Information regarding

Documents and templates

In use it's easier to make a document or template

first effective and then efficient

than the other way around

to ensure compliance that benefits your organization.

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) using a flow chart for a visual overview of your process and an activity table to indicate what requires to be performed by who.

The approach in forms/ templates is evidence-based (what requires to be recorded by whom and how) using mostly a "Clear at point of use""One stop shop" and a "One stop shop" approach.

This choice has been made to ensure meeting regulatory requirements to create documents that are presented in a clear, organized, readily searchable and unambiguous manner. 

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.

REMARK:

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

Information regarding

Customization

The documents or templates/ forms

typically never fully fit an organziation

therefore customization is required

Every organization is different therefore customization is typically required.

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 format that fit your organization.

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

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