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Welcome to the Whittington & Associates e-Newsletter! Visit and bookmark our web site today: http://www.WhittingtonAssociates.com This
e-newsletter is in HTML format and may not be displayed properly by some
email programs.
The first International Standard for managing business records is expected to result in cost savings for users, whether large or small enterprises, as well as, improved risk management. ISO 15489, Information and Documentation - Records Management, focuses on the business principles behind records management and how organizations can establish a framework to enable a comprehensive records management program. According to Robert McLean, member of ISO technical committee ISO/TC 46, Information and Documentation, Subcommittee 11, Archives/Records Management, which developed the new standard, ISO 15489 will significantly improve the way organizations manage records. "Global organizations will find specific benefits in this truly international standard. Experts from Europe, North America, Asia, and Australia forged agreement on a clear and systematic approach to the essentials of record keeping. " "ISO 15489 clearly shows how an organization can systematically and effectively improve its record keeping - and do so in such a way that the business objectives are supported. Senior management will be able to identify tangible benefits such as reduced costs and better managed risks, thereby contributing to better corporate governance." The standard will provide a common international language for people to record and file material, in any medium or format, or in any combination of media. Regardless of the size of the enterprise, the type of organization, or its level of technology, users will benefit from reviewing their record keeping activities against the standard's best practices. "The new standard enables organizations to develop policies, strategies, and programs which will ensure that information assets have the essential characteristics of accuracy, integrity, and reliability," further noted Mr. McLean. "It demonstrates why good records management practice is essential to create, capture, and use information essential for the organization to fulfill its obligations and meet the expectations of its stakeholders. The new standard identifies the key issues involved in retaining the information and making it available in a usable and reliable way, as well as, how it may be selectively and securely disposed of at the appropriate time." ISO 15489 is aimed at individuals responsible for setting policies, standards, and guidelines for information management within organizations, including records managers, archivists, special librarians, knowledge management professionals, database managers, business administrators, and individuals within organizations who are responsible for the oversight of record keeping practices. ISO 15489-1, Information
and Documentation - Records Management - Part 1: General, is available
for $54.00 at the ANSI
Electronic Store. ISO 15489-2, Information and Documentation - Records
Management - Part 2: Guidelines, is available for $76.00.
An important objective for ISO 9001:2000 was to have the amount and detail of the required documentation be more relevant to the desired results of the organization’s process activities. It significantly reduced the documentation requirements and is much less prescriptive than the 1994 standard. An organization has more flexibility in the way it chooses to document its quality management system. Each organization should develop the minimum amount of documentation needed to demonstrate the effective planning, operation, and control of its processes (and continual improvement of its system). Required Documentation You must establish, document, implement, maintain, and continuously improve your quality system in accordance with ISO 9001 requirements. The standard identifies some mandatory procedures and requires any other documents needed for the effective operation and control of your processes. Procedures are required for document control, record control, internal audit, nonconformity control, corrective action, and preventive action. Other documents are required as evidence of conformity with requirements, e.g., a quality policy and a quality manual. ISO 9001 says that work instructions may be needed, but does not specifically require them. However, QS-9000 for the automotive industry requires set up, operator, and rework instructions. Requirements for documentation may arise from customer contracts, industry standards, relevant regulations, and your own organizational needs. Ensure your planned documents serve a business need and will reflect actual operation. Be careful writing documents to satisfy future plans if those plans may not be implemented before the documents are issued. Why Document? There are a number of good reasons why documentation at the appropriate level of detail can be of benefit to your company and its employees. It is important for your organization to clearly understand the management policies that are meant to guide activities. Documenting these policies may help management reach agreement on them and also provide a method of communicating them for training and operational purposes. Measurable quality objectives must be established. Documented objectives are easier to convey, plus it serves as proof of their existence for audits. Your responsibilities and authority must be defined and communicated to facilitate effective quality management. The ISO 9001:2000 standard requires specific documented procedures, as well as, any procedures needed by your organization to ensure the effective operation and control of its processes. Using documented procedures and instructions should result in more consistent and repeatable processes, and ultimately in improved quality. Documents preserve information and experience, plus share organizational knowledge. Your documented quality system will be examined for audit purposes and may be reviewed by your customers as part of their supplier evaluation process. The documentation could even be used as a model by your suppliers. Why Not Just Defined? A degree of formality is necessary to clearly and consistently communicate policies and procedures. Informal or verbal directions may be misunderstood, not satisfy management policies, and be difficult to evaluate during audits. If everyone sees the system through the same documentation, they are much more likely to have a uniform understanding of the quality system. Workers having access to documented instructions will perform their tasks more consistently. Having a documented
system provides a known platform for evaluating, approving, and making
changes in a controlled manner. Taking all this into consideration, there may still be some processes that do not warrant documentation due to the education, training, skills, and experience of the people performing the activities. What is the Objective? Keep in mind that the primary reason for documentation is to add value and serve the company. Each document should be of value to its users. If it is not required by ISO 9001, see if it is really needed, or if the training, skills, and experience of qualified workers will be sufficient. Remember, documents should be created for the readers, not to satisfy the creativity of the author. Process users are your customer. Write for them. Although not created especially for auditors, well written and organized documents will be easier for them to understand and use during assessments. Documents capture the policies and practices in place during its development. As your business changes, the documentation must keep pace to maintain the benefits of your quality system. Anticipate process changes and keep the related documents current. How Much is Needed? The extent and nature of the documentation should be appropriate for the organization. The documents may be in any suitable form or media. Process users have defined responsibilities. Write documents based on their required qualifications, such as, training, skill, and experience levels. Write documents that are simple, clear, and concise. However, be warned. It is more difficult to write a short, simple document than a long, rambling one. Avoid generating too much documentation. It may reduce process flexibility and will certainly require more effort to maintain and keep current. Rewrite All our Documents? An organization with an existing quality management system should not need to rewrite all its documentation to meet the requirements of ISO 9001:2000. This is particularly true if their system was structured using a process approach. The current documentation might be adequate and could be simply referenced from the revised quality manual. However, if the process approach was not used in the past, the organization will have to pay special attention to the definition of its processes, their sequence, and interaction. Since many policy statements do not address management’s commitment to continually improve the effectiveness of its quality management system, these policy statements will have to be changed. Quality manuals will need to be revised. The six required procedures must be examined to see if they need to be revised to address the new or clarified requirements. Other procedures that are retained (or created) must also comply with the new and changed requirements. Work instructions are optional and so specific to a task that it is unlikely they will require modification (unless impacted by a change to a related procedure). Evidence of conformity with requirements must be supplied. The expanded focus on system and product planning may require additional documentation. Needed (But Not Required) Documents Some organizations, particularly large ones or those with complex processes, may need additional documented procedures (especially those relating to product realization). Other organizations, due to their size or culture, may be able to effectively implement additional processes without them being documented. There are several ISO 9001:2000 requirements where an organization could add value to its system and demonstrate conformity by the preparation of other documents (even though the standard does not specifically required them). Many organizations will update and retain their current procedures, although they may no longer be required by ISO 9001:2000. These companies have decided the procedures are useful for the reasons covered earlier. All these documents, such as, requirements, design, purchasing, test, and training procedures, must be controlled in accordance with clause 4.2.3. Documents versus Records Documents are “revisable” and are under document control to indicate the current revision level. Records are not revisable and are under record control to indicate the retention time. When a document is superseded, it is archived as a record for a suitable retention period. Records required by the quality management system must be controlled. They provide evidence of conformity to requirements and of effective operation. Most ISO 9001 clauses require records. Some are explicitly mentioned and others implied for proof of conformity. Both documents and
records are examples of evidence (or documentation) for audit purposes.
ISO 9001:2000 clause 5.2, Customer Focus, simply states: top management must ensure customer requirements are determined and met with the aim of enhancing customer satisfaction. Have you wondered about the appropriate response by top management for this requirement? The guidance in ISO 9004:2000 discusses the needs and expectations of customers. However, another source of ideas may be TL 9000. TL 9000, the telecommunications sector scheme, expands on the ISO 9001:2000 requirements in a number of areas, including Customer Focus. These TL 9000 requirements are summarized below: Customer Relationship Development Top management must demonstrate active involvement in establishing and maintaining mutually beneficial relationships between the organization and its customers. Customer Communication Procedures Establish and maintain a documented procedure for communicating with selected customers. The documented procedure must include a:
It is not possible to provide the same level of communication with all customers. The level provided depends on the amount of business, the history of problems, customer expectations, and other factors. For further insight on Customer Focus, remember that clause 5.2 refers readers to 7.2.1 and 8.2.1. Clause 7.2.1 is an appropriate link for customer focus because it covers determining product requirements. Likewise, 8.2.1 is a good reference because it covers customer satisfaction. From a TL 9000 perspective,
you can see that clause 7.2.3 on Customer Communication is another useful
reference. In fact, the Customer Focus section of TL 9000 refers its readers
to Appendix F for "Guidance on Communication with Customers".
After more than three years of extensive research among professionals, employers and their customers, the leaders of the IEEE Computer Society realized the time had come to develop and offer a Certified Software Development Professional designation Professional certification has three critical components:
Many software vendors, training companies, and vendor-independent groups created their own brand of certification since the 1960s. When the rapidly emerging field of computer technology began to experience exponential growth in the 1980s, more than 200 different certifications emerged. Computing professionals now face a complex and confusing array of choices for determining and demonstrating their competence. The CSDP credential is a primary certification because it is the only one administered and endorsed by the IEEE Computer Society, which is the only professional society in the world that has provided the highest levels of leadership and expertise needed to unify software engineering standards in the field. For more information, see <http://computer.org/certification>. Whittington &
Associates is pleased to announce that Larry Whittington, Jr.,
our webmaster, and a Project Manager for Metavante, was in this first
group of software engineers to become Certified Software Development Professionals.
Larry is also an ASQ Certified Software Quality Engineer.
ISO has published guidelines for the food and drink industry for implementing quality management systems based on ISO 9001:2000. The new ISO 15161, Guidelines on the Application of ISO 9001:2000 for the Food and Drink industry, is aimed at organizations involved in sourcing, processing, and packaging food and drink products. ISO 15161 allows an organization to integrate its quality management system with a food safety system such as HACCP (Hazard Analysis and Critical Control Point). It is available for $72.00 at the ANSI Electronic Store. According to the document authors, application of HACCP within an ISO 9001:2000 quality management system can result in a food safety system that is more effective than the application of either ISO 9001:2000 or HACCP alone, leading to enhanced customer satisfaction and improved organizational effectiveness. To assist the reader,
the requirements of ISO 9001:2000 are given in boxed text, followed by
guidance relevant for the industry. Linkages between the basic HACCP principles
and specific clauses of ISO 9001:2000 are shown in an appendix.
To enroll in any of these public classes, go to the Class Schedule at our web site, or call us at 800-404-7585. The classes taught by Larry Whittington are shown in gold. ISO 9001:2000
Lead Auditor (ANSI/RAB-NAP Accredited) - CEEM, Inc.
ISO 9001:2000
Internal Auditor (ANSI/RAB-NAP Accredited) - CEEM, Inc.
ISO 9001:2000
Auditor Transition (RAB-Approved)
Implementing ISO
9001:2000 (for New Systems)
ISO 9001:2000
Conversion (for Existing Systems)
Quality System
Documentation (Revised for ISO 9001:2000)
Understanding
ISO 9001:2000 Requirements
To arrange an economical
on-site class, please call us at 800-404-7585.
ISO 9000 / ISO 14000 Conference Second International SPICE Conference 56th Annual Quality Conference Quality Expo Detroit Conference On Quality In Commercial Aviation 11th Annual Service Quality Conference 22nd Southeastern Quality Conference 12th International
Conference on Software Quality Customer-Supplier Division Conference
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