ISO 9001 : 2000 - List of Records

Following are the clause wise RECORDS to be maintained as per ISO 9001 : 2000 standard.

01. ISO Clause - 4.2.3 : Record of controlled Documents.
02. ISO Clause - 5.6.1 : Record of Management Review.
03. ISO Clause - 6.2.2 : Human resource records of education, training, skill and experience.
04. ISO Clause - 7.1 : Records providing evidence that product realization processes and resulting product meet requirements.
05. ISO Clause - 7.2.2 : Records of the results of review of requirements related to the product.
06. ISO Clause - 7.3.2 : Design and development inputs relating to the product requirement.
07. ISO Clause - 7.3.4 : Records of design and development review.
08. ISO Clause - 7.3.5 : Design and development verification.
09. ISO Clause - 7.3.6 : Design and development validation.
10. ISO Clause - 7.3.7 : Design and development changes.
11. ISO Clause - 7.4.1 : Records of purchasing process e.g. supplier's evaluation, and action arising out of the same.
12. ISO Clause - 7.5.2 : Records of process validation e.g. process deficiencies become apparent only after the product is in use or the service has been delivered.
13. ISO Clause - 7.5.3 : Product Identification for traceability requirements.
14. ISO Clause - 7.5.4 : Record of customers property to identify, verify, protect and safeguard.
15. ISO Clause - 7.6 : Record of equipments calibration and verification, basis of calibration in the absence of traceable national or international standards.
16. ISO Clause - 8.2.2 : Records pertaining to internal audit, report results as well as follow up activities for verification of the actions taken.
17. ISO Clause - 8.2.4 : Records of monitoring and measurement of product, as evidence of conformance and release of product.
18. ISO Clause - 8.3 : Records of non conforming products, nature of non conformities and actions taken.
19. ISO Clause - 8.5.2 : Records of results of corrective actions taken.
20. ISO Clause - 8.5.3 : Records of results of preventive actions taken.
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Tips to Rememer RECORDS in ISO 9001 : 2000

Anybody tell me, How many types of records to be maintained as per ISO 9001 : 2000 standard?

There are 104 types of records to be maintained as per ISO 9001 : 2000 standard (if applicable).

How to remember it?

Answer is simple....

Just look at the bracket....something could be written there....what is it?

is it (see 4.2.4) word ?

Yes.....

Whenever you see this bracket within the ISO 9001 : 2000 standard, it seems to be records are maintained and its MANDATORY....
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Tips to Remember 6 Mandatory Procedures

As we know that, there are 6 MANDATORY PROCEDURES in ISO 9001 : 2000 Standards. How to remember it forever? Just look at the following word, we came across it at every time :

DRINK

D - stands for "procedure for Control of DOCUMENTS" - ISO Clause No. : 4.2.3

R - stands for "procedure for Control of RECORDS" - ISO Clause No. : 4.2.4

I - stands for "procedure for Control of INTERNAL AUDITS" - ISO Clause No. : 8.2.2

N - stands for "procedure for Control of NON-CONFORMING PRODUCTS" - ISO Clause No. : 8.3

K - stands for "procedure for Control of K = CORRECTIVE and PREVENTIVE ACTIONS" - ISO Clause No. : 8.5.2 and 8.5.3 respectively.


is it really easy to remember? if not, take a glass of wine and ask ourselves "What I am going to do now?"

Finally, you would get the answer......
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ISO 9001 : 2000 - Documents

In generic way, ISO 9001 : 2000 standard require for only those types of documents and records which are objectively essential to serve the purpose of :

1. Meeting the customer's satisfaction and
2. Leading towards the continual improvements.

The documents and the records those are essentially required to meet the responsibilities of standard are as follows :

ISO Clause No. : 4.2.3, Purpose : Documented procedures shall, The Documents : Control of Documents. define the controls needed for the documents and records required by the QMS.

ISO Clause No. : 4.2.4, Purpose : Established documented, The Documents : Control of Records. Procedures for the identification, storage, retrieval, protection, retention time and disposition of quality records.

ISO Clause No. : 8.2.2, Purpose : Documented procedure for, The Documents : Internal Quality Audit. Planning and conducting quality audits and for reporting results and maintaining records.

ISO Clause No. : 8.3, Purpose : Documented procedures shall, The Documents : Control of Non-conforming Products. Define the controls and related responsibilities and authorities for
dealing with non-conforming products.

ISO Clause No. : 8.5.2, Purpose : Documented procedures shall, The Documents : Corrective Action. Define requirements for corrective actions appropriate to the effects of nonconformities encountered.

ISO Clause No. : 8.5.3, Purpose : Documented procedures shall, The Documents : Preventive Action. Define requirements for preventive action appropriate to the effects of the potential problems.

Related Links :

01. Do You Know About QCFI?
02. QCFI and its Contribution to Quality Circle Movement In INDIA
03. Dr. K. Ishikawa : Founder of Quality Circle
04. History of Early 1950's
05. Services Offered By QCFI
06. Tips to Deal With Interruptions
07. Tips to give Good Feedback
08. Benefits of ISO 9001 : 2000 Quality Management System
09. Debatable Points Related to ISO 9001 : 2000 Quality Management System
10. Re-Defined : Quality
11. Job Titles in Quality Field
12. Four Absolutes of Quality Management
13. Crosby's 14 steps to quality improvement
14. Tips to Create Your Own Luck
15. Cost of Poor Quality

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Cost of Poor Quality

COPQ - Cost of Poor Quality is the cost incurred for the repairing of the defective goods.

Cost towards any work that must be repeated is to be seen as COPQ.

For example : a company dispatches an incorrect shipment is to be called back and correct shipment should be sent to the customer. Similarly the returned shipment, is to be sent to the correct customer. These involve a lot of corrective actions, repetition of works already done, re-verification and confirmations.

Every activity involves costs and all are COPQ. Similarly certain costs routinely incurred in a company are accepted as inevitable. For example, cost of redesigning a product due to deficiencies in fitness for use, or cost of changing a manufacturing process because of the inability to meet product specifications. These are seen as normal activities of production, planning and control, but they are really part of COPQ.

To understand COPQ better, one should know about QUALITY COST. Quality cost comprises of
(i) Operating Quality Cost and
(ii) External Assurance Quality Cost.

OPERATING QUALITY COSTS are those costs incurred by a company in order to attain and ensure specified quality levels.

EXTERNAL ASSURANCE QUALITY COSTS are those costs relating to the demonstration and proof required by a customer w.r.t. quality provisions (e.g. cost of testing for a specific parameter at an external agency as demanded by the customer).

Related Links :

01. Do You Know About QCFI?
02. QCFI and its Contribution to Quality Circle Movement In INDIA
03. Dr. K. Ishikawa : Founder of Quality Circle
04. History of Early 1950's
05. Services Offered By QCFI
06. Tips to Deal With Interruptions
07. Tips to give Good Feedback
08. Benefits of ISO 9001 : 2000 Quality Management System
09. Debatable Points Related to ISO 9001 : 2000 Quality Management System
10. Re-Defined : Quality
11. Job Titles in Quality Field
12. Four Absolutes of Quality Management
13. Crosby's 14 steps to quality improvement
14. Tips to Create Your Own Luck

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Tips to Create Your Own Luck

01. Be Proactive :

The unluckiest people are those who wait for things to happen (it often doesn't). Lucky people go out to make them happen.

02. Take Time to Congratulate Yourself:
When something goes well, think about what you have achieved and congratulate yourself. Make your reflections personal, permanent (will continue to be true) and universal (a general achievement- e.g. "I am great at selling", not "that client was nice i that meeting".

03. Don't Take it Personally:
When something goes less well look at it as specific, temporary and external, e.g. "that was a tricky meeting but it's over."

04. Ask Questions, Listen and Gather Information:
If you know about what is going on and what other people are thinking you are more like to be "lucky". For example : "How fortunate you mentioned that just now - I was talking to Megan and...."

05. Recognize the Difference Between "Unlucky" and "Probable"
You aren't unlucky each time you miss a parking space - in fact, it would be extraordinary if you didn't every so often.

06. Change the Way You See Yourself:
By seeing yourself as unlucky you create a self - limiting belief, which becomes re-enforcing. Think of yourself as unlucky and it will become true. This also works the other way around (luckily)

07. Re-frame Failure as an Opportunity to Learn:
The only thing that all successful people have in common is that they made mistakes, and usually quite a lot of them.

08. Move On:
Challenge the value of dwelling on previous misfortunes - there is rarely anything to be gained from it.

09. Share Your Good Luck:
Praise others for their contribution - if people think they will gain from your good fortune then they will do more to make it happen.

10. Work For It:
If all else fails, remember Thomas Eddison's adage:"I"m a great believer in luck, and I find that the harder I work more I have of it"

ABOVE 10 POINTS HELPS TO BUILT GOOD QUALITY ?

Related Links :

01. Do You Know About QCFI?
02. QCFI and its Contribution to Quality Circle Movement In INDIA
03. Dr. K. Ishikawa : Founder of Quality Circle
04. History of Early 1950's
05. Services Offered By QCFI
06. Tips to Deal With Interruptions
07. Tips to give Good Feedback
08. Benefits of ISO 9001 : 2000 Quality Management System
09. Debatable Points Related to ISO 9001 : 2000 Quality Management System
10. Re-Defined : Quality
11. Job Titles in Quality Field
12. Four Absolutes of Quality Management
13. Crosby's 14 steps to quality improvement

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Crosby's 14 steps to quality improvement

01. Management commitment.
02. Develop a quality improvement team.
03. Quality measurement.
04. Cost of quality evaluation.
05. Quality awareness
06. Corrective action.
07. Zero defects planning.
08. Employee education.
09. Zero defects day.
10. Goal setting.
11. Error - cause removal.
12. Recognition.
13. Quality councils.
14. Do it over again.

Related Links :

01. Do You Know About QCFI?
02. QCFI and its Contribution to Quality Circle Movement In INDIA
03. Dr. K. Ishikawa : Founder of Quality Circle
04. History of Early 1950's
05. Services Offered By QCFI
06. Tips to Deal With Interruptions
07. Tips to give Good Feedback
08. Benefits of ISO 9001 : 2000 Quality Management System
09. Debatable Points Related to ISO 9001 : 2000 Quality Management System
10. Re-Defined : Quality
11. Job Titles in Quality Field
12. Four Absolutes of Quality Management

EatonWeb Blog Directory