
September 7, 2017
Implementation, maintenance, training, and knowledge products for Information Security Management Systems (ISMS) according to the ISO 27001 standard.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
All required policies, procedures, and forms to implement an ISMS according to ISO 27001.
Train your key people about ISO 27001 requirements and provide cybersecurity awareness training to all of your employees.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Compliance and training products for critical infrastructure organizations for the European Union’s Network and Information Systems cybersecurity directive.
All required policies, procedures, and forms to comply with the NIS 2 cybersecurity directive.
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Compliance and training products for financial entities for the European Union’s DORA regulation.
All required policies, procedures, and forms to comply with the DORA regulation.
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Compliance and training products for personal data protection according to the European Union’s General Data Protection Regulation.
All required policies, procedures, and forms to comply with the EU GDPR privacy regulation.
Accredited courses for individuals and privacy professionals who want the highest-quality training and certification.
Implementation, training, and knowledge products for Quality Management Systems (QMS) according to the ISO 9001 standard.
All required policies, procedures, and forms to implement a QMS according to ISO 9001.
Accredited courses for individuals and quality professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 and the QMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for Environmental Management Systems (EMS) according to the ISO 14001 standard.
All required policies, procedures, and forms to implement an EMS according to ISO 14001.
Accredited courses for individuals and environmental professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 14001 and the EMS using Advisera’s proprietary AI-powered knowledge base.
Implementation and training products for Occupational Health & Safety Management Systems (OHSMS) according to the ISO 45001 standard.
All required policies, procedures, and forms to implement an OHSMS according to ISO 45001.
Accredited courses for individuals and health & safety professionals who want the highest-quality training and certification.
Implementation and training products for medical device Quality Management Systems (QMS) according to the ISO 13485 standard.
All required policies, procedures, and forms to implement a medical device QMS according to ISO 13485.
Accredited courses for individuals and medical device professionals who want the highest-quality training and certification.
Compliance products for the European Union’s Medical Device Regulation.
All required policies, procedures, and forms to comply with the EU MDR.
Implementation products for Information Technology Service Management Systems (ITSMS) according to the ISO 20000 standard.
All required policies, procedures, and forms to implement an ITSMS according to ISO 20000.
Implementation products for Business Continuity Management Systems (BCMS) according to the ISO 22301 standard.
All required policies, procedures, and forms to implement a BCMS according to ISO 22301.
Implementation products for testing and calibration laboratories according to the ISO 17025 standard.
All required policies, procedures, and forms to implement ISO 17025 in a laboratory.
Implementation products for automotive Quality Management Systems (QMS) according to the IATF 16949 standard.
All required policies, procedures, and forms to implement an automotive QMS according to IATF 16949.
Implementation products for aerospace Quality Management Systems (QMS) according to the AS9100 standard.
All required policies, procedures, and forms to implement an aerospace QMS according to AS9100.
Implementation, maintenance, training, and knowledge products for consultancies.
Handle multiple ISO 27001 projects by automating repetitive tasks during ISMS implementation.
All required policies, procedures, and forms to implement various standards and regulations for your clients.
Organize company-wide cybersecurity awareness program for your client’s employees and support a successful cybersecurity program.
Accredited ISO 27001, 9001, 14001, 45001, and 13485 courses for professionals who want the highest-quality training and recognized certification.
Get instant answers to any questions related to ISO 27001 (ISMS), ISO 9001 (QMS), and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Find new clients, potential partners, and collaborators and meet a community of like-minded professionals locally and globally.
Implementation, maintenance, training, and knowledge products for the IT industry.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
Documentation to comply with ISO 27001 (cybersecurity), ISO 22301 (business continuity), ISO 20000 (IT service management), GDPR (privacy), NIS 2 (critical infrastructure cybersecurity), and DORA (cybersecurity for financial sector).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Compliance, training, and knowledge products for essential and important organizations.
Documentation to comply with NIS 2 (cybersecurity), GDPR (privacy), ISO 27001 (cybersecurity), and ISO 22301 (business continuity).
Company-wide training program for employees and senior management to comply with Article 20 of the NIS 2 cybersecurity directive.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for manufacturing companies.
Documentation to comply with ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for transportation & distribution companies.
Documentation to comply with ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for schools, universities, and other educational organizations.
Documentation to comply with ISO 27001 (cybersecurity), ISO 9001 (quality), and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS) and ISO 9001 (QMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, maintenance, training, and knowledge products for telecoms.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
Documentation to comply with ISO 27001 (cybersecurity), ISO 22301 (business continuity), ISO 20000 (IT service management), GDPR (privacy), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, maintenance, training, and knowledge products for banks, insurance companies, and other financial organizations.
Automate your ISMS implementation and maintenance with the Risk Register, Statement of Applicability, and wizards for all required documents.
Documentation to comply with DORA (cybersecurity for financial sector), ISO 27001 (cybersecurity), ISO 22301 (business continuity), and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and security professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 and the ISMS using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for local, regional, and national government entities.
Documentation to comply with ISO 27001 (cybersecurity), ISO 9001 (quality), GDPR (privacy), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS) and ISO 9001 (QMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for hospitals and other health organizations.
Documentation to comply with ISO 27001 (cybersecurity), ISO 9001 (quality), ISO 14001 (environmental), ISO 45001 (health & safety), NIS 2 (critical infrastructure cybersecurity) and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS), ISO 9001 (QMS), and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for the medical device industry.
Documentation to comply with MDR and ISO 13485 (medical device), ISO 27001 (cybersecurity), ISO 9001 (quality), ISO 14001 (environmental), ISO 45001 (health & safety), NIS 2 (critical infrastructure cybersecurity) and GDPR (privacy).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 27001 (ISMS), ISO 9001 (QMS), and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for the aerospace industry.
Documentation to comply with AS9100 (aerospace), ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for the automotive industry.
Documentation to comply with IATF 16949 (automotive), ISO 9001 (quality), ISO 14001 (environmental), and ISO 45001 (health & safety), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 (QMS) and ISO 14001 (EMS) using Advisera’s proprietary AI-powered knowledge base.
Implementation, training, and knowledge products for laboratories.
Documentation to comply with ISO 17025 (testing and calibration laboratories), ISO 9001 (quality), and NIS 2 (critical infrastructure cybersecurity).
Company-wide cybersecurity awareness program for all employees, to decrease incidents and support a successful cybersecurity program.
Accredited courses for individuals and quality professionals who want the highest-quality training and certification.
Get instant answers to any questions related to ISO 9001 and the QMS using Advisera’s proprietary AI-powered knowledge base.
During manufacturing, a medical device is either in the final stage of manufacturing (finished goods) or in the semi-finished goods stage. Industrial processes in medical device manufacturing facilities convert raw materials into semi-finished materials, and semi-finished goods to finished goods. The results from the industrial process are verified by an inspection or some predefined quality tests, in order to demonstrate that the process has produced an output (in-process or final) that meets the specified requirements. The question arises – what should we do with processes whose outputs cannot be verified (due to destructive testing, unverified product characteristics, or expensive inspection)? The solution to this problem is process validation. Thus, ISO 13485:2016, under clause 7.5.6, mandates that organizations validate those processes for which verification is not possible.
Validation shows the capability of industrial processes to attain planned results consistently. Validation can be avoided in processes where the organization performs 100% inspection of product outputs, or they can fully verify the results of processes based on valid statistical rationale. According to ISO 13485:2016, organizations must validate computer software used in production or service provision of medical devices, as well as processes like sterilization and sterile barrier systems.
By performing validation, an organization can make sure that the processes can produce the planned results consistently. ISO 13485 helps organizations by requiring them to do the following:
Identify processes with unverified outputs. The first step for organizations to validate their processes is to identify processes where outputs cannot be verified. The organization should make a list of such processes where verification is not possible.
Document procedures for validation of processes. The organization should document a procedure that explains the validation of processes, along with defined responsibilities. An organization can document a procedure by inclusion of the following:
Document procedures for validation of computer software. The organization should create a procedure that explains the validation of computer software used in production of medical devices and related services, along with defined responsibilities. The procedure can include the frequency of software validation, which is based on the level of risk that may affect the ability of the product to meet the desired specifications. Records of the software validation results shall be maintained, along with a conclusion and, if required, necessary actions from the validation. Records of validation results can include screenshots of software inputs and outputs during validation testing and a list of actions arising from validation results.
Document procedures for validation of sterilization and sterile barrier systems. The organization should develop a procedure that describes the validation of sterilization and sterile barrier systems, along with defined responsibilities. Sterilization is the process of removing biological agents from medical devices, whereas a sterile barrier system is the system that protects sterilized medical devices from biological agents during packaging, storage, and distribution. Both of these processes must be validated before implementation of the process or any changes being made to it. The ISO 11607 standard (Packaging for terminally sterilized medical devices) provides specifications of test methods for materials, sterile barrier systems, and packaging systems that are projected to maintain the sterility of terminally sterilized medical devices until the point of application. Therefore, the procedure should also be compliant with ISO 11607 for providing a robust validation of sterile barrier systems. Records of validation for both sterilization and sterile barrier systems must be maintained (e.g., gross leak detection test, dye penetration test, seal strength test, or burst test). Learn more about the sterilization process in the article How to manage the medical device sterilization process according to ISO 13485.
Process validation is vital for medical device manufacturers, and can be thought of as a stand-alone discipline. ISO 13485 has specifically mandated requirements for process validation, for identifying the processes where verification cannot be done, for processes affected by computer software in production, and for sterilization and sterile barrier systems. Process validation helps organizations to avoid uncertainty in the production of sensitive devices, and for critical value-added services like computer software and sterilization.
Process validation enables organizations to ensure that processes operate effectively and do not produce defective outputs. Therefore, validated processes have qualified personnel, qualified equipment, process parameter controls, and additional record-keeping protocols. The fulfillment of ISO 13485 process validation requirements gives manufacturers, suppliers, and customers the necessary confidence to keep the business cycle running.
To implement ISO 13485 easily and efficiently, use our ISO 13485 Documentation Toolkit that provides step-by-step guidance and all documents for full ISO 13485 compliance.
You may unsubscribe at any time. For more information, please see our privacy notice.