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Iso 9001 2000 Dynamic Strategies


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ISO 9001 2000 Dynamic Strategies

Iso 9001 2000 Dynamic Strategies

  1. 1. SUMMARY OF CHANGES TO ISO 9001:2008 Vs. ISO 9001:2000 DYNAMIC STRATEGIES MANAGEMENT SYSTEM There is nothing to worry about if you are already certified to ISO The good news is that the 2008 release will not have the same impact. 9001:2000. The only likely impact would be on organizations that had In fact, the ISO technical committee (TC176) who develops the ISO previously misunderstood the intent of certain parts of the standard and, 9000 series of standards is purposely planning the next release as an due to the clarifications in the 2008 version, it is recognized that the amendment rather than a formal revision. The difference is that an standard had been mistakenly applied incorrectly. A process or quot;amendmentquot; is focused on making changes for clarification purposes procedure here or there might need some minor modification in this only and for better alignment with ISO 14001, the standard for case. environmental management. With the 2008 release, the committee is purposely intending not to introduce substantive changes that will affect the QMS processes and documentation of currently certified So, the upcoming release of ISO 9001:2008 should be a fairly simple organizations. Thus, the new ISO 9001:2008 standard should have transition for most certified organizations. If you are currently preparing limited impact on companies already certified. Here are a few examples for your initial ISO 9001 certification, there is no reason to delay or to of the types of changes in the currently available DIS ISO 9001:2008 change your approach. If you are correctly implementing an ISO draft: 9001:2000 quality management system in preparation for your initial certification audit, the new standard will not impact you significantly. As • usual, we expect there will be a 1 - 2 year quot;transition periodquot; following There are some terminology changes that are intended to the release of the new revision to make any necessary changes to clarify ideas or make documentation more consistent - e.g. comply with the new standard. But, as we have said, there aren't likely quot;devicesquot; is changed to quot;equipmentquot;. • to be any substantive changes anyway. There are several additional or revised quot;Notesquot; within the standard. However, notes are not considered part of the auditable requirements but are, instead, included for Regardless of the schedule, most users of the ISO 9001:2000 standard clarification. (whether certified, conforming or preparing) want to know what is going • The phrase quot;where applicablequot; is used more extensively with to change in 2008. Those who went through the previous transition from regard to several requirements within the standard. This was ISO 9001:1994 to ISO 9001:2000 know first-hand the disruption that done to help more organizations in various industries more was caused by the significant changes introduced by the last revision. It easily apply the standard to their particular business. was very costly for all certified companies to change over to the new • A number of sentences and paragraphs have been re-worded version. to be easier to understand and apply the language. ● ● ● ISO 9001:2008 Quality Management Systems – Requirements is intended for use in any organization which designs, develops, manufactures, installs and/or services any product or provides any form of service. It provides a number of requirements which an organization needs to fulfill if it is to achieve custom er satisfaction through consistent products and services which meet customer expectations. It includes a requirement for the continual (i.e. planned) improvement of the Quality Management System, for which ISO 9004:2000 provides many hints. This is the only implementation for which third-party auditors may grant certification. It should be noted that certification is not described as any of the 'needs' of an organization as a driver for using ISO 9001 (see ISO 9001:2000 section 1 'Scope') but does recognize that it may be used for such a purpose (see ISO 9001:2000 section 0.1 'Introduction'). • The key focuses of the ISO 9001:2008 amendment were to enhance the clarity of ISO 9001:2000 and to enhance its compatibility with ISO 14001:2004. The changes incorporated in this ISO 9001:2008 edition were classified in terms of impact into the following categories: o No changes or minimum changes on user documents, including records o No changes or minimum changes to existing processes of the organization o No additional training required or minimal training required o No effects on current certifications ● ● ●
  2. 2. ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. No new requirements were introduced in ISO 9001:2008 edition but, in order to benefit from the clarifications of ISO 9001:2008, users of the DYNAMIC STRATEGIES MANAGEMENT SYSTEM former version will need to take into consideration whether the clarifications introduced have an impact on their current interpretation of ISO 9001:2000, as changes may be necessary to their QMS. ISO 9001:2008 is intended to be generic and applicable to all organizations, regardless of type, size and product category. It is recognized, however, that not all the requirements of this standard will necessarily be relevant to all organizations. Under certain circumstances, an organization may consider the exclusion of the application of some requirements of ISO 9001:2008 from its QMS. ISO 9001:2008 makes allowance for such situations, through sub-clause 1.2 Application.  FAQs on ISO 9001:2008 1. What are the main changes in ISO 9001:2008? ISO 9001:2008 has been developed in order to introduce clarifications to the existing requirements of ISO 9001:2000 and changes that are intended to improve compatibility with ISO 14001:2004. ISO 9001:2008 does not introduce additional requirements nor does it change the intent of the ISO 9001:2000 standard. Certification to ISO 9001:2008 is not an ―upgrade‖, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008 All changes between ISO 9001:2000 and ISO 9001:2008 will be explained by the Process Consultants engaged in the process of assisting your Organization in generating Process Compliance with respect to ISO 9001 Certification. 2. What are the main benefits to be derived from implementing an ISO 9000 quality management system? The ISO 9000 standards give organizations an opportunity to increase value to their activities and to improve their performance continually, by focusing on their major processes. The standards place great emphasis on making quality management systems closer to the processes of organizations and on continual improvement. As a result, they direct users to the achievement of business results, including the satisfaction of customers and other interested parties. The management of an organization should be able to view the adoption of the quality management system standards as a profitable business investment, not just as a required certification issue. Among the perceived benefits of using the standards are: The connection of quality management systems to organizational processes The encouragement of a natural progression towards improved organizational performance, via: - The use of the Quality Management Principles - The adoption of a quot;process approachquot; - Emphasis of the role of top management - Requirements for the establishment of measurable objectives at relevant functions and levels - Being orientated toward quot;continual improvementquot; and quot;customer satisfactionquot;, including the monitoring of information on quot;customer satisfactionquot; as a measure of system performance. - Measurement of the quality management system, processes, and product - Consideration of statutory and regulatory requirements. - Attention to resource availability 3. How will the implementation of the amended standard help my organization to improve its efficiency? ISO 9001:2008 aims at guaranteeing the effectiveness (but not necessarily the efficiency) of the organization. For improved organizational efficiency, however, the best results can be obtained by using ISO 9004 in addition to ISO 9001:2008. The guiding quality management principles are intended to assist an organization in continual improvement, which should lead to efficienc ies throughout the organization. 
  3. 3.  4. How can the processes in an organization be determined? Identify the organization's intended outputs, and the processes needed for achieving them. These will need to include processes for DYNAMIC STRATEGIES MANAGEMENT SYSTEM Management, Resources, Realization and Measurement and Improvement. Identify all process inputs and outputs, along with the suppliers and customers, who may be internal or external. Identify the sequence and interactions of the processes. 5. Should an organization define and document all its processes? The main purpose of documentation is to enable the consistent and stable operation of an organization's processes. Although statutory, standards' or customer requirements may require certain documentation, there is no defined ―catalogue‖, or list of processes that has to be documented in ISO 9001, apart from the 6 indicated ones. The organization should determine which processes are to be documented on the basis of: The size of the organization and type of its activities, The complexity of its processes and their interactions, The criticality of the processes and Availability of competent personnel. A number of different methods can be used to document processes, such as graphical representations, written instructions, checklists, flow charts, visual media, or electronic methods. 6. How much detail is required in process documentation? The extent of detail is likely to depend upon factors such as: The size of an organization and its types of activities, The complexity of its processes and their interactions, and The competence (level of education, training, skills and experience) of its personnel. 7. Is there a standard way of describing a process? No, there is no standard way to describe a process. It depends on the culture, management style, staff literacy, personal attributes and their interactions. A process may be described using a flow chart, block diagram, responsibility matrix, written procedures or pictures. Process flowcharts or block diagrams can show how policies, objectives, influential factors, job functions, activities, material, equipment, resources, information, people and decision making interact and/or interrelate in a logical order. 8. What is the impact of ISO 9001:2008 on certification? Certification to ISO 9001:2008 is not an ―upgrade‖, and organizations that are certified to ISO 9001:2000 should be afforded the same status as those who have already received a new certificate to ISO 9001:2008. ISO and the International Accreditation Forum (IAF) have agreed the following ―Implementation Plan‖ with respect to accredited certification to ISO 9001:2008: ―Accredited certification to the ISO 9001:2008 shall not be granted until the publication of ISO 9001:2008 as an International Standard. Certification of conformity to ISO 9001:2008 and/or national equivalents shall only be issued after official publication of I SO 9001:2008 (which should take place before the end of 2008) and after a routine surveillance or re-certification audit against ISO 9001:2008. 
  4. 4. SUCCESSFUL ISO 9001 : 2008 IMPLEMENTATION MADE EASY DYNAMIC STRATEGIES MANAGEMENT SYSTEM Making the decision to become registered to ISO 9001 is often 2. UNDERSTAND THE PROCESS APPROACH a very simple one, as the benefits are well documented. A more difficult task is putting together and successfully completing an implementation plan that balances the requirements of the ISO 9001 promotes a process approach to quality management standard, your deadline to become registered and the normal systems. Successful management system implementation pressures of your business. depends on understanding the process approach in addition to the standard‘s requirements. Begin your understanding by ordering the There is no single blueprint for implementing ISO 9001 that ISO 9000:2000, ISO 9001:2000 and ISO 9004:2000 family of will work for every company, but there are however some common standards. Copies can be purchased through Dynamic Strategies steps that will allow you to balance the often conflicting Management Systems at requirements and prepare you for a successful registration assessment. Before opening the ISO 9001 Requirements standard, review the quality concepts described in the ISO 9000:2000 Fundamentals This ‗Practical Guide‘ considers the key phases in your and Vocabulary standard. implementation project from start to finish and suggests ‗best practice‘ for each while directing you to further helpful When you examine ISO 9001, pay particular attention to the resources as you embark on your ISO 9001:2000 journey. process approach described in its Introduction section. A ‗process‘ is a system of activities that uses resources to transform inputs into 1. THINK OF IMPLEMENTATION AS A PROJECT outputs. The ‗process approach‘ promoted by ISO 9001 requires that you systematically identify and manage these processes and their interaction within a quality management system. An The way to treat the implementation process is as a project, which advantage of the process approach is the ongoing control it means appointing a project team with a project manager, preparing provides over the linkage between individual processes within a a project plan and evaluating and monitoring progress according to system of processes, as well as their combination and interaction. the plan. This demands certain prerequisites, including top According to Clause 4.2.2 in ISO 9001:2000, the quality manual management commitment, good communications at all levels must describe the interaction of the processes within the quality and ownership of the quality system by all. management system. If ISO 9001 Management Systems are a completely new ISO 9004:2000 provides guidance on performance improvements subject area for your organization, or you lack time, expertise or beyond the basic requirements of ISO 9001. objectivity you may want to consider the use of a Quality Management System Consultant to assist with implementation. Further guidance on processes and the process approach is available An experienced consultant can be a very beneficial part of your from the ISO website project team, particularly if you have an implementation deadline as they can undertake the project manager role. Please see the bordered area below ‗Key Concepts of ISO 9001‘ for further information on the major principles of ISO 9001. A consultant should not write your quality system for you, as ownership of processes and procedures is important for a successful Key Objectives management system. For more information on how to select and use a consultant, download our free ‗Ten Tips for Selection and Use I. Understand the process approach of a Quality Management System Consultant‘ from II. Read the standards Key Objectives I. Approach Implementation as a project II. Consider use of a consultant
  5. 5.  ● ● ● Check—This means monitor and measure what you‘re doing so KEY CONCEPTS OF ISO 9001 that you have data to evaluate and improve the processes and overall system. Continual Improvement In ISO 9001:2000, ‗continual improvement‘ is defined as: ‗Recurring Act—After you have data, you must do something with it to activity to increase the ability to fulfill requirements.‘ It is a improve, and, of course, plan for the improvement (which begins the cycle again). The ‗act‘ usually stems from management reviews, continual process through the use of audit findings and audit conclusions, analysis of data, management reviews or other means internal audits, customer audits, data gathering or even third-party and generally leads to corrective or preventive action.‘ assessments. PDCA Process Approach 4 Key Clauses of ISO 9001 The ISO 9001 requirements document follows a concept called the Plan-Do-Check-Act model—a process that is designed for 5. Management Responsibility continual improvement of any management system. This cycle is Top management has an ongoing commitment to the quality critical to understand the new standard and its requirements. management system. They are responsible for identifying all of the The basic concepts of the PDCA cycle are straightforward: relevant business requirements, communicating organizational policy and providing resources to ensure implementation, Plan—This is a critical stage, and ISO 9001 has planning maintenance and continual improvement of the quality requirements and suggestions in nearly every clause. But the basic management system. concept is simple—formulate a plan to fulfill your quality policy and the objectives of the system. 6. Resource Management The day-to-day management of quality and effectiveness relies on Do—This is a fairly simple concept as well. It means implement the using the appropriate resources for each task. These include processes you‘ve laid out in your plan. competent staff with relevant (and demonstrable) training, the correct tools and supporting services. 7. Product Realization This is the design (where applicable) and production of the products and services you provide. In addition to production planning and scheduling resources, product realization includes determining and measurably meeting customer requirements. 8. Measurement, Analysis and Improvement This is a key requirement for a successful business. It involves those measurements being made to help improve your organization and demonstrate product conformity. Statistical techniques should be used where appropriate. ● ● ●  of meetings in the beginning for implementation planning, setting 3. ASSEMBLE AN IMPLEMENTATION TEAM objectives and the quality policy, you should consider personnel who work well together in groups. Group decisions can provide a lot of Choosing the right team to implement your ISO 9001 based creative feedback, which is often critical in providing more employee quality management system is key to any successful quality ownership and buy-in to the project. Other personality traits you program, but it‘s not the easiest thing to do. There is no right or should consider could include: wrong way to choose a team because organizations vary in size, • Action-oriented—The team needs to be ready to act and scope and complexity. It is optimal to have people on the team with implement change. different skill sets from cross-functional parts of the business that • Experienced—It is a good idea to have team members who can provide valuable input to the implementation process. This know the business of the organization. People who have been allows business synergies and communication to occur across the around a while and know how things operate can be invaluable business. to your team. • Detail-driven—Documentation and implementation means Team members for implementation and assessments should be dotting the ‗is‘ and crossing the ‗ts‘, and deadlines are often identified early in the process, but make sure you have people who represent all relevant departments. It is vital that Senior absolute. • Holistic thinkers—When implementing ISO 9001 for an Management is represented on the team as overall responsibility for the quality management system lies with them, but it is equally organization, team members must be able to see the ‗Big Picture.‘ important that staff from all levels form part of the team as • Good communicators—Once the system begins, awareness and everyone can provide a valuable insight. It is key to have team understanding is crucial. This is where a strong team becomes members who understand how the interdepartmental interfaces essential, because spreading the word about quality is important. function and processes link so that a process based management Also ensure that the information that is communicated is system can be effectively implemented. consistent and relevant. Additionally, it is a good idea to consider personality traits for the members of the team. For example, because there will likely be a lot
  6. 6. 4. GET MANAGEMENT SYSTEM TRAINING RECOMMENDED TRAINING ROUTE FOR ISO 9001 IMPLEMENTERS Many of your Implementation Team will require ISO 9001 Management DYNAMIC STRATEGIES MANAGEMENT SYSTEM System training to aid understanding of the requirements, and to plan and develop your Management System. It is important to get training early in the implementation project as in the long term it will bring significant time and money savings to your organization if staff are correctly trained. Dynamic Strategies Management Systems has created a ‗recommended training route‘ for Implementers. The ‗training route‘ is an easy to use summarized model. More detailed course descriptions and our class schedule are available at Key Objectives I. Identify training requirements early 5. IMPLEMENTING THE SYSTEM Now you are appropriately prepared with an understanding of the fundamentals, have a project plan and a trained team assembled. Next is the hard part, the actual implementation. Here we will present the three core elements of implementation: 5a. – Gap analysis 5b. – Write and develop documentation 5c. – Communicate implementation These cannot be done in series, but must be done at the same time and often done multiple times. They are presented here in no particular order. 5A. GAP ANALYSIS A gap analysis is a process an organization goes through to determine the difference between what the process or quality management system is like now and what it should be when it conforms to the requirements of ISO 9001 (or any management system standard). At the early implementation phase a gap analysis should focus on: ❑ Whether procedures have been established when necessary and/or required ❑ Compliance to established procedures and processes ❑ Proper resource allocation ❑ Effective communication of objectives and responsibilities ❑ Competency of personnel and training programs ❑ The organization‘s ability to make changes when necessary Once you have a full understanding of these issues you may realize that you are a long way on the road to ISO 9001 already. You can then evaluate the best way to formalize what you have and make strategic decisions on how best to fill those gaps that were Key Objectives discovered so that established requirements can be met and customer satisfaction enhanced. I. Determine where your processes are now II. Determine where they need to be Later in the implementation process a gap analysis may include the following areas: ❑ The organization‘s quality culture. ❑ Knowledge of the quality management system and ISO 9001. ❑ Awareness of the Quality Policy and quality objectives. ❑ The suitability and effectiveness of the quality system.
  7. 7. 5B. WRITE AND DEVELOP DOCUMENTATION 5C. COMMUNICATE IMPLEMENTATION Everyone on the team must have a clear understanding of what As you write your documentation you should also simultaneously documentation needs to be created and this includes identifying the begin the process of implementing your quality management system. needs and expectations of your customers as they form the basis for many of your processes and procedures. All of the ISO 9001 The key to implementation is communication and training. During documentation requirements are laid out clearly in Clause 4.2. The the implementation phase, everyone must operate to the procedures table below details these and splits the required documents into a and collect records that demonstrate the organization is doing what it says it‘s doing. Consequently, if personnel are to implement the simple four level hierarchy. system correctly, they need to be aware of what they‘re supposed DYNAMIC STRATEGIES MANAGEMENT SYSTEM M Documented Procedures to do. The six required documented procedures shown in the table below are the minimum needed for your management system, and it may If staff have been involved in writing the documentation, implementation be necessary to retain or write other procedures to ensure effective and compliance with the procedures should be easier. All staff operation of the quality management system. For example, you may should be briefed accordingly of the procedures, although as the wish to look at design, control of monitoring and measurement procedures should essentially be what they currently do, only devices, and other areas, depending on the organization. changes need to be highlighted. Training can then be entered in the training records as evidence that proper instruction has been Other processes may or may not be documented, depending on provided. whether the organization needs the documents for effective planning, operation and control of its quality management system. Once the training process has been completed and staff are implementing the procedures, periodically walk around the There are other issues that you should consider during the business informally asking if the procedures are working or being documentation phase as well. ISO 9004:2000 suggests that implemented you should satisfy the ‗contractual, statutory and regulatory requirements, and the needs and expectations of customers and Key Objectives other interested parties‘ concerning the nature and extent of the I. Communicate implementation documentation. This means that items such as contracts, standards II. Train Staff used by the organization, applicable regulations and other information regarding the needs of your stakeholders should be considered. Dynamic Strategies Management Systems offers a Quality Systems Documentation Course that gives practical guidance on how to write readable and useable quality system documents. More information and a class schedule is available at Key Objectives I. Identify customer needs II. Develop documentation Level Document Definition ISO 9001:2000 Required Documents (Clause 4.2.1) Quality 1 Overview of the company and its products and services; agreement a) Documented statements of a quality policy Policy & to comply with applicable ISO 9001 requirements; system (5.3) and quality objectives (5.4.1) Manual scope; exclusions; organization and responsibilities; sequence b) A quality manual (4.2.2) and interaction of processes; documented procedures. Procedures 2 Describes the quality processes and interdepartmental controls c) Documented procedures that are required that address the ISO 9001 requirements; may be in ISO 9001 by ISO 9001:2000. These are: order or process order; reference lower-level documentation. 4.2.3—Control of Documents ISO 9001 mandates six specific procedures. 4.2.4—Control of Records 8.2.2—Internal Audit 8.3—Control of Nonconforming Product 8.5.2—Corrective Action 8.5.3—Preventive Action Work 3 Explains details of specific tasks or activities: the how of performing d) Documents needed by the organization to Instructions a specific task. This level may include quality plans, ensure the effective planning, operation and work instructions, drawings, flowcharts, workmanship standards, control of its processes product specifications, machine manuals, etc. Other 4 Forms, tags, labels and other documents that prompt the e) Records required by ISO 9001:2000 (see documents recording of evidence (per levels 1,2 and 3 documentation) of 4.2.4) (Records) compliance to requirements. Records may be mandatory or implied for each ISO 9001 clause.
  8. 8. 6. IMPLEMENTATION TIME SCALE 8. CHOOSE A REGISTRAR The time scale to implement a quality management system that Registration to ISO 9001 takes place when an accredited 3rd party DYNAMIC STRATEGIES MANAGEMENT SYSTEM M conforms to the requirements of ISO 9001 depends on a such as Dynamic Strategies Management Systems visits an number of factors such as resources, a sound plan, commitment organization, assesses the management system and issues a certificate from top management and personnel and the complexity of the to show that the organization meets the requirements of ISO 9001. A system. It is very important that you consider all of these issues number of factors should be considered when choosing a registrar during the planning phase. You also need to take into account including industry experience, geographic locations, price and service time constraints if you are implementing ISO 9001due to a level offered. contractual requirement. Key Objectives Ideally, the implementation phase should last about six months to I. Choose a Registrar appropriate for your organization allow you sufficient time to collect enough records to verify that the system is working, but you should be getting data back for analysis within two to three months. Some good examples of records are purchase orders, sales records, contracts, internal audits, meeting minutes, test data and anywhere ISO 9001 requires a record to be maintained. Records must be legible and retrievable in a reasonable timeframe (You decide what is reasonable to your organization). Also, registrars usually want to see at least three months of system operation before conducting a third party audit. This operating period should also include an entire internal audit cycle and a management review. You will need to collect records as evidence your system is complying with planned arrangements, meeting requirements and effectively achieving the planned results. Key Objectives I. Plan Implementation to allow sufficient time to collect records II. Ensure you meet your Registrar‘s minimum requirements REASONS TO CHOOSE DYNAMIC STRATEGIES MANAGEMENT SYSTEMS 7. REVIEW MANAGEMENT Dynamic Strategies Management Systems has several registered SYSTEM EFFECTIVENESS clients in various countries, making us one of the leading and most experienced ISO Consultants. This places Dynamic Strategies in an unrivalled position of knowledge about companies' needs, irrespective of One of the final stages of implementation and also a continual size and industry sector. improvement process is to check that your system is working effectively and conforming to the requirements of ISO 9001. The breadth of Dynamic Strategies‘ services allows you to purchase the This is the check and act part of the PDCA cycle and involves standards, train your staff and gain registration - all from one committed monitoring your system by recording and interpreting data and business partner. conducting internal audits. Dynamic Strategies‘ range of course offerings is among the most ISO 9001 requires that data generated as a result of comprehensive available and addresses the needs of quality monitoring and measurement should be analyzed as a means of professionals across the Americas. Add to this, the large number of determining where continual improvement can occur. Specific areas dates in convenient locations and you have a network of excellence, where data should be collected are customer satisfaction, product dedicated to your development. conformity, processes and products trends including opportunities for preventive action, and suppliers. If you would like to find out more about how we can help you implement your ISO 9001 Quality Management System For more information regarding planning and undertaking internal please contact Dynamic Strategies. audits, download our free ‗Ten Tips for Internal Auditing‘ from Dynamic Strategies Management Systems also offers a RAB Accredited ISO 9001Internal Quality Systems Auditor, more details are available at or contact us at . Key Objectives I. Review Management System to determine effectiveness II. Continual Improvement
  10. 10. Dynamic Strategies Chandigarh: Mr Narendra Singh 1001, First Floor, Sector 40-B Chandigarh – 160 036 Mobile: +91-98784-37767 Phone: +91-172-4607767 New Delhi: Mr Rajan Singh 58 - A / 1, Third Floor, Kalu Sarai, Sarv Priya Vihar, Near IIT Delhi New Delhi – 110 016 Mobile: +91-9899733733 Jaipur: