ISO 9001:2008 For Companies and Organizations providing services, ISO 14001:2004 for environmental management, measurement, evaluation and auditing, OHSAS18001 Occupational Health & Safety Management System, ISO 22000: 2005 Food Safety Management System, ISO 27001:2005 Information Security Management System, ISO 13485 is a quality system standard for organizations that design, develop, produce or service medical devices, (NABL) is an autonomous body under the aegis of Department of Science & Technology, international standards called ISO/IEC 17025 or ISO 15189, National Accreditation Board for Hospitals & Healthcare Providers (NABH) , Certification to suit your needs as a business or for an Organization. An ISO Certification is essentially an agreement to meet specific standards in the way that you run your business. The aim of the certification is to lay out a certain standard that you are going to base your business upon and this is one of the reasons that an ISO Certification is suitable for all businesses - big and small because everybody needs to outline the standards they are going to use.
What is ISO 9001 ?
ISO 9001 is an international Standard. It's one of the most widely known and internationally accepted models for a quality system, and the basis of many highly effective quality systems. The Standard can be applied to any size of company or organisation, any industry and any country, for both services and products.The Standard itself consists of a set of requirements. These requirements specify what a company must do, but not how. On the down side, the Standard was written by a committee, and has the inherent weaknesses of multiple authorship. It can be a little difficult to understand in places. Because it states generic requirements, and is intended to apply to all kinds of businesses, some interpretation and experience is required to apply it to your business.
An ISO 9001 system is a management system - that is, a system for how you manage your business. This isn't something that you just do once: you have to maintain the system, things may change a bit, so you'll need to update bits, and your external auditor will come back and audit you at regular intervals. Why waste time and effort on something difficult or awful to work with? It's your company and your system, so why not aim for something that works well and adds value? A good ISO 9001 system should work with and for your business, not make things harder than they have to be.
The requirements are organised in these 4 broad groups:
Management responsibility - requirements for planning, having measurable objectives, review and general requirements, including for system documentation. Resource management - requirements for how you organise your people, premises, etc. Product/service realisation - a horrible term! Requirements for how you make your products or services 'real' - ie, how you do what you do, whether that is making widgets or providing services. Checking - requirements for measuring performance against objectives, analysing performance, identifying and fixing various problems, and improving your system. Key points of an ISO 9001 system are that it must be documented and it must be auditable - ie, capable of being audited.
What are the benefits of ISO 9001?
Our clients report many benefits from their ISO 9001 system including: greater management control, greater clarity about what they do and how, improvements in customer satisfaction, having a 'much better handle' on what they are doing, increased employee satisfaction, reduced rework and frustration, and reduced maintenance effort. In a recent survey of 227 US firms (results published in the ISO magazine, ISO Management Systems). Eight out of 10 surveyed companies reported that the transition and implementation costs were at least covered by savings 56% reported better use of data by management after certification 54% reported improved customer satisfaction 51% reported their management reviews were more effective, and 41% reported improved customer communication. Many of the companies also said that as a result of identifying and analysing their processes, as required by the Standard, they had improved their processes and streamlined their systems. In a survey by BSI (a global quality certifier), a US firm reported a sales increase after certification of $6m. Another company reported a 75% improvement in customer satisfaction. Certification to ISO 9000 was recognised as a powerful means for recognising best practice and adopting it elsewhere, and for identifying the issues that contribute most to customer satisfaction. Other benefits cited: a greater understanding of how their organisations worked (leading to shorter training times), clearer communication and accountabilities, and significant reductions in product development time and customer complaints.
How long and how much does it cost?
How long is a piece of string? (Sorry, couldn't resist). An analogy: would you simply ask a travel agent: How long is a holiday? They need to know things such as: Where do you want to go? When? Plane, train, bus or driving? If driving, your car, or do you want to hire one? Are you stopping, or will you direct? And so on. The real answer to 'how long' is: it depends. As for cost, again it depends, There are 3 kinds of costs: the cost of the certifier, the cost of consulting (if you use a consultant) and the cost of your own resources. You will need to ask for quotes from KVALITY for overall cost. The cost varies somewhat, depending on factors such as:
In what type of business you are?
what size and how complex?
What are your services or products?
Do you have multiple locations? Where?
How many employees?
What's your current system like?
Does it meet all requirements of ISO 9001?.
Where are the gaps?
How much work will you want do?
How much do you want us to do? And so on.
If you would like an obligation-free assessment, please ask us, if your system is in comfortable position, Direct Certification process may be done... Over all what important is? your requirement:
The Key Features of ISO 9001:2000?
Greater emphasis on customer focus and orientation.
Process based approach.
Emphasis on continual improvement.
Measurable quality objectives.
Greater emphasis on planning.
More focused management commitment to achieve customer satisfaction and provide resources.
Consideration of regulatory requirements for products is mandatory.
Internal communications is a requirement.
Reduced emphasis on documentation but more on providing evidence.
Emphasis on assuring skills of personnel.
Judging the effectiveness of the training.
Provision of suitable work environment is a requirement.
Requirement to measure customer satisfaction introduced.
Requirement to measure process performance introduced.
Language made simpler.
Standard structure aligned with actual business processes in an organization.
Manufacturing bias has been reduced.
Standard made fully relevant to non-manufacturing organizations.
ISO 9001:2000 is not a benchmark of product quality. Merely having ISO 9001:2000 management system does not imply that every product has to be of super grade. It is equally applicable to all grades of products.
ISO 9001:2000 based QMS is as good as the way you design and implement it.