Software ISO for 13485:2003 ISO 14971:2000 management system

Modules

1.  Documents 
2.  Risks 
3.  Correspondence 
4.  Processes 
5.  Trainings 
6.  Audits 
7.  Equipment 
8.  Complaints 
9.  Non-conformities 

Establishment of an effective document control system is a basic requirement for a management system addressing requirements of any ISO standard. In other words, setting up, implementing and maintaining the document control & management system is a-must prerequisite for effective Management System. "ISO-MED" is the tool that will help you to get the prerequisite realized.

It is quite place/time consuming idea to describe all capabilities of ISO-MED realized to help you in organizing effective control of the organization documents, so we will point out below just some of them:

1. Quick adding (registration) of documents in the database.
2. Control of documents during the life cycle (creation/approval/issue/distribution)
3. Continuous monitoring of documents' status during the life cycle
4. Automatic notification of stakeholders about necessity to take planned actions in due time
5. Automatic distribution of the updated versions of documents to stakeholders
6. System of authorized access of users to documents/files
7. System to prove the fact of opening the document's file by users
8. Control of hard copies of documents.
9. Control of filled records.
10. Control of external documents.
11. Control of passive (obsolete) versions of documents.
12. Filtering/sorting/grouping of documents by any number of the document's parameters.
13. Quick search of a needed document record
14. Composing of new files of documents using consistently designed templates.
15. Work with files of all formats that are supported by Windows.
16. One-click generating of more than 20 kinds of reports on document control system, their converting/saving in Word/Excel formats.
17. And many, many other useful features which you could evaluate if decide to get familiarized with the program.

The "Risks - ISO-MED" module is intended for companies which develop Quality and Risk Management System applicable to medical devices (standards ISO 13485:2003 and ISO 14971:2007). The module is, basically, the Risk Management File in terms of Ch. 3.6 of ISO standards 14971:2007. It will assist in setting up the Risk Management System - i.e.:

1. Defining the scope and boundaries of your Quality/Risk Management System
2. Planning responsibilities of all stakeholders
3. Determining goals of the management system and monitoring their achieving
4. Defining resources needed for functioning the management system and monitoring their allocation
5. Designing risk assessment approach of an organization
6. Determining objects of risk analysis - medical devices, and their lifecycle stages
7. Identifying hazards for each object at a particular lifecycle stage
8. Identifying consequence of events that might lead to a hazardous situaiton
9. Identifying harms potentially caused by the hazardous situations
10. Evaluation and assessment of risks assosiated with each hazardous situation/harm indetified
11. Planning risk control measures needed to reduce the risk to acceptable levels
12. Verification of implementation and effectiveness of the control measures planned
13. Conducting "Risk-Benefit" analysis and determining the residual risk acceptability
14. Designing Risk Management Plan

"Correspondence" module will assist you to establish an effective system of control over "non-system" documents of your organization - letters, orders, requests, etc., etc.

Below just few of useful features of Correspondence module are listed:

1. Registration of correspondence with assigning of the unique code (incoming/outgoing ID)
2. Application of resolution on a document and monitoring of its fulfilment
3. Classification and quick search of correspondence by any parameter (class, type, chapter, subject, sender, receiver, date, ID, etc.)
4. Automatic notification of stakeholders about necessity to take planned actions in due time
5. System of authorized access of users to records/files of correpsondence
6. "Control of documents" mode - quick filtering/sorting/grouping of documents by any number of parameters.
7. Planning of actions with correspondence, monitoring/follow-up of delayed actions
8. Composing of new files of correspondence by all users using consistent common templates.
9. Work with files of all formats that are supported by Windows.
10. And many, many other useful features which you could evaluate if decide to get familiarized with the program (to get the file-installer of the software just click here )

ISO standards promote the adoption of a process approach, description of business process and process-oriented management of the business system when developing, implementing and improving management systems. To implement the process approach, we have to understand what is needed to meet the requirements and what is the cost & value of the meeting the requirements for both the company and its customers. In other words, to start implementing a process approach, we need a tool to describe the processes. The eventual target is to determine those aspects of the processes which the organization resources must be focused at to reach the continuous improvement of the processes performance.

The part of this approach is identifying, describing and measuring inputs, operations and outputs of the process we are looking at. Begin asking the question, "What other processes interact with this process?". In other words, what processes provide input to or receive output from this process? Who are the stakeholders in this process? Customers and suppliers of the business processes may nor be forgotten. How do our processes impact them?

To help you in applying and adopting the "Process Approach" philosophy "ISO-MED" provides you with the unique, simple and relevant technique based on IDEF/0 approach of processes description. It will make you capable in quick and comprehensive describing the processes of your organization, figuring out the critical steps of importance in each process, identifying links between processes, activities, measures and flows of resources to be planned and managed. Below is just a snapshot of the long list of tasks which "ISO-MED" will help you to fix:

1. Define, classify and describe/document business processes within your company, using IDEF/0-based technique (inputs/resources - suppliers, outputs - customers and their requirements, process operations - responsible, criteria of the processes evaluation, etc.)
2. Determine and fix the range and scope of responsibility and authority within the processes.
3. Describe links/interactions within a process and between different processes ("output-input" approach).
4. Determine multi-level structure of business processes, make up a "hierarchy tree" of the processes
5. Determine parameters of effectiveness of business processes and monitor their performance at regular intervals.
6. Assess the needs for resources for business processes and monitor their providing at regular intervals.
7. Quick documenting of all aspects of business processes.
8. Compose flow-charts of business processes using built-up flow-chart editor.
9. Work in "Control of processes" mode - quick searching/filtering/grouping/sorting of process records by needed parameter(s)
10. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

This module will be your assistant in implementing requirements of ch. 6.2 "Human resources" of several ISO standards as well as requirements of ISO 10015:1999 "Quality management. Guidelines for training".

1. Module "Trainings" is a specially structured database; each records in the database corresponds one training for an employee of a company
2. When the training record is added to the database the following parameters of the training are being defined: a trainee (department/position), training date (planned and actual), training subject, responsible for training (trainer), mark for the training, date of carrying out the evaluation of training effectiveness, mark for the training effectiveness.
3. Determination of competency as a basis for designing the training plan.
4. Training plan is designed based on competence analysis and taking into account organizational structure of a company - "by departments" and "by positions" for each single employee (realization of the requirement "determination of required competency level for all employees").
5. Control of training plan, monitoring of trainings' sessions conducting.
6. Quantitative evaluation of conducted trainings and their effectiveness.
7. Continuous monitoring of in-time conducting the trainings planned and evaluation of their effectiveness; notification of users about necessity to conduct planned actions and/or overdue events.
8. Access of users to training database information in accordance with different levels of authorization.
9. "Control of trainings" mode - quick search of necessary record(s), sorting/grouping/filtration of trainings records by required parameters.
10. "One-mouse-click" generating of different reports documenting the training process.
11. Built-in "self-learning" database with training process data (lists of departments. positions, employees, types and sources of training, etc.) to facilitate/optimize the process of filling the database with new records.

Standard ISO 9001:2000, ch. 8.2 says:
"The organization shall conduct internal audits at planned intervals to determine whether the quality management system:
a) conforms to the planned arrangements (see 7.1) to the requirements of this International Standard and to the quality management system requirements established by the organization, and
b) is effectively implemented and maintained.
An audit program shall be planned, taking into consideration the status and importance of the processes and areas to be audited, as well as the results of previous audits. The audit criteria, scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shall ensure objectivity and impartiality of the audit process. Auditors shall not audit their own work".

Module "Audits" assists the software users in achieving these objectives.

1. Full correspondence of the process of planning and conducting audits/corrective actions to ISO 9001:2000 and 19011:2002 requirements.
2. Determination of audit team and requirements to auditors.
3. Organization of training process of auditors, control over the level of competency of auditors
4. "Audit report" - quick composing audit reports in a consistent format corresponding to ISO 19011:2002 requirements
5. "Action plan" mode - quick composing corrective/preventive action plans in a consistent format corresponding to ISO 19011:2002 requirements).
6. Automatic notification of all involved parties about upcoming audits
7. Automatic distribution of files of relevant documents to involved parties
8. Monitoring of audits conducting and taking planned corrective/preventive actions.
9. Monitoring of effectiveness of corrective/preventive actions fulfilled.
10. Automatic notification of users about overdue audits conducting and fulfilling the actions planned.
11. Access to audit/action plant information in accordance with different pre-defined authorization levels.
12. "Control of audits" mode - grouping/filtering/sorting/quick search of appropriate audit records
13. One-click generating of consistently shaped required documents (audit reports, corrective/preventive action plans, etc.)
14. Automatic transferring the non-conformities found into the "Non-conformities" module for their qualitative analysis

This module will assist you in establishing appropriate level of control of equipment of your organization (including monitoring and measuring equipment). Working with the "Equipment" module the users will be able to:

1. Control/plan process of purchasing equipment
2. Monitor financial performance of the purchasing process
3. Automatize control of planned actions with equipment at regular intervals, including periodical ones (calibration, verification, etc.)
4. Automatically inform responsible users about overdue planned action(s)
5. Control location of the equipment within the organization, responsibilities
6. Determine and control responsibilities of persons involved in the process
7. Make up and keep register of suppliers of the organization
8. Control status of suppliers of the organization
9. Work in "Control of equipment" mode - quick searching/filtering/grouping/sorting of equipment by needed parameter(s)
10. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

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"Complaints" module

This module will be your assistant in implementing requirements of ISO 10002:2004 "Quality management. Customer satisfaction. Guidelines for complaints handling in organizations" and ISO 9001:2000, Ch. 7.2.3. "Customer feedback". Working with the "Complaints" module, ISO-MED users will be able to:

1. Determine an explicit customer-focused complaints-handling policy of the organization
2. Define responsibilities and authorities of all parties involved in the process of handling of complaints
3. Establish complaints-handling objectives for relevant functions and levels within the organization and monitor meeting the objectives at regular intervals.
4. Assess the needs for resources for complaints-handling process and monitor their providing at regular intervals.
5. Make up and keep register of customers of the organization.
6. Quantitatively evaluate level of satisfaction of each customer.
7. Track and control the full path of complaints within the organization.
8. Automatize complaints registering process.
9. Define a single responsible person for handling of each complaint.
10. Monitor timeliness of executing of planned actions on each complaint.
11. Ensure continuous and automatic warning of stakeholders if actions planned are overdue.
12. Organize access to complaints-handling process information in accordance with authorization levels.
13. Analyze effectiveness of the complains-handling process.
14. Conduct audit of the complaints-handling process.
15. Work in "Control of complaints" mode - quick searching/filtering/grouping/sorting of complaints records by needed parameter(s)
16. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

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"Non-conformities" module

Standard 9001:2000, ch. 8.5.1 "Continual improvement" requires: " The organization shall continually improve the effectiveness of the quality management system through the use of the quality policy, quality objectives, audit results, analysis of data, corrective and preventive actions and management review".

Ch. 5.6 "Management review" of the Standard says: " Top management shall review the organization's quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness" - in other words, effectiveness of the management system should be reviewed/assessed on a regular basis.

Module "Non conformities" will help you to fulfill these (as well as many other) requirements of ISO standards. In particular, using ISO-MED you could:

1. Develop a system for classification of nonconformities
2. Define criteria of their quantitative evaluation.
3. Organize registration of non-conformities and effective control over their in-time elimination
4. Carry out comparative quantitative analysis of nonconformities (number, "severity", reason, area of occurring, responsible for elimination, etc.) .
5. Carry out quantitative evaluation of effectiveness of your organization's management system.
6. Work in "Control of complaints" mode - quick searching/filtering/grouping/sorting of complaints records by needed parameter(s)
7. Summarize and present results of the analysis in the vivid (graphics, charts, incl. Pareto charts) form suitable for needs of management analysis and taking business decisions
8. Work in "Control of non-conformities" mode - quick searching/filtering/grouping/sorting of non-conformities records by needed parameter(s)
9. Generate needed reports by "one-mouse" click, convert/save the reports in Word or Excel formats

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