Archive for October, 2009
Assistance in Developing Your Management System. Can the Registrar Provide These Services?
No, your registration company will not provide consulting services. The purpose of 3rd party assessments is to provide your organization with an unbiased, impartial review of your quality management system. If the registrar were to be involved in the development and implementation of your quality management system, impartiality would no longer exist. Additionally, the registrar reviews all auditor activities to ensure that auditors who are also consultants have not been involved in the development and implementation of the QMS scheduled for assessment; this includes not only the audit but decisions related to the client. Most registrars have access to a listing of consultants and are happy to provide you recommendations or references to consultants in your area.
There are consultants that specialize in small business management implementations. These consultants are usually cost effective and will provide a service which will customize your quality management system to meet your individual needs. Always remember to review the credentials of the consultants you select. There are a few questions that you should get answers to before you contact with a business management consultant. Most importantly make sure your consultant has been responsible for managing a quality management system and is certified to the standard they will help you implement.
The ISO Standard Says That Internal Audits Cannot be Completed by Someone Involved in the Activity. How Does a Small Business Meet This Requirement?
An organization that has fewer resources must look to other options, like outsourcing or cross-functional activities, to fulfill internal requirements for audit. There are many individuals and organizations that provide internal audit services to small companies at a fraction of the cost of employing personnel full time. The contracted individual or organization manages the planning process for internal audit based on your established procedures or you can develop the plans for ongoing internal audit. Another option is to train individuals within your organization that can perform internal audits and alternate audit activities between processes. For small companies this is often not possible as people are actively involved in all the processes and activities of the company; therefore, outsourcing is a better option to ensure objectivity.
Seven Steps To Implentation of ISO 9001
For a successful implementation of your Quality Management System, the following seven steps are recommended:
- Fully engage top management – Determine and define why you want to implement ISO 9001, Determine and define your mission, vision, and values in your organization , Define your organization’s stakeholders : customers, suppliers, stockholders, employees, society, etc., Define your quality policy, and , Define and align organizational objectives and related product/service quality objectives.
- Identify key processes and the interactions needed to meet quality objectives
- Implement and manage the QMS and its processes (using process management techniques
- Build ISO 9001-based QMS-Identify ISO 9001 requirements, Map these requirements with your implemented QMS, where applicable, Make a gap analysis : identify where in your existing system the requirements are fulfilled, and where they are not, Include in your QMS processes the activities, procedures and controls needed.
- Implement the system, train company staff and verify effective operation of your processes
- Manage your QMS- Focus on customer satisfaction, Monitor and measure the operation of your QMS, Strive for continual improvement, Consider implementing business excellence models in the company operations.
- If necessary, seek third party certification/registration of the QMS or alternatively, issue a self-declaration of conformity
ISO 9001 and Fulfillment of Customer Expectations
ISO 9001 is used when you are seeking to establish a quality management system that provides confidence in your organization’s ability to provide products that fulfill customer needs and expectations.
This is the standard in the ISO 9000 family against which your quality management system can be certified by an external body. The standard recognizes that the term “product” applies to services,
processed material, hardware and software intended for your customer. There are five sections in the standard that specify activities that need to be considered when you implement your system :
- Overall requirements for the quality management system and documentation Management responsibility, focus, policy, planning and objectives
- Resource management and allocation
- Product realization and process management, and
- Measurement, monitoring, analysis and improvement.
The requirements in four of the sections are applicable to all organizations – Quality management system, Management responsibility, Resource management, and Measurement, analysis and improvement. The Product realization section may be tailored to meet the needs of your organization. Your quality manual or other documentation will demonstrate how you meet the ISO 9001 requirements in your company.
ISO 9001 And Corrective Action
A corrective action is a change implemented to address a weakness identified in a quality management system. Normally corrective actions are implemented in response to a customer complaint, internal nonconformities, nonconformities identified during an internal audit or adverse trends in product and process monitoring such as would be identified by In-coming, in process and final inspection.
In order to implement a corrective action one must first determine root cause. Root cause analysis is a type of problem solving aimed at identifying the root causes of problems or events. The practice of root cause analysis is based on the belief that problems are best solved by attempting to correct or eliminate root causes, as opposed to merely addressing the immediately obvious symptoms. By directing corrective measures at root causes, it is hoped that the likelihood of problem recurrence will be minimized. However, it is recognized that complete prevention of recurrence by a single action is not always possible. Therefore, root cause analysis is often considered to be a repetitive process, and is frequently viewed as a tool of continuous improvement.
Root cause analysis, initially is a reactive method of problem detection and resolving. This means that the analysis is done after an event has occurred. Expertise in root cause analysis can become a pro-active method. This means that root cause analysis is able to predict the possibility of an event even before it could occur.
ISO 9001 Business Management System; Corrective vs. Preventive Action
Corrective and Preventive Action Processes are two different processes within ISO 9001 requirements.
There is a great deal of confusion between the 3 areas covered under the ISO 9001 standard, corrective action, preventive action and preventive maintenance.
Corrective action treats a nonconformity or problem that has already occurred. The problem exists. The nonconformity lives and needs to be addressed.
Preventive maintenance focuses on the care of machines. It is a system that protects machines from breaking down. ISO 9001 auditors do not look at preventive maintenance as preventive action. Preventive maintenance is important for the infrastructure (resource management) section of the ISO 9001 standard.
Preventive action determines and eliminates potential causes of non conformities. This means the non conformity has not yet happen. If you act to prevent a problem from occurring then this is a preventive action. The ISO 9001 standard requires you to take preventive action to eliminate potential nonconformities.
There are ISO 9001 software applications that can help guide an organization through this murky area within the ISO standard. A certified CIS consultant can show an organization just how simple it is to report, track and follow-up on corrective and preventive actions. If that’s not enough, there are also ISO 9001 templates available to help clarify the standard requirements for these and other areas of your business management system. So if you are looking to start a new quality management system, or just take your old system and reengineer your process to promote continual improvement, help is not far away.
ISO 9001 Return On Investment
The ISO 9001standard is not designed to tell you how to run your business, but instead give you a basis to comply with the requirements in a way that best meets your specific business goals, requirements, needs, and environment, etc. On the range from “no quality system” to “world-class quality system,” an ISO 9001 quality management system is a starting point roughly in the middle. It is not in itself going to radically change someone’s business. It is however a place to begin and many industries have used it as such. Aerospace, automotive, and chemicals are a few examples of industries that began with ISO 9001 and added additional requirements for their suppliers and partners. Many companies do the same. They begin with ISO 9001, learn, improve, and continually build on their management system.
Should you implement an ISO 9001 quality management system? And, should you certify your ISO 9001 system? As companies undertake the initiative, they look for the benefit and return on investment. A quality management system that is ISO 9001 certified provides discipline, improves processes and increases the productivity and effectiveness of the companies’ operations. Consistent, reliable, well documented quality management systems result in reduced scrap and waste, less human errors, and therefore increased profitability and customer satisfaction.
ISO 9001 A Marketing Advantage
With competition in the marketplace today, customers are looking for better suppliers, and certification can make a difference. ISO certification gives you a recognized, readily accepted business credential. It provides a means for delineation in the market. Talk with your sales and marketing teams, customers, and trade groups to determine what certification means to them.
Many customers require certification. As a minimum, they require ISO 9001, but many are moving to the industry sector standards that have increased requirements, like AS9100, and RC14001. To become a preferred supplier, or even bid on contracts, you may be required to be certified to 9001 or other standards. In this case, certification has a clear and quantifiable value. Use the information you gather to put a solid plan in place based on your business, requirements, resources, and timing. If you wait until you have to do it to save business or get that one new, big customer, you endanger the effective implementation and real benefits to your business operations.
If you are not sure how to go about implementing an effective quality management system, there are plenty of competent business management consulting firms that can help. In today’s world, a small business does not have the resources to invest like larger businesses, so they wait. This puts the small business at a distinct disadvantage for growth. But the good word is, you don’t need to spend an arm and a leg or invest huge amounts of time and resources to reach your certification goal. So don’t let what you have heard stop you from moving forward.
What Is The Role Of ISO 9001?
The objective of any standard, whether it relates to the manufacture of cars, airplanes, machinery, or the delivery of a service – transportation, hospitals, etc. – is the same. Standards are designed to promote, facilitate and enable consistency in a process or product; to provide assurance that the process or product output will meet requirements; to provide a uniform and predictable output every time a set of procedures are executed. Because standards assist buyers and consumers in establishing confidence levels in the products and services they procure, standards facilitate fair trade practices.
Without satisfied customers, an organization’s future is at risk! To keep customers satisfied, the organization needs to meet and/or exceed their requirements. The ISO 9001 standard provides a universally recognized, tried and tested framework for taking a systematic approach to managing the organization’s processes, so that they consistently turn out product that satisfies customers’ expectation.
So, who shall survive the resent economic down turn, and who will succumb to it? Small businesses are in a unique situation to position themselves for the future. Obtaining certification need not be a costly time consuming process. There are many business consulting firms available today that are uniquely equipped to provide the newest and lest expense tools and guidance to help an organization of any size obtain certification. So if you believe that ISO 9001 is something that can help your company meet the changes of today’s world, you don’t need to spend hundreds of thousands of dollars to get there, and don’t let anyone tell you that you do.
The Goal Of The AS9101 Rewrite
The AS9101 rewrite goal is to provide requirements on process auditing and development of AS9100 series audit approaches and tools that focus not only on conformity, but also on effectiveness of a AS9100 quality management system (QMS). The AS9101 proposal is to develop an enhanced audit process for evaluating process-based management systems that aligns with ISO 17021 and consists of:
• Process-based information gathering.
• Assessment or analysis and audit planning.
• Development of performance-based and process-oriented audit methods and techniques.
• The ability to capture objective evidence of process conformity and effectiveness.
The major proposed changes in the rewrite of AS9101 include:
• Creation of one document covering AS9100, AS9110 and AS9120.
• Elimination of scoring and key requirements designations.
• Use of data and customer feedback concerning organizational QMS performance as an input for process-oriented audits (for example, Online Aerospace Supplier Information System (OASIS) customer satisfaction or performance scores).
• Inclusion of determination of effectiveness, in addition to conformity.
• More emphasis on performance measuring.
• Introduction of the objective evidence record.
A major theme of the AS9101 rewrite is examining process effectiveness. ISO 9000:2005 defines effectiveness as the extent to which planned activities are realized and planned results achieved. The ultimate measure of QMS effectiveness is customer satisfaction.
What has not changed in AS9101 includes determining conformity to the standards, documenting discovered nonconformities and drawing conclusions on conformity of the organization’s QMS based on information collected during the audit.