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iso tagged articles (0-17 of 17)

  • Management Systems, ISO 14001 Environmental Guidelines - Those of us closely involved with management system development and improvement are frequently consulted on the relative merits of separate rather than integrated systems for these two standards - and of course other combinations. Staying away from the trap of taking sides with a specific group within the company posing the question, the logical answer is to combine the systems from the beginning. Most of the necessary material for the environmental standard is currently available as a section of the quality management system, and the benefit of possessing a single total management task is definitely a real asset. The review status of the two standards at the current time (2008) introduces a possible cause for separating the systems, particularly with regard to the differing emphases on statutory and legal obligations required by the documents.
  • ISO 13485:2003 ' Managing Forms - One of the controversial issues with interpretation of ISO 13485:2003 Standard and other standards is control of forms. Many companies, by some reason, treat forms differently than documents, leaving them not controlled. Per ISO 13485:2003, clause 4.2.3, "Documents required by the quality management system shall be controlled. Let's see if a form qualifies to be a "document" that "shall" be controlled. Forms and tables are frequently used as lower-level documents. Very often, it is not necessary to write a traditional instruction with the purpose, scope and instructions if a simple table is sufficient to provide these instructions.
  • Business management Principles - In order for a business to be successful it is essential that it must have a management system capable of ensuring the business can achieve its goals and objectives.
  • ISO 9001-Quality Department Elimination - Wherever the ISO9001 Standard is talked over, the one particular item will be that of Improvement. Most often considered is the Continual Improvement requirement of the ISO Standard (section 8) or feasible improvements to the Standard itself. This latter particularly at the present time as we await the publication of ISO9001:2008. Seldom heard is any discussion on the fundamentals of Quality Management as it is determined by individual organisations, both within and without the ISO 9001 registration scheme. It is this that is discussed within this short article.
  • Environmental Management and ISO 14001 - There is an increasing importance given to the management of environmental factors affecting our personal lives, our community and the world at large. As individuals, it is tough to see how our contribution can have any effect on the grand scheme of things, but equally, any large scale change comes about as a consequence of numerous small changes. Individual initiatives tend to be cocentrated more on cash savings than on the general good - no harm in that, but overall, no great benefit either.
  • Management of the Contract Process through ISO9001 - In an effort to define an effective set of management processes, ISO 9001:2000 has a section dedicated to the management of the contract process. Earlier versions of the Standard (e.g. ISO9001:1994) defined this activity as Contract Review, a clear indication of its nature and objective. ISO 9001:2000 has located it in a section (7.2.2) "Review of requirements related to the product". In both cases the objective was to ensure that organisations were able to, and required to, clearly assess the customer requirements prior to entering into a contract, and also to ascertain their capability to meet those requirements. But isn't this obvious? Possibly, and no one is claiming any originality for this inclusion in the Standard.
  • Risk Management - ISO 9001 Way - In every human endeavour there is an element of risk; personal, project or financial, or a combination of them all. The task of the responsible individual is to identify the risk and act accordingly. We all do these 'risky' things, almost daily, aware that we are taking a risk.
  • ISO 9001 and Organisational Output - A common perception of the requirement 'continual improvement' contained within the ISO9001 Standard (8.5.1) is that in some way it relates to an improvement of product or service. Some more serious thought might reveal this to be a misinterpretation, as the document is not a product or service specification, but a system for controlling the quality of the product or service through the output. Title - ' ISO9001:2000 Quality management systems - Requirements'. So, in so far as the Standard relates to the organisations' output, it defines a control and assurance system that should provide a measure of conformance for the outgoing product. The improvement requirement refers to the manner in which this control is affected.
  • ISO Standard Internal Audits - This ISO Standard contains an element (8) intended to encompass a range of features which together support a procedure to perk up the performance of the management system.

  • ISO9001 Standard and Quality Management Systems - With the proliferation of companies claiming to conform to the requirements of this international Standard, we might well come to believe that product and service quality has reached its peak and every customer is satisfied with the performance of their ISO9000 registered supplier. On the other hand we could have simply misunderstood the purpose of this Standard and the registration process. Maybe the Standard isn't about quality of service or product. ISO 90001's current version, which was released in year 2000, is clearly focussed on defining a Quality Management System. This is by convention the mechanism by which an organisation defines and manages the quality of its output delivery.
  • HACCP (Hazard Analysis And Critical Control Points) - HACCP (Hazard Analysis and Critical Control Points) is basically a food safety management system that focuses on proactive approach of prevention for hazards rather than inspection of finished products. HACCP addresses all biological, chemical and physical hazards associated with food safety. HACCP has been successfully used in food and pharmaceutical industry in identification of potential safety hazards and in taking key actions to eliminate or reduce the risks caused by them. The HACCP system can be used at various stages of production and processing to ensure food safety and protection of public health. The concept of HACCP was incepted in 1960s when Pillsbury designed and manufacture of food for space flights for NASA – the first venture of its kind. After that the concept was internationally recognized and traditional methods of inspection were replaced by science based food safety management system.
  • ISO Certification Basics – Part 2 - Previously I discussed the basics of ISO certification and what it meant. Here are some additional certifications that are specific to specialty industries. AS 9100 is the Aerospace Quality Management System. Its foundation is ISO 9000:2000, with additional requirements specific to aerospace manufacturers. This is for companies that supply and work with the aerospace industry. ISO 13485 is the Medical Quality Management System. Again, the foundation is ISO 9000:2000 with additional requirements that are specific to medical device manufacturers. Organizations currently manufacturing private label medical devices must have ISO 13485 registration if they sell their product in the European Union.
  • ISO Certification Basics – Part 1 - If you operate an international company or a company working within a specialized industry such as the automotive, aerospace, medical or food industries, you may have considered becoming ISO certified. There is even a possibility you are required to have an ISO certification. So what are the ISO certification basics? What does it mean to be ISO certified? Here are some of those answers. ISO stands for International Standard Organization. It is recognized as an international standard, and it is accepted globally. ISO standards were developed as a generic layout of requirements. Every company can use those standards as a basis to build a quality management system or business management system resulting in creating a quality product or service. However, ISO doesn’t tell a company how to operate, or how to run its operations.
  • Steps in the ISO Registration Process - Once the manuals are done, processes are documented, and people trained, the company will contact a registrar to schedule their audit. That is step one for registration, a document review. The audit process includes: Document Review An auditor reviews the company’s quality manual to be sure they have all the policies and procedures required by the standards. The documentation review can be done off site or on-site. The stage one process is finalizing the document review preparing for the registration.
  • How to Become ISO Certified - Becoming ISO certified is not as complicated as some may think, but it does take time and dedication. In fact, many companies will contract support services that do training or consulting to help them through the ISO certification process. However, some companies find, after reviewing the ISO requirements, their company is already compliant with many of the requirements. The initial outlay of time and money can sometimes appear large, but in the long run, they will find that the savings and cost effectiveness will save money. The first step you can take in becoming ISO certified is to call a management company that will take you through each step of the process. They can talk with you to ascertain where you are in the process, and what it is that you need.
  • Find an ISO Registrar or Auditor that “Fits” with Your Company - Finding an ISO registrar or auditor that fits well with your company is vital. You want to work with a person or a company that you are comfortable with and that is comfortable with you! Here are some tips that you can follow to find a registrar or auditor that you know you will work well with your company: Try to find a registrar that has somebody who can answer your questions, someone that you feel comfortable with.
  • Unhappy with Your ISO Registrar or Auditor? - Whether or not your ISO auditor ‘fits in’ with you company is important. If you are unhappy with your current auditor or registrar, start by reviewing your contract closely. If the contract does not have a cancellation clause mandating that you pay ahead or that you cannot change during the certification cycle, you can transfer to anyone at any time. Even if a company is in a three year certification contract with one registrar or audit service, it can be easy to transfer if that company has a cancellation clause. To transfer ISO 9000 or ISO 14000 registrations, the registrar would review previous reports, findings, etc. then perform the next audit as scheduled.

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