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.

Things That Must Know About the ISO 13485 Standard

ISO 13485 standard is specifically established for the manufacture of medical devices, ISO 13485’s main objective is to help enable consistent medical device regulatory requirements in the industry. It contains a comprehensive list of necessities meant to guide organizations that belong to the medicinal supply chain by referencing specific requirements for the manufacture, installation, and servicing of supplies. Its applicability is extended by the fact that it is useful to organizations that operate in any stage of the industry, with special attention to organizations that service medical device manufacturers.

Despite it being based upon ISO 9001, ISO 13485 shifts its attention from continual improvement to meeting regulatory requirements and risk management. The system makes its parallel with the requirements to match those of the FDA and other foreign regulators, which offers the framework to increase upon additional regulatory as well as customer requirements.

Why ISO 13485 standard is important?

The necessities of ISO 13485 are flexible and sufficient to apply to any organization of any size any type. These organizations could be tangled in the design, production, distribution, servicing, or even external suppliers. ISO 13485 starts specific requirements for organizations to follow through on to confirm that they can meet customer and regulatory requirements. Because of its adaptability and range within the market, ISO 13485 has become a staple necessity for organizations in the market, especially competitive ones.

How to become ISO 13485 certified?

The progression of becoming certified in ISO 13485 involves developing a management system based on the standards’ guidelines customized to the organization and then hiring a recognized third party to conduct regular audits. The prime objective of the management system development process must revolve around the product policy and quality manual; these set the base for the implementation of the system. Starts with management support and identifying the customer requirements for the management system, initially the documentation needs to start with defining the quality policy, objectives, and manual which will work to determine the scope and extent of implementation of the management system.

Additional processes and procedures – including mandatory ones, need to be created to ensure efficient delivery of products and services. For this, must consult the list of mandatory ISO 13485:2016 documents required. Once all of this is accomplished, the management system will need to be operational for a period to collect the necessary records and documentation required for audits and system reviews to become certified. So, here are the five important elements of the ISO 13485 standard.

1. Quality Management System

In the QMS section, let’s discuss the general quality management system requirements, as well as the documentation needed to implement and maintain an effective quality management system. According to ISO, organizations need to:

• Regulate the processes the quality management system necessitates and what’s needed to apply these procedures throughout the organization, considering the several roles involved,
• Apply a risk-based approach to the control of the appropriate processes needed for the quality management system, and
• Determine the sequence and interaction of these processes.

2. Measurement, analysis, improvement

According to ISO standards, every organization should plan and implement the monitoring, measurement, analysis, and improvement processes correlated to the quality management system and products.
In this pursuit, organizations need to:

• Authenticate conformity of the product
• Ensure the proper quality management system
• Keep the productivity of the quality management system

3. Management responsibility

This section outlines the unique roles and responsibilities of management as it pertains to quality management system execution and maintenance. Management should provide evidence of its commitment to the growth and maintenance of the quality management system and its efficiency. To do that:

• Communicate the importance of meeting regulatory necessities
• Found a high-value quality policy
• Confirm that quality objectives are established
• Conduct management reviews
• Confirm the availability of quality management system resources

4. Product realization

In a hurry to get products into development as soon as possible, many organizations often overlook the planning phase. The requirements need to match to plan that realization effort.
More specifically, it states that it should:

• Start the quality requirements for the products
• Define the required procedure and what necessary documentation will be needed for those processes
• Outline the company structure that will need to be created and what the work environment should be like
• Define employee qualification and ISO 13485 auditor training requirements
• Start the actions for verification, validation, measurement, monitoring, handling, inspection, storage, distribution, and traceability
• Lastly, it’s important to organize all that information in such a way that it can be effortlessly accessed and understood.

5. Resource management

At this stage, planning the proper resource management to implement the quality management system and maintaining system effectiveness. Its requirements are needed to meet major regulatory and customer requirements.
Resources in this section include:

• The facility of resources
• Human resources
• Infrastructure
• Work environment
• Contamination control

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.

How an Effective ISO 13485 Audit Checklists Can Minimize Certification Process?

ISO 13485 is the global international standard for establishment and maintenance of a documented quality management system in the medical device industry. If a manufacturer has implemented ISO 13485, it will have a foundation upon which to certify for regional medical device regulations such as the EU Medical Device Directive. An effective ISO 13485 Audit Checklist can be always very important tool used during ISO 13485 system implementation and certification. Well defined ISO 13485 audit checklist can minimize repetitive job while certification in any organization. Medical devices – Quality management systems – Requirements for regulatory purposes represent the requirements that the medical device manufacturers must incorporate into their management systems and an ISO 13485 audit checklists assures that it effectively implemented.

What is the ISO 13485 Standard?

ISO 13485 standards are international standards set by the International Organization for Standardization (ISO) and are designed for organizations designed, manufactured, installed and serviced medical devices. ISO 13485: 2016 is the most current version. It places more emphasis on risk-based decision-making and changing regulatory changes in the supply chain.

These quality standards provide a practical foundation for QMS requirements. They are critically important for all stakeholders in the medical device industry to: 

• manage quality standards
• meet QMS compliance regulations
• demonstrate competency and consistency
• meet customer safety and regulatory requirements 

The Effective ISO 13485 Audit Checklist to Ensures Readiness

ISO 13485:2016 requires Stage 1 and Stage 2 audits. The best ISO 13485 audit checklist can help you prepare for both stages and an internal audit prior to certification or recertification. Stage 1 and Stage 2 audits differ in duration, depth, and scope.

Stage 1 ISO 13485 Audits:  An ISO auditor from your certifying body will provide a report of positive and negative findings to determine whether your company is ready to proceed to stage 2.

Stage 2 ISO 13485 Audits:  This is a comprehensive evaluation of your organization’s compliance with ISO 13485:2016 standards. The auditor will review documentation, controls, internal audits and management review, and all relevant processes. The auditor may produce a list of non-conformances which have to be corrected before you can be certified or receive recertification.

The ISO 13485 Audit Checklist contains a series of questions and status updates to ensure that everything matches the plans defined in the organization’s QMS regarding internal activities, supplier evaluation, and an evaluation of the supplier audit reports. 

ISO 13485 Documents – Requirements for Medical Device Quality System Certification

The latest version of ISO 13485 was published in 2016, and the transition from the previous version is ahead. One of the most important steps in the transition process, as well as in the initial implementation, is determining what documents and records are needed for an effective Quality Management System (QMS) based on ISO 13485.

The key sections of ISO 13485 set out a range of document requirements for developing, implementing, and maintaining a Quality management system tailored to the design and production of medical devices.

Requirements of Documents for ISO 1345 Certification

• Quality Manual :

The ISO 13485 quality manual is a mandatory document for ISO 13485 Certification, which maintains quality management system in medical devices. This is a roof document for QMS, and it usually includes the QMS scope, role(s) undertaken by the organization, exclusions from the standard, references to relevant documents, and the business process model.

• ISO 1345 Quality System Procedures :

ISO 13485 procedures documentsrequired as necessary for effective planning, operation, control and monitoring of realization processes improvements. Mandatory procedures cover all the clause requirements to follow while implementation of Quality management system for preparing and maintaining medical devices.

• ISO 13485 Exhibits :

ISO 13485 exhibits documents are very useful tools that cover all the details for training to the user to implement the processes and get detail ideas for process implementation and improvement.

• ISO 13485 Formats :

ISO 13485 formats documents designed and required to maintain records as well as establish control and make system in the organization. The ISO 13485 samples formats given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements.

• ISO 13485 SOPs :

ISO 13485 SOPs documents cover sample copy of work instructions to link with significant aspects issues in the organization. It takes care of all such issues and used as a training guide as well as to establish control and make system in the organization. The samples given are as a guide and not compulsory to follow and organization is free to change the same to suit own requirements.

• ISO 13485 Audit Checklist

ISO 13485 audit checklist documents audit questions based on ISO 13485:2003 requirements as well as for Clause wise questions and department wise question. It will be very good tool for the auditors to make audit Questionnaire / clause wise audit Questionnaire while auditing and make effectiveness

Requirement of ISO 13485 Audit Checklists for Effective Quality Management System Audit

The set of ISO 13485 Audit Checklist and guide includes introductory description, how to apply and use the audit checklist, brief introduction to audit requirements, discerning minor verses of major or critical non-conformities, and how to summarize the respective findings and rate the overall performance.

So, before conducting a Quality management system audit to ISO 13485 for medical devices, you may be looking for some kind of an ISO 13485 audit checklist. The ISO 13485 audit checklist is a systematic, documented verification process of objectively obtaining and evaluating audit evidence to determine whether an organization’s QMS conforms to the QMS audit criteria, and the results of this process to the client. The QMS audit criteria are defined as the policies practices procedures or requirements.

The audit checklist of ISO 13485 is a very useful & important document for auditors, who are new or experienced. The ISO 13485 Audit checklist helps auditors to organize, plan, conduct and report audit observations in a consistent manner. The definition of ISO 13485 audit checklists is such a list of tasks that must be completed as part of ISO 13485 audit is an integral part of the evaluation process for the internal audit plan. Medical device manufacturer has to plan and carry out regular internal audits, for the requirement purpose of ISO 13485 audit checklists, which is essentially a list of tasks that must be completed during implementation.

As per the organization’s processes, and the requirements of the audit for ISO 13485 standard; the format of this Audit checklist encourages the ISO 13485 auditor to document objective evidence. The ISO 13485 audit checklist is created as well as managed by the ISO 13485 lead auditors.

Purpose of an ISO 13485 Audit Checklist is:

• To assist memory-nothing is missed inadvertently;
• To ensure comprehensive coverage of  all  applicable element ;
• To ensure continuity/repeatability/consistency of the audit;
• To manage time;
• To organize note taking; and subsequent review by auditors.
• Can become part of an Audit report.

The ISO 13485 Audit should focus on the quality objectives and action plans of the organisations to allow problem areas to be identified so that remedial action can be taken.  Generally, the audit is a means of assisting managers at all levels to improve the performance of the operations under their control. There is no such kind of checking on how well people are doing their job!

Or we can say, within the overall quality management system for medical devices, ISO 13485 audit checklists are used to determine whether quality management activities conform to the stated program, whether these activities are effectively implemented system, and how effective the Quality management system is in fulfilling the quality policy.

The ISO 13485:2016 Audit Checklist for Quality management system certification of medical devices contains ISO 13485:2016 clause-wise as well as department-wise audit questionnaires. Punyam Academy’s Online ISO 13485 Auditor Training Course fulfils all the requirements of ISO 13485 audit and become a certified ISO 13485:2016 Auditor.