ISO 9001:2008 External Internal

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1 ISO 9001:2008 The ISO 9001 standard is generic and meant to be applied to all organizations, without regard to their business, size, profit or no profit, or whether in the private, or public sector. In the past few years, industry groups have developed sector specific applications of the ISO 9001 standard. These include the automotive, aerospace, environmental, telecommunications, health and safety, etc. All these sector specific standards incorporate the full requirements of ISO 9001 as their foundation and then add new requirements or amplify ISO requirements. ISO 9000 quality management standards have been around for over 30 years. Nearly a million organizations have been certified to one or more of the various ISO published business management standards. Many studies have been conducted on the impact of these standards on industry and the overall feedback on how it has helped companies is summarized below: External Improves customer confidence and satisfaction in an organization s QMS capability and consistency in meeting requirements. Improves conformity to quality requirements Increases competitive edge and market share Increasingly recognized as a requirement for contractual relationships in the global arena. Internal Improves business efficiency and productivity Reduces organizational waste, inefficiencies, and defects Facilitates continual improvement in business processes and customer satisfaction Improves process consistency and stability Facilitates employee competence and consistency of performance

2 Improves employee motivation and empowerment through improved participation communication and interaction Generates objective evidence to support the assessment of QMS conformity and effectiveness Improves supplier performance by developing relationships that foster cooperative interaction in understanding and fulfilling customer requirements. ISO 9001:2008 Standard clause headings: 0. Introduction 1.Scope 2.Normative Reference 3.Terms and Definitions 4.Quality Management System 5.Management Responsibility 6.Resource Management 7.Product Realization 8.Measurement, Analysis and Improvement The ISO 9000 standards are internationally recognized management concepts, principles and practices that have been formalized into a set of standardized requirements for a quality management system (QMS). These standardized requirements define controls that focus on improving an organization s ability to deliver products or services that: Consistently meet customer s quality requirements Meet applicable regulatory requirements Enhance customer satisfaction Achieve continual improvement of its performance in pursuit of these objectives. The ISO 9001 standard focuses on improving an organization s management system and processes. It does not specify any requirements for product or service quality. Customers typically set product and service quality requirements. However, the expectation is that an organization with an effective ISO 9001 based QMS will indeed improve its ability to meet

3 customer and regulatory requirements. ISO 9001requirements are complementary to contractual and applicable regulatory requirements. Those implementing a QMS conforming to ISO 9001 must ensure that the specific requirements of their customers and regulatory agencies are met. The standard covers five broad categories or clauses, each of which includes several subclauses. The five categories are: Quality Management System sets requirements to identify, plan, document, operate and control an organization s QMS processes and to continually improve QMS effectiveness. Management Responsibility sets requirements for top management to demonstrate its leadership and commitment to develop, implement and continually improve the QMS. Resource Management sets requirements to determine, provide and control the various resources needed to operate and manage QMS processes; to continually improve QMS effectiveness; and to enhance customer satisfaction by meeting customer requirements Product Realization sets requirements to plan, operate and control the specific QMS processes that determine, design, produce and deliver an organization s product and services. Measurement, Analysis and Improvement sets requirements to plan, measure, analyze and improve processes that demonstrate product and QMS conformity and continually improve QMS effectiveness. CERTIFICATION PROCESS

4 1.Pre assessment Before the actual certification audit, a CB auditor makes a preliminary visit of your facilities, briefly reviews your QMS documentation and conduct an informal check of the QMS implementation. In essence, this preliminary audit intended to uncover areas in your QMS that might need special attention. During the initial visit the audit scope and audit program is agreed upon, as well. A Pre assessment is an optional activity. It adds value in that it provides an organization with a clear view of the gaps in its state of readiness, a few months prior to the formal certification audit. More and more organizations now prefer experienced consultant auditors to do the Pre assessments as they not just identify the gaps, but also provide solutions to correcting them. CB auditors may only report on the gaps, but are not allowed to provide solutions. 2. Documentation review The CB audit team evaluates your QMS manual to determine the adequacy of its scope and conformity to the requirements of the standard. The documentation review report summarizes any findings from this process. The report indicates if your organization is ready to proceed with the certification audit. 3. Certification audit During the certification audit, the CB audit team conduct interviews, examinations and observations of the system in operation. It provides the team essential information required for the certification process and assesses the degree of conformity of the QMS with the requirements of the standard. When found conforming, the CB issue the certificate of conformity to ISO 9001:2008.

5 4. Surveillance audits Each issued certificate has a three year life period. Upon certification, the CB creates a periodic audit schedule for surveillance audits over the three year period. These audits confirm the on going compliance of the QMS with specified requirements of the standard. At least one periodic audit per year is required. 5. Re certification audit After the three years are up, your certification will be extended through a re certification audit.