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ISO 9001:2008 - New & Revised standard

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Why revision from ISO 9001:2000 to ISO 9001:2008 ?	What are the changes in the new ISO 9001:2008 standard ?
What shall I do to implement and achieve ISO 9001:2008 certification ?	Up gradation consultancy from ISO 9001:2000 to ISO 9001:2008 at U.S. $ 500
what happens to my existing ISO 9001:2000 certificate	Details on amendments in ISO 9001:2008

Why revision from ISO 9001:2000 to ISO 9001 : 2008

As many of you who have worked with the ISO 9000 standards know, the standards are periodically updated. The last revision of the ISO 9001 standard was in the year 2000 (hence the title "ISO 9001:2000"). The next revision (technically an "amendment") is scheduled to be released October 31, 2008, but it will more likely be available by the end of 2008. ISO and the IAF have agreed an implementation plan to ensure a smooth migration of accredited certification to ISO 9001: 2008, after consultation with international groupings representing quality system or auditor certification bodies, and industry users of ISO 9001 certification services.

ISO 9001: 2008 does not contain any new requirements
They have recognized that ISO 9001: 2008 introduces no new requirements. ISO 9001: 2008 only introduces clarifications to the existing requirements of ISO 9001: 2000 based on eight years of experience of implementing the standard worldwide with about one million certificates issued in 170 countries to date. It also introduces changes intended to improve consistency with ISO14001: 2004. The good news is that the 2008 release will not have the same impact. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is purposely planning the next release as an amendment rather than a formal revision. The difference is that an "amendment" is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified

What happens to my existing ISO 9001:2000 Certificate

Certification of conformity to ISO 9001: 2008 and/or national equivalents shall only be issued after official publication of ISO 9001: 2008, which should take place before the end of 2008, and after a routine surveillance or recertification audit against ISO 9001: 2008. One year after publication of ISO 9001: 2008 all accredited certifications issued�new certifications or recertification�shall be to ISO 9001: 2008. Twenty-four months after publication by ISO of ISO 9001: 2008, any existing certification issued to ISO 9001: 2000 shall not be valid.

Contact us to align your existing ISO 9001:2000 quality management system with ISO 9001:2008 QMS. We offer quick & cost effective up - gradation consultancy services for ISO 9001 : 2008 certification.

What are the Changes in new ISO 9001:2008 standard - Summary of changes to ISO 9001 : 2008 Vs. ISO 9001:2000

There is nothing to worry about if you are already certified to ISO 9001:2000. The only likely impact would be on organizations that had previously misunderstood the intent of certain parts of the standard and, due to the clarifications in the 2008 version, it is recognized that the standard had been mistakenly applied incorrectly. A process or procedure here or there might need some minor modification in this case.
So, the upcoming release of ISO 9001:2008 should be a fairly simple transition for most certified organizations. If you are currently preparing for your initial ISO 9001 certification, there is no reason to delay or to change your approach. If you are correctly implementing an ISO 9001:2000 quality management system in preparation for your initial certification audit, the new standard will not impact you significantly. As usual, we expect there will be a 1 - 2 year "transition period" following the release of the new revision to make any necessary changes to comply with the new standard. But, as we have said, there aren't likely to be any substantive changes anyway.

Regardless of the schedule, most users of the ISO 9001:2000 standard (whether certified, conforming or preparing) want to know what is going to change in 2008. Those who went through the previous transition from ISO 9001:1994 to ISO 9001:2000 know first-hand the disruption that was caused by the significant changes introduced by the last revision. It was very costly for all certified companies to change over to the new version.

The good news is that the 2008 release will not have the same impact. In fact, the ISO technical committee (TC176) who develops the ISO 9000 series of standards is purposely planning the next release as an amendment rather than a formal revision. The difference is that an "amendment" is focused on making changes for clarification purposes only and for better alignment with ISO 14001, the standard for environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified organizations. Thus, the new ISO 9001:2008 standard should have limited impact on companies already certified. Here are a few examples of the types of changes in the currently available DIS ISO 9001:2008 draft:

� There are some terminology changes that are intended to clarify ideas or make documentation more consistent - e.g. "devices" is changed to "equipment".
� There are several additional or revised "Notes" within the standard. However, notes are not considered part of the auditable requirements but are, instead, included for clarification.
� The phrase "where applicable" is used more extensively with regard to several requirements within the standard. This was done to help more organizations in various industries more easily apply the standard to their particular business.
� A number of sentences and paragraphs have been re-worded to be easier to understand and apply the language. .....TOP

ISO 9001 : 2008 changes can be summarized as follows :
Clause 0.2 (Process approach)
Text added to emphasize the importance of processes being capable of achieving desired outputs.

Clause 1.1 (Scope - General)
Clarification that product also includes intermediate product.
Explanation regarding statutory, regulatory and legal requirements.

Clause 4.1 (General requirements)
Addition of a note to clarify outsourced processes as well as the types of control that may be applied to such processes.

Clause 4.2.1 (Documentation requirements - General)
Clarification that QMS documentation also includes records.
Clarification that one document may include the requirements of one or more procedures, and that the requirements of one procedure may be covered by more than one document.

Clause 4.2.3 (Control of documents)
Clarification regarding the documents of external origin that need to be controlled.

Clause 5.5.2 (Management representative)
Clarifies that this person must be a member of the organization�s own management.

Clause 6.2.2 (Competence, training and awareness)
Now requires the organization to ensure that necessary competence has been achieved.

Clause 6.4 (Work environment)
A note has been added to clarify the term work environment.

Clause 7.2.1 (Determination of requirements related to the product)
Clarifies that post-delivery activities may include actions under warranty provisions, contractual obligations such as maintenance services and supplementary services such as recycling or final disposal. .....TOP

Clause 7.3.1 (Design & development planning)
Clarifies that design and development review, verification, and validation have distinct purposes but may be conducted and recorded separately or in any combination as suitable for the product and the organization.

Clause 7.3.3 (Design & development outputs)
Clarifies that information needed for production and service provision may include preservation of the product.

Clause 7.5.4 (Customer property)
A note has been added to specify that personal data should be considered customer property.

Clause 7.5.5 (Preservation of product)
Clarification that preservation of the product relates to the maintenance of conformity to requirements.

Clause 7.6 (Now retitled Control of monitoring and measuring equipment)
Addition of a note related to the confirmation of computer software used as monitoring and measuring equipment.

Clause 8.2.1 (Customer satisfaction)
Note added to provide examples of how customer satisfaction data could be collected.

Clause 8.2.2 (Internal audit)
Editorial changes to clarify this requirement of the standard.

Clause 8.2.3 (Monitoring and measurement of processes)
Note added to clarify that when deciding on appropriate methods, the organization should consider impact on the conformity to product requirements and on the effectiveness of the quality management system.

Clause 8.2.4 (Monitoring and measurement of product)
Clarification that the release of the product relates to the delivery to the customer.

Introduction of ISO 9001 QMS

ISO 9000 is a family of standards for quality management systems. ISO 9000 is maintained by ISO, the International Organization for Standardization and is administered by accreditation and certification bodies. Some of the requirements in ISO 9001 (which is one of the standards in the ISO 9000 family) include:-

a set of procedures that cover all key processes in the business;
monitoring processes to ensure they are effective;
keeping adequate records;
checking output for defects, with appropriate and corrective action where necessary;
regularly reviewing individual processes and the quality system itself for effectiveness; and
facilitating continual improvement

A company or organization that has been independently audited and certified to be in conformance with ISO 9001 may publicly state that it is "ISO 9001 certified" or "ISO 9001 registered."ISO 9000 includes the following standards: .....TOP

ISO 9000:2004, Quality management systems � Fundamentals and vocabulary. Covers the basics of what quality management systems are and also contains the core language of the ISO 9000 series of standards. A guidance document, not used for certification purposes. This has been revised in year 2005.
ISO 9001:2008 Quality management systems � Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve customer satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints. This is the only implementation for which third-party auditors may grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction').
ISO 9004:2000 Quality management systems - Guidelines for performance improvements. covers continual improvement. This gives you advice on what you could do to enhance a mature system. This standard very specifically states that it is not intended as a guide to implementation.

Note that the previous members of the ISO 9000 family, 9001, 9002 and 9003, have all been integrated into 9001. In most cases, an organization claiming to be "ISO 9000 registered" is referring to ISO 9001.

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What shall i do implement ISO 9001 : 2008

4. GENERAL REQUIREMENTS	4.1 DEVELOP YOUR QUALITY MANAGEMENT SYSTEM (QMS)
	Establish your organization's QMS. Document your organization's QMS. Implement your organization's QMS. Maintain your organization's QMS. Improve your organization's QMS.

4.2. DOCUMENT YOUR QUALITY MANAGEMENT SYSTEM (QMS)

4.2.1 MANAGE QUALITY MANAGEMENT SYSTEM DOCUMENTS

Develop documents for your organization's QMS.
Make sure that your organization's QMS documents
respect and reflect what you do and how you do it.

4.2.2 PREPARE QUALITY MANAGEMENT SYSTEM MANUAL

Establish a quality manual for your organization.
Maintain your organization's quality manual.

4.2.3 CONTROL QUALITY MANAGEMENT SYSTEM DOCUMENTS

Control your organization's QMS documents.
Control documents that are used as QMS records.

4.2.4 ESTABLISH QUALITY MANAGEMENT SYSTEM RECORDS

Establish your organization's QMS records.
Establish a procedure to control your QMS records.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

5. MANAGEMENT REQUIREMENTS	5.1 SHOW YOUR COMMITMENT TO QUALITY
	Support the development of your organization's QMS. Support the implementation of your organization's QMS. Support efforts to continually improve the effectiveness of your organization's QMS.

	5.2 FOCUS ON YOUR CUSTOMERS
	Enhance customer satisfaction by ensuring that customer requirements are being identified. Enhance customer satisfaction by ensuring that customer requirements are being met.

5.3 SUPPORT YOUR QUALITY POLICY

Ensure that your organization's quality
policy serves its overall purpose.
Ensure that your quality policy makes
it clear that requirements must be met.
Ensure that your quality policy makes a commitment
to continually improve the effectiveness of your QMS.
Ensure that your quality policy supports
your organization's quality objectives.
Ensure that your quality policy is communicated
and discussed throughout your organization.
Ensure that your quality policy is periodically
reviewed to make sure that it is still suitable.

5.4 CARRY OUT YOUR QMS PLANNING

5.4.1 ESTABLISH QUALITY OBJECTIVES

Support the establishment of quality objectives.
Establish quality objectives for your organization.
Make sure that your quality objectives are effective.

5.4.2 PLAN QUALITY MANAGEMENT SYSTEM (QMS)

Plan the establishment of your QMS.
Plan the documentation of your QMS.
Plan the implementation of your QMS.
Plan the maintenance of your QMS.
Plan the continual improvement of your QMS.

5.5 ALLOCATE QMS RESPONSIBILITY AND AUTHORITY

5.5.1 DEFINE RESPONSIBILITIES AND AUTHORITIES

Ensure that QMS responsibilities and authorities are defined.
Ensure that QMS responsibilities and authorities are
communicated throughout your organization.

5.5.2 CREATE MANAGEMENT REPRESENTATIVE ROLE

Appoint a member of your organization's
management to oversee your QMS.
Give your management representative authority
over and responsibility for your organization's QMS.

5.5.3 SUPPORT INTERNAL COMMUNICATION

Ensure that appropriate communication processes
are established within your organization.
Ensure that internal communication
occurs throughout your organization.

5.6 PERFORM QMS MANAGEMENT REVIEWS

5.6.1 REVIEW QUALITY MANAGEMENT SYSTEM (QMS)

Carry out management reviews of your
organization's QMS at planned intervals.
Evaluate improvement opportunities.
Assess the need to make changes.
Maintain a record of your management reviews.

5.6.2 EXAMINE MANAGEMENT REVIEW INPUTS

Examine information about your QMS (inputs).

5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS

Generate management review decisions and
actions (outputs) to improve your organization.
Generate management review decisions and actions
(outputs) to change your general quality orientation.
Generate management review decisions and
actions (outputs) to address resource needs.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

6. RESOURCE REQUIREMENTS	6.1 PROVIDE REQUIRED QMS RESOURCES
	Identify the resources that your QMS needs. Provide the resources that your QMS needs.

6.2 PROVIDE COMPETENT QMS PERSONNEL

6.2.1 ENSURE THE COMPETENCE OF WORKERS

Ensure the competence of anyone within your
QMS who could directly or indirectly affect your
ability to meet product requirements.

6.2.2 MEET COMPETENCE REQUIREMENTS

Identify the competence requirements of personnel
within your QMS who perform work that could directly
or indirectly affect your organization's ability to meet
product requirements.
Provide training, or take other suitable steps, to meet
your organization's QMS competence requirements.
Evaluate the effectiveness of your organization's
QMS training and awareness activities.
Maintain suitable records which show that
personnel within your QMS are competent.

	6.3 PROVIDE NECESSARY INFRASTRUCTURE
	Identify the infrastructure that your organization needs in order to ensure that product requirements are met. Provide the infrastructure that your organization needs in order to ensure that product requirements are met. Maintain the infrastructure that your organization needs in order to ensure that product requirements are met.

	6.4 PROVIDE SUITABLE WORK ENVIRONMENT
	Identify the work environment that your organization needs in order to ensure that product requirements are met. Manage the work environment that your organization needs in order to ensure that product requirements are met.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

7. REALIZATION REQUIREMENTS	7.1 CONTROL PRODUCT REALIZATION PLANNING
	Establish a product realization planning process. Use your product realization planning process to plan the realization of your organization's products. Prepare planning outputs that are suitable and consistent with your organization's methods. Develop the processes that you will need to use in order to realize products.

7.2 CONTROL CUSTOMER-RELATED PROCESSES

7.2.1 IDENTIFY YOUR UNIQUE PRODUCT REQUIREMENTS

Identify the requirements that your
customers want you to comply with.
Identify the requirements that are dictated
by your product's intended use or purpose.
Identify the requirements that are imposed
on your products by external agencies.
Identify any additional requirements that are
important to your organization and must be met.

7.2.2 REVIEW CUSTOMERS' PRODUCT REQUIREMENTS

Review your customers' product requirements.
Maintain a record of your product requirement reviews.
Control changes in customers' product requirements.

7.2.3 COMMUNICATE WITH YOUR CUSTOMERS

Establish customer communication arrangements.
Implement customer communication arrangements.

7.3 CONTROL PRODUCT DESIGN AND DEVELOPMENT

7.3.1 PLAN PRODUCT DESIGN AND DEVELOPMENT

Plan the design and development of your products.
Control the design and development of your products.
Update your planning outputs whenever product design
and development progress makes this necessary.

7.3.2 IDENTIFY DESIGN AND DEVELOPMENT INPUTS

Define product design and development inputs.
Maintain a record of design and development inputs.
Review your product design and development inputs.

7.3.3 GENERATE DESIGN AND DEVELOPMENT OUTPUTS

Produce product design and development outputs.
Approve product design and development
outputs before they are formally released.
Verify that product design and development outputs
meet design and development input requirements.

7.3.4 CARRY OUT DESIGN AND DEVELOPMENT REVIEWS

Perform systematic design and development reviews
throughout the design and development process.
Maintain a record of design and development reviews.

7.3.5 PERFORM DESIGN AND DEVELOPMENT VERIFICATIONS

Carry out design and development verifications.
Maintain a record of design and development verifications.

7.3.6 CONDUCT DESIGN AND DEVELOPMENT VALIDATIONS

Perform design and development validations.
Maintain a record of design and development validations.

7.3.7 MANAGE DESIGN AND DEVELOPMENT CHANGES

Identify changes in design and development.
Record changes in design and development.
Review changes in design and development.
Verify changes in design and development.
Validate changes in design and development.
Approve changes in design and development
before you implement these changes.

7.4 CONTROL PURCHASING AND PURCHASED PRODUCTS

7.4.1 ESTABLISH CONTROL OF YOUR PURCHASING PROCESS

Establish criteria that you can use to control suppliers.
Evaluate your suppliers' ability to supply products
that meet your organization's requirements.
Select suppliers that are capable of supplying products
that meet your organization's specified requirements.
Make sure that purchased products meet
specified purchase requirements.

7.4.2 SPECIFY YOUR PURCHASING REQUIREMENTS

Describe your purchasing requirements.
Ensure that purchasing requirements are adequately
specified before you discuss them with suppliers.

7.4.3 VERIFY YOUR PURCHASED PRODUCTS

Establish product verification or inspection methods in order
to ensure that purchased products meet purchase requirements.
Implement product verification or inspection methods in order
to ensure that purchased products meet purchase requirements.

7.5 CONTROL PRODUCTION AND SERVICE PROVISION

7.5.1 ESTABLISH CONTROL OF PRODUCTION AND SERVICE

Carry out production under controlled conditions.
Carry out service provision under controlled conditions.

7.5.2 VALIDATE PRODUCTION AND SERVICE PROVISION

Validate production and service provision processes
whenever process outputs cannot be measured, monitored,
or verified until after the product is in use or the service
has been delivered (such a process is often referred
to as a special process).
Establish arrangements to control special processes.

7.5.3 IDENTIFY AND TRACK YOUR PRODUCTS

Establish the unique identity of your
organization's products (if appropriate).
Identify the monitoring and measurement
status of your organization's products.

7.5.4 PROTECT PROPERTY SUPPLIED BY CUSTOMERS

Identify property supplied to you by customers.
Verify property supplied to you by customers.
Protect property supplied to you by customers.
Safeguard property supplied to you by customers.

7.5.5 PRESERVE YOUR PRODUCTS AND COMPONENTS

Make sure that your products and components
continue to conform to requirements while they
are being processed internally.
Make sure that your products and components
continue to conform to requirements while they
are being delivered to the intended destination.

7.6 CONTROL MONITORING AND MEASURING EQUIPMENT

Identify your organization's monitoring
and measuring needs and requirements.
Select equipment that can meet your organization's
monitoring and measuring needs and requirements.
Establish monitoring and measuring processes.
Calibrate your monitoring and measuring equipment
whenever necessary to ensure that results are valid.
Protect your monitoring and measuring equipment.
Confirm that monitoring and measuring software
is capable of doing the job you want it to do.
Evaluate the validity of previous measurements
whenever you discover that your measuring or
monitoring equipment is out-of-calibration.

ISO 9001 2008 QUALITY MANAGEMENT REQUIREMENTS

8. REMEDIAL REQUIREMENTS	8.1 ESTABLISH MONITORING AND MEASUREMENT PROCESSES
	Identify the monitoring, measurement, and analytical processes that your organization needs to have in order to be able to demonstrate conformity and make improvements. Plan how monitoring, measurement, and analytical processes will be used to demonstrate conformity and make improvements. Implement your organization's monitoring, measurement, and analytical processes.

8.2 CARRY OUT MONITORING AND MEASUREMENT ACTIVITIES

8.2.1 MONITOR AND MEASURE CUSTOMER SATISFACTION

Establish methods that you can use to monitor
and measure customer satisfaction (perceptions).
Monitor and measure customer satisfaction.

8.2.2 PLAN AND PERFORM REGULAR INTERNAL AUDITS

Establish an internal audit procedure.
Carry out internal audits of your QMS.
Take action to address audit results.

8.2.3 MONITOR AND MEASURE YOUR QMS PROCESSES

Select suitable methods to monitor and measure
the processes that make up your organization's QMS.
Monitor and measure your QMS processes.
Take appropriate action whenever your QMS
processes fail to achieve planned results.

8.2.4 MONITOR AND MEASURE PRODUCT CHARACTERISTICS

Monitor your organization's product characteristics.
Measure your organization's product characteristics.

	8.3 IDENTIFY AND CONTROL NONCONFORMING PRODUCTS
	Establish a nonconforming products procedure. Document your nonconforming products procedure. Implement your nonconforming products procedure. Maintain your nonconforming products procedure.

	8.4 COLLECT AND ANALYZE QUALITY MANAGEMENT DATA
	Figure out what kind of data you need to collect about your organization's QMS. Collect data about your organization's QMS. Provide information by analyzing your QMS data.

8.5 MAKE IMPROVEMENTS AND TAKE REMEDIAL ACTIONS

8.5.1 IMPROVE THE EFFECTIVENESS OF YOUR QMS

Continually improve the effectiveness of your QMS.
Use information to improve the effectiveness of your QMS.

8.5.2 CORRECT NONCONFORMITIES TO PREVENT RECURRENCE

Establish a corrective action procedure.
Document your corrective action procedure.
Implement your corrective action procedure.
Maintain your corrective action procedure.

8.5.3 PREVENT THE OCCURRENCE OF NONCONFORMITIES

Establish a preventive action procedure.
Document your preventive action procedure.
Implement your preventive action procedure.
Maintain your preventive action procedure.

Up gradation consultancy from ISO 9001: 2000 to ISO 9001:2008 From U.S. $ 500 .....TOP

We offer quick, easy and cost effective approach to migrate from ISO 9001:2000 to ISO 9001:2008. With a team of highly qualified consultants and trainers having vast industrial experience, Lakshy Management Consultant Pvt. Ltd. partners organizations across the world to implement and achieve ISO 9001 certification. Our consulting approach is highly professional, time bound and effective resulting in ease of implementation and adds value to the business processes of the client organization.

If your company is ISO 9001:2000 certified, you need to upgrade to ISO 9001 : 2008 standard. There are very few operational changes required in the ISO 9001:2008 standard as compared to ISO 9001:2000 and we offer online consulting @ U.S. 500. You send us your existing ISO 9001:2000 documentation and we convert it to ISO 9001:2008 complied within 7 days & email you back.

Up gradation from ISO 9001:2000 to ISO 9001:2008 is really easy, fast and cost effective with online ISO 9001 : 2008 up-gradation service offered by Lakshy.

Visit us at our special ISO 9001:2008 online up-gradation consultancy page to start upgrading your existing ISO 9001:2000 documentation system to ISO 9001:2008 requirements.

Contact us at info@lakshy.com or call us at +91 9821780035 to get your organization ISO 9001:2008 certified or upgrade your QMS system from ISO 9001:2000 to ISO 9001:2008.

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