compulsory Records required by ISO 9001 : 2008

There are 21 records required by ISO 9001 : 2008 to be in compliant. The detailed list along with definitions are explained in this article.
What is a Record?
According to ISO 9000:2005, Record is defined as a document stating results achieved or providing evidence of activities performed.
Records shall remain legible, readily identifiable, and retrievable according clause 4.2.4 of ISO 9001:2008.
The Records maintained by the organization are to be controlled. 
Clause 4.2.4 deals with control of records
ISO 9001:2008 requires some records to be maintained mandatory. A statement saying “records shall be maintained” (See 4.2.4) against various clauses for identifying them.
The Mandatory records to be in complaint with ISO 9001:2008 are 

  1. Records from Management Reviews (5.6.1)
  2. Appropriate records of Education, Training, Skill and Experience for personnel performing work (6.2.2)
  3. Records which can provide evidence that the realization process and the resultant product meets the requirements (7.2)
  4. Results and actions arising out of review of requirements related to the product  (7.2.2) (For eg Sales Records)
  5. Design and development inputs relating to the product (7.3.2)
  6. Results and actions arising out of the review of design and development m(7.3.4)
  7. Results and actions arising out of verification of design and development (7.3.5)
  8. Results and actions arising out of validation of design and development (7.3.6)
  9. Results and actions arising out of review of design and development changes (7.3.7)
  10. Results and actions arising out of evaluation of suppliers (7.4.1)
  11. Records to demonstrate validation of special processes (7.5.1)
  12. Records of unique identification of the product  (where traceability is a requirement) (7.5.3)
  13. Records of information to the customer in case the customer property is lost, damaged or otherwise found to be unsuitable for use (7.5.4)
  14. Validity of the previous measuring results when measuring equipment is found to be out of calibration
  15. Results of calibration and verification of the monitoring and measuring equipment (7.6)
  16. Records of basis used for calibration or verification of monitoring and measuring equipment in case of absence of  specified standards (7.6)
  17. Records of audits and their results including follow up actions (8.2.2)
  18. Records of person(s) authorizing release of product for delivery (8.2.4)
  19. Records of product non-conformities and the subsequent actions (8.3)
  20. Results of corrective action (8.5.2)
  21. Results of preventive action (8.5.3)
In addition to the records listed above, the organization may decide to maintain additional records but it is always advisable to maintain the record maintained are  simple
Also Note that the records can be combined where appropriate and also maintain a record in one or more parts. 
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Originally posted 2011-06-12 08:47:00.

Types of Quality Audit

The Quality Audit is a very important value adding tool for an organization to prove the compliance with the requirements and for continuous improvement. The types of quality audit which are faced by the organization are first, second and third party audits.
First Party Audits : – These are done internally.They are a management tool with the emphasis on continuous improvement. The auditor(s) must be independent of the audit area. The audit should be aligned with the Company goals and metrics. These audits are also called as internal audits. The out come in this audit is the management is aware of the status of the organization. These reports may be required to be shared with some of the third parties.Normally these are conducted by the Quality Department or the MR or their representative.

Second Party Audits :- These  are the audits conducted by those who have some vested interest in the outcome of this audits. These may be OEM’s, Suppliers, Customers etc. These are also called as survey or assessment. These may be conducted for having a relationship or even for the compliance. Normally these are conducted by the second party employees. In some cases, these may be outsourced to a third party with mutual agreement with the organization and the party who wants the audit to be conducted.
Third Party Audits :- These audits are conducted by an organizations which has no interest in the final outcome. These may be Independent Certification Bodies, Regulators or a firm hired by the company. The out come of this audit may be certification, license, acceptance or even an award. 
Categories of Audits
The Quality audits can be categorized as follows
System Audits : 
These audits are conducted on a system spread across multiple processes and may include several employees and several departments. For Eg: Calibration System audits
Conformance Audits:
These are conducted against different requirements. For eg: A third party audit for certification of ISO 9001:2008
Compliance Audits: 
These are conducted to verify the compliance of the regulations. For Eg: A government employee auditing a firm.
Process Audits: 
This audit focuses on a set of processes within the organization, to examine the adherence to the procedures or specifications
Product Audit : 
This is more of an inspection activity. The main objective of this audit is to ensure the product is confirming to the requirements.
Department Audit : 
The main focus of this audit is only one department. within the department many processes, procedures and specifications. It also focuses on department training and organization.

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Originally posted 2011-06-05 02:15:00.

What is an Audit

According to ISO 9000, the following is the definition.
An audit is Systematic, independent and documented process for obtaining evidence and evaluating it objectively to determine the extent to which audit criteria are fulfilled
Comparison of activity : You look at what is done and how it is done; and Compare it with the processes / procedures describing this, the way it should be done
If there are differences you have a “finding” (possibly even a non-conformity).
The Auditor should look for :

  • Fact finding’ (not ‘fault finding’)
  • The auditor should seek “compliance” (implementation) of the Process not “non-compliance” with it
  • Focus on ‘Performance’ as well as ‘Conformance’
  • Focus on audit for ‘Continuous Improvement’
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Originally posted 2011-05-23 00:59:00.

What are Principles of Quality Management Systems

The function of Top Management include Management of Quality Management along with other disciplines. To succeed in Business, the top management can utilize the quality management principles identified by the International Standards like ISO 9000 Family. The Same principle apply for the other standards like AS 9100, TS 16949 which are supplement to ISO 9001. The Principles of Quality Management Systems are
Customer Focus
The Organization depend its our customers and should understand the current and future customers’ needs, should meet their requirements, and strive to exceed their expectations.
The organization must make sure that:
Customer needs & expectations are determined
Customer needs are converted into specific requirements
Customer requirements are fulfilled with the aim of “exceeding” expectations to “enhance” customer Satisfaction.
Customer Satisfaction : Customer’s perception of the degree to which the customer’s requirements have been fulfilled”(Ref: ISO 9000:2000, 3.1.4)
Customer Complaints are a common indicator of low customer satisfaction, but their absence does not necessarily imply high customer satisfaction. Even when customer requirements have been agreed with the customer and fulfilled, this does not necessarily ensure high customer satisfaction.Research shows that fewer than 5% of dissatisfied customers actually complain.
Leadership
Leaders establish a unity of purpose and the direction of the organization.  They must create and maintain the internal environment in which all employees can become fully involved in achieving the organizations objectives. There is a need for “Top Management” to play an active role in the operation & performance of the QMS.
“Top Management” involvement in the implementation & improvement of the QMS will be checked by external auditors.
Involvement of People
People at all levels are the essence of the organization and their full involvement enables their abilities to be used for the organization’s benefit. the most valuable assets of an organization is its Human Resources. The organization should create an internal environment for people at all levels feel the ownership of their task and improving it to achieve the desired customer satisfaction.
Process Approach
A desired result is achieved more efficiently when activities and related resources are managed as a process.
What is a “Process”? : “an activity using resources and managed to enable the transformation of inputs to outputs”. Often the output from one process directly forms the input to the next.
Systems Approach to Management
Identifying, understanding and managing interrelated processes as a system contributes to the organizations effectiveness and efficiency in achieving its objectives. Though this term looks like the previous one Process approach, there is distinct difference between them. to Identify clearly, “A set of processes interacting symmetrically will become a system”.
continual Improvement
Definition : Recurring activity to increase the ability to fulfill requirements (ref. ISO 9000:2000, 3.2.13)
The organization Shall strive to enhance its overall performance and this should be a permanent objective of the organization. There is a scope for everyone in the organization to Working in the business ( doing their Job) and Working on the business(improving the efficiency)
Factual Approach to Decision Making
Appropriate data should be identified, gathered and analyzed for trending and tracking to provide opportunities for improvement. This will lead to effective decision-making.
Mutually beneficial Supplier Relations
An organization and its suppliers are interdependent and a mutually beneficial relationship enhances the ability of both to create value.
If an organization buys in poor (good) quality, it can negatively (positively) affect the organization’s performance.
The above principles identified by the ISO 9000 Family of standards as the basis for any Quality Management Systems.
If these principles are used effectively, the organization will have a sound quality management system and will lead to success.
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Originally posted 2011-04-30 19:39:00.

Correction, Corrective Action and Preventive Action

These three words have been widely discussed among the Quality community. For beginners, these are really confusing terms and especially not very popular with the Regulators. Very often Corrective Action and Preventive action are used with the same sense.
According to the ISO 9000 – Quality Management Systems – Fundamentals and Vocabulary the following are the definitions.
Preventive Action : (3.6.4) – Action to the eliminate cause of potential Nonconformity or other potential undesirable situation.
The word to notice here is the Potential. This means that the nonconformity has not occurred or  detected. This action is taken pre- problem.Though this is not a perfect example, this can explain the terms. A water pipe is likely to break and leak. Here the problem is not occurred but it is identified that it is likely to occur. The action may be reducing the pressure in the pipe, replacing the pipe or anything else. Even in this case the causes are found and the causes are addressed.
Preventive actions are proactive, continuous and targeted actions to reduce the instances of Corrections and corrective actions
Corrective Action (3.6.5) : Action taken to eliminate the cause of the detected Nonconformity or other undesirable situation
Correction(3.6.6) : Action taken to eliminate a detected  Nonconformity
In the cases of correction and corrective action, the noticeable word is “detected”. These actions are taken after the occurrence of the problem. Again taking the example of water pipe, the problem in this case will be the water pipe is broken or leaking” . The action to be taken in this case has be in two parts. 1) Correction : Repair the pipe or arrest the leak. This stops the leak. However this does not solve the problem. 2) The next action needed is corrective action: Find the cause which has led to the problem of leak and eliminate the cause. In this case the cause may be faulty pipe, or High pressure in the pipe, or any other or a combination of these. The problem can only be solved only if all the causes are eliminated.
There can be cases where correction not possible and only corrective action can be made. For example the pipe is broken.
The words correction, corrective action and preventive action are a little bit confusing but if used carefully, they convey very good meaning.
Preventive actions contribute to cost efficiencies, and timely delivery of the product which leads to customer satisfaction.
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Originally posted 2011-04-24 05:38:00.

documents required for ISO 9001 : 2008

To be in compliance with ISO 9001:2008, the organization must have some mandatory documents. These requirements are stated under various clauses of ISO 9001:2008. The documents required for ISO 9001 are listed below.
According to ISO 9000 (QMS Fundamentals and Vocabulary), A Document is defined as “Information and its supporting medium“. This is further explained in the notes to this definition.
The medium can be paper, magnetic, electronic or optical computer disk, photgraph or master sample or combination there of.
A set of documents is called as “Documentation
The requirements of documentation for compliance with ISO 9001:2008 are as follows.
The following Clauses define the documentation requirements in the Quality Management System
4.21. General
The Quality Management System Shall Include the following documentation
(4.2.1 a)  – A documented Statement of Quality Policy
( 4.2.1 a)  – A documented Statement of Quality Objectives
(4.2.1 b)  – Quality Manual
(4.2.1 d)  – The documents including records which are to be determined by the organization as necessary for effectiveness of its QMS
(4.2.1 c) In addition to the above, the Standard identifies some documents and records which are identified under different sections of the standard
To meet the requirement of 4.2.1 c, we need to scan through the standard for further requirements. This will be found as follows.
( 4.2.3 ) A documented procedure to define the document control
(4.2.4 )  A documented Procedure to define the controls needed for various records
(8.2.2)  A documented procedure to define the responsibilities and requirements regarding internal audit.
(8.3) A documented procedure to define the control of non-conforming product
(8.5.3) A documented procedure to define the requirements concerning the Corrective Action
(8.5.4) A documented procedure to define the requirements regarding Preventive Action.
To comply with these requirements, documented Procedure means  that the procedure is established, Documented, implemented and Maintained.
The Documentation requirements can be covered in more than one document, and a single document may address one or more requirements.
All these documentation requirements may or may not be part of the Quality Manual. Where these are not part of the Quality Manual, The reference to these procedures must be provided in the Quality Manual.
Please note in addition to the requirements listed above, the organization may require some additional documents which may or may not be part of Quality Manual.

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Originally posted 2011-04-19 16:42:00.

Introduction to AS 9100

Introduction to AS 9100
AS 9100 is the most accepted, adapted and standardized Quality Management System (QMS) Standard, addressing the requirements of Aerospace Industry.
History of AS 9100
During the decade of Nineties, Aero Space Industry does not have a standard requirement of QMS. Each major organization has a basic requirements of ISO 9000 and developed its own documentation/Specific Standards. One such Standard is D1-9000 used by Boeing to evaluate its suppliers. The other contractors have developed their own supplementary standards.This has resulted in difficulties in enforcing or compliance issues.
This has resulted in Major Aerospace Contractors coming together to set up a Single, Unified QMS Standard Acceptable to all of them. This is released as AS 9000, by the Society of Automotive Engineers (SAE) in 1999.
The relation to ISO 9000 Came in 2000, when the rewrite of ISO is being undertaken for its 2000 version. This time AS Group worked closely with ISO and the standard is based on ISO 9000 family of standards and principles. The additional requirements of safety and Regulatory requirements are added.
The current revision of AS 9100 is Rev C which has been released in Jan 2009. This revision incorporates compatibility with the latest ISO Standard ISO 9001:2008 and some additional requirements specific to defense aviation are added.
The AS Family of Standards
AS 9100 :  Quality Management Systems – Requirements for Aviation, Space and Defense Organizations.
AS 9110 : Quality Management Systems – Requirements for Aviation Maintenance Organizations
AS 9120 :  Quality Management Systems – Requirements for Aviation, Space and Defense Distributors.
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Originally posted 2011-04-19 02:03:00.