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ISO 9000 Keys to Success
This is our
Keys to Success white paper to get you started, and Quality Manual samples to
give you an idea of typical style and layout.
Also, take a look at our
FAQ
page. If you like the style, may I suggest you buy our product
CD 9000 which includes
a full ISO 9000 database and quality manual & procedure templates (£118.57
GBP)
Are You Responsible for ISO 9000 ? In this paper, we aim show you the intent behind the Standards, and what the requirements really are. • It includes a detailed introduction to ISO 9000:2000 • An extensive list of tips including links to free information • And our proven project plan. With our knowledge you can avoid complicating an otherwise simple tool. Only by ensuring a minimal amount of time is spent on administrative tasks, can the true power of your quality system deliver real business benefits.
Q: ISO 9000:2000 - What's Todays Biggest Problem ? A: It is often wrongly assumed that the "safest way" is to create ever more paperwork. Unfortunately, many consultants are happy to oblige with over-documented and out-dated solutions. When you understand that ISO 9000:2000 is fundamentally different from ISO 9000:1994 you realise that your normal business practices already meet most of what ISO 9001 requires and the few additional requirements are aimed at improving business performance and customer satisfaction. ISO 9000:2000 defines a procedure as a "specified way to carry out an activity or a process", which does not necessarily have to be documented. You simply have to demonstrate that you meet the requirements. Auditors now verify this by reviewing your records and interviewing staff to ensure a level of consistency. Many people talk about the high cost of implementing ISO 9000. Our approach: Base your quality system on what you are already doing.
The ISO 9000:2000 Committee say... "ISO 9001:2000 has significantly reduced the documentation requirements and is much less prescriptive than the 1994 version of the standard. It allows an organization more flexibility in the way it chooses to document its quality management system (QMS). This enables each individual organization to develop the minimum amount of documentation needed in order to demonstrate the effective planning, operation and control of its processes and the implementation and continual improvement of the effectiveness of its QMS." Taken from Document N525 (my emphasis) - you can download N525 from the ISO 9000 Committee To Your Success ! Stephanie Keen Stephanie Keen E-mail info@iso9001help.co.uk Web http://www.iso9001help.co.uk Use the menu and your browsers BACK button to navigate this page
What Are The Benefits of CD 9000 & QM 9001? Introducing CD 9000 and QM 9001 Streamlined Quality System Solutions Designed for Small Business The unique combination of ease of use, practical guidance and exceptional value for money makes CD 9000 the best all-in-one solution for your business. We've worked hard to make CD 9000 easy to use - see our screenshots http://www.iso9001help.co.uk/screenshots.htm CD 9000 features Self-directed Training Software that Provides You with Detailed Explanations of ISO 9001:2000 and Practical Guidance INCLUDING Proven Templates to Speed the Development of Your ISO 9001 Quality Policy, Quality Manual and Mandatory QMS Procedures •
meet all ISO 9001:2000
requirements For the more experienced user QM 9001 is the Quality & Procedure module from CD 9000, but excludes the training database. Use CD 9000
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History ISO 9000 is a series of quality management systems standards created by the International Organization for Standardisation (ISO), a federation of 132 national standards bodies. The ISO 9000 quality management systems (QMS) Standards are not specific to products or services, but apply to the processes that create them. The Standards are generic in nature so that they can be used by both manufacturing and service industries. First released in 1987 and revised in a limited manner in 1994, they underwent a major revision in 2000. The approval Standard, ISO 9001:2000, uses a simple process-based structure, which is fits easily the process management structure of most businesses. ISO 9000 Introduction ISO 9000 has evolved into a Standard designed to assist organisations in achieving 'quality' whilst helping to assure customers that quality will be achieved. Whatever definition you choose to use for quality, and there are many, it is essential that your customers are happy with the product/service being supplied. ISO 9000 is intended to assist that aim by helping to ensure that the product/service is right - for both the organisation itself and its customers. The poor implementation of the 1994 series resulted in many people claiming that the Standards did not prevent organisations producing sub-standard product. The 2000 edition clearly requires organisations to satisfy their customers and undertake continual improvement of their quality management systems therefore compliance with ISO 9001:2000 should result in significant benefits for organisations and their customers. The ISO 9000:2000 series consists of
ISO 9000:2005 Fundamentals and vocabulary ISO 9000 is an introduction to the philosophy of quality management and also contains the definitions used in ISO 9001 and ISO 9004. It also contains the 8 management principles which provide the foundation for the ISO 9000 series of Standards. These are:
These principles are NOT elements against which the organisation can be directly assessed but their influence can be seen throughout the Standard. They should be considered by any organisation wishing to comply with the spirit, as well as the text of ISO 9001.
ISO 9001:2000
Requirements ISO 9002 and ISO 9003 became obsolete in December 2000. ISO 9001 contains all of the requirements which an organisation must address within their Quality Management System (QMS) if they wish to be certified against the Standard. The majority of these requirements would be identified by many organisations as 'common sense' topics which they would want to address in order to run their business well eg sales, design, purchasing, training, calibration of test equipment, control of records. ISO 9001 is written by a committee (TC 176) and is designed for use in any type of organisation. This inevitably means that there are compromises in the wording of the Standard and some interpretation is often needed. There are 8 sections in ISO 9001: 1. Scope It is sections 4, 5, 6, 7 & 8 which contain the Requirements themselves and organisations wishing to be certified against ISO 9001 will need to demonstrate that they have addressed all of these requirements. There are over 250 individual requirements in ISO 9001 that can be condensed into five key statements. The organisation shall:
ISO 9001:2000 Approval ISO 9001:2000 registration gives the organisation the benefit of an objectively evaluated and enforced quality management system. It is a tangible expression of a firm’s commitment to quality that is internationally understood and accepted. ISO 9001:2000 registration is carried out by certification bodies (registrars), accredited organisations that review the organisation’s quality manual and working practices to ensure that they meet the Standard. Using ISO 9001:2000 It is important that when an organisation is certified to ISO 9001, it is clear which aspects of the organisation are covered by the certificate. This is addressed through the Scope of Registration, and this must clearly identify what is included so as not to mislead. It is a requirement that all elements of ISO 9001 must be addressed by the organisation. However, there are specific circumstances under which certain requirements of the Standard can be excluded, yet compliance with ISO 9001 still be claimed:
The company's quality manual must also clearly identify why specific requirements of ISO 9001 have been excluded and the justification for that exclusion. What 9001 is not ISO 9001 is NOT a product Standard - it contains no product requirements. It is a series of generic requirements for quality management systems. Approval to ISO 9001 does not guarantee product or service quality. Customer focused leadership, not Standards produces satisfied customers. Approval to ISO 9001 demonstrates that you meet the minimum requirements of quality management. ISO 9004:2000 Guidelines for performance improvement ISO 9004 is not a guide on how to implement ISO 9001, rather a guide on how to improve on the basic requirements that ISO 9001 specifies. The requirements statements in ISO 9001 may be seen sometimes as a little brief and it rarely, if ever, tells the user 'how' to achieve compliance with it. ISO 9004 takes the basic requirement and expands on it. It gives options for the organisation to consider if they wish to progress beyond basic compliance and into excellence. Given that 'Continual Improvement' is a requirement of ISO 9001, it is strongly recommended that you consider using ISO 9004 as a way forward in the journey of continual improvement. Certification bodies cannot certify organisations against ISO 9004 but auditors may use it for guidance. You should consider using ISO 9004 to assist internal auditors when seeking improvement of the more mature processes. ISO 9004 reproduces the full requirement of ISO 9001. It may also be that some of the guidance contained in ISO 9004 may one day become part of the requirements of ISO 9001 when the Standard is updated again in the future.
Get Free information: • Start with our FAQ page • Get a work book (PDF format) from Association of British Certification Bodies • Follow this link for some limited interpretations (PDF format) on the ISO Committee's site http://www.tc176.org/Interpre.asp • NOTE: you will need Acrobat Reader to open these files. Click here for free Acrobat Reader download. • Take a look at the public documents on the ISO 9000 committee site
•
I'm not
sure of the copyright status of this and it may contain
errors, but you can download ISO 9004
(in MS Word) from
www.uml.org.cn/rjzl/doc/Ezhinan.doc.
However, as with ANY file
download, we recommend that your anti-virus software is enabled and current • They’re often cheaper from Australian Standards http://www.Standard.com.au/catalogue/script/search.asp • Follow this link to the ISO 9001 Audit Practices Group and learn more about modern audit techniques. The leading UK Certification Bodies NQA and Lloyds Register Quality Assurance both provide free, and useful information on 21st Century quality thinking. Identify any gaps - typical gaps: no process map (Para 4.1), no policy or objectives (Para 5.3, 5.4), no internal audits (Para 8.2.2) misunderstanding Preventive Action (Para 8.5.3)
What is an appropriate level of documentation ? • See http://www.iso9001help.co.uk/ISO_9001_quality_documentation_42.htm TOP TIP #1 What the Standard doesn't tell you is how all this information should be documented As a rule, you should avoid creating overly complex or burdensome documentation. You may decide to merely "Define" simpler processes (by giving an overview in the Quality Manual) rather than "Document" them in detailed Procedures. Rely instead on the skills, training and experience of the people doing the work. Balance lightweight procedures with heavyweight Training records. TOP TIP #2 Start with the assumption that you are already DOING most of what ISO 9001 requires- You probably are. Many people talk about the high cost of implementing ISO 9000 - I believe this is a false assumption. If you do it right and understand the Standard then implementation should not be that big a problem - as 75% of your quality system is already in place. TOP TIP # 3 The traditional method of controlling a process is to write a procedure. The typical procedure will be ‘text based', comprise a number of pages broken down into paragraphs of information which direct the reader to perform certain activities. Alternatively, they may be in the form of flowcharts which generally contain less specific information but are easier for the reader to obtain a quick ‘snapshot' of what is happening in the process. Flowcharts may be backed up by text if the process is complex. An equally valid method for controlling a process is the use of software. e.g. the sales department may have a piece of software which ‘drives' the order system and provides the necessary control. For example, the software helps the staff to enter the correct information by prompting inputs in appropriate fields, and throws up an error message when incorrect data has been entered, why have a documented procedure defining how to perform the task? It may be more appropriate to train people in its use and then evaluate their competence by reviewing performance. Smart Forms are another alternative. Smart forms which contain enough information to help ensure that the activity is performed correctly can be used to provide the necessary control. FAQ's
Q Is a production process different from a
business process? Too many 'quality systems' have tonnes of documentation. They are Quantity Systems, NOT Quality Systems. Quality Manuals are NOT full of weird words and convoluted language that no one can even understand much less use…
Do a risk assessment - if your product or service fails what is the worst that will happen? How serious are the consequences?
If
the answer is "the end of civilisation
as we know it" then you need lots of controls (checks & records).
If you've done
ISO 9000 before, forget everything you thought you knew -
2000 is more about performance and less emphasis on procedures.
DON'T insult people's intelligence by stating the obvious - "Complete form 17. In the box marked "Customer Name" insert the customer's name..." DON’T use language that you don't understand DON'T say things that you know you don't do DON'T keep more records than required. Where ISO 9001 says "...see 4.2.4" that means keep a record. Records are for managers, not for auditors Is there a record in your system with no clear business
purpose? If so, get rid of it!
The key purpose of the latter form of record (the old ISO 9000 used to helpfully call them 'quality records'!) is to capture data that provides you with management information about how well - or otherwise - your system is working and the progress that is being made in achieving your objectives. It is not the purpose of any record to provide 'evidence' to auditors - this is incidental. KEEP records long enough to cover your period of product liability - unless the law or some other Standard says different Develop training records - that show staff are competent, Para 6.2 http://www.iso9001help.co.uk/Training_62.htm Develop meaningful targets for improvement (quality objectives) Para 5.4.1. http://www.iso9001help.co.uk/Quality_objectives_541.htm First, use the quality policy statement as a framework for establishing your process and product goals. Then set specific, measurable targets on the path to attaining these goals. Product objectives will largely be determined by your product specifications. Focus your attention on the process objectives and the methods you'll use to measure process performance. These objectives must be established at the relevant functions and levels within your organisation. Integrate ISO 9000 into the business process DON'T develop an alien system that sits separately from the business DO face an audit with pride - "We are good at what we do" DON'T face an audit with fear Done PROPERLY ISO 9001 is a useful tool that may tell you something useful about your business
A good ISO 9001 system is practical, manageable and works FOR you… - It does NOT tie you in knots, weigh you down with bureaucracy, nor demand useless documentation, nor make you do pointless things just for the auditor Done BADLY you have a meaningless pile of paperwork - Many people even believe that 'proper' quality manuals must have a separate policy, and procedures for every clause. You DON'T need to do it. DO develop a simple, robust system appropriate for the size of the company and the type of business DO use a simple numbering system for documents and paragraphs.
1. Find out about ISO 9001:2000. ISO 9001:2000 is intended to be generic (i.e., applicable to all organisations, regardless of type, size and product category). However, not all requirements in the new Standard will necessarily be relevant to all organisations. Under certain circumstances, an organisation may exclude some specific requirements. ISO 9001:2000's clause 1.2, Application, states that requirements can be excluded only if they're limited to clause 7, Product realization. Exclusions are acceptable only if they don't affect an organisation's ability, or responsibility, to provide products that meet customer and applicable regulatory requirements. Do a gap analysis - you are probably doing most of what ISO 9001 requires already as part of your normal business practice.
Get the backing of your Top Management. Every sub-clause of ISO 9001 Section 5, Management Responsibility, begins with the phrase, "Top management shall." Top management must provide evidence of its commitment to developing and implementing the quality management system, as well as continually improving its effectiveness. Develop your project plan based on your gap analysis and decide how much or how little documentation you need to demonstrate control.
Get information on potential certification bodies. See
http://www.ukas.org. NOTE: Accreditation Bodies audit and "accredit" the Certification Bodies who audit and "certify" you. 2. Top Management to define Quality Policy The reason you need to define 'quality' is simply that, if you don't know what it is, you'll never know whether or not you are achieving it.Not knowing where you want to get to also makes it difficult to communicate to other people what is to be achieved and why, let alone to motivate them to act. The only definition of quality that counts is the one on which you and your senior management colleagues are agreed. Clearly if you have a definition that clashes with what your customers, your suppliers, your partners, or the people in your organisation believe, that would be a problem. So you will no doubt listen carefully to these stakeholders before you decide. But - the decision is yours ISO 9001 helps you make this key decision by requiring top management to establish measurable quality objectives. These measurable objectives define what you mean by 'quality'. The standard also helps by requiring objectives that improve the degree to which your products and services meet requirements, the effectiveness of your processes and the perceptions of your customers. Start communication process E-mail for our Tips on Objectives 3. Define the processes A process is a system of activities that uses resources to transform inputs into outputs. The process approach promoted by ISO 9001:2000 systematically identifies and manages these processes and their interaction within a quality management system. For example - how do Sales relate to Design, Design to Purchasing, Purchasing to Manufacturing, etc. 4. Select internal auditors Choose people from across the organisation Ideal profile: Bright, inquisitive, open-minded, used to thinking for themselves. E-mail for our Auditors Top Ten Questions Most certification bodies require
at least three months history between the formal implementation date of the
quality system and the certification audit. Typically, they require that at
least one internal audit covering all elements of the quality system is
completed and followed by a management review before the certification audit.
This enables the company itself to identify problems and to resolve them prior
to assessment by the certification body.
5. Train internal auditors Develop internal audit schedule Management review of progress against plan
6.
Implement Management systems Start internal audits 7. Select Certification Body Agree Scope of Registration and pay fees. Continue implementation plan
8.
Continue implementation plan Most certification bodies wish to see at least 3 months of history. 9. Management Review This your final check to ensure that everyone is happy therefore you should review the business, not just "quality" This vital step is traditionally represented by a minimal, typically annual, senior management review of the QMS. ISO 9001:2000 now requires that the review generates decision on key matters such as process improvement, resource allocation, product improvement driven by customer requirements, and the establishment of new improvement objectives. Bearing in mind the importance of these sorts of topics, it is best not to hold a separate review, knowing that this sends signals to people in the organisation that quality is outside the normal activities of management. Summary of management actions and benefits
10. Implement any system changes 11. Certification Body preliminaries Documentation Audit - a desk-based exercise, carried out by auditors either in their own offices or at the company being audited. The audit is restricted to the quality manual and related systems. Its aim is to ensure that the documentation addresses the elements of ISO 9001. If the auditors identify major gaps in your QMS, there is no point in proceeding with the assessment until these are rectified. Pre-Assessment Audit (optional) - A pre-assessment is a mock audit in preparation for the real thing. A pre-assessment identifies problems and enables the company to benefit from the advice of the auditor on how to eliminate those problems.
You have to pay extra but it is often
worthwhile to arrange a pre-assessment visit and have the certification body to
do a preliminary assessment. Make sure you understand and agree any
non-conformances. If not, ask for a second opinion. 12. Certification Day
The first areas generally examined are management commitment (esp. quality policy and communication), management reviews, corrective actions taken, quality objectives, continual improvement and changes made as the result of the pre-assessment audit. Make sure you understand and agree any non-conformances. If not, ask for a second opinion.
13.
Maintain and improve your management system Generally, Certification Bodies audit small companies for 1 day, once per year. Bigger organisations are audited twice per year.
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