is necessary to identify and provide the equipment that will be utilized to monitor and maintain the environment.
4. Provide the infrastructure for monitoring & measurement – At the time of inspection, all equipment utilized to monitor and gauge the quality of the product should be noted and available. These devices must be calibrated both within and externally to ensure their effectiveness.

Comprehend the ISO 13485 Quality Management System for Medical Devices’ Plan-Do-Check-Act Cycle

The ISO 13485 standard was created for regulatory compliance even though it is based on the “Plan, Do, Check, Act” concepts from the ISO 9001 process model. As a result, some of the inappropriate ISO 9001 criteria are not included in ISO 13485, which instead includes specific requirements for organizations involved in the life-cycle of medical devices. Because of this, it becomes more prescriptive and necessitates a QMS with more extensive documentation. Here, describe how the PDCA improvement cycle is applied to the QMS; brackets indicate which clause numbers of the standard are relevant.

Plan – The development of quality objectives and the quality system, which will ultimately be used to monitor the QMS and its operations, is one of the most crucial components of the QMS. The commitment of the leadership to develop a quality policy and specify organizational roles and duties will follow next. This will help the organization become more customer-focused. The next step is to identify the risks and opportunities present in the QMS and take appropriate action to address them. After that, quality goals are created, and improvements are planned to support ongoing improvement. Each plan must be kept maintained in ISO 13485 documents as a long-term reference. This phase’s final step is to decide on and put into place the framework that will enable the organization to carry out its plans. This framework will include processes for resource planning, competency identification, awareness-building, communication setup, and the creation and management of necessary documentation.

Do – If the organization doesn’t execute these plans, all of their preparation is to waste. Both product and/or service requirements and operational controls must be established for the QMS. For any goods, services, or procedures that are given by a third party, designs must be created and controls must be put in place. Any non-conformities in products or services must be addressed, and the production process must be set up with controls for their release. In conclusion, every task necessary for the development and delivery of goods and/or services to the clients must be accomplished.

Check – The standard specifies the necessity to evaluate the QMS processes to make sure they are operating as intended in several requirements. This will entail keeping an eye on, measuring, analyzing, and assessing the goods and/or services to make sure they adhere to specifications, that processes are appropriate and efficient, and that customer service objectives are met. An internal audit of the QMS’s procedures is a crucial way for evaluating its performance. In addition, a management assessment of the data gathered should be carried out to find any problems and make any necessary modifications.

Act – Any problems that might have come up during the Check stage should be addressed right now. The goal is improvement, thus addressing nonconformity through corrective and preventative measures to avoid and remedy nonconformities must be part of the action phases.

Yes, a cycle has now been finished here, and it’s time to ready to begin again and put strategies in place to assure further advancement. The results of the internal audit during the Check phase might have called for taking action during the Act phase. If so, the organization will need to make adjustments during this Plan phase to satisfy the revised specifications in the subsequent Do phase. The management review will consider the findings of the internal audit as well as any corrective measures implemented to offer planned resources to support the required improvements. Each time business demands change, resources will be re-evaluated and then raised, diminished, or redistributed.

How to Handle Process Validation Using the ISO 13485 Standard in the Medical Device Manufacturing Sector?

ISO 13485 allows organizations, specifically medical device manufacturers, to connect their quality management system (QMS) with medical device industry requirements. ISO 13485 offers significant benefits to organizations that manufacture medical equipment and related services. It ensures a commitment to quality and enhances organizational efficiencies.  

Manufacturing facilities for medical devices use industrial processes to transform raw materials into semi-finished products and finished products into semi-finished products. To show that the industrial process has generated an output that satisfies the required specifications, the results are validated by an inspection or some present quality tests. What should we do with processes whose results cannot be verified? is a pertinent question. Process validation is the answer to this issue. Therefore, clause 7.5.6 of ISO 13485:2016 requires organizations to verify those processes for which verification is not feasible.

Validation demonstrates the ability of industrial processes to consistently produce the desired outputs. Processes that are 100% product output inspected by the organization or that fully validate process outcomes using a sound statistical justification can obviate the need for validation. Organizations are required by ISO 13485:2016 to certify processes like sterilization and sterile barrier systems as well as computer software that is utilized in the manufacture or service of medical devices.

Management of process validation by ISO 13485

An organization can ensure that the procedures can consistently generate the desired outputs by undertaking validation. Organizations are helped by ISO 13485 since it requires the following:

Identify processes with unverified outputs: Identifying procedures whose outcomes cannot be confirmed is the first step for organizations to validate their processes. The company must establish a list of these ISO 13485 procedures where verification is difficult.

Document procedures for validation of processes. A procedure explaining the validation of processes should be documented by the organization, along with clear roles and responsibilities. By including a criterion that details the validation program’s evaluation and approval process, an organization can record a procedure. The equipment qualification, also known as installation qualification, verifies that the equipment is in compliance during installation and is accomplished with the aid of certified specifications from the equipment manufacturer. The initial certification of the machinery for the delivery of essential services. Personnel qualification, practical performance evaluations, and other measures ensure that the operators who are responsible for operating the equipment are well-qualified. Any personnel with ISO 13485 training online certification, can manage and fulfil this requirement.

Procedures for validating software should be documented: The organization should develop a procedure with clear roles that outlines the validation of computer software used in the creation of medical devices and associated services. Depending on the level of risk that could have an impact on the product’s capacity to satisfy the required requirements, the procedure may involve the frequency of software validation. All of the procedures must be included in the ISO 13485 documents for future reference. As well as records of the software validation results, along with the conclusion and, if necessary, follow-up activities from the validation, must be kept.

Procedures for validating sterile barrier and sterilization systems should be documented: The organization needs to create a procedure with clear roles and instructions for validating sterilization and sterile barrier systems. A sterile barrier system shields sterilized medical devices from biological agents while they are being packaged, stored, and distributed. Sterilization is the process of eliminating biological agents from medical devices. Before starting the process or making any modifications to it, both of these processes need to be validated. The ISO 11607 standard (Packaging for terminally sterilized medical devices) stipulates test procedures for components, sterile barrier systems, and packaging systems intended to keep medical equipment sterile up to the point of application.  This means that the process must also comply with ISO 11607 to provide reliable validation of sterile barrier systems. Records of validation tests (such as burst tests, dye penetration tests, gross leak detection tests, and seal strength tests) must be kept for both sterilization and sterile barrier systems.

Process validation – Regulation for medical device manufacturers

Process validation is essential for companies that produce medical devices and is regarded as a separate discipline. Process validation, identifying the processes where verification cannot be performed, procedures impacted by computer software in production, and sterilization and sterile barrier systems are all particularly mandated by ISO 13485 standard. Process validation enables businesses to eliminate risk in the creation of delicate goods and essential value-added services like software and sterilization.

Process validation enables organizations to guarantee that processes run efficiently and don’t result in poor outcomes. As a result, validated processes have trained staff, trained equipment, process parameter controls, and enhanced record-keeping procedures. Manufacturers, suppliers, and customers are given the essential assurance to maintain the business cycle by the fulfilment of ISO 13485 process validation standards.

Understand the Documents Specifications of the ISO 13485 Standard for QMS – Medical Devices

The ISO 13485 standard quality management system (QMS) criteria are a globally accepted set of guidelines for any business engaged in the design, manufacture, distribution, installation, and maintenance of medical devices. The first edition of ISO 13485 was released in 1996, and updates followed in 2003 and 2016. The most recent version of the ISO 13485 standard, becomes applicable in March 2016. These specifications are meant to guarantee that medical products and services constantly live up to consumer expectations as well as pertinent legal and regulatory requirements.

With the help of the ISO 13485 standard, organizations may create safer and more cost-effective workplaces while also removing any potential legal issues. Because ISO 13485 is an internationally recognized standard of quality and safety for the manufacturing of medical equipment, having it helps firms be perceived as more dependable, trustworthy providers. However, many businesses begin creating the ISO 13485 Documents before beginning implementation in the organization to gain an idea of what truly needs to be done and how to accomplish it. So, to assist everyone to understand the ISO 3485 standard better, here are a few of the necessary ISO 13485 documentation requirements:

For every implementation process, documentation of ISO 13485 QMS for medical devices is crucial. The purpose of documentation should be to specify processes and keep the records necessary to prove they are being followed. Objective evidence requires documentation. Provide your staff with unbiased help while they design, develop, produce, and maintain medical devices. proof that can be objectively used to prove that requirements are being met One of the most significant core components of a QMS is the establishment of comprehensive yet practical document management practices for your company.  

Quality Manual: The quality handbook is a vital component of your quality management system. Making a lengthy policy-level document that deconstructs various sections of ISO 13485 and provides a high-level overview of how the medical device business treats the clauses is the typical method for achieving this need for a quality manual. This method is appropriate. The following requirements must be met by the quality manual:

• Describe the scope of the QMS. Include any clauses that are avoided or non-applications that are justified.
• Identify or include the QMS processes in the procedures.
• Describe the methods by which QMS processes interact.
• A brief description of the QMS documentation’s structure.

Medical Device File: Each type or category of a medical device must have its medical device file. A medical device file’s material must consist of:

• Description of the product, including intended use and indications for use.
• Product labeling and instructions for use.
• Specifications for the product.
• Specifications and procedures for manufacturing, inspection, labeling, packaging, storage, handling, and distribution.
• Measurement and monitoring specifications.
• Conditions and procedures for product installation (if relevant).
• Actions for product servicing (if relevant).

Document Control: Documentation is an essential component of a quality management system. A document control procedure must establish as per the company’s document control criteria. This includes ensuring that papers are evaluated and approved before implementation, methods for revising documents and recognizing changes, and ensuring that current versions are available at the point of usage.

Control of Records: Strict limits are needed for records as for documents. Additionally, there are situations when the difference between a document and a record can be a little unclear. Records serve as proof that specific procedures were followed. There are other notes on records scattered throughout this manual. Regarding review and approval, the same kind of requirements are applied. However, records are usually not versioned.

Six Common Mistakes That Avoid While Implementing ISO 13485

ISO 13485 is a standalone QMS standard evolved from the ISO 9000 quality management standard series. ISO 13485 is a process-based paradigm for a regulated medical device manufacturing environment that adapts the previous edition of ISO 9001, ISO 9000:2008. While ISO 13485 is based on the ISO 9001 process model concepts of Plan, Do, Check, and Act, it is intended for regulatory compliance; thus, it is more prescriptive in structure and requires a more fully documented QMS.

ISO 13485 was created to assist medical device manufacturers in developing a quality management system (QMS) that creates and maintains the efficacy of their operations. It assures the consistent design, development, production, installation, and distribution of medical devices that are safe for their intended use, all the way through to disposal. Six mistakes to avoid when executing the ISO 13485 standard are listed below.

• The Checkbox Impact: It is normal in today’s culture to consider repetitive duties like a to-do list; do a work assignment, check the box, and move on to the next activity. Unfortunately, when it comes to establishing ISO 13485 processes to achieve compliance, device makers have adopted a checkbox mentality. When manufacturers begin implementing ISO 13485, they should employ a comprehensive approach that prioritizes quality from the start. This strategy will aid in the establishment of a foundation and company culture based on quality standards throughout the whole organization, as well as all future operations and regulatory processes.
• Insufficient Internal Auditing: Another step that causes many errors for manufacturers and is frequently viewed as a checkbox activity is internal auditing. Internal audits should be undertaken at least once a year. This method enables organizations to examine their document management, CAPA protocols, and other critical systems to ensure that activities and functions are functioning properly. Internal audits must be viewed as a significant opportunity for product and process improvements and upgrades.
• Failure to consider Risk-Based Processes: The ISO 13485 standard lays a strong emphasis on the use of risk-based procedures. The standard requires producers to think about whether they adequately analysed risk after finishing any procedures or tasks. With different levels of risk in medical device development and quality assurance, manufacturers must document and link every part of a risk assessment to their Risk Management File. From here, all files may be managed effectively and granted a proper score, which cannot be ticked off casually. When implementing a complaint-handling process, the risk-based approach is equally critical. If such a mechanism is not in place, operations can swiftly succumb to “passing by CAPA.”
• Ignored CAPA Processes: Corrective and preventive procedures made by manufacturers to address problematic occurrences such as systemic issues and quality events are referred to as CAPA. To guarantee proper application, manufacturers must build a solid knowledge of these principles. Unfortunately, many firms have poorly defined processes in place or misunderstand these words, which can lead to additional errors and long-term issues. Here are the classifications according to ISO 13485:
  • Corrective Action: eliminates the cause of nonconformities to prevent a recurrence.
  • Preventive Action: eliminates the causes of potential nonconformities to prevent their occurrence.
• Auditors are likely to go into the details of the business, specifically a company’s CAPA procedures, to ensure full compliance with the methods and instruments being employed. However, don’t rush through the process of developing efficient CAPA procedures inside the quality system.
• Management has not been reviewed: According to ISO 13485, management reviews are required. These audits are designed to guarantee that procedures are properly conducted and followed from the top down. However, because of the amount of documentation needed, many manufacturers have overlooked or missed this step. The ISO 13485 standard, Section 5.6.2, provides a list of inputs that medical device businesses should evaluate during management reviews, which includes:
  • Results of audits
  • Customer feedback
  • Process performance
  • Product conformance
  • Status of corrective and preventive actions
  • Follow-up on previous reviews
  • Changes that could impact quality systems
  • Improvements
  • New regulatory requirements

• Any organization with bad ISO 13485 documents will struggle to conduct effective management reviews with all nine of these inputs. This is especially true because poor procedures make it difficult to keep information appropriately updated and ready to give record traceability.
• Failure to recognize the value of customer feedback: Many organizations are struggling with obtaining and seeking client feedback and finding value in it. When attempting to execute this quality procedure proactively, as ISO 13485:2016 recommends, it can become increasingly difficult. The most difficult area for businesses to understand is that a complaint is a beneficial kind of feedback. Regardless of the situation, both ISO 13485 best practices and end-users of these devices require organizations to banninating feedback to adopt a proactive approach.

Consider 7 Modifications Throughout ISO 13485 Implementation That Will Benefit the Organization

ISO 13485 is a collection of international standards for quality management systems that can assist medical device manufacturers in designing, manufacturing, and distributing quality medical devices that fulfill client needs. These seven modifications can aid in the improvement of ISO 13485 quality management systems for medical devices.

• A Risk-Based Focus: ISO 13485 placed an exceptional focus on a risk-based methodology, with over a dozen mentions of risk in the reference manual. To accomplish safety and compliance, a risk-based strategy balances the quality management operations with the probability of damage. Instead of only in product development processes, a risk-based methodology is now necessary across the entire QMS. The particular standards are less specific beyond the necessity for risk management at all stages of the product life cycle. The manufacturer is responsible for actively identifying and assessing risks in all aspects of the QMS and implementing suitable controls. There has not been any defined risk level or outline of how device manufacturers should balance risk management with efficiency. So, a simple scale can be used to convey risk assessment results Risks, for example, can be classified as low, medium, or high using predefined scales in several aspects of the QMS, such as supplier management and corrective and preventive action.
• Enhanced Documentation Control: ISO 13485 process-based document control criteria are particularly for documenting “release.” The release is a set of criteria that must be completed for  ISO 13485 documents to continue to the next stage. For example, an instrument calibration exercise may need to meet certain requirements for results and supervisory review before it is declared accomplished and released. If organizations are trying to handle release requirements on a paper-based system, the additional document control requirements can be complex and time-consuming. It’s common to lose paperwork or forget to obtain a required verification. So, enhanced documentation control can help to keep track of the document process.
• Increased Training Efficiency: Clause 6.2 of ISO 13485 includes a subtle expansion of training requirements to address the need for effective training. Specifically, the quality management system must:
  • Document processes for establishing competence
  • Provide training and ensure awareness
• Effective ISO 13485 awareness training is an important component of any QMS. However, the 13485 update makes it clear that training activities should be more rigorous.
• Enhanced Customer-Related Processes: Under 13485, device manufacturers must collect feedback during production and post-production and incorporate it into the QMS and risk management activities. ISO 13485 has continued to expand the requirements for non-conformance investigations and CAPA processes. Extra sub clauses have expanded the requirements to measure complaint handling activities and report specific complaints to regulators when required. The requirement is strongly intertwined with the risk-based approach, which is a major focus of ISO 13485. The standard is being updated to include tighter feedback mechanisms and a more progressive approach to continuous improvement. Continuously measuring a product’s ability to meet customer requirements can assist organizations in addressing unforeseen risks and avoiding quality issues that can lead to patient safety issues or product recalls.
• Improved Design-Development Correlation: Developing a system of traceability from design inputs to outputs has been established as an official requirement while being a best practice under ISO 13485:2003.  The current edition requires design verification efforts to be documented, including explicit evidence-based rationale when necessary. A planned testing activity, for example, should provide a testing sample size and explain why this sample size is statistically significant. ISO 13485 added a requirement for design transfer to manufacturing to make a comprehensive standard of product quality, which is based on strong, logical evidence.
• More rigorous supplier management: ISO 13485 established a clear requirement to evaluate the level of risk that each supplier potentially introduces. Suppliers must be monitored frequently to generate an accurate and up-to-date risk assessment. Most of all, there is a need for regular communication between manufacturers and suppliers about risk and quality issues. The frequency and depth of supplier audits can vary depending on the supplier’s potential impact on product quality.
• Improved Complaint Handling: ISO 13485 addressed complaint handling as mandatory input for management review. In addition, clause 8.2.2 defines a list of procedural requirements for medical device suppliers:
  • Comply with regulatory complaint-handling requirements
  • Make a process to receive and route information
  • Assess complaints
  • Report complaints to regulatory authorities, if needed
  • Perform a root-cause investigation
  • Handle related complaints, such as inputs or suppliers
  • Implement helpful and protective action
  • Address any third-party involvement
  • Assess servicing records, if applicable
  • Apply complaints to the risk-management lifecycle