Awareness 1 [Compatibility Mode]
Transcript of Awareness 1 [Compatibility Mode]
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Session 1 1
AWARENESSAWARENESSTRAININGTRAINING
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Sigur Ros Sdn. Bhd.
Session 1: Background & History of ISOSession 1: Background & History of ISO
ItineraryItinerary
Session 2: Basic Structure of ISO 9001:2008Session 2: Basic Structure of ISO 9001:2008-- Process Model QMSProcess Model QMS
-- Process ApproachProcess Approach
Session 3: ISO 9001:2000 StandardSession 3: ISO 9001:2000 Standard-- Clause 1~3 (General, Ref, Terms & Definitions)Clause 1~3 (General, Ref, Terms & Definitions)
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---- Clause 5 (Management Responsibility)Clause 5 (Management Responsibility)-- Clause 6 (Resource Management)Clause 6 (Resource Management)-- Clause 7 (Product Realization)Clause 7 (Product Realization)-- Clause 8 (Measurement, Analysis & Improvement)Clause 8 (Measurement, Analysis & Improvement)
Background ISO=
Session 1: Background & History of ISOSession 1: Background & History of ISO
HQ: Geneva, Switzerland
ISO 9000 Standard developed by Technical Committee176 (TC 176)
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,5 years periodic review
Required minimum 75% committee agreement
Scheduled review & up-datepresent standard
Countrys Reps Countrys Reps
Scheduled review & up-datepresent standard
ISO & INTERNATIONAL STANDARD FLOWISO & INTERNATIONAL STANDARD FLOW
75% Agreed
TC 176
Relevant government authorities/bodies
Clients
ISO standard
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AccreditationBodies
(UKAS, RAB, DSMetc.)
Certification
Bodies (SIRIM,LRQA, BVQI etc.)Companies
National standard
ISO Cert.
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Session 1 2
History of series ISO 9000:Session 1: Background & History of ISOSession 1: Background & History of ISO
e on: rom r s an ar
2nd edition: 1994
3rd edition: 2000 (valid til l Nov 2009)
4th edition: 2008
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iso = equality (Greek)
Session 1: Background & History of ISOSession 1: Background & History of ISO
ISO standard responses as a measurement point
Easier international business
Basic std to generate/produce product/service
Different people, same method/system practice
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Session 2 1
Session 2: Basic Structure of ISO 9001:2008
Process Model Quality Management System (QMS)
Process Approach
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Session 2: Basic Structure of ISO 9001 :2008
Process Model Quality Management System (QMS)
ISO 9001:2008 is a Genera St ; can e a apteto all kind of industries/businesses & organisations
Standard based on Quality Management System(QMS)
WHAT to do, not HOW to do concept to fulfillthe standard
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Organisation have to explain how they operates
Session 2: Basic Structure of ISO 9001:2008Process Model Quality Management System (QMS)
ISO 9001:2008 consists of simple approachingelements:
Documentation Management commitment & responsibility
Resources management
Product / Service realization
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Measurement, Ana ysis & improvement
Continual improvement
Concept of Process Model
Continual Improvement
Session 2: Basic Structure of ISO 9001:2008
Process Model Quality Management System (QMS)
ManagementResponsibility
ResourceManagement
Measurement,Analysis &
Improvement
CUSTOMERREQUI
CUSTOMERSATISF
Information Flow
InformationFlow
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ProductInput OutputProduct
Realization
EMENT
CTION
Value-Adding Activities
Value-Adding Activities
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Session 2: Basic Structure of ISO 9001:2008
Process Approach
A process involves use of resources for thetransformation of inputs into outputs
No isolated process in the organisation
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- (Input Action Output)
Session 2: Basic Structure of ISO 9001 :2008
Process Approach
Company Business Process
Company Tendering Execution
Company Project Execution
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Session 3: ISO 9001:2008 Standard
Clause 1~3 Scope
Reference
Terms & Definitions
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4.1 General requirements
Organisation shall:
Session 3: ISO 9001 :2008 StandardClause 4 (QMS)
Establish, document, implement & maintain a QMS
Identify the sequence & interaction of processes
Control & ensure the processes are effective
Resource & info to be available
Monitor, measure, analyse & improve the processes
Control process that are outsource
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4.2 Documentation requirement
Document must ensure process effectiveness Paper/electronic
Session 3: ISO 9001 :2008 StandardClause 4 (QMS)
Size/complexity; customised to organisation Min required documents:
Quality Policy and Quality Objective Quality Policy = Company Motto (5.3) Quality Objective = Company/Dept Target (5.4.1)
Quality Manual = Company Profile (4.2.2) 6 Mandatory Procedures
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. . Control of Records (4.2.4) Internal Audit (8.2.2) Control of Nonconforming Product (8.3) Corrective Action (8.5.2) Preventive Action (8.5.3) Records & Others (document to ensure effective operation,
any defined method/format: flowchart, diagram, picture etc.
Session 3: ISO 9001 :2008 StandardClause 4 (QMS)
Basic Structure of Documentation
Quality Manual
Procedures
Work Instructions
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Support Document
* Refer to Company Quality System Document (QSD)
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4.2.2 Quality Manual Company scope of processes/activities.
Ex lanation of documented rocedures reference
Session 3: ISO 9001 :2008 StandardClause 4 (QMS)
A description of the interaction between processes (processmapping)
4.2.3 Control of Documents Ensure, review, revise, document status
Identification, controlled copy
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4.2.4 Control of Records Legible, readily identifiable and retrievable
Identification, storage/protection, retention time anddisposition
Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)
5.1 Management Commitment Management must demonstrate its commitment
Must meet customer needs & requirements
Must meet regulatory & legal requirements
QMS must be driven by top management
Establish quality policy & objectives (5.3 & 5.4.1)
Conduct management review (5.6)
Ensure availability of resources (6)
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5.2 Customer/ Client focus Determined customer requirements
Aim to achieve customer satisfaction (7.2.1 & 8.2.1)
Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)
5.3 Quality Policy Must appropriate to the purpose/target of the organization
Communicated within organization
Commitment for continually improve the QMS
Company Quality Policy
5.4.1 Quality Objectives Measurable and in line with Quality Policy
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Use as one of the factors to facilitating continual improvement
Company Quality Objective
Departmental Quality Objective
Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)
5.5 Responsibility, authority and communication
5.5.1 Res onsibilit & authorit
Responsibilities defined and communicated (Jobs Description)
5.5.2 Management representative
Responsible for implementing/maintaining & reporting theQMS
Report on needs of improvement
Promote awareness of customer needs
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5.5.3 Internal communication Communication between various level (processes &
effectiveness of QMS)
Organization Chart
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Session 3: ISO 9001 :2008 StandardClause 5 (M anagement Responsibi l ity)
5.6 Management Review Review input
eac ve .e. pro em ren s
Proactive (i.e. opportunities)
Review output Improvement of QMS, customer requirement
Resources needs
Record shall be maintained (Management Review
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Procedure
Session 3: ISO 9001 :2008 StandardClause 6 (Resource management)
6.1, 6.2 Human resources Must ensure staff:
ompe en
Provide training
Aware of importance of their activities
Maintained records (Training Procedure)
6.3 Infrastructure
Must have correct infrastructure to achieve aims (i.e.
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buildings, hardware, software, transportation etc.)
6.4 Work environment
Must be right environment to achieve conformingproduct (i.e. Food industry; humidity & temperature etc.)
Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)
7.1 Planning of product realization Determine following, as appropriate:
ualit re uirement for the roducts
The need to establish project specific process, documents, resources(4M method)
Inspection & testing requirement & criteria required Records (Project Planning Procedure)
7.2 Customer-related process Must be method:
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To make sure requirements (regulatory/legal) understood and met
For communicating with customer
For controlling changes to requirements
Tendering Planning Procedure
Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)
7.3 Design & Development (D&D)
Establish design & development route with:
D&D Planning (Design Plan)
D&D inputs (from clients, supplier)
D&D outputs D&D review
D&D validation (performance test etc.)
D&D changes
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es gn on ro roce ure
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Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)
7.4 Purchasing
Must ensure that an urchased oods services are toan acceptable standard & criteria
Purchase document & information must be precise
Supplier must be evaluated
Verification of purchased products
Procurement Procedure, Subcontracting Procedure
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Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)
7.5 Production/Construction and service provision 7.5.1 Control of Construction & service provision
Summaries the core activities on how the product/service canbe provided in a controlled and consistent way, i.e.:
Clear instructions (WP, PP, DPP etc.)
Suitable equipments, monitoring activities, test equipments
Construction procedures, WP, PP etc.
7.5.2 Validation of processes
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,
(i.e. proof of good welding). Special process validation required Review criteria, equipments, competency, procedures, records
Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)
7.5 Production/Construction and service provision
7.5.3 Identification & traceability
Identification: what the product/service is?
Traceability: where the product/service gone/come from?
Identification, Traceability & Preservation of Material,Equipment & Work Procedure
7.5.4 Customer property Information/data/hardware belong to customer must be looked
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a er
Control of Client Property Procedure
7.5.5 Preservation of product
Ensure product/service is not damaged
Session 3: ISO 9001 :2008 StandardClause 7 (Product Realization)
7.6 Control of monitoring & measuring equipmentCalibration
To ensure any device used for accurate measurement isitself accurate
Device is routinely checked/calibrated
Protected from damage
Control of Monitoring & Measuring Devices Procedure
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Session 3: ISO 9001 :2008 StandardClause 8 (Measurement, Analysis & Improvement)
8.1 General 8.2 Monitoring & measurement
. . Key measures must be defined (survey/project feedback form
etc.)
8.2.2 Internal Audit QMS is audited to check:
The system followed, effective? Meets ISO9001 requirement?
Internal Audit Procedure
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8.2.3, 8.2.4 Monitoring & measurement oprocesses/product To defined that processes/products meet customer
requirement? Inspection & Test Plan (ITP) Inspection & Testing Procedure
Session 3: ISO 9001 :2008 StandardClause 8 (Measurement, Analysis & Improvement)
8.3 Control of nonconforming product
o ensure fault roduct service is not accidentallused including those detected after delivery
Control of Nonconformities Procedure
8.4 Analysis of Data
Data from Internal Audit, customer complaint,processed, suppliers must be analyzed so as to find
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ways o improving usiness Analysis of Data Procedure
Session 3: ISO 9001 :2008 StandardClause 8 (Improvement)
8.5 Improvement
8.5.1 Continual improvement
Improve QMS effectiveness through the use of quality policy &objective, audit result, analysis of data, management review
etc. 8.5.2 Corrective action
Take action to avoid recurrence of nonconformities/problems
Corrective & Preventive Action Procedure
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8.5.3 Preventive action Take action to avoid occurrence of potential
nonconformities/problems
Corrective & Preventive Action Procedure