QMS & Quality Manual

According to ISO, API Standards  a Quality System must be documented. The QMS should have the following documentation,

1. Quality policy

2. Quality objectives

3. Quality manual

4.  Mandatory procedures of ISO 9001 : nonconformity, corrective & preventive action, document control, records management, internal audit. Please refer the Procedures List for all other procedures. 

For API Q1 and Q2: API QMS requires  Risk Management/ Contingency Planning for Product/Service Quality & Delivery as mandatory additional procedures, including other procedures as listed here  API Spec Q1/ Q2 Documented Procedures - List

5. The necessary documents for company business ( Work Instructions/ Method Statements, Procedures, Policies, Inspection Test Plans, Forms, Checklists, etc)

The Quality Manual is describing a QMS-Quality Management System and explains how the QMS should work in an Organization. The Quality Manual can be a single document or collection of individual documents. It can be a in a form of hard copy / Soft copies/ Websites.

A Quality Manual is the top-level document of a Quality Management System. The QMS Standards are specifiying the minimum content to be stated a quality manual,

1. The scope of the Quality Management System
2. Quality Policies/ Objectives or references to them
3. Details and justification of any exclusions
4. Documented procedures or reference to the procedures
5. Risk Assessment and Management (for API Q1 and API Q2 QMS)
6. A description of the process interaction

Our Services:
We prepare and deliver the Quality Manual, Procedures, Forms and other documents requirred by the QMS.  Please contact us to get a Quality Manual & Docs for your specific business need. 

For Queries/ Orders please contact: qaqc.estores@gmail.com

http://www.qaqcdocumentstores.com/