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: _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.evaluation

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

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