6.0 ISO STANDARDS : Quality Management System Requirements
6.0 ISO – STANDARDS - 9001 : 2008 Quality Management System Requirements (1) ISO 9001:2008 is part of the ISO 9000 family of Standards, and is the do...
6.0 ISO – STANDARDS - 9001 : 2008 Quality Management System Requirements (1) ISO 9001:2008 is part of the ISO 9000 family of Standards, and is the document that lists the requirements an organization must comply with to become ISO 9001 Registered. ISO 9001 is an internationally recognized Quality Management System. ISO9001 evaluates whether your quality management system is implemented appropriate and effective, as per the requirements of the standard.
eFresh – Empowering Indian Food and Agriculture
Operating Principle: The Plan-Do-Check-Act (PDCA) cycle is the operating principle of ISO’s management system Standards. Its is the most widely used tools for continuous improvement and includes: Plan: Set objectives and make plans Do: implement the plans Check: Measure the current performance against planned objectives Act: Improve the plans for the next implementation and correct outcome improvement. ACT
PLAN
CHECK
DO
eFresh – Empowering Indian Food and Agriculture
Model of a Process –Based Quality Management System Quality Management Systems Continual Quality Management Systems Improvement
Continual Improvement
Quality Management System
Customer
Measurement, Analysis, Improvement
Resource Management
Satisfaction
Requirements
Customer
Management Responsibility
Input Product (and/or service) Realization
Output
Product / Service
Value-adding activities Information flow eFresh – Empowering Indian Food and Agriculture
System approach to management
Principles
Clauses
Continual Improvement QMS
Management Responsibility
Custom er Require ments
Mesasurement
Management
Analysis Improvement
Custom er satisfact ion
A U D I T
input
Design: Lt Col K.Bhaskara Reddy
Resource
Product Realization
PROCESS BASED QMS
PDCA
out put
eFresh – Empowering Indian Food and Agriculture
Development: Bharath
ISO 9001:2008-Structure
1. 2. 3. 4.
The organization need to develop documentation meeting the compliance to the following main requirements in the form of Food Safety Quality Manual with sections such as Policy Document Procedures Work instructions Format Std. Clause
Title of the Clause
1
Scope
1.1
General
1.2
Application
2
Normative reference
3
Terms and definitions
4
Quality management system
eFresh – Empowering Indian Food and Agriculture
ISO 9001:2008-Structure continuation….. Std. Clause
Title of the Clause
4.1
General requirements
4.2
Documentation requirements
5
Management responsibility
5.1
Management commitment
5.2
Customer focus
5.3
Quality policy
5.4
Planning
5.5
Responsibility ,authority and communication
7.2
Customer Related Processes
7.3
Design and Development
7.4
Purchasing
7.5
Production and Service Provision
7.6
Control of Monitoring and Measuring Equipment
8
Measurement, analysis and improvement
eFresh – Empowering Indian Food and Agriculture
ISO 9001:2008-Structure continuation….. Std. Clause
Title of the Clause
5.6
Management Review
6
Resource Management
6.1
Provision of Resources
6.2
Human Resources
6.3
Infrastructure
6.4
Work Environment
7
Product Realization
7.1
Planning of Product Realization
7.2
Customer Related Processes
7.3
Design and Development
7.4
Purchasing
7.5
Production and Service Provision
7.6
Control of Monitoring and Measuring Equipment
8
Measurement, analysis and improvement
eFresh – Empowering Indian Food and Agriculture
Cost of certificate: Cost of certificate depends on number of employees for eg.An organization with one location with 50 employees, the cost of certification will be around Rs.50,000/-(stage 1 & stage 2 assessments). Incase the organization is already registered with another management standard, then reduction of fees is possible up to 20%. However this fees is only for certification and if the organization intends to avail guidance on the implementation then it must appoint consultant separately, which may cost around Rs.50,000 to Rs.75,000/Please note that the certification body should not provide any consultancy as it amounts to conflict of interest and incase if it is done the certification may be cancelled at the request of the accreditation body in case of any complaints.
