Industry Specific international Standards

There are many industry specific international standards other than ISO 9000 family. ISO 9000 family is the most widely used Quality Management System across the world. This is not specific to any Industry or Group of Industries. The requirements specified in ISO 9001 are generic and can be applied to a grocery shop to a Large OEM. However, some of the Industries have felt the need for inclusion of specific Requirements based on the industry conditions. These are further included in the ISO family of standards with a distinct identification. Generally these are built upon ISO 9001 Quality Management System, with additional requirements. Whenever the ISO 9001 Standard changes, these industry specific standards are also changed.
I have put together the list of standards which are applicable for different industries. Although there is a huge list, we have added few things which are adopted by major industries.
Standard Industry Standard Prepared by and controlled by
ISO 9001:2008 General ISO
ISO/TS16949:2009 Automotive International Automotive Task Force (IATF)
ISO/IEC 17025 Laboratory ISO
ISO/AS 9100 Rev C Aerospace IAQG
ISO 22000 : 2012 Food Industry ISO
ISO/TS 29001:2010 Petroleum, petrochemical and natural gas industries ISO

In addition to these there are many other international standards which are industry specific, which are not listed above. However, these are not so popular as the ones listed above.

The OEMs in these industries insist that the suppliers be certified to or at least complaint to the industry specific standards. This will help reduce the pressure on these companies for supplier inspections rigor. This will also help the suppliers to reduce the number of audits faced. This way the cost of audit on both the supplier and the OEM are reduced.

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Originally posted 2012-09-27 04:49:00.

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 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.
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.

What is ISO standard

ISO (International Organization of Standardization) is the worlds largest developer and publisher of International Standards or ISO standard
Note: ISO is often wrongly called as International Standards Organization. This is wrong. It is not an abbreviation. This is a word from Latin meaning Equal. The background goes that ISO is a multi Language organization. to avoid confusion between languages, the Latin word is chose. Irrespective of Language, the name of the organization is ISO.
The Headquarters of this organization is located Geneva, Switzerland. It is not a Government Organization. It is a association of 160 national Standards Organizations and they are called as “member bodies”. Though ISO is non governmental, Its members may be part of their National Government. The most representative organization of the country is chosen as a member of the organization, and only one from each country can become a member. See the list of members Here.
There are other members called as Correspondent Members and Subscriber Members.
The role of ISO is limited to specify the requirements for products, Services, good conformity assessment, Managerial and organizational practices. ISO is not involved in certification nor has any control over the certification business.
The standards developed by ISO are designed to be implemented worldwide.
The most popular of ISO Standards are ISO 9000 Family on Quality Management Systems and ISO 14000 Family on Environmental Management Systems.
ISO 9000 forms basis for many other industry specific Standards like TS16949 for automobile Industry, ISO 17025 for Laboratories and AS 9100 for Aviation Industry. 
These are few examples of industry specific Standards only.
Also ISO has provided standards for Various Processes too. There are specific Standards for processes such as Risk Management, Configuration management Etc.
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Originally posted 2011-03-19 04:21:00.

Risk Management II – Benefits of Risk Management Program

The earlier article on Risk Management is Risk Management I – A proactive approach to resolve future root causes and their potential consequences.

Purpose of a Risk Management Plan
Risk management program helps the organization to deal with potential occurrences.  It defines the approach and attitude towards risks. This program helps in
  1. identifying what are those risks the organization is ready to accept.
  2. The plan to deal with those unacceptable risks
  3. defines the main requirements of risk mitigation plan.
 The risk Management program helps the organization in the following ways:
  • To identify risks and prepare an action plan to deal with the risk
  • To reduce occurences and impacts of risk
  • To understand significance/severity of risks
  • To promote organizational behaviors focused on risk management
  • To increase effectiveness of product and service delivery to customer
  • Create a process for who, what, when, where, how and how much.
  • Maintain information on historic issues.
  • Capitalize on historic issues to prevent future issues.
  • Bring out hidden risk knowledge, so it can be managed.

Benifits of Risk Management Program

  • Encourage proactive management
  • Be aware of the need to identify and treat risk throughout the organization
  • Improve the identification of threats
  • Comply with relevant legal and regulatory requirements and international norms
  • Improve financial reporting and governance
  • Improve stakeholder confidence and trust
  • Establish a reliable basis for decision-making and planning
  • Improve organizational controls
  • Effectively divide and use resources for risk treatment / handling
  • Improve operational effectiveness and efficiency;
  • Cost of risk management is typically less than the cost of issue management
  • Enhance health and safety performance
  • Enhance environmental protection
  • Minimize losses and improve loss prevention
  • Minimize the cost and efforts in managing incidents
  • Improve organizational learning and resilience
  • Increase the likelihood of achieving goals

The most important benefit of the risk mitigation program is that it gives the organization a future visibility. It deals with future events and not manage the current issues. The organization will be ready to face the realization of the risk. This gives a state of readiness against the potential consequences

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Originally posted 2013-10-27 17:48:00.