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Establish a complete and effective medical device regulatory strategy.
Increase product and service quality with Stendard's ISO consulting.
Writing ISO-related Manual, Procedures and etc. Is it really that difficult? The conventional way is.
Fresh to Quality Management Systems? Want to take the leap on your own?
Step 1
Decide on the type of standards and regulations that’s applicable to your company and products
Step 5
Clearly define the content in each of the procedures
Step 2
Establish the relevant scope of business processes
Step 6
Identifying the necessary forms that would be applicable to each business process (there can be up to 70+ to 100+ types of form needed for an entire business operation)
Step 3
Set the parameters within the quality policy and objectives
Step 7
Define the step-by-step instructions needed for each operation within the Work Instructions
Step 4
Decide on the list of procedures that would be applicable for your scope of business, as well as the applicable standards (there are typically 20+ to 40+ procedures or SOPs.
Step 8
Run through a mock audit by ISO consultants to identify and plug the gaps
A common question that we get is whether we provide template documentations.
The short and direct answer to this is — No.
Template documentations are usually provided as an entire folder, with fixed amount of documentation and will also include those documentation that may not be applicable to an organisation. We do not believe in selling template because of the amount of additional customisation needed.
And the worse of all — You won’t know if the content you modified is compliant or not.
We spent years of our consultants’ time and knowledge to put together a documentation bank that reacts to our questionnaire. Depending on different standards, our algorithm (we call him Butler) decides what questions to ask. Based on your answers given, Butler decides which documents apply to you.
Besides the document, the content and form attachments of each procedure is decided by our algorithm, down to every single document page and paragraph that you receive — at >90% accuracy.
Just think of Butler as your reliant consultant that you have been going to for years, but a lot smarter, faster and cheaper.
What’s better? Butler grows smarter each time our client goes through an audit.
Referring back to the 8-steps in the conventional method above, using Stendard Solution™’s Document Generator cuts away the first 6 steps.
So what do you need to do as a user in order to be audit-ready?
Use our document generator to generate each Manual, Procedure, Form Templates and etc.
Define the step-by-step instructions needed for each operation within the Work Instructions
Run through a mock audit by our consultants to identify and plug the gaps
The last 2 steps are completely optional, but we do provide the additional supports to let all our clients reach 100% audit-ready state easily.
Here are the available standards through our Document Generator:
For other standards, do contact us to find out more!
Stendard’s Smart Virtual Assistant is a system allowing users to answer various questions pertaining to their organisation’s structure and requirements. From there, our smart virtual assistant will be able to generate your own customised set of compliance documents in record time.
To pay for your customised documents, simply click on the “get document” button. This will trigger a pop up window with two options namely “free preview” and “get full document content”. Depending on the actions undertaken, paid documents will be generated into your Library module.
KRIS is a windows based database management program with the ability to capture, manage and retain unstructured organisational information. Like a document management software, it helps organisations by effectively managing their data thus providing a sustainable and robust documentation management framework within the organisation.
Although Stendard Solution™ is not based off the KRIS document management system, our software could perform as well, if not better in most aspects when compared.
Unlike other document management software in the market, Stendard Solution™ does not only allow you to store, manage and track electronic documents. We understand that organisations want to build themselves a robust document management system because it is one of the criteria to be ISO certified.
With this in mind, we have created a customised document generator where you can generate ISO related documents based on their unique organisational needs.
Let us show you the difference between the conventional way of generating document versus Stendard’s proprietary document generator.
In order to get an audit-ready set of documentation, these are the generic steps that we observe from every companies:
We spent years of our consultants’ time and knowledge to put together a documentation bank that reacts to our questionnaire. Depending on different standards, our Smart Virtual Assistant decides what questions to ask. Based on your answers given, our Smart Virtual Assistant decides which documents apply to you.
Besides the document, the content and form attachments of each procedure are decided by our algorithm, down to every single page and paragraph that you receive — at >90% accuracy.
Referring back to the 8-steps in the conventional method above, using Stendard Solution™’s Document Generator cuts away the first 6 steps with a cheaper price.
So what do you need to do as a user in order to be audit-ready?
The last 2 steps are completely optional, but we do provide the additional supports to let all our clients reach 100% audit-ready state easily.
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