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

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Four Absolutes of Quality Management

01. Quality is defined as conformance to requirements, not as goodness.

02. The system for causing quality is prevention, not appraisal.

03. The performance standard must be zero defects, not that's close enough.

04. The measurement of quality is the price of nonconformance, not indexes.

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

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Job Titles in Quality Field

01. Director :
Coordinates all aspects of the organization's QA/QC program, such as developing and administering the program, training and coaching employees, and facilitating change throughout the organization. Responsible for establishing strategic plans, policies and procedures at all levels to ensure the QA / QC program will meet or internal and external customer's needs and expectations.

02. Vice President :
Establishes the direction for the development and administration for the organization's QA / QC programs. Consults with peers on the attitudes and practices of quality throughout the organization to develop an environment of continuous improvement in every aspect of the company's products and services. Acts as a champion for quality.

03. Manager :
Ensures the administration of the organization's QA / QC program within a defined segment of the suppliers on quality issues.

04. Consultant :
Provide advice, facilitation and training on the development, administration and technical aspects of a company's quality assurance (QA) or quality control (QC) program at any or all levels in the organization. Has an expertise or specialty in some or all aspects of the quality field. Is in the forefront of keeping abreast of changes in his or her field. This person can be from outside the organization or can be an employee.

05. Auditor :
Primarily performs and reports an internal and/or external quality system audits.

06. Associate :
Participates in quality improvement projects but does not necessarily work in a traditional quality area.

07. Analyst :
Initiates and coordinates quality related data from production and service activities and reports these data using statistical techniques.

08. Coordinator :
Collects, organizes, monitors and distributes any information related to the functions of the quality department. Might also communicate information on the latest standards, procedures and requirements related to the company's products or services. Typically generates reports using computer skills and distributes those reports to various users in the organization, customers or suppliers.

09. Inspector :
Inspects, audits and reports on materials, processes and products using variable or attribute measuring instruments and techniques to ensure conformance with the company's quality standards.

10. Product Engineer :
Performs engineering work related to researching, designing, developing and producing machines, tools, production equipment, engines or related products. Duties might include the development of processes to ensure quality, cost and efficiency requirements are met. Might also research and recommend purchase of equipment or upgrades of existing equipment.

11. Quality Engineer :
Designs installs and evaluates QA / QC process sampling systems, procedures and statistical techniques; designs or specifies inspection and testing mechanisms and equipment; analyzes production and service limitations and standards; recommends revision of specifications when indicated; formulates or helps formulate QA / QC policies and procedures; conducts training on QA / QC concepts and tools; and interfaces with all other engineering components within the organization and with customers and suppliers on quality related issues.

12. Reliability Engineer :
Uses principles of performance evaluation and prediction to improve the safety, reliability and maintainability of products ans systems. Plans reliability tests and conducts analysis of field failures. Develops and administers reliability information systems for failure analysis and performance improvement.

13. Software Quality Engineer :
Applies quality principles to the development and use of software and software based systems. Designs and implements software development and maintenance processes. Designs or specifies test methods for software inspection, verification and validation.

14. Specialist :
As the primary assignment, performs a specific quality related function, such as quality training, auditing or reliability testing, in the organization's quality program. Has either received direct training or has been performing the activity for a number of years. Shows a very high degree of skill performing the activity.

15. Supervisor :
Administers the organization's QA / QC program within a defined department of the organization. Has direct reports that implement some aspect of the policies and procedures of the quality program.

16. Technician :
Performs basic quality techniques to track, analyze and report on materials, processes and products to ensure they meet the organization's quality standards. Might calibrate tools and equipment.

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

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Re-Defined : Quality

There have been various definitions of the word "Quality" all these days by learned individuals and the quality professionals. Some of them being as under :

01. Quality is conformance / compliance to design / specifications / requirements.
02. Quality is that which makes an object what it is.
03. A degree of excellence.
04. Consistency.
05. Value for money.
06. The best.
07. Degree to which a set of inherent characteristics fulfills requirements (ISO 9001:2000).
08. Fitness for use.
09. The totality of features and characteristics of a product or service that bears on its ability to satisfy given needs.

If we analyze the above definitions, we can visualize that all of them are generally indicative of positive aspects of an object / product or the service. Also, most of them define to a situation where the quality will lead towards a sense of providing levels of comforts and satisfaction out of a product or service.

The new definition of QUALITY could therefore be -

"The level of performance and satisfaction that could be achieved, from a product or service against the intended / Specified requirements"

It is the fact that, characteristics of a product / service are finally accountable to define the quality of the product using them for the evaluation of quality but characteristics themselves can't be the quality as quality is a singular word and has to give a singular meaning.

Quality could be categorized as excellent, average or poor depending upon its vital characteristics and their evaluation but while defining, characteristics shouldn't find mention.

When there is talk on features of Quality, well; the characteristics very much have to find mention, not otherwise. It is like asking the name of someone and where one has to reply the name only and not the history attached to it.

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

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Debatable Points Related to ISO 9001 : 2000 Quality Management System

ISO 9001:2000 standard is described as "Quality Management Systems - Requirements". The description has following four words :

01. Quality,
02. Management,
03. Systems,
04. Requirements.

The above 4 words describing the standard however, are offering 2 different objective meanings after analysis :

01. Requirements for Systems for Quality - Management : It means that standard is meant for the systems of the management of Quality function; in any establishment.

02. Requirements for Quality of Management - Systems : It means the standard is meant for establishing the quality of Management - Systems and not the function of Quality as such; in any establishment.

What is required to be done?

The description of the standard is to be mentioned in grammatically clarified manner as follows :

01. Management-Systems-Requirements for Quality - that would give meaning of the requirements for management systems for Quality.

02. Systems-Requirements for Quality - Management - that would give meaning of systems requirements for the Quality of Management.

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

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Benefits of ISO 9001 : 2000 Quality Management System

01. Internal quality audits by certified internal auditors.
02. Developing vendor evaluation and selection methods.
03. methodology to preventive measures to control deviations in performances.
04. Reduction in cost and increase in customer loyalty.
05. Documentation of processes and requirements as per the Quality Management System planning.
06. An international tag which acclaim the credibility, helps in entering overseas market.

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

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Tips to give Good Feedback

01. Do it often
Virtually no one thinks they get enough feedback and that's because virtually no one gives enough.

02. Don't be shy
Give feedback as close to the event it refers to as possible. This way what happened is fresh in everybody's mind and it will be easier to learn from it.

03. Give it some meaning
Always provide the context before you give feedback. For example : "I wanted to talk to you about the report that you wrote yesterday."

04. Be specific
Talk about what went well and what could have gone better for the individual or the team.

05. Describe actual behaviors where possible
Avoid the infamous "feedback sandwich" (good-bad-good) - it comes across as disingenuous and dilutes the impact of good feedback.

06. Give a wider context
Describe the impact it had and on whom. This gives an idea of how important it is.

07. Be generous with positive feedback
With positive feedback describe what it tells you about the individual. There aren't many greater motivators than being told you are a wonderful person.

08. Allow people the chance to respond.
If they would like time to reflect, let them, and agree to talk about it again at a future date. Don't force people to talk about it though.

09. Remain objective
Don't let your personal prejudices get the better of you. Remember you are giving feedback for the other person's benefit and not to vent your own spleen.

10. Build an action plan
With critical feedback make sure there is an agreed way to progress. Find the right time and place.

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

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Tips to Deal With Interruptions

01. Ask what they want
How we treat the interruption not only affects how our time is spent now but the likelihood that we will be interrupted later.

02. Relish the right interruptions
They can be a source of great insight, creativity and strengthen working relationships - or they can simply wake us up.

03. Recognize what's in it for you
Does it make you feel good, helpful or supportive when people come to ask for your advice or approval? If so, you have a choice: you can get acknowledgment of your positive qualities from another source, or you can happy with all the interruptions.

04. Coach People
When someone asks you for help, coach them to solve the problem themselves rather than taking on the task. It will save you time later.

05. Change your default setting
If you always say yes immediately, leave a pause before you agree. Use those moments to ask yourself the right questions to decide whether it is in your own best interests to agree to the request.

06. Stick to the process
When you delegate put a clear reporting and checking process in place and keep to it. Otherwise you may end up fielding endless requests for guidance and reassurance.

07. Keep it brief
Once the immediate problem is solved, close the discussion quickly.

08. Be a role model
Think carefully about how and when you interrupt others. If you aren't being a great role model then don't be surprised if others follow your poor example.

09. Schedule a discussion
For those who persist, explain the impact on your time. Then fix a specific time in the week or day to discuss all their issues.

10. Say no
Get used to saying "no" or at least "not now" every once in a while. The interrupters may then seek out someone who is a softer touch.

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

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