qmsWrapper Blog
![ISO 9001 implementation: Mandatory documents and records ISO 9001 implementation: Mandatory documents and records](/files/Pictures/blog/ISO9001_documents/important_documents_ISO9001_cover.png)
ISO 9001 implementation: Mandatory documents and records
Mandatory documents and records when it comes to the ISO 13485 implementation are previously discussed. It is turned to discuss the same regarding ISO 9001:2015 implementation.
These are the documents to produce in order to be compliant with ISO 9001:2015:
4. Context of the organization
Clause 4.3: Scope of the QMS
5. Leadership
Clause 5.2: Quality policy
6. Planning
Clause 6.2: Quality...
![ISO 13485 implementation: Mandatory documents and records ISO 13485 implementation: Mandatory documents and records](/files/Pictures/blog/documets_ISO13485/important_documents_ISO13485_cover_small.png)
ISO 13485 implementation: Mandatory documents and records
Preparation of the QMS documentation is based on the organizational needs, and it is crucial for an efficient QMS.
![Software as a medical device - life cycle Software as a medical device - life cycle](/files/Pictures/blog/software_lifecycle/software_lifecycle_cover_small.jpg)
Software as a medical device - life cycle
The life cycle of the medical device is a development process of the product, from its beginning to the end.
![Validation efforts Validation efforts](/files/Pictures/blog/validation_effort/validation_effort_cover_small.png)
Validation efforts
If you want to use secured and reliable software, this is what you must know about QMS software validation.
![Remote audits – what are the limits? Remote audits – what are the limits?](/files/Pictures/blog/Remote_Audits_3/limit_remote_audit_cover_small.png)
Remote audits – what are the limits?
A virtual audit is a method of conducting an audit distantly, using electronic means such as videoconferencing, email, and telephone to acquire audit evidence.
![Benefits of remote auditing Benefits of remote auditing](/files/Pictures/blog/Remote_Audits_2/benefits_remote_audit_cover_small.png)
Benefits of remote auditing
Remote audits can have many benefits in terms of efficiency, access to competencies, increased reach and risk mitigation. Check out what the benefits might be.
![Do remote audits becoming 'new normal'? Do remote audits becoming 'new normal'?](/files/Pictures/blog/Remote_Audits_1/Do_remote_audits_becoming_new_normal_cover_small.png)
Do remote audits becoming 'new normal'?
Remote audits refer to the use of information and communication technology for collecting information, questioning audited personnel, etc.
![Continual Improvement and Nonconformity and corrective action – Lecture 24 Continual Improvement and Nonconformity and corrective action – Lecture 24](/files/Pictures/blog/ISO_9001_seria/24_ISO_9001/Nonconformity_and_corrective_action_cover_small.png)
Continual Improvement and Nonconformity and corrective action – Lecture 24
Improvement means, in a way, finding the parameters that affect the realization of goals and submitting them to change.
![Management review – Lecture 23 Management review – Lecture 23](/files/Pictures/blog/ISO_9001_seria/23_ISO_9001/Management_review_ISO9001_cover_small.png)
Management review – Lecture 23
It is one of the methods dictated by the ISO 9001 standard for monitoring the QMS and evaluating its performances and effectiveness.
![Internal audit – Lecture 22 Internal audit – Lecture 22](/files/Pictures/blog/ISO_9001_seria/22_ISO_9001/Internal_audit_cover_small.png)
Internal audit – Lecture 22
The internal audit is one instrument for self-review of whether requirements are achieved. More in our next lesson.
![Monitoring measurement, analysis, and evaluation – Lecture 21 Monitoring measurement, analysis, and evaluation – Lecture 21](/files/Pictures/blog/ISO_9001_seria/21_ISO_2021/Monitoring_measurement_analysis_and_evaluation_cover_small.png)
Monitoring measurement, analysis, and evaluation – Lecture 21
This part of the ISO 9001:2015 is critical for assessment of the performance of your QMS. Find out more about monitoring, measurement, etc.
![Control of Nonconforming Outputs – Lecture 20 Control of Nonconforming Outputs – Lecture 20](/files/Pictures/blog/ISO_9001_seria/20_ISO_9001/Control_of_Nonconforming_Outputs_ISO9001_cover_small.png)
Control of Nonconforming Outputs – Lecture 20
Controlling the nonconforming outputs will allow you to minimize their effect, map the problem, and track down the root cause – learn more with qmsWrapper.
![Release of products and services – Lecture 19 Release of products and services – Lecture 19](/files/Pictures/blog/ISO_9001_seria/19_ISO_9001/Release_of_products_and_services_ISO9001_cover_small.png)
Release of products and services – Lecture 19
Release of the product or services is about verification that the product and service requirements have been met according to customer requirements.
![Production and service provision – Lecture 18 Production and service provision – Lecture 18](/files/Pictures/blog/ISO_9001_seria/18_ISO_9001/Production_and_service_provision_cover_small.png)
Production and service provision – Lecture 18
Learn how to control, identify and preserve production and service provision according to ISO 9001:2015, with qmsWrapper.
![Control of externally provided processes, products, and services – Lecture 17 Control of externally provided processes, products, and services – Lecture 17](/files/Pictures/blog/ISO_9001_seria/17_ISO_9001/Control_of_externally_provided_processes_products_services_cover_small.png)
Control of externally provided processes, products, and services – Lecture 17
It all varies widely depending on the nature of the processes, products, and services.
![Design and Development of products and services – Lecture 16 Design and Development of products and services – Lecture 16](/files/Pictures/blog/ISO_9001_seria/16_ISO_9001/Design_and_development_of_products_and_services_cover_small.png)
Design and Development of products and services – Lecture 16
ISO 9001 standard requires you to control the entire design and development cycle - explained step by step by qmsWrapper through its lectures.
![Requirements for products and services – Lecture 15 Requirements for products and services – Lecture 15](/files/Pictures/blog/ISO_9001_seria/15_ISO_9001/Requirements_products_services_cover_small.png)
Requirements for products and services – Lecture 15
This chapter is the point to determine exactly what your product's specifications are, and to evaluate them later, to make them clear, documented, etc.
![Operational planning and control – Lecture 14 Operational planning and control – Lecture 14](/files/Pictures/blog/ISO_9001_seria/14_ISO_9001/Operational_planning_and_control_cover_small.png)
Operational planning and control – Lecture 14
The ISO 9001 requires practical actions for planning and control so you can conduct it through the processes. It includes a Quality plan as well – learn more.
![Documented information – Lecture 13 Documented information – Lecture 13](/files/Pictures/blog/ISO_9001_seria/13_ISO_9001/Documented_information_cover_small.png)
Documented information – Lecture 13
Documented information is the key element of your QMS and it has to be controlled – why and how – find out here. ISO 9001 lectures by qmsWrapper.
![Communication of support – Lecture 12 Communication of support – Lecture 12](/files/Pictures/blog/ISO_9001_seria/12_ISO_9001/Communication_of_support_ISO9001_cover_small.png)
Communication of support – Lecture 12
Efficient flow of data, information, and knowledge shared between as requirements by ISO 9001.
![Awareness of support in ISO 9001 – Lecture 11 Awareness of support in ISO 9001 – Lecture 11](/files/Pictures/blog/ISO_9001_seria/11_ISO_9001/Awareness_of_support_ISO9001-_cover_small.png)
Awareness of support in ISO 9001 – Lecture 11
Awareness of the QMS increases the motivation and devotion of employees in your company – emphasizes ISO 9001, clarifies qmsWrapper.
![Top 5 trends in the MedDev industry for 2021 Top 5 trends in the MedDev industry for 2021](/files/Pictures/blog/Top_5_trends_2021/5_top_trends_in_MedDev_industry_2021_cover_small.png)
Top 5 trends in the MedDev industry for 2021
Follow trends related to MedDev industry with qmsWrapper. 5 fields are innovative and impactful as technology and healthcare are developing daily.
![Competence in Support of ISO 9001 – Lecture 10 Competence in Support of ISO 9001 – Lecture 10](/files/Pictures/blog/ISO_9001_seria/10_ISO_9001/Competence_in_Support_of_ISO9001_cover_small.png)
Competence in Support of ISO 9001 – Lecture 10
Employees' competency is crucial for your successfully produced product or service. What is the importance of training, education, and qualification?
![Resources of Support – Lecture 9 Resources of Support – Lecture 9](/files/Pictures/blog/ISO_9001_seria/9_ISO_9001/Resources_of_Support_cover_small.png)
Resources of Support – Lecture 9
They are critical zones and should be support for achieving your QMS goals, aligned with the objectives – how, why, when – more here in lectures by qmsWrapper.
![Planning of changes – Lecture 8 Planning of changes – Lecture 8](/files/Pictures/blog/ISO_9001_seria/8_ISO_9001/Planning_of_changes_cover_small.png)
Planning of changes – Lecture 8
Understanding the purpose of the change is critical for the planning of the change – ISO 9001 - now easy to understand by qmsWrapper.