QMS ISO 9001:2008 Introduction to QMS 9001:2008 and system auditing
QMS ISO 9001:2008 Mohsen Mersal QC manager Siemens Wind Power
QMS ISO 9001:2008 Management systems
QMS ISO 9001:2008 ISO 9001:2008, Quality ISO 14001:2004, Environment OHSAS 18001, Health & safety
QMS ISO 9001:2008 Management systems Why?
QMS ISO 9001:2008 Competition Legislation Product quality Production stability Economy CSR Continuous improvement
QMS ISO 9001:2008 How is a management system built? Deming´s PDCA
QMS ISO 9001:2008 Documentation Management responsibility Resource management Product realization Measurement, analysis and improvement
QMS ISO 9001:2008 Documentation Policy and objectives Procedures Manual Records
QMS ISO 9001:2008 http://www.vestas.com/Files//Filer/EN/Policies/Quality_and_Health_Safety_Policy.pdf
QMS ISO 9001:2008 Management responsibility Commitment to development and implementation Communication Customer focus Policy Responsibility Management review
QMS ISO 9001:2008 Resource management Competence Infrastructure Work environment
QMS ISO 9001:2008 Product realization Planing, requirements to product Customer related processes Customer communication Design and development, inputs & outputs Purchasing Identification & traceability
QMS ISO 9001:2008 Measurement, analysis and improvement Customer satisfaction Internal audit Monitoring & measurement of processes Control of nonconforming product Analysis of data Improvement Corrective actions Preventive actions
QMS ISO 9001:2008 Auditing
QMS ISO 9001:2008 Definition An audit is an evaluation of a person, organization, system, process, enterprise, project or product.
QMS ISO 9001:2008 An audit seeks to provide only reasonable assurance that the statements are free from material error. Hence, statistical sampling is often adopted in audits
QMS ISO 9001:2008 Quality audits are essential to: Verify the existence of objective evidence showing conformance to required processes Assess how successfully processes have been implemented, for judging the effectiveness of achieving any defined target levels Providing evidence concerning reduction and elimination of problem areas and are a hands-on management tool for achieving continual improvement in an organization.
QMS ISO 9001:2008 Audit types
QMS ISO 9001:2008 Internal System/certification Customer Management Process Supplier assessment
QMS ISO 9001:2008 Auditors
QMS ISO 9001:2008 External auditor An independent firm engaged by the client subject to the audit Internal auditor Employed by the organizations they audit
QMS ISO 9001:2008 Setting up and performing an audit
QMS ISO 9001:2008 · What do I need to do? · Where should I start? · What requirements will need to be met? · How much time is it going to take?
QMS ISO 9001:2008 Guidance ISO 190011
QMS ISO 9001:2008 Authority for the audit program Establishing the audit program Implementing the audit program Monitoring and reviewing the audit program Improving the audit program Competence and evaluation of auditors Audit activities Plan Do Check Act
QMS ISO 9001:2008 ❍planning and scheduling ❍ team leader and auditor competence ❍ team composition ❍ how to carry out the audit ❍ how to carry out follow-up audits ❍ keeping records ❍ how to monitor performance ❍ reports to senior management on how well the audit program is working
QMS ISO 9001:2008 • Check lists • Audit report and findings • Positive, minors, majors & improvements