
April 11, 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.
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Accredited courses for individuals and security professionals who want the highest-quality training and certification.
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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.
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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.
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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.
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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.
Medical instruments are critical healthcare and life-saving devices that are meant for surgeries, implantation, and other medical objectives. Many medical instruments are reused after they have gone through the sterilization process. Any non-conformity in a medical device is simply not acceptable, even after its use or after delivery. Therefore, ISO 13485:2016 addresses the management of non-conformity in a medical device even after its use or after its delivery.
The management system covered within the scope of ISO 13485 deals with production, delivery, and supplies of sensitive healthcare devices that are critical to life; hence, the likelihood of releasing a non-conforming device is addressed exclusively in ISO 13485:2016.
Clause 8.3 of ISO 13485:2016 addresses control of nonconforming product. The standard under clause 8.3.3 addresses the risk of releasing a nonconforming product, and thus addresses actions to be taken after delivery. According to clause 8.3.3, an organization is required to detect nonconformity after use or delivery, to act against nonconformities with records, and to establish a procedure of advisory notices with records on its proceedings.
The organization is required to detect nonconforming products after release or after use. It’s possible that a nonconforming product is released to the market because the sample-based inspection plan did not detect it during in-house processes. For example, some lots, i.e., WIP (Work in Process) were identified with a particular defect because of an error in raw material. That specific batch of raw material was also used in some identified shipped lots that were not detected in sample-based in-process and final inspections. All those shipped lots are detected after the issue is traced out and analyzed. Therefore, in the non-conformance report, not only in-process lots are identified, but also the ones being shipped.
The organization is mandated to take appropriate measures to eliminate the adverse effects of its products. Appropriate measures for a nonconforming product being shipped depend upon multiple factors, for example:
In Situation 1, where it is unacceptable to regulatory authorities, the organization must issue a return shipment for reversing nonconforming products back. The organization should analyze the root cause and take a corrective action. The organization is required to clearly tag, label, and quarantine all nonconforming material and, if needed, dispose of it. The effectiveness of the corrective action that is taken should be measured (e.g. nonconformance is checked in the next three shipments for measuring effectiveness of the corrective action).
In Situation 2, where it is acceptable to regulatory authorities and no health risk is assessed – the organization can communicate with the customer regarding monetary compensation, reworks, etc. If the customer agrees, then the organization takes the measure immediately. However, it is better for the organization to analyze the root cause and take a corrective action so as to avoid this non-conformity in the future.
In Situation 3, where it poses a health risk, it means it is unacceptable for the customer as well as for regulatory authorities; the organization is required to issue a withdrawal from the market or a recall of the product. The organization must analyze the root cause and take corrective action. The effectiveness of the corrective action will be measured. Advisory notices, addressing the nonconformity and recall status of the devices, are issued to the relevant stakeholders, e.g.: customers, health care practitioners, regulatory authorities, etc. Non-conforming products are clearly tagged, identified, placed in a quarantine area, and disposed of if the issue cannot be corrected. When a product is recalled, a health hazard evaluation is conducted by regulatory bodies – for example, the Food and Drug Administration (FDA) in the U.S. The FDA also classifies the recall as Class 1, Class 2, or Class 3 based on the health hazard posed by the non-conformity.
All those actions that are being taken must be recorded and maintained. All the records starting from the identification of the non-conformity to the root cause analysis, and from the root cause analysis to all measures for corrections and corrective actions – have to be maintained. In the (above-mentioned) Situation 2, when the customer agrees to a concession, the standard specifies an additional requirement: to keep records of the agreed concessions.
The organization needs to develop and clarify a procedure of advisory notices. An advisory notice is initiated to send information regarding what proceedings should be undertaken in the implementation, servicing, disposal, or return of a medical device. The procedure should require the committee who issues advisory notices to answer the following questions:
Maintain a record of the proceedings held when advisory notices are distributed – issuance and receipt records of these notices should be maintained, along with their traceability. Proceedings on advisory notices include records of completed recommended actions provided in the notices, the records of measuring effectiveness of the notices, etc.
The new version of ISO 13485:2016 specifies a new requirement to maintain records of actions relating to the issuance of advisory notices, and even records of concessions. This is all done to ensure safe business and medical processes for all customers, suppliers, medical practitioners and, ultimately, the patients. Record keeping creates a win-win situation for all stakeholders, whereby every process for post-delivery non-conformances is recorded and every concern is addressed.
The benefit of implementing this part of the standard is a hallmark of your organization’s commitment to patients’ safety, product conformance, and adherence to regulatory bodies. Your organization will gain an increased level of trust in the eyes of customers, and this trust will bring more business opportunities and will open new ventures.
Download a free preview of the ISO 13485 Documentation Toolkit to see the structure for each document mentioned above.
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