Simplicity in Quality Systems

SHOP

Why invent the wheel and spend valuable time

Make use of this well-established benchmark to start with


Purchases from webshop available now

Documents and templates


The documents and templates present in the shop have been established to:

  1. Setup a QMS or QMS processes,
  2. Setup Technical Documentation, or for 
  3. Planning, performing and reporting of audits.


The approach in procedures is activity-based (who does what), and in templates it is evidence-based (what requires to be recorded by whom and how).


The documents and templates are:

  1. Based on the Philosophy of SinQS
  2. Effective in demonstrating the requirements of ISO 13485 and the relevant regulatory requirements (EU and MDSAP related jurisdictions where indicated), and
  3. A starting point for efficiency improvements that typically will be established once experience from use occurs.


In use it's easier to make a document or template first effective and then efficient than the other way around.


REMARK:

The documents and templates are  made with Microsoft Office Applications (Word, Excel, or Powerpoint).

Use the "Contact form" to assess other purchase possibilities. 

Customization


Since every organization is different customization would typically be required.


Therefore, the documents and templates include highlighted sections that require your decision for customization.


Other sections could require customization as well depending on your organization's needs.


The formats used have been established using the Philosophy of SinQS, these formats can be adapted to your preferred formats that fit your organization.


Any changes made without input from SinQS are at your organizations liabiltiy. SinQS is not liable for these changes made.

Use the "Contact form" to assess services provided related to customization and / or training.