
May 26, 2021
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.
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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.
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.
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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.
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.
The primary purpose of ISO 17025 is to guide laboratories to be competent – meaning they can generate valid test or calibration results and work consistently. The challenge is how to manage competence. This is because, in ISO 17025, the term refers to all aspects of laboratory competence, and a specific approach is not prescribed. There may also be differences in language interpretations and translations.
This article will help by providing an overview of what is needed to comply with ISO 17025 requirements for competence, focusing on personnel competence.
Let us start by understanding what competence is. As one of the core definitions of ISO Quality Management System standards, competence is “the ability to apply knowledge and skills to achieve intended results” ISO 9000:2015 Quality management systems – Fundamentals and vocabulary).
Ensuring competence is crucial for implementing and maintaining compliance with ISO 17025 regulatory and safety requirements.
A laboratory must manage both internal and external competence. Internal competence involves the laboratory’s skills and knowledge. On the other hand, external competence is ensuring the skills of the laboratory’s service providers.
The table below represents the internal and external competence requirements of a laboratory.
Internal competence (ISO 17025 clause 6.2) | External competence (ISO 17025 clause 6.6) |
Knowledge and skills of laboratory personnel to:
|
Knowledge and skills of external providers of products and services:
|
The mandatory ISO 17025 requirements for managing personnel are some of the most prescriptive in the standard. This is because people are a key contributor to the overall competence of a laboratory. In a laboratory, you typically need a range of competences. It helps to assign competence levels from basic to expert level to each job function.
A suitable approach for managing personnel competence is defined in the following eight steps.
Step 1: Document each key laboratory activity that contributes to:
Step 2: Document the competence requirements for each function listed in step one. Include the required competence level, education, qualification, skills, technical knowledge, training, and experience requirements. Review and revise the laboratory’s job descriptions. While the focus is often on specific qualifications or technical abilities, it is also important to consider general and soft skills. For example, an internal auditor needs to be an effective communicator, a good listener, and an observer.
Step 4: Review personnel appointments. Refer to job descriptions and personnel records (detailed curriculum vitae, training, and competence) and assess the suitability of existing personnel. Meet with each person and discuss specific responsibilities, duties, and authorities. Discuss any gaps, opportunities for development, and training needs.
Consider recruiting additional personnel or assigning existing personnel to different roles if there are risks that cannot be corrected through training.
Step 5: Establish a training program for the laboratory. Because training requires resources and funding, plan in time to budget for the following financial year. A training program record should include suitable information such as the activity, proposed dates, objectives, name of trainer, trainee names, and a list of the resources needed (for example, financial, venue).
Step 6: Establish a training record for each activity. Include the criteria to deem training successful (e.g., passed test with >85%). For each person, indicate if the training was successful. If not, specify the action to be taken.
Step 7: Evaluate and assign a competence level. Establish a competence and authorization record for each person. Include the information from the training record, plus the competence details such as monitoring period and record of evaluation. Competence criteria should be linked to expected behaviors or abilities and expected outcomes for the laboratory.
An example of a behavioral (non-technical) personnel competence is client focus. Here, one of the competence criteria would be the person’s ability to understand clients’ needs and provide advice. The demonstrated competence will come from observation and feedback from clients.
An example of technical competence is accurate testing and reporting. Competence can be demonstrated by the technician’s participation in a proficiency testing scheme, where the technician achieves an acceptable performance as defined by the provider and/or laboratory.
Step 8: Monitor personnel competence to ensure consistent operation and improvement in the laboratory. Set goals for maintaining or increasing the level of competence for all personnel.
Competence can easily be assessed during two existing laboratory activities:
For further support, have a look at the Advisera ISO 17025 toolkit documents, where you can preview the Competence, Training and Awareness Procedure, and the four appendices Training Program, Training Record and Performance Monitoring, Record of Attendance and Competence Approval and Authorization Record.
By setting aside time to manage your laboratory competence requirements systematically, you can rest assured: your entire management system will benefit from fewer nonconforming events. By following these eight steps, the management system will be more robust, and personnel more confident that they can contribute to the laboratory’s goals.
To comply with all ISO 17025 requirements, use this helpful ISO 17025 Documentation Toolkit that provides all documents for laboratories.
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