ISO 9001 Standards – Quality Manuals

ISO 9001 is a quality management system (QMS) created and maintained by the International Organization for Standardization (ISO), the largest developer of international standards in the world. QMS systems are meant to provide organizations with a formal framework for process improvements and quality standards. The system provides a set of procedures that covers all key processes to ensure they are effective. It also provides a methodology for record-keeping, checking for defects and continuous improvement and maintenance of these functions.

- Provide resources needed to support process operations, monitoring and the management review process.

- Transform and maintain physical workspaces, equipment, hardware, software, utilities and support services needed to meet requirements.

- Develop a system to review transportation (if any), communication and information services for sharing data relating to ISO 9001 standards.

- Provide adequate training for management reviewers (MRs) and internal auditors. They should have the right experience, education and skills needed to ensure that competence requirements are being met.

- Keep a record of the review process. This includes corrective and preventive action procedures.

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How To Keep ISO 9001 System?

How To Keep ISO 9001 System?

The dreaded “program-of-the-month” syndrome: Here today, with much sound and fury—and, after a slow, embarrassing fade-away—gone tomorrow.

Your ISO 9001 system won’t fade away as long as top management remains committed to it. Top management will remain committed to it as long as they see that it is returning some sort of benefit. That benefit may take one of two general forms:

1. Current business stays as a result of the ISO 9001 system.

2. New business comes as a result of the ISO 9001 system.

Net result: Organization achieves incremental cost savings as a result of the ISO 9001 system. Since most companies get into ISO 9001 due to customer pressure, the first benefit is the most operative one. The second benefit is speculative. The net result, surprisingly, is genuine—ISO 9001 registrants, with virtually no exception, realize proven cost savings—but, like mating elephants, it is accompanied by much roaring and screaming, and takes two years to see the results.

Top management will stay committed to the system if only to maintain existing business and, hopefully, obtain new business. This requires that the organization remain registered. For the organization to remain registered, it must undergo and pass surveillance assessments, usually every six months. This is probably the most potent of the four reinforcement mechanisms of ISO 9001—the attributes that keep the system from fading away as another program of the month.

The second reinforcement mechanism is the Management Review process required by the Standard. Management reviews require that senior management review the ISO 9001 system from top to bottom—its implementation, its suitability, its effectiveness, its results. Management must do this on a scheduled basis. Records must be kept to prove that it is done. The reviews have the effect of forcing management to pay attention to the system. The reviews are also an educational process for management. Over time, they see how useful the ISO 9001 system can be as a management and communications tool.

The third reinforcement mechanism is the internal audit process required by the Standard. Trained, independent employees audit the entire quality system on a scheduled basis and record the results. Corrective actions must be carried out and verified against deficiencies found during these audits. Internal auditing is not only an outstanding implementation tool. It also keeps the entire organization tuned in to the system and improving it on an ongoing basis.

The fourth reinforcement mechanism—and arguably the most important one—is the measurement and analysis processes required by the Standard. If you do a good job of establishing meaningful process and quality measures—and then gather, analyze, and react to the data on a disciplined basis—you will see how well the system is working for you. Word to the wise: Establish the measures early in the implementation, so you have a set of baseline measures to compare with subsequent results.

What Does ISO 9001 Offer?

What Does ISO 9001 Offer?

For one thing, it offers you continued business with customers who may be requiring you to register. That is a pretty strong benefit right there. These customers may never question your quality, but these customers depend heavily on their main suppliers. They know they can improve their quality and through-put, if you improve yours. ISO 9001 mandates a continuous improvement system. You can wriggle and fudge, but if you implement that system and work it conscientiously, you cannot help but improve. Continuous improvement is not just a buzz term. It is an imperative.

Has your industry changed? Has your organization changed? A well-implemented ISO 9001 helps your organization adapt to change. It brings independence of individuals and consistency of practices—two features that tend to resist declines in performance.

What else does ISO 9001 bring you? When well implemented, an ISO 9001 quality system improves organization performance. That is, after all, the whole point. In cases where it does not, the fault tends not to be in the ISO 9001 process (its inherent deficiencies notwithstanding). When an ISO 9001 system does not provide substantial benefits and improvement in performance, it is usually because management has consciously chosen to cut corners, blow smoke, stay uninvolved, and starve the system of all but the most essential resources. “We’ll do this stupid thing, but we’re sure not going to change the way we operate.”

ISO 9001 registration brings you one more thing that your organization may not have today: International credibility. ISO 9001 is deployed and practiced in nearly 100 countries around the world. In today’s ever-growing international economic climate, this is not a bad emblem to have, however narrow the scope of your market today.

ISO 9000 Standards – Design and development

ISO 9000 Standards – Design and development

Planning the design and development of a product means determining the design objectives and the design strategy, the design stages, timescales, costs, resources and responsibilities needed to accomplish
them. Sometimes the activity of design itself is considered to be a planning activity but what is being planned is not the design but the product.

The purpose of planning is to determine the provisions needed to achieve an objective. In most cases, these objectives include not only a requirement for a new or modified product but also requirements governing the costs and product introduction timescales (Quality, Cost and Delivery or QCD). Remove these constraints and planning becomes less important but there are few situations when cost and time is not a constraint. It is therefore necessary to work out in advance whether the objective can be achieved within the budget and timescale. One problem with design is that it is often a journey into the unknown and the cost and time it will take cannot always be predicted. It may
in fact result in disaster and either a complete reassessment of the design objective or the technology of the design solution. This has been proven time and again with major international projects such as Concorde, the Channel Tunnel and the International Space Station. Without a best guess these projects would not get off (or under!) the ground and so planning is vital firstly to get the funding and secondly to define the known and unknown so that risks can be assessed and quantified.

Design and development plans need to identify the activities to be performed, by whom they will be perform and when they should commence and be complete. One good technique is to use a network chart (often called a PERT chart), which links all the activities together. Alternatively a bar chart may be adequate. There does need to be some narrative in addition as charts in isolation rarely conveys everything required.

Design and development is not complete until the design has been proven as meeting the design requirements, so in drawing up a design and development plan you will need to cover the planning of design verification and validation activities. The plans should identify as a minimum:
- The design requirements
- The design and development programme showing activities against time
- The work packages and names of those who will execute them (Work
packages are the parcels of work that are to be handed out either internally or to suppliers)
- The work breakdown structure showing the relationship between all the parcels of work
- The reviews to be held for authorizing work to proceed from stage to
stage
- The resources in terms of finance, manpower and facilities
- The risks to success and the plans to minimize them
- The controls that will be exercised to keep the design on course
Planning for all phases at once can be difficult as information for subsequent phases will not be available until earlier phases have been completed. So, your design and development plans may consist of separate documents, one for each phase and each containing some detail of the plans you have made for subsequent phases.
Your design and development plans may also need to be subdivided into
plans for special aspects of the design such as reliability plans, safety plans, electromagnetic compatibility plans, configuration management plans. With simple designs there may be only one person carrying out the design activities. As the design and development plan needs to identify all design and development activities, even in this situation you will need to identify who carries out the design, who will review the design and who will verify the design. The same person may perform both the design and the design verification activities, however, it is good practice to allocate design verification to another person or organization because it will reveal problems overlooked by the designer. On larger design projects you may need to employ staff of various disciplines such as mechanical engineers, electronic engineers, reliability engineers etc. The responsibilities of all these people or groups need to be identified and a useful way of parcelling up the work is to use work packages that list all the activities to be performed by a particular group. If you subcontract any of the design activities, the supplier’s plans need to be integrated with your plans and your plan should identify which activities are the supplier’s responsibility. While purchasing is dealt with in clause 7.4 of the standard, the requirements also apply to design activities.

Why is ISO 9000 Important?

ISO 9000 is important because of its orientation. While the content itself is useful and important, the content alone does not account for its widespread appeal.
ISO 9000 is important because of its international orientation. Currently, ISO 9000 is supported by national standards bodies from more than 150 countries. This makes it the logical choice for any organization that does business internationally or that serves customers who demand an international standard of excellence.
ISO is also important because of its systemic orientation. We think this is crucial. Many people wrongly emphasize motivational and attitudinal factors. The assumption is that quality can only be created if workers are motivated and have the right attitude. This is fine, but it doesnt go far enough. Unless you institutionalize the right attitude by supporting it with the right policies, procedures, records, technologies, resources, and structures, you will never achieve the standards of quality that other organizations seem to be able to achieve. Unless you establish a quality attitude by creating a quality management system, you will never achieve a world-class standard of quality.
Simply put, if you want to have a quality attitude you must have a quality system. This is what ISO recognizes, and this is why ISO 9000 is important.

Hidden Businees Opportunities

The ISO 9001:2000 Standard has been revised after eight years. And the buzz is rapidly reaching a crescendo. We continue to receive numerous emails and phone calls regarding the impact of the new release. First, let me dispel any anxiety about the November 15, 2008 official “2008” release. There are no new requirements. The changes are largely interpretive, and focus on terminology clarifications. The changes to the ISO 9001 amendment, however, will have considerable benefit.As a back drop, keep in mind that ISO 9001 is not just an International Standard for a Quality Management System. It is the world’s most recognized business management standard. And it makes a strong business case. It focuses attention on leadership, business planning, organizational business processes, your customers (internal and external), measurement and reporting, and continual improvement. That translates to improved business results and a sustainable competitive advantage.
Overview of the Changes
The points of clarification focus on outsourcing, documentation, management representative, employee competence, design verification and validation, process monitoring, control of nonconforming product and corrective and preventive action. But bear in mind, no “shalls” (requirements) were added or removed.Examples of select changes include: In an attempt to clarify the term “outsourcing,” notes were added that require the organization to identify processes (and the control of these) to be completed by an external party. With respect to documentation, the changes focus on improving the compatibility between ISO 9001 and ISO 14001.The only significant addition to the management representative sub clause was to require that the MR be a member of the organization’s management team. This means a contracted person could serve in this role as long as he or she is also considered part of management. The management representative does not have to be full-time.With regard to competence of employees, a note was added to make training more pervasive throughout the organization. Training applies to all employees directly or indirectly responsible for delivering a service or producing a product (everyone that is part of the quality chain). A complete listing of changes can be found in Annex B (Table B.1) of the Standard. Also, note that there is better alignment with ISO 14001:2004.

ISO 9001 And ISO 14001 Information Site

ISO 9001 And ISO 14001 Information Site
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Revising the ISO 9000 Quality Manual

Revising the ISO 9000 quality procedures and the ISO 9000 quality manual should be a normal part of the ever-improving ISO 9000 quality system. These revisions can reach from small corrections to a total makeover of the entire ISO 9000 quality system. If you find your company’s ISO 9000 system to be bureaucratic and cumbersome, if you find your employees completely negative about ISO 9000, and if you end up extensively preparing for each audit, then your ISO 9000 system has plenty of opportunities for improvement and you should consider a complete makeover.
Problems related to ISO 9000It is not uncommon to find employees with negative opinions on ISO 9001. Most of them complain about excessive bureaucracy, much paperwork and extra work before audits. At the same time, they feel that there are no benefits to ISO 9001.
These problems are not the fault of ISO 9001 – these problems result from the way the ISO 9001 quality management system was implemented!