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What is ISO 9001 QMS

ISO 9001:2008 is the International standard for Quality Management Systems (QMS).

It provides an organization with a set of principles that ensure focussed, informed, scientific and proven approach to the management of your business activities to consistently achieve customer satisfaction and continually improve operational effectiveness.

Every organization would like to improve the way it operates, whether that means increasing market share, driving down costs, managing risk more effectively or improving customer satisfaction. A quality management system gives you the framework you need to monitor and improve performance in any area you choose.

ISO 9001 is by far the world’s most established quality framework, currently being used by around 897,000 organizations in 170 countries worldwide, and sets the standard not only for quality management systems, but management systems in general.

It helps all kinds of organizations to succeed through improved customer satisfaction, staff motivation and continual improvement.

Any organisation can benefit from implementing ISO 9001:2008. It doesn't matter what size they are or what they do. It can help both product and service organizations achieve standards of quality that are recognized and respected throughout the world.

ISO 9001 QMS is based on eight quality management principles:


a customer focused organisation leadership the involvement of people ensuring a process approach a systematic approach to management a factual approach to decision making mutually beneficial supplier relations continuous improvement


Benefits of iso 9001:2008

Competitive advantage
ISO 9001 should be top-management led, which ensures that senior management take a strategic approach to their management systems. Our assessment and certification process ensures that the business objectives constantly feed into your processes and working practices to ensure you maximise your assets.
Improves business performance and manages business risk
ISO 9001 helps your managers to raise the organization’s performance above and beyond competitors who aren’t using management systems. Certification also makes it easier to measure performance and better manage business risk.
Attracts investment, enhances brand reputation and removes barriers to trade
Certification to ISO 9001 will boost your organization’s brand reputation and can be a useful promotional tool. It sends a clear message to all interested parties that this is a company committed to high standards and continual improvement.
Saves you money
Evidence shows that the financial benefits for companies that have invested in and certified their quality management systems to ISO 9001 include operational efficiencies, increased sales, higher return on assets and greater profitability.
Streamlines operations and reduces waste
The assessment of your quality management system focuses on operating processes. This encourages organizations to improve the quality of products and the service provided and helps to reduces waste and customer complaints.
Encourages internal communication and raises morale
ISO 9001 ensures that employees feel more involved through improved communication. Continued Assessment visits can highlight any skills shortages sooner and uncover any teamwork issues.
Increases customer satisfaction
The ‘Plan, Do, Check, Act’ structure of ISO 9001 ensures that the needs of the customer are being considered and met.


How to achieve ISO 9001 certification - ISO 9001 implementation / Certification steps


Lakshy Management Consultant Pvt Ltd. offers a well defined and globally proven implementation methodology for ISO 9001:2008 certification.


Gap AnalysisAwareness TrainingProcess Identification and definitionDocumentation Design and finalizationImplementationInternal Auditor Training and conduct of internal auditManagement Review MeetingReview of ImplementationPre-assessmentStage 1 – certification auditStage 2 – certification auditAward of ISO 9001 certificationContinual improvement of the system through value added consulting and training services


What are the requirements of ISO 9001 standard ?


The major requirements of the ISO 9001:2008 standard are described in sections 4.1 through 8.5.3 of the actual Standard covered from clause 4 to clause 8.


Clause 4. Quality Management System
Clause 5. Management Responsibility
Clause 6. Resource management
Clause 7. Product / Service Realization
Clause 8. Measurement, Analysis and Improvement


Summary of documents / records required by ISO 9001:2008


Documented statements of a quality policy and objectives:
Quality Manual:
 Documented procedures:


4.2.3 Control of documents4.2.4 Control of records8.2.2 Internal audit8.3 Control of nonconforming product8.5.2 Corrective action8.5.3 Preventive action


Documents needed by the organization to ensure the effective planning, operation and control of its processes:


In order for an organization to demonstrate the effective implementation of its QMS, it may be necessary to develop documents other than documented procedures. However, the only documents specifically mentioned in ISO 9001:2008 are:

» Quality policy (clause 4.2.1.a)
» Quality objectives (clause 4.2.1.a)
» Quality manual (clause 4.2.1.b)


There are several requirements of ISO 9001:2008 where an organization could add value to its QMS and demonstrate conformity by the preparation of other documents, even though the standard does not specifically require them. Examples may include:

» Process maps, process flow charts and/or process descriptions » Organization charts » Specifications » Work and/or test instructions » Documents containing internal communications » Production schedules » Approved supplier lists » Test and inspection plans » Quality plans


Records:


Clause Record required
5.6.1 Management reviews
6.2.2 e) Education, training, skills and experience
7.1 d) Evidence that the realization processes and resulting product fulfil requirements
7.2.2 Results of the review of requirements related to the product and actions arising from the review
7.3.2 Design and development inputs relating to product requirements
7.3.4 Results of design and development reviews and any necessary actions
7.3.5 Results of design and development verification and any necessary actions
7.3.6 Results of design and development validation and any necessary actions
7.3.7 Results of the review of design and development changes and any necessary actions
7.4.1 Results of supplier evaluations and any necessary actions arising from the evaluations
7.5.2 d) As required by the organization to demonstrate the validation of processes where the resulting output cannot be verified by subsequent monitoring or measurement
7.5.3 The unique identification of the product, where traceability is a requirement
7.5.4 Customer property that is lost, damaged or otherwise found to be unsuitable for use
7.6 a) Basis used for calibration or verification of measuring equipment where no international or national measurement standards exist
7.6 Validity of the previous measuring results when the measuring equipment is found not to conform to requirements
7.6 Results of calibration and verification of measuring equipment
8.2.2 Internal audit results and follow-up actions
8.2.4 Indication of the person(s) authorizing release of product.
8.3 Nature of the product nonconformities and any subsequent actions taken, including concessions obtained
8.5.2 e) Results of corrective action
8.5.3 d) Results of preventive action


Integrate ISO 9001 with other management system standards


ISO 9001 is designed to be compatible with other management systems standards and specifications, such as OHSAS 18001, ISO 22000, ISO 17025, ISO 27001, ISO 14001 Environment and other ISO standards. They can be integrated seamlessly through Integrated Management system approach. They share many principles so choosing an integrated management system can offer excellent value for money and an easier approach to implement, manage and improve multiple standards simultaneously.


What we offer in the field of ISO 9001 standard and certification


As one of the largest ISO management system certification consulting companies across the world with clients in more than 40 countries, our knowledge and experience of the standards is unsurpassed. We understand how to fully exploit the benefits of your quality management system to ensure you unlock the true potential in your organization.

We provide unmatched expertise and technical competence to ensure that your ISO 9001 quality management system certification project adds value to your organization.

We provide consulting, training, internal audits, pre assessment audits and facilitation during ISO 9001 certification audit.

We offer our global knowledge moulded locally to bring in the best results for our clients and partner their journey of standardization, compliance, growth, success and continual improvements.

Contact us now, to get your organization ISO 9001:2008 certified in the most effective and efficient manner while realizing the true benefits of the certification using our specialized ISO implementation methodology that is less time consuming, fast, easy to understand and implement, result oriented, time bound and cost effective. Get ISO 9001 certified now with us….

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