What are the Role and Responsibilities of ISO 13485 Consultant and Steps for Effective ISO 13485 Implementation

ISO 13485 certification ensures high-quality medical equipment in healthcare settings. It helps business owners meet customer, regulatory, and legal requirements, reducing costs and demonstrating a global commitment to safety, quality, and competence in medical device manufacturing. When you are developing a Quality Management System (QMS) for medical device manufacturing organization, it is necessary to assign ISO 13485 documents with the roles and responsibilities of your management system. With an increased emphasis on patient safety, regulatory regulations in the medical device business are regularly evaluated and updated.

Medical device companies must hire professional ISO 13485 consultant or a consulting firm that is knowledgeable about all risk-class devices. The organization must manage and extract value from huge quantities of organized and unstructured information and data, while also staying up-to-date and in compliance with regulatory, regional, and specific laws. By ISO 13485 criteria, the organization should build effective systems to track and monitor safety and benefit-risk information throughout the life-cycle of their goods.

Why is ISO 13485 necessary?

ISO 13485 assures that medical devices used by healthcare professionals are developed, manufactured, installed, and serviced by the highest standards. That allows organizations to demonstrate best practices as well as their commitment to safety, quality, and expertise.

To ensure safe and effective use, medical device goods and equipment must consistently meet customer and regulatory standards. The internationally respected standard ISO 13485 guarantees that enterprises meet these requirements. The ISO 13485 standard can help you ensure that your organization produces safe and efficient products.

ISO 13485 Consultant Roles and Responsibilities

ISO 13485 consultants are medical device quality management system experts. They offer invaluable advice and assistance to organizations attempting to implement and maintain ISO 13485 certification. Their responsibilities include the following:

• Identifying holes in an organization’s existing quality management system is a critical step in gaining ISO 13485 certification. Consultants undertake detailed assessments to identify areas for advancement, enabling organizations to establish effective compliance strategies.
• Consultants provide training programs to help organizations’ employees improve their knowledge and abilities. Consultants assist in the overall efficiency of the certification method by ensuring that staff understand the criteria and best practices described in ISO 13485.
• Identifying holes in a business’s existing quality management system is a critical step towards ISO 13485 certification. Consultants undertake comprehensive assessments to identify areas for improvement, allowing businesses to establish effective compliance strategies.
• Identifying the QMS standard requirements
• Identifying all legal and regulatory obligations based on the product’s classification.
• Stage-by-stage planning for establishing the standard requirements.
• Creating and documenting processes
• Applying the QMS
• Internal Quality Audits
• Organizing Management Evaluation Meetings
• Creating a continual enhancement strategy for the entire QMS
• Evaluating the efficiency of the company’s QMS

Steps to a Successful ISO 13485:2016 Implementation

An organization must be able to supply medical devices and related services that consistently meet consumer and regulatory criteria, according to ISO 13485:2016. This is accomplished by demonstrating its ability to put in place a quality management system. These firms may be involved in one or more aspects of the life cycle in the planning and creation of products, manufacture, storage and distribution, the setup, or servicing, as well as the design and development of corresponding services such as technical help.

• Quality system design
• Observing regulatory guidelines
• Design controls are being applied.
• Management procedures for documents, records, and training
• Consultants in ISO 13485 audit

List of Procedures that Should Be Documented for ISO 13485 Certification

No matter the size, structure, or type of organization, ISO 13485 is a globally accepted standard for quality management system (QMS) requirements for any organization who partially or entirely involved in the lifecycle of a medical device. The initial edition of ISO 13485 was released in 1996, and updates followed in 2003 and 2016. It was implemented in March 2016 and is known as ISO 13485:2016. The primary objective of an ISO 13485 QMS for medical device manufacturers standard is to demonstrate the manufacturer’s dedication to the performance, safety, and efficacy of medical devices. These specifications are meant to make sure that medical products and services consistently meet consumer expectations as well as any applicable legal requirements.

Organizations must have a Quality Management System (QMS) that is documented and conforms with the standard and all relevant regulatory criteria to receive the ISO 13485 certification. In addition to the documents, the organization must also prepare other types of documents, such as the Quality Policy, Manual, ISO 13485 Procedures, Records, Forms, SOPs, Audit Checklist, and so on. The objective of the ISO 13485 documents in the ISO 13485 standard is to guarantee that crucial operations are strictly controlled. Remember that ISO 13845 simply specifies that a list or index of the manufacturer’s method is required; it does not mandate that organization must lay down each of its procedures step-by-step in the quality manual. The following is a list of ISO 13485 QMS procedures that are required to be included in the documentation.

Mandatory ISO 13485 Procedures

The several mandatory ISO 13485 procedures require companies to document or reference in the quality manual, including:

• ISO 13485 procedure for control of documents
• Control of records
• Internal audit
• Control of non-conforming products
• Corrective and preventive actions for ISO 13485
• Validation of computer software
• Customer specifications (for inspection, manufacturing, packaging, and delivery)
• Monitoring and measurement
• Servicing and installation (if applicable)
• Management review
• Work environment and contamination control
• Design and development
• Validation of sterilization and sterile barrier systems (if applicable)
• Identification and traceability
• Preservation of product
• Calibration or verification for measuring equipment
• Feedback and complaint handling
• Reporting to regulatory authorities
• Advisory notices rework, data analysis

ISO 13485 Standard Operating Procedures (SOPs):

• Measurement of Temperature and Humidity
• Validation of Autoclave
• Microbial Monitoring of the Production Area
• Temperature Monitoring of the Sterility Room and Microbiology Laboratory
• Temperature & Humidity Monitoring
• Clean Room Condition Monitoring

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