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

Mandatory Documents and Records Required by ISO 13485:2016

The new ISO 13485 is based on ISO 9001: 2008, which means that the requirements for documentation are based on the requirements of earlier versions of ISO 9001, with the addition of specific documentation in the medical device industry.

So, here is the list – below you will see the mandatory documents, but keep in mind that Quality Management System documentation includes not only the mandatory documents but also other documents specified by the applicable regulatory requirements.

• ISO 13485 2016 Manual
• ISO 13485 Procedures
• Exhibits
• Sample Formats / Templates
• Quality SOP
• forms
• ISO 13485 Audit Checklist
• Medical Device File

How ISO 13485 Documents is Useful?

• ISO 13485 2016 documentation kit is ideal for individual learning as well as group training to ensure the successful implementation of the quality management system for medical devices.
• The set of readymade documents is extremely useful to ISO 13485 consultants for complying with requirements.
• It can be a perfect tool to educate all employees to achieve better performance of Medical devices in the pharmacy sector.
• The ISO 13485 certification is internationally recognized as an indicator of reputable business and high quality products, so it can improve the reputation of your business among current and potential customers, investors, partners, suppliers and other stakeholders.
• Certification to ISO 13485 also helps you to manage risks by increasing the traceability and consistency of your products and services.
• The documentation required by ISO 13485 can help your organization build an integrated knowledge base, which can help you identify problems and improve your products and processes.
• The documentation required by ISO  13485 can help your organization build an integrated knowledge base, which can help you identify problems and improve your products and processes. Documentation also helps you insure team members have access to information where needed.

The importance of documentation

The purpose of documentation in QMS is to ensure that critical processes, where you need to ensure that all employees perform the same task consistently, are understood and repeated. To do this, it is prudent to make these processes as simple as possible and easy to understand. Often, the use of graphical flow charts is sufficient to quickly and easily relay all relevant information. The less complicated the process documentation, the easier it will be to ensure that all employees can provide repetitive, quality results for the processes.

How to Define Roles and Responsibilities within a QMS Based on ISO 13485

When developing a Quality Management System (QMS), it is necessary to assign and document the roles and responsibilities of your management system. The ISO 13485 certification highlights it as shown mainly in the requirements. So, what roles and responsibilities do you need to identify and how should you do it? Here are some ideas on what to do.

What does the ISO 13485 Certification requires?

The requirements of the ISO 13485 Certification with respect to the roles and responsibilities are very broad, so that the organization can define them in the way it considers most appropriate. Top management must ensure that responsibilities and authorities are defined, documented and communicated within the organization. It must also define the interrelation of all the personnel who manage and carry out the work that affects quality and guarantees the independence and authority necessary to perform these tasks.

The lack of knowledge and commitment on the part of senior management for the implementation and maintenance of a quality management system based on ISO 13485 is often the cause of implementation failure. It can also mean that the standard is implemented only informally. The main concern of top management is to ensure the long-term success of your company, increase profitability, monitor new initiatives, reduce risks, etc. You can achieve an increase in your participation by explaining the benefits that the implementation of ISO 13485 certification can have for a company and the possible negative consequences of a poorly established information quality management system.

Communicate the importance of satisfying regulatory and customer requirements: As in any other quality management system, the focus is on the customer, but considering how highly regulated the medical device sector is, it is important that top management guarantees compliance these requirements communicate with the rest of the organization.

Establishment of the quality policy: Top management must publish the quality policy, which will define the intention of the QMS.

Establishment of objectives: Through the objectives, senior management defines in which direction the QMS will follow. The objectives also provide a clear measure of the validity of the system.

Perform management reviews: The management reviews are the final check to see if the quality management system is effective and what measures should be taken to improve it.

Provide all the necessary resources: Without enough money or time, the ISO 13485 certification project will fail and the administration’s support must be very real and tangible.

ISO 13485 Audit Checklist: Most Important Document for Making Audit More Efficient

ISO 13485 audit checklist is a very useful & important document for auditors, who are new or experienced. It helps auditors to organize, plan, conduct and report audit observations in a consistent manner. Even though ISO 13485 audit checklist is not mandatory but it is highly recommended as it provides a systematic approach to auditing.

The ISO 13485 audit checklist that defines 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 this purpose ISO 13485 audit checklists is required, which is essentially a list of tasks that must be completed during implementation. The format of this checklist encourages the auditor to document objective evidence based on the organization’s processes, the characteristics of the process, and the requirements of the audit standard. Typically, the lead auditor creates and manages the ISO 13485 audit checklist.

The Set of ISO 13485 Audit Checklist and guide contains introduction description, how to apply and use the audit checklist, short introduction into audit requirements, discerning minor verses major or critical nonconformities, and how to tally respective findings and rate the overall performance.

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.

How a Good Corrective Action Plan Helps You to Comply with ISO 13485:2016

ISO 13485:2016 is the latest revision of the standards for quality management systems in medical device manufacturers and their suppliers.

ISO 13485 Corrective Action and Compliance

In addition to being mandated by medical device manufacturing regulations, a corrective action system may be the best tool to fix problems in your toolkit, if done correctly.

Corrective Action helps your organization to continuously reduce risks and ensure that they operate according to ISO 13485: 2016 standards.

A good corrective action system:

• Links to compliance records
• Has a defined workflow with action items
• Links to risk assessment
• Closes the loop

As companies have until September 2018 to comply with these standards, it’s important to understand ISO 13485 Corrective Action Plans and the main conclusions of the latest revision:

• The standard provides a step-by-step framework for creating or evaluating a Quality Management System (QMS).
• The ultimate goal of the standard is to protect consumers from the risk of defective medical devices.
• Emphasis is placed on improving operational efficiency by examining current processes, identifying gaps and implementing new processes.
• ISO 13485:2016 incorporates most items from ISO 9001:2015, but adds additional requirements on ISO 13485:2016 documentation of regulatory requirements for medical devices.
• ISO 13485:2016 lacks the high-level structure of other standards (including 9001:2015) in favor of a more direct requirement approach.

ISO 13485 and the Need for Problem Solving

One of the most important updates in the 2016 revision of ISO 13485 was the emphasis on risk. The updated standard adopts a risk-based approach to the development of a QMS as well as product realization and post-market feedback.

This encourages organizations to improve their quality issues and cultures according to new standards. The standards suggest that organizations take a “Plan-Do-Check-Act” approach to problem solving, but that alone may not be enough.

General Requirements to Understand while Preparing ISO 13485 Manual

The Quality Management System described in ISO 13485 manual must intended to meet the requirements of quality management system of ISO 13485 standard. It addresses Regulations quality system for the production of medical devices. The requirements of this manual will be communicated to all employees in whole or in part, depending on the scope of responsibilities of the employee and the impact on the quality system and product integrity.

The purpose of ISO 13485 Quality Manual is to establish and clarify the terms and conditions of the Quality Management System. These policies define intentional delivery of management to control the operation and activities in accordance with the framework established by ISO 9001 and ISO13485 standard. These are top – policy level represents the company’s protocols in order to achieve quality assurance and customer satisfaction. All departmental policies and written procedures shall be consistent with these parallel and above – high-level policy. Any changes in policies and procedures should be reviewed to ensure that there are no conflicts with this quality manual.

ISO 13485 Manual for Medical Devices describes the company’s quality management system and defines authorities and responsibilities scene of personnel within the system. The manual also includes procedures or references for all activities, including QMS to describe companies’ compliance with the standard.

ISO 13485 manual used internally to guide employees of the company through the requirements of ISO standards that must be met and maintained to ensure customer satisfaction, continuous improvement, and create an empowered workforce.

The ISO 13485 manual is used externally to introduce QMS to customers and other external organizations or individuals. The manual familiarizes them with the controls that have been implemented, and assures them that the integrity of the QMS is maintained and focuses on customer satisfaction and continuous improvement.

Requirements for ISO 13485 Manual

• Identify the processes needed for the QMS and their application in the organization and documented on the process diagram at the end of this section of the ISO 13485 manual.
• Determined the sequence and interaction of these processes and illustrated the process flow diagram.
• Criteria and methods needed to ensure that the operation and control of processes are effective and documented in quality plans, work instructions and measurement, monitoring and analysis of specific table.
• Ensure the continued availability of resources and information necessary to achieve planned results and continual improvement of these processes.
• Surveillance systems measure and analyze these processes established.
• Established processes to identify and implement the actions necessary to achieve planned results and continual improvement of these processes.

 

What Standard Operating Procedures (SOPs) Required for ISO 13485 Certification?

The Medical Device Industry requires specific Quality Management tools and controls. Quality Management Manual and SOP templates are built mainly on ISO 13485 Certification requirements. Their document portfolio consists of a wide range of documents, templates and forms for the Design Controls and the Life Cycle Management of Medical Devices.

The Standard Operating Procedure (SOP) describes the process on how to write SOPs. Standard Operating Procedures (SOPs) must be written, approved and followed for any routine operation, activity or task that may impact the safety, quality, purity and efficacy or distribution of medical devices to ensure consistent application and meet regulatory compliance. The purpose of this Standard Operating Procedure (SOP) is to standardize and systematize the creation, revising, approving and issuing of Standard Operating Procedures.

ISO 13485 Standard Operating Procedures 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

List of ISO 13485 Standard Operating Procedures

1. Measurement of Temperature and Humidity
2. Validation of Autoclave
3. Microbial Monitoring of Production Area
4. Temperature Monitoring of Sterility Room and Microbiology Laboratory
5. Temperature & Humidity Monitoring
6. Clean Room Condition Monitoring

How ISO 13485 Manual Satisfy Organizational Need?

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

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

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

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

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

ISO 13485 Consultancy – A Easiest Way to Achieve Certification for Medical Device Manufacturers

The primary objective of ISO 13485 standards is to facilitate harmonized medical device regulations for quality management systems. As a result, it includes some particular requirements for medical devices and excludes some requirements of ISO 9001 that are not appropriate as regulatory requirements. Because of these exclusions organizations whose quality management systems conform to this International Standard does not claim conformity to ISO 9001 unless the quality management systems meet all the requirements of ISO 9001.

ISO 13485 Consultants specialize in the preparation and installation of highly efficient ISO 13485 compliant quality management systems, minimizing overheads and complexity, whilst maximizing the benefits of ISO 13485 certification. Team of ISO 13485 Consultancy driven by Punyam Management System has highly experienced consultants for helping hundreds of medical device and manufacturers to achieve ISO 13485 certification. ISO 13485 Consultancy Services mainly focus on medical device and manufacturers so they understand the unique needs and manufacturing scenarios of the industry. ISO 13485 Consultancy will fully customize Organization ISO 13485 quality system to meet specific needs, and make sure for a certification audit.

Achieving ISO 13485 Certification under the guidance of ISO 13485 Consultancy has been harmonized against the three medical device directives. ISO 13485 Consultancy by Punyam.com assist organization in awareness training, documentation, implementation, internal auditing and overall process optimization as per ISO 13485 standard. This means that compliance with this standard automatically demonstrates compliance with the specific parts of the directives that require a quality management system. When manufacturers are active in the world market, the focus on global or international standards such as ISO 13485 is not only advantageous – it may be stipulated by certain countries.

Benefits getting implementation by ISO 13485 Consultancy

• Increase the probability of making safe and effective medical devices
• Meet regulatory requirements
• Meet customer expectations
• Help monitor the effectiveness of your supply chain

Overview on ISO 13485 Manual

ISO 13485 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and regulatory requirements for medical devices and related services.

About ISO 13485 Manual

ISO 13485 Manual describes the company’s quality management system and defines the authorities and responsibilities of the scene of staff within the system. The manual also provides procedures or references for all activities including the QMS to describe the corporate compliance with the standard.

ISO 13485 Manual is used internally to guide employees of the company through the requirements of ISO standards that must be met and maintained to ensure customer satisfaction, continuous improvement, and create an empowered workforce

ISO 13485 Manual is used outdoors to introduce QMS to customers and other external organizations or individuals. The manual familiarizes them with the controls that have been implemented, and assures them that the integrity of the QMS is maintained and focuses on customer satisfaction and continuous improvement.

Purpose of ISO 13485 Manual

The purpose of ISO 13485 quality manual is to establish and clarify the terms and conditions governing the Quality Management System. These policies define the intentional provision of management to manage our operations and activities in accordance with the framework established by the ISO 9001 and ISO 13485.

ISO 13485 system is maintained and continually improved through the use of the quality policy, quality objectives, internal & external audit results, analysis of data, corrective and preventive action and periodic management reviews.

To design and implement the QMS within ISO 13485, we have to:

• Identify the processes needed for the QMS and their application throughout the organization,
• Determined the sequence and interaction of these processes,
• Criteria and methods needed to ensure that the operation and control of processes are effective determined,
• Ensure the continued availability of resources and information necessary for the operation and monitoring of processes,
• Systems established to monitor, measure and analyze these processes,
• Established processes to identify and implement the necessary actions to achieve results and maintain the effectiveness of these processes,
• Established control processes to identify and implement the actions necessary to achieve planned results of outsourced processes,
• Determined criteria and information necessary to ensure that regulations and required standards are met.