Field

The present invention relates to a computer implemented method for generating a plurality of documents related to compliance with an international standard.

Background

Definitions of certain related conventional solutions are briefly set out below.

Software as a Service (SaaS): SaaS is conceptualised as a software licensing model, where software is typically licensed on a subscription basis and data processed by the software are usually centrally hosted. SaaS is commonly deployed for various business applications, e.g. for office and messaging software, payroll processing, database management, customer relationship management, enterprise resource planning and etc.

Enterprise Software: Enterprise Software refer to online and/or offline software. Most such software provide a large enterprise solution that includes usages from document management, sales, human resources, finances, customer relationship, quality management, project management to enterprise resource planning. Certain software may also include a document generator, but however provides little assistance in the way of helping users to properly fill in documents to be generated by the document generator. Often, users are assumed and required to be of certain proficiency, before able to use the software with ease.

Quality Management Software: Some Quality Management Software are devised to be heavily focused for a single industry purpose, e.g. to help entities achieve ISO 13485 compliance. The software uses various terminologies, or workflow requirements specific to only requirements of the single industry, and so inexperienced users may find it difficult to understand or learn the software. Also, most such software does not include a document generator, and thus, users are expected to upload necessary pre-prepared documents to those software. Moreover, some software may further require user to have adequate prior knowledge in order to directly input information via the software, which is less than desirable.

General Document Management Software: Some general Document Management Software are devised for document version control, access and storage, generally across different industries. As the name implies, Document Management Software are normally used only for document management, and typically do not include workflow/process management (which are usually available in Quality Management Software) that may be important to companies.

Background to the above solutions, there are two primary methods in which businesses may obtain compliance certification (for an international standard), with each method having its own set of problems.

• Engage a consultant - It is expected that different consultants and consultancy teams have their own viewpoints towards deliverable standards for obtaining compliance certification. This may however cause potential inconsistencies, depending which consultant team is engaged and whether the consultant team is sufficiently experienced with processes for the compliance certification. Needless to say, this may consequently result in differing time lines, costs incurred and methodology in obtaining the compliance certification. This method is also not sustainable in the long term for companies, with no in-house capabilities to improve their own internal quality system, because that would result in over-reliance on external consultants.

• Use online/offline related software - Most of the software are designed for experienced users, which assume them to have a certain level of prior knowledge and understanding of the software for proficient usage. It is highlighted that some software are designed to include only limited functions, focusing only on a certain narrow scope, rather than covering functionalities of an entire Quality Management System (QMS). Most software are also in the form of a customised closed-system, which provides an exclusive solution only to medium and large enterprises at a much higher cost. In a commercial environment where outsourcing of processes is fairly common, a closed-system also causes inconveniences when handling documents with these suppliers (where most suppliers still use hardcopy documents to communicate). As such, small and medium sized businesses generally prefer an open system having the flexibility to handle hardcopy documents, and at a competitive pricing.

One object of the present invention is therefore to address at least one of the problems of the prior art and/or to provide a choice that is useful in the art.

Summary

According to a 1 ^st aspect of the invention, there is provided a computer implemented method for generating a plurality of documents related to compliance with an international standard. The method comprises: (i) providing information related to an entity by a user; (ii) receiving respective answers provided by the user to a first plurality of questions provided by the method to generate a first document, which is arranged with the answers to describe processes and procedures within the entity as part of the compliance; (iii) receiving respective answers provided by the user to a second plurality of questions provided by the method to generate at least a second document, which is arranged with the answers to facilitate implementation of a set of standard operating procedures within the entity as part of the compliance, the standard operating procedures further determined based on the answers provided at step (ii); and (iv) configuring the first and second documents to be downloaded to a computing device of the user. The method is further configured to provide recommended answers at steps (ii) and (iii) to the user, using statistical reference to a historical database of answers.

Preferably, the entity may be a legally incorporated entity.

Preferably, the information related to the entity may include company information and a logo of the company.

Preferably, the first document may be assigned a unique document number. Preferably, the second document may be assigned a unique document number. Preferably, the at least second document may include a plurality of second documents, and each second document is assigned a unique document number.

Preferably, the first document may be assignable with a status having first or second value, the first value indicative that the first document is determined to be acceptable by the user, and the second value indicative that the first document is determined to be unacceptable by the user.

Preferably, the second document may be assignable with a status having first or second value, the first value indicative that the second document is determined to be acceptable by the user, and the second value indicative that the second document is determined to be unacceptable by the user.

Preferably, the first and second documents may digitally be configurable to be downloaded as DOCX or PDF file format.

Preferably, the first and second documents may be downloadable if the respective statuses are assigned with the first value.

Preferably, the method may further comprise: (v) enabling editing by the user for the answers stored in at least one of the first document and the second document.

Preferably, the at least second document may include a plurality of second documents, and the method may further comprise: (v) enabling editing by the user for the answers stored in each second document.

Preferably, the method may be arranged to be executed on a server configured for cloud-based computing, and the executed method may be provided as a Software as a Service.

Preferably, the international standard may include a standard developed and published by the International Organization for Standardization. It should be apparent that features relating to one aspect of the invention may also be applicable to the other aspects of the invention.

These and other aspects of the invention will be apparent from and elucidated with reference to the embodiments described hereinafter.

Brief Description of the Drawings

Embodiments of the invention are disclosed hereinafter with reference to the accompanying drawings, in which:

FIG. 1 is a flow diagram of a process for login to first software configured based on a computer implemented method for generating a plurality of documents related to compliance with an international standard, according to a first embodiment.

FIG. 2 is a flow diagram of a process for configuring company settings, via the first software.

FIG. 3 is a flow diagram of a process for configuring an organisation chart, via the first software.

FIG. 4 is a flow diagram of a process for setting up QMS, via the first software. FIG. 5 is a flow diagram of a process for editing QMS, via the first software. FIG. 6 is a flow diagram of a process for viewing documents, via the first software.

FIG. 7 is a flow diagram of a process relating to showing compliance progress, via the first software.

FIG. 8 is a flow diagram of a process for checking notifications, via the first software.

FIG. 9 is a flow diagram of a process for auditing, via the first software.

FIG. 10 is a flow diagram of a process for contacting helpdesk, via the first software.

FIG. 1 1 is a flow diagram of a process for managing projects, via the first software.

FIG. 12 is a flow diagram of a process for login to second software configured based on a computer implemented method for generating a plurality of documents related to compliance with an international standard, according to a second embodiment. FIG. 13 is a flow diagram of a process for configuring company settings, via the second software.

FIG. 14 is a flow diagram of a process for setting up QM, SOPs and editing QMS, via the second software.

FIG. 15 is a flow diagram of a process for reviewing and exporting documents generated, via the second software.

FIG. 16 is a flow diagram of the computer implemented method on which the second software is based.

Detailed Description of Preferred Embodiments

Any reference hereinafter to the expression 'website' is to be construed to imply a reference to an online platform connecting the following elements together, in the form of but not limited to a usable HTML, CSS, sass, PHP or similar scripts compatible of operating on multiple computing devices:

• 'Document generator engine' includes combinations of workflow arranged to utilise answers submitted by users to generate customised documents by replacing default values stored in templates;

• 'Online server', which may include but is not limited to an associated server or third-party database, is used for purpose of hosting the engine information, generated document values and any other files deemed appropriate to be hosted separately; and

• Other information and instructional know-hows towards proper usage of the engine.

Any reference hereinafter to the expression 'mobile application' is to be construed to imply a reference to a packaged application operating on mobile systems such as Apple™ iOS™, Android™, Windows™, or similar output compatible of operating on multiple computing devices including, but not limited to, mobile devices, tablets or the like. Usage of mobile applications may be for similar purposes as the website described above.

Any reference hereinafter to the expression 'platform' is to be construed to imply a reference to the entire cloud software including the 'Document generator engine' and the 'Online server' described above, which receives data input from users, and returns the compiled output.

Any reference hereinafter to the expression 'Quality Management System (QMS)' is to be construed to imply that the QMS is part of the documented requirements in order for an entity (e.g. a company) or a product to achieve a certain level of quality standard. Adopting an internationally-recognised standard is often used to demonstrate that the entity's QMS achieves compliance and is usually certified by auditors.

Any reference hereinafter to the expression 'QM' is to be construed to imply Quality Manual, which includes some documents as part of the Quality Management System (QMS).

Any reference hereinafter to the expression 'SOP' is to be construed to imply Standard Operating Procedure, which includes some documents as part of the Quality Management System (QMS).

Any reference hereinafter to the expression 'Wl' is to be construed to imply Work Instruction, which includes some documents as part of the Quality Management System (QMS).

Any reference hereinafter to the expression 'Forms' is to be construed to imply that the forms are documents as part of the Quality Management System (QMS).

According to a first embodiment, there is disclosed a computer implemented method for generating a plurality of documents related to compliance (by an entity/product) with an international standard. The international standard may include a standard developed and published by the International Organization for Standardization (ISO), or the like. It is to be appreciated that entity refers to a legally incorporated entity, such as an incorporated company/business. A corresponding first software (not shown) is implemented based on said method, and flow processes pertaining to the software are described below with reference to FIGs. 1 to 1 1 .

FIG. 1 shows a flow diagram 100 of a process for login to the first software, which is hosted on a server configured for cloud-based computing, and in one example, the software is provided as a Software as a Service (SaaS). The first software may have a commercial name of "Stendard". A user uses a computing device for the login via a website/mobile application through which the first software is configured to be accessible. The user is then requested to login to his account. The first software is configured to screen the user to validate whether the user has valid login credentials, wherein failure to detect valid login credentials consequently results in the user being requested to register for an account by contacting a sales team in charge of the first software, or by contacting the user's company's administrator for further assistance (i.e. this is for existing subscribers of the first software).

Upon successful login to the account, a Dashboard (page) of the first software is displayed to the user, where digital links for the following functionalities (but not limited to as such) are presented on screen to the user: "Company settings", "Organisation Chart", "Set up QMS", "Edit QMS", "View All documents", "Compliance Progress", "Notifications", "Audits", "Speak to us", and "Manage Project". It is to be appreciated that once an associated link is clicked by the user, the related page is then shown (by the first software) to the user (e.g. clicking on the "Company settings" shows the "Company settings" page to the user). This is to be understood for the relevant description hereforth below, even if this aspect is not explicitly stated.

FIG. 2 depicts a flow diagram 200 of a process for configuring company settings, via the first software (i.e. "Company settings" link). In this case, the first software is configured to provide hints and guidance (where necessary) to guide the user to begin furnishing data of company information, when the "Company Settings" link is selected. Company information refers to data pertinent to the company at where the user is employed, and that the company is applying for the compliance certification. Specifically, if the user is an appointed administrator of the company, the user is guided to fill in all relevant company information and upload a logo of the company onto the server. Upon completion of providing the data, all the furnished data are locked by the first software to prevent accidental editing of the data by other users. It is to be appreciated that the locked data are not editable by all types of account permission granted by the first software. If is necessary to edit any of said data, the user is then required to contact the software team running the first software to make direct backend edits. This feature is implemented to protect any sensitive data involved and also to prevent the first software from generating voluminous amounts of incorrect company data that may digitally corrupt other related documents to be generated by the first software.

Also, if the user is an administrator of the company, the user is presented with an option if he wishes to make changes to a user account list. For this function, administrators are able to create more accounts for their colleagues, or make edits to any information furnished to the first software. Where a new account is to be created, the new user's name, email and permission level are required and a notification email is then sent to the new user to complete the account set up via the first software. Once completed, the user is then guided to an optional next step of creating the Organisation Chart", as depicted in FIG. 3 which is a flow diagram 300 of a process for configuring an organisation chart (of the company), via the first software.

Referring to FIG. 3, the creation of an organisation chart begins by providing a default layout of a typical organization to the user, in which the default layout includes the following five departments: Management, Administration, QA & RA, Product Development and Business Development. Respective suggested designations of the Head of Department (HOD) are also provided under this default layout. Hereon, elaborate and hints are strategically provided by the first software throughout the process in FIG. 3 to guide the user through the different steps to ensure full understanding and conformance. The user is also permitted to make edits to the default layout by adding new departments/designations, editing department/designation labels and/or removing completely unrelated departments/designations. As mentioned, hints are provided to advise the user on the typical organizational set up of a company and the required functionalities in order to attain conformance to the international standard, which the company is applying to get certified. The hints include respective names of departments, suggested designations of respective HODs, suggestions on roles and responsibilities of employees, types of documents attached to each department, functional roles of smaller teams on an organisation chart designed for typically larger teams, or the like. Once the organization chart has been created by the user for his company, the completed organisation chart is exported as an image, which is to be used in some required documents for certification compliance with the international standard. The process in FIG. 3 is continued by checking against the account list generated via the "Company Setting" functionality, and to ensure that details of organization teams of the company are fully furnished; otherwise, the user is reminded to fill in any missing information in order to continue with the workflow.

FIG. 4 is a flow diagram 400 of a process for setting up QMS, via the first software (i.e. "Set up QMS" link). The process begins with showing the completed organisation chart and progress bar of each department (of the company). The purpose of the progress bar is to trace a progress of completion for the Quality Manual (QM) and Standard Operating Procedures (SOPs), thereby providing a feedback to the entire team (of the company) regarding the progress towards completion. Selecting any of the department leads the user to a list of documents designated under the charge of the department. The list includes information such as document number, name, progress percentage, revision number and date of last revision. All the QM, SOP, Wl & Forms of each department are shown in a list (displayed on the first software), with different tabs segregating the individual type of document. If the 'Form' tab is selected, the first software is configured to retrieve the list of available forms to the user. Upon selecting a form from the list, a brief description of the form (and its prerequisites, if any) is provided to the user to indicate a basic outline of the form and its purpose.

Next, the process in FIG. 4 is continued by the first software providing a list of questions to obtain respective answers from the user for generating the selected form. The answers provided are compiled and presented in a 'Preview' section for the selected form to be generated. At this point, the user is able to decide whether to save the form as a draft version or to be exported. Then, if the 'QM' or 'SOP' tab is selected, the first software retrieves the list of available QM or SOP to the user. Upon selecting a choice out of the list, a brief description of the document is provided to indicate a basic outline of the document and its purpose. The process in FIG. 4 is further continued by a list of questions provided by the first software to obtain respective answers from the user in order to generate the selected QM or SOP document. The answers provided are compiled and presented in a 'Preview' section for the selected QM or SOP document to be generated. At this point, the user is able to decide if the QM or SOP document is to be saved as draft version or be exported. If the document is selected to be exported, a document number and revision number are issued and a 'Document Change Process' form is generated automatically for printed use as a hardcopy for approval by the management of the company. If the 'WT tab is selected, the first software is arranged to offer an option for the user to add new Work Instruction (Wl) document. A brief description of how to use a Wl is given to the user to provide a basic outline and its purpose. The process in FIG. 4 is continued by a list of questions being provided by the first software to obtain respective answers from the user for generating the Wl document. At each step, a choice to import an image is provided so that the user is able to upload images to accompany a work step. Upon completion of all required steps, the information collected are compiled and presented in the 'Preview' section for the Wl document. At this point, the user is able to decide if the Wl document is to be saved as draft version or be exported. If the Wl document is to be exported, a document number and revision number are issued and a 'Document Change Process' form is generated automatically for printed use as a hardcopy for approval by the management of the company. If any of the QM, SOP, Wl or Forms are determined by the administrator to be irrelevant to (existing operations/workflows practiced by) the company, the administrator is then able to select 'Edit' in the Tabbed List and thereafter be guided towards "View all documents" (to be elaborated below). The user may also be guided to the next section of "Edit QMS", if necessary.

Accordingly, FIG. 5 shows a flow diagram 500 of a process for editing QMS, via the first software (i.e. "Edit QMS" link). In connection, FIG. 6 is a flow diagram 600 of a process for viewing documents (i.e. "View All documents" link). The process of FIG. 5 begins with the tabbed list of documents mentioned above. The tabbed list includes documents from all the departments and includes information such as document number, name, progress percentage, revision number and date of last revision of the respective documents. If the 'QM' or 'SOP' tab is selected, the first software retrieves the list of completed QM or SOP documents to the user. Upon selecting a choice from the list, a preview section is displayed to the user. The process in FIG. 5 is continued when the user selects to edit a selected document. A whole list of questions and the respective answers previously provided by the user are compiled in a single page (displayed on the first software), allowing the user to directly edit values of the respective answers. Upon completion and selection of "Confirm and Preview" button, the edited document is displayed in the 'Preview' section again. At this point, the user is able to decide if the edited document is correct and then to be saved as draft version or be exported as new revision. If the document is to be exported, a new revision number is then issued and a 'Document Change Process' form is generated automatically for printed use as a hardcopy for approval by the management of the company.

If the 'Form' tab is selected, the first software retrieves the list of completed Forms for the user. Upon selecting a choice from the list, a preview section is displayed to the user. The process in FIG. 5 is continued when the user selects to edit the selected form. A whole list of questions and the respective answers previously provided by the user are compiled in a single page, allowing the user to directly edit values of the respective answers. Upon completion and selection of "Confirm and Preview", the edited form is displayed in the 'Preview' section again. At this point, the user is able to decide if the edited form is correct and should be saved as draft version or be exported. If the document is to be exported, the new values are accepted as the latest copy and the old values are subsequently saved as a previous revision.

If the 'Wl' tab is selected, the first software retrieves the list of completed Wl documents for the user. On selecting a choice from the list, a preview section is displayed to the user. The process in FIG. 5 is continued when the user selects to edit the selected Wl document. A whole list of questions and the respective answers previously provided by the user are compiled in a single page, allowing users to directly edit values of the respective answers. Upon completion and selection of "Confirm and Preview", the edited Wl document is displayed in the 'Preview' section again. At this point, the user is able to decide if the edited Wl document is correct and should be saved as draft version or be exported as new revision. If the Wl document is to be exported, a new revision number is issued and a 'Document Change Process' form is generated automatically for printed use as a hardcopy for approval by the management of the company. In a case where the user selects "View all Documents" link from the Dashboard, the process is continued to the tabbed list of documents, showing all QM, SOP, Wl and Forms generated so far by all the departments of the company. The process is continued by the first software doing a backend check on whether the user is an administrator or a normal user. Administrators are allowed to hide any documents irrelevant to the company and to show any hidden documents, which certain users may find to be relevant. This is important as the percentage of progress for the entire project is based on a number of documents completed and the total number of "shown" documents. The process is continued to this step if the administrator selects to hide a document. An immediate check is performed by the first software to determine if the document has already been completed previously. Hiding a completed document has the effect of obsoleting the document (based on how the first software is currently devised), while hiding an uncompleted document disables the document immediately (which is then shown greyed out to the user).

Alternatively, if the administrator selects to show a document, an immediate check is performed by the first software to determine if the document has already been completed previously. Showing a completed document un- obsoletes the document and the document retains its original document and revision number, while showing an uncompleted document would enable the document immediately.

If the user is not an administrator, the user is consequently allowed only to edit, or to view and export a document from the tabbed list. If the latter option is selected, the document is previewed to the user and an option is given to the user to re-export the document again. But if the former option is selected, the user is directed to the section "Edit QMS" described above. In certain instances, the user is able to assign the task to another colleague and set deadlines for completing the task. Users assigned the task are notified via email via the "Notifications" functionality described below.

FIG. 7 illustrates a flow diagram 700 of a process relating to showing compliance progress, via the first software (i.e. "Compliance Progress" link). Specifically, the user is able to select the "Compliance Progress" link from the Dashboard and the first software then conducts a backend check on whether the user is an administrator or a normal user. An administrator is granted access to full progress bar of the entire QMS, progress of each department, and last updated document and revision. On the other hand, a normal user is granted access to only view the progress of the department he belongs to, his allocated document and deadline for each task. Then, the user is able to select the "Notification" link from the Dashboard, in which the flow continues to an inbox set up for the user, which contains all notifications for the said user. In relation, FIG. 8 is a flow diagram of a process for checking notifications, via the first software (i.e. "Notifications" link). Allocated tasks, reminders, deadlines and all other types of notification for the user are compiled in the inbox. Moreover, the user is able to configure email settings and mail frequency from inbox, as well as to view notifications that were sent to other users and to view the overall work progress. Tasks that have been completed may be checked by the user too. In certain instances, the process in FIG. 8 continues to a "Draft" list within the "Notification" page. If any user generates any documents up until the preview page, but did not export the documents successfully, the documents are placed in a list of draft works, which can be continued or deleted completely.

FIG. 9 is a flow diagram 900 of a process for auditing, via the first software (i.e. "Audits" link). Particularly, the user is able to select the "Audit" link from the Dashboard, and the process is continued to various options of "Past Audits", "Upcoming Audits" and "Edit Auditor View" displayed on the relevant page. Selecting the "Past Audits" option shows all results and records of past audits. Selecting the "Upcoming Audits" option displays all information of any upcoming audit, like dates, auditor's company, nature of audit (i.e. internal/external), and any other additional comments. Selecting the "Edit Auditor View" option directs the user to the section "View all Documents" page explained above, and allows the administrator to hide or show any documents.

FIG. 10 is a flow diagram 1000 of a process for contacting helpdesk, via the first software (i.e. "Speak to us" link). The user is able to select the "Speak to us" link from the Dashboard and then an online messenger pop-up is shown to the user which enables him to send a digital message or query to a technical help team in charge of the first software. If a technical staff is online, the staff starts an online chat with the user to provide immediate direct assistance to the user. But if the technical staff is unable to provide any useable solution for the user, a digital 'ticket' is issued for the query. If no technical staff is online, a 'ticket' is also issued for the query, which triggers an online notification to the technical team that allows the technical team to later discuss and respond to the query, when at least one technical staff becomes available for assistance. If there is a situation whereby the problem posed in the query is temporarily unsolvable due to technical limitations, the problem is recorded and the technical team conducts a follow up once there are sufficient updates or a solution is found for the problem. All problems that have been solved are also logged by the first software and the respective solutions recorded for future references.

FIG. 1 1 is a flow diagram 1 100 of a process for managing projects, via the first software (i.e. "Manage Project" link). The user is able to select the "Manage Project" link from the Dashboard, and the list of documents required to be set up and maintained throughout the lifecycle of the product is displayed to the user. By selecting each individual document, the first software links the user to begin populating the content using the same interface. The forms are viewable in the "Preview" section and may be saved as draft version or be exported as a new or as an updated copy.

Further embodiments of the invention will be described hereinafter. For the sake of brevity, description of like elements, functionalities and operations that are common between the embodiments are not repeated; reference will instead be made to similar parts of the relevant embodiment(s).

According to a second embodiment, there is disclosed a variant computer implemented method 1600 for generating a plurality of documents related to compliance with an international standard. Similarly, a corresponding second software (not shown) is implemented based on the variant method 1600, and operating processes of the software are described below with reference to FIGs. 12 to 16.

FIG. 12 shows a flow diagram 1200 of a process for login to the second software, which is also provided as a Software as a Service (SaaS). It is highlighted that the present process corresponds to the portion of the process in FIG. 1 , depicted in dotted lines. In this instance, if the user is previously subscribed as a paid user, the user is then directed to the Dashboard. On the other hand, if the user is signing up for a new account, the user is provided a choice of whether to start with a free trial, or to subscribe to a paid account. It is to be appreciated that for the free trial, usage limit is capped. Further, any consultant using their own assigned consultant's account may also edit the existing templates library, and use them for their clients by paying the subscription. The consultant is then able to access the account of their client after payment is made, in which they are then directed to the Dashboard.

FIG. 13 is a flow diagram 1300 of a process for configuring company settings, via the second software. It is highlighted that this process corresponds to the portion of the process in FIG. 2, depicted in dotted lines. Briefly, the user is directed to sequentially furnish data of the company information. Upon completion, the data are digitally locked and no further modifications are allowed. Thereafter, the user is directed to a process for setting up QM, SOPs and editing QMS, which is depicted in a flow diagram 1400 of FIG. 14.

Similar in the first embodiment, Quality Manual (QM) is the first document to be set up. An introduction text is first provided, followed by a series of questions and answers (to be provided by the user) that determines content of the QM document. At this point, the second software may be configured to suggest recommended answers to the user; this aspect will be elaborated below. Subsequent previewing of the QM document allows the user to make amendments, if necessary. Once the content of the QM document is determined to be correct and acceptable, the user is given a choice to assign a document number to the QM document. Thereafter, the user may choose to change the status of the document by selecting "Mark as Reviewed". This step is optional because certain users may have a preference to let their advisor/consultants mark the document instead. Upon completion, the user is led to set up at least one SOPs document(s). The entire process of setting up the SOPs documents is similar to setting up the QM document, except that upon completion of providing answers to the questions for the SOPs documents, the user is led to a process for reviewing and exporting documents. It is to be appreciated that there may be varying numbers of SOPs recommended to each user's organisation, based on their answers given in the Q document.

It is to be appreciated that the process of editing QMS (i.e. labelled as "Edit QMS" in FIG. 14) largely corresponds to the portion in dotted line in FIG. 5, but with some new steps added. The new steps collectively correspond to a way of editing the document. Under the first embodiment, the only way to change content of the document is through modifying the answers in the questions and answers (Q&A) segment. If the user chooses to edit the QMS through conventional approach of "Edit Q&A", the entire list of Q&A records is presented to the user to be modified. For this purpose, the second software may also suggest recommended answers to the respective questions to assist the user. With the new way of document modification, the user can choose to directly edit the text of the entire document to make further modifications. Upon completion, the user is directed to the "Review Process", in which the user is given a choice to mark a document as "Reviewed" or let the advisor/consultant make the change instead. Specifically, each document is assignable (by the second software) with a status having first or second value; the first value indicates that the document is determined to be acceptable by the user (i.e. "Reviewed"), whereas the second value indicates that the document is determined to be unacceptable by the user (i.e. not "Reviewed").

It is to be highlighted that recommendation of answers by the second software is a new implemented feature that enables answer recommendations to be made to users. The suggestions are made with statistical reference to a historical database of answers. That is, by observing a majority of answers furnished by different users, the second software is able to collate the data and to observe a pattern based on percentages, i.e. if a majority of an individual answer categorically falls into a small range of values, the pattern is manually detected and incorporated into an algorithm to make recommendation to users. Needless to say, the recommendation of answers further contributes to the hints and guidance that the second software is already configured to provide to users.

FIG. 15 is a flow diagram 1500 of a process for reviewing and exporting documents generated, via the second software. It is to be appreciated that this process is a new addition (with reference to the first embodiment), where all QM, SOPs, Forms (templates) and Work Instruction (templates) are listed with all the status of each document shown. The user is able to preview any of the documents and make amendments by using afore described process of editing QMS. The next verification is whether the documents are marked as reviewed. At this stage, the user is still able to mark individual documents as "Reviewed". This is a crucial step as documents without the "Reviewed" status are not included in the list of documents to be exported.

Upon the user clicked a button labelled as "Export as Package", the entire list of documents are downloaded on the user's computing device, correctly segmented into respective folders which includes, but not limited to "Quality Manual", "Standard Operating Procedures (SOPs)", "Forms" and "Work Instruction", as well as the choice of downloading the documents as "DOCX" or "PDF" file format.

With reference to FIG. 16, the variant method 1600 broadly comprises: at step 1602, providing information related to an entity by a user; at step 1604, receiving respective answers provided by the user to a first plurality of questions provided by the method to generate a first document, which is arranged with the answers to describe processes and procedures within the entity as part of the compliance; at step 1606, receiving respective answers provided by the user to a second plurality of questions provided by the method to generate at least a second document, which is arranged with the answers to facilitate implementation of a set of standard operating procedures within the entity as part of the compliance, the standard operating procedures further determined based on the answers provided at step 1604; and at step 1608, configuring the first and second documents to be downloaded to a computing device of the user. The method 1600 is further configured to provide recommended answers at steps 1604 and 1606 to the user, using statistical reference to a historical database of answers.

In summary, the proposed first and second software (using the disclosed methods) adopt a tutorial-based question and answer (Q&A) methodology to collect and collate answers from users and subsequently store the collated answers into a library of templates, which are utilised to generate the documents. The generated documents are also neatly maintained digitally to provide strong guidance and control for subsequent document editing, versioning and exporting for audits/certifications. Additionally, the first and second software are implemented as a fully cloud-based online system for quick generation and efficient management of created documents to facilitate an entity to achieve or stay compliant with international standards, directives, regulations or laws. So the first and second software may also be termed as a Compliance Software as Service system (ComSaaS).

It is to be appreciated that the first and second software may have one or more of the following characteristics:

• Enable a quick and standard way of generating and managing compliance documents to equip users with an efficient tool to generate a large amount of compliance documents in a standardised and approved format, providing consistency in output to the users.

• The software are configured to be hosted on cloud servers, allowing users to have full access to the software from any location and at any time. The cloud servers are arranged to host the website (through which the software may be accessed), backend framework and related databases. This way, high availability of the software is ensured.

• A tutorial-based education module is arranged within the software, and is devised to ensure users get trained up to have good knowledge of the QMS system and to have the necessary skillsets to maintain the QMS system within their company with the acquired knowledge and capability. The users are further assisted by ease of creating and managing compliance documents using the software.

• The question & answer (Q&A) style of data collection offers strong assistance and usefully guide the users to fill in the appropriate answers. The answers are used to efficiently fill up the respective compliance documents. Hence, this allows any layman to quickly get up to speed with the knowledge to handle the entire QMS system in a systematic and guided manner. • As explained, hints are strategically suggested by the software to assist users during the Q&A data collection phase. The hints are configured to appear upon detecting mouse-over actions on answer columns (in which answers are to be filled in), showing examples and commonly filled answers that work as recommendations. In some cases, hints may be used to explain the entire section, if that section is elaborate and tricky in nature to answer.

• It is recognised that many users still prefer to have their compliance documents managed in a structured and optimised workflow, but in hardcopy format. Accordingly, the disclosed software has been devised to also properly allow users to exercise their preferences, without jeopardising quality of work and management of the entire QMS.

• Users may access the software and perform their tasks through mobile computing devices, thus enabling convenience of working on the compliance documents anytime and anywhere.

• Users may be notified and/or reminded via emails or messages over associated mobile applications (used to access the software) when a task is assigned to him/her has a deadline tagged to the task.

While the invention has been illustrated and described in detail in the drawings and foregoing description, such illustration and description are to be considered illustrative or exemplary, and not restrictive; the invention is not limited to the disclosed embodiments. Other variations to the disclosed embodiments can be understood and effected by those skilled in the art in practising the claimed invention.