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

QMS ISO 9001:2008

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 9001:2008Quality 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