ISO 9001:2008

i am starting with a brief on the iso9001:2008 version. pl give your views

ISO 9001:2008 IN A NUTSHELL

Sl. No.	ISO 9001 Clause	ISO 9001 Clause Title	Stipulation in simple words
1.	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)
2.	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.
3.	4.2	Documentation Requirements	Say what you do – in your documents. (E.g. methodology, Procedures, Drawings, Specifications)
4.	4.2	Documentation requirements	Document your working system as quality manual, procedures and work instructions.
5.	4.2.3	Document Control	Only approved current documents should be made available for work. (Eg. Drawings, Specification, Procedures etc.)This includes external standards also. The organisation will need to control other external origin documents necessary for planning and operation of QMS. This can even include excise regulations.
6.	4.2.4	Control of records	Prove that you are following the system by maintaining appropriate records.
7.	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).
8.	5.3	Quality Policy	Express your overall intention and direction towards Quality Improvement and customer satisfaction.
9.	5.4.1	Quality Objectives	Set measurable objectives & targets for improvement. (E.g. reduce complaints, reduce inventory) It should cover relevant functions
10.	5.4.1	Quality Objectives	Targets for improvement should be time bound. (That is “before 31.03.200--)
11.	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 practise in ad hoc basis.
12.	5.5.1	Responsibility & Authority	Communicate limits of responsibility and authority what is expected from each post in your organisation.
13.	5.5.2	Management Representative	Appoint an internal co-ordinator for implementing & following up ISO 9001 QMS. MR shall be a member of the organisation’s own management
14.	5.5.3	Internal communication	Activate top down and bottom up communication. Discuss about effectiveness of the organisation.
15.	5.6	Management Review	How is your organisation performing as per your declared system? – Check. Make decisions for improvement
16.	6	Resource Management	Identify and provide necessary resources. (Manpower equipment & other facilities)
17.	6.2.2	Competence awareness & training	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. Competence requirements shall be relevant for any personal who are included in implementation of QMS.
18.	6.2.2	Competence awareness & training	Identify training needs based on skill gap, carry out training, verify effectiveness of training
19.	6.3	Infrastructure	Give necessary building, work space, utilities transport, information system and communication facilities and maintain them properly
20.	6.4	Work Environment	physical, environmental and other factors such as noise, temperature, lighting or weather Sanitation, dust free conditions, ventilation, humidity control, safety etc as needed for the work to be done properly
21.	7.1	Planning of product realisation	Define your SPECIFICATION, MANUFACTURING METHODS, And TESTING METHODS.
22.	7.2.2	Customer requirement review	Query your customer at your threshold. Do not accept impossible orders.
23.	7.3	Design control	Plan, review, verify and validate your product design.
24.	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.
25.	7.5.1	Control of production	Do what you say – follow your documents while doing your work
26.	7.5.2	Validation of processes	Carry out special processes (whose results are difficult to verify immediately) under controlled conditions.
27.	7.5.3	Identification & Traceability	A place for everything and everything in its place. Allot batch number for traceability
28.	7.5.3	Identification & Traceability	Templates, Jigs & fixtures should bear proper identification. Use tags labels and boards to show inspection status of the material
29.	7.5.4	Customer property	Take care of customer’s belongings. (E.g. tools, packing material, labels, personal data (for BPOs & IT companies) etc.) servicing items also
30.	7.5.5	Preservation of product	Ensure conformity to requirements, Proper handling and storage practices otherwise defects will arise.
31.	7.6	Control of monitoring & measuring equipments	Are your instruments telling the truth? (Proper Instrument Selection & Calibration). Calibrate your instruments against gauges that are traceable to national and international standards.
32.	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?
33.	8.2.2	Internal audit	Are procedures / defined processes followed and objectives achieved? Report lapses in audit report.
34.	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
35.	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.
36.	8.2.4	Monitoring & Measurement of product	Product / service delivery should be carried out only after ensuring that all specifications are met.
37.	8.2.4	Monitoring & Measurement of product	Only authorised persons should inspect and certify product’s / service acceptance.
38.	8.3	Control of non conforming product	Segregate & REGRADE, SCRAP, ACCEPT CONCESSIONALLY OR REWORK defects where practicable. Market returns are also to be treated in the same way
39.	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.
40.	8.5	Improvement	Improve your performance through systematic analysis and action. Make improvement time-bound
41.	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. ... .Verify effectiveness of corrective action.
42.	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. ... .Verify effectiveness of preventive action.

Note:

1. Remember the PDCA (PLAN ,DO CHECK,ACT) cycle in whatever you do on the above steps .
2. The ISO9001 standard is not a replacement of the code of practice and industry standards to be followed by the industry
3. It is an enabler to do things in a systematic manner in a better way.
4. The process approach is to be followed