ISO 9001:2008 CLAUSE NUMBER


                                                                                                                                             4.1
QMS (Quality Management System)
Define your working system as a series of processes and identify the criteria to measure the effectiveness of each process. (E.g Timely delivery etc)
4.1
QMS (Quality Management System)
Proper controls like supervision, inspection, training, documentation etc. should be exercised on outsourced (Subcontracted) processes to ensure acceptable results.
4.2
Documentation Requirements
Say what you do – in your documents. (E.g. methodology, Procedures, Drawings, Specifications)
4.2
Documentation requirements
Document your working system as quality manual, procedures and work instructions.
4.2.3
Control of Document
Only approved current documents should be made a                                                                                                                       vailable for work. (Eg. Drawings, Specification, Procedures etc.)This includes external standards also.
4.2.4
Control of records
Prove that you are following the system by maintaining appropriate records.
5.2
Customer focus                                                                                                                
Set targets to   enhance customer satisfaction. (E.g. better products, better delivery)
Ensure that everyone focuses on satisfying customer needs (both internal and external).
5.3
Quality Policy
Express your overall intention and direction towards Quality Improvement and customer satisfaction.
5.4.1
Quality Objectives
Set measurable objectives & targets for improvement. (E.g. reduce complaints, reduce inventory) It should cover relevant functions
5.4.1
Quality Objectives
Targets for improvement should be time bound. (That is “before 31.03.200--)
5.4.2
QMS planning
Prepare your system so as to meet the requirements of 4.1 and also your quality objectives.
In case you make changes in your system also ensure the above. Do not change your actual practice in ad hoc basis.
5.5.1
Responsibility & Authority
Communicate limits of responsibility and authority what is expected from each post in your organization.
5.5.2
Management Representative
Appoint an internal co-coordinator for implementing & following up ISO 9001 QMS
5.5.3
Internal communication
Activate top down and bottom up communication. Discuss about effectiveness of the organization.
5.6
Management Review
How is your organization performing as per your declared system? – Check. Make decisions for improvement
6
Resource Management
Identify and provide necessary resources. (Manpower equipment & other facilities)
6.2.2
Competence ,training and awareness
Identify the education skill training and experience needed for each job. Put the right person on the right job. Ensure that everyone is aware of improvement targets.
6.2.2
Competence awareness & training
Identify training needs based on skill gap, carry out training, verify effectiveness of training
6.3
Infrastructure
Give necessary building, work space, utilities transport and communication facilities and maintain them properly
6.4
Work Environment
Sanitation, dust free conditions, lighting, ventilation, humidity control, safety etc as needed for the work to be done properly
7.1
Planning of product realization
Define your SPECIFICATION, MANUFACTURING METHODS, And TESTING METHODS.
7.2.2
Customer requirement review
Query your customer at your threshold. Do not accept impossible orders.
7.3
Design control
Plan, Input, Output, review, verify and validate your product design and Control of Design &Development.
7.4
Purchasing
Select suitable suppliers and subcontractors.
Carry out rating of subcontractors /suppliers.
Ensure that they are informed about the controls they are expected to follow while executing your requirements.
7.5.1
Control of production
Do what you say – follow your documents while doing your work
7.5.2
Validation of processes
Carry out special processes (whose results are difficult to verify immediately) under controlled conditions.
7.5.3
Identification & Traceability
A place for everything and everything in its place. Allot batch number for traceability
7.5.3
Identification & Traceability
Templates, Jigs & fixtures should bear proper identification. Use tags labels and boards to show inspection status of the material
7.5.4
Customer property
Take care of customer’s belongings. (E.g. tools, packing material, labels etc.) servicing items also
7.5.5
Preservation of product
Ensure Proper handling and storage practices otherwise defects will arise.
7.6
Control of monitoring & measuring Equipment
Are your instruments telling the truth? (Proper Instrument Selection & Calibration). Calibrate your instruments against gauges that are traceable to national and international standards.
8.2.1
Customer satisfaction
What does the customer think / feel about us? Does the customer feel satisfied?Listen to your customer’s voice. What are the changes in customer needs?
8.2.2
Internal audit
Are procedures / defined processes followed and objectives achieved? Report lapses in audit report. Depending upon the audit frequency fixed by the Management
8.2.3
Monitoring & Measurement of process
Monitor and control your processes to achieve desired results. In case results are not ok, take action for improvement
8.2.4
Monitoring & Measurement of product
Is the material / product acceptable? (As per our own specifications or as agreed with the customer) Check against the quality plan and record it. Do not allow non-conforming product to the next stage.
8.2.4
Monitoring & Measurement of product
Product / service delivery should be carried out only after ensuring that all specifications are met.
8.2.4
Monitoring & Measurement of product
Only authorized persons should inspect and certify product’s / service acceptance.
8.3
Control of non conforming product
Segregate & REGRADE, SCRAP, ACCEPT CONCESSIONALLY OR REWORK defects. Market returns are also to be treated in the same way
8.4
Analysis of data
How well (or how badly) are we doing? Measure your performance (timely delivery, productivity, customer complaints etc), as an aid for improvement Is the level of defects increasing? Monitor supplier and subcontractor performance trends.
8.5
Improvement
Improve your performance through systematic analysis and action. Make improvement time-bound
8.5.2
Corrective action
Find out why you have failed and ensure that it is not repeated. Take action on the root cause of nonconformities, which have occurred.
8.5.3
Preventive action
Find out how you may fail and ensure that failure is avoided. Take action on the root cause of probable nonconformities