8/13/2019 -03-ISO- Req.
1/89
1
INTERPRETATION
OFISO 9001:2008
REQUIREMENTS
8/13/2019 -03-ISO- Req.
2/89
C - 2
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
ISO 9001:2008 CLAUSES
8/13/2019 -03-ISO- Req.
3/89
C - 3
ISO 9001: 2008QUALITY MANAGEMENT SYSTEMS - Requirements
4.1 General Requirements
4.2 Documentation Requirements
5.1 Management Commitment
5.2 Customer Focus
5.3 Quality Policy
5.4 Planning
5.5 Responsibility, Authority andCommunication
5.6 Management Review
6.1 Provision of Resources
6.2 Human Resources
6.3 Infrastructure6.4 Work Environment
7.1 Planning of ProductRealization
7.2 Customer-Related Processes
7.2 Customer-Related Processes
7.3 Design and Development
7.4 Purchasing
7.5 Production and ServiceProvision
7.6 Control of Monitoring and
Measuring Devices8.1 General of Measurement,
Analysis and Improvement
8.2 Monitoring andMeasurement
8.3 Control of Nonconforming
Product8.4 Analysis of Data
8.5 Improvement
8/13/2019 -03-ISO- Req.
4/89
C - 4
General requirements Establish, document, implement, maintain and
continually improve a Quality Management System in
accordance with the standard
Identify the processes including those for outsourcing
Determine the sequence and interaction of these
processes
Determine criteria and methods
Resources and information
CLAUSE 4 : QUALITY MANAGEMENT SYSTEM
PLAN
DOCHECK
ACTION
8/13/2019 -03-ISO- Req.
5/89C - 5
General requirements (cont.d) Monitor, measure and analyze
processes
Continual improvement
Documentation is dependent on:- size and type of organization
- complexity and interaction of the processes
- competence of personnel
Documentation can be in any form or type ofmedium
CLAUSE 4 : QUALITY MANAGEMENT SYSTEM
8/13/2019 -03-ISO- Req.
6/89C - 6
Quality Manual
Scope of QMS
Exclusions : Clause 7 Reference
Sequence and Interaction of Processes of the QMS
Procedures
Procedures
CLAUSE 4 : QUALITY MANAGEMENT SYSTEM
8/13/2019 -03-ISO- Req.
7/89C - 7
PERMISSIBLE EXCLUSIONS
Quality Manual
May only exclude QMS requirements that ;
do not affect the organization's ability orresponsibility to provide product that meetscustomer and regulatory requirements.
are limited to clause 7, Product Realization.
Nature of an organization and its products
8/13/2019 -03-ISO- Req.
8/89C - 8
Control of Documents
Approve, review, update
Current revision status
Available at points of use
Legible and readily identifiable
External documents
Obsolete documents Documented procedure
CLAUSE 4 : QUALITY MANAGEMENT SYSTEM
8/13/2019 -03-ISO- Req.
9/89C - 9
DOCUMENT CONTROL
Include:Hardcopies, electronic media; external documents
Steps:
Assign document controller Provide storage and minimize vulnerability: e.g. electronic data Maintain register or master list of documents Review and approve documents by authorizedpersonnel Create unique identification for each document Maintain register or distribution list
Ensure accessibility and security: electronic media Maintain obsolete document Control document changes
8/13/2019 -03-ISO- Req.
10/89C - 10
Control of records Identification
Storage
Legible
Retrieval
Protection
Retention time
Disposition Documented Procedure
CLAUSE 4 : QUALITY MANAGEMENT SYSTEM
8/13/2019 -03-ISO- Req.
11/89C - 11
As objective evidence Compiling & analysing of data / trend Form of quality records
HardcopyLogsPrint-outMicro FilmFloppy Disk
Quality record register
Retention timeExtent of referenceRequirements by customer, contractual or statutory
regulation
CONTROL OF RECORDS
8/13/2019 -03-ISO- Req.
12/89C - 12
Scope; e.g. Management Review Contract Review Design Review/Verification/Validation Evaluation of Vendor Inspection/Testing Calibration Non-Conformity Review Corrective Actions
Internal Audit Training etc. (as established by company)
CONTROL OF QUALITY RECORDS
8/13/2019 -03-ISO- Req.
13/89
C - 13
COMPARISON BETWEEN CONTROLLEDDOCUMENT & QUALITY RECORD
1. Established to guide operations
2. Subject to control on issue, change,distribution and withdrawal
3. Living document for use at the pointof application
4. Distributed to copy holders on a need-to-use basis
5. Being used until withdrawn
1. Generated as a result of activities
2. Subject to proper maintenance, storage and
disposal
3. Historical record to be filed or archived forreference or as documentary evidence of
quality assurance
4. Usually maintained at a fixed location by the
process owner and participants that generate
the record
5. Disposed off when exceeded specified
retention period
CONTROLLED DOCUMENT QUALITY RECORD
8/13/2019 -03-ISO- Req.
14/89
C - 14
Labelling of cabinet for easy retrieval
8/13/2019 -03-ISO- Req.
15/89
C - 15
Labelling of records for easy identification
8/13/2019 -03-ISO- Req.
16/89
C - 16
Proper identification of shelf for types of forms orrecords
8/13/2019 -03-ISO- Req.
17/89
C - 17
DOCUMENTS/QUALITY RECORDS
Quality manual/procedures/work instruction
Calibration reports
Purchase orders
Checklists
Drawings
Are these controlled documents or quality records?
8/13/2019 -03-ISO- Req.
18/89
C - 18
Questions and Answers ?
8/13/2019 -03-ISO- Req.
19/89
C - 19
5.0 MANAGEMENT RESPONSIBILITY
Productrealization
C
U
S
T
O
M
E
R
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Requiremen
ts
Managementresponsibility
Measurement,analysis,
improvement
Input
Resourcemanagement
Output
5.1 Managementcommitment
5.2 Customer focus
5.3 Quality policy
5.4 Planning
5.5 Responsibility, Authorityand Communication
5.6 Management review
8/13/2019 -03-ISO- Req.
20/89
C - 20
Management Commitment
Top management providescommitment
Communication : the importance ofmeeting customer, regulatory andstatutory requirements
Establish quality policy and objectives
Conduct management reviewAvailability of resources
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
21/89
C - 21
Customer Focus
Determine customer requirements
Achieve customer satisfaction
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
22/89
C - 22
Quality Policy Meet requirements
Continual improvement
Communicated and understood at appropriate
levels Review continuing suitabilityNotes:
a) Policy should be easy to understand
b) Set overall intentions and direction of an organizationrelated to quality as formally expressed by topmanagement
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
23/89
C - 23
QUALITY OBJECTIVES
Formulation of quality objectives transmits thepolicy intention of top management to alllevels of company
The objectives should be SMART:
Specific, Measurable,Achievable, Realisticand with a Time frame
e.g.
To reduce service time to 5 minutes percustomer by end 2001.
A maximum of 1 failure per 1,000,000 usagesof vending machine by end 2001.
SMART
8/13/2019 -03-ISO- Req.
24/89
C - 24
Quality Management System Planning Processes
Resources
Criteria and Methods
Monitor, measure and analyzeprocesses
Continual improvementofthe QMS
Change
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
25/89
C - 25
Responsibility and Authority
Functions and their interrelations
Define and communicated
This is your responsibilityand authority
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
26/89
C - 26
Management Representative
Member of the management
Promoting awareness of customerrequirements
Ensuring processes of the QMS areestablished; implemented and maintained
Reporting on the performance of the QMS
Liaison with Certification Body
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
27/89
C - 27
Internal Communication
Communication Processes
Effectiveness of QMS
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
28/89
C - 28
Management Review
Planned interval
Suitable, adequate & effective QMS
Changes to QMS, Quality Policy & Objectives
Review input:- Current performance
- Improvement opportunities
Review output
- Actions related to QMS,
processes, product, resources
Records
CLAUSE 5 : MANAGEMENT RESPONSIBILITY
8/13/2019 -03-ISO- Req.
29/89
C - 29
MANAGEMENT REVIEW
Example
Management Review Team CEO as chairperson
Management Representativeas secretary
Heads of Departments as members
Minimum of one review per year
8/13/2019 -03-ISO- Req.
30/89
C - 30
Review Topics Internal/External Quality Audit
Outcomes Policy & System
Non-Conformances Corrective & Preventative Actions
Customer Complaints
Customer Feedback
Process Performance
Follow-up actions from previous reviews
Changes and recommendations for improvements
MANAGEMENT REVIEW
8/13/2019 -03-ISO- Req.
31/89
C - 31
Questions and Answers ?
8/13/2019 -03-ISO- Req.
32/89
C - 32
Product
realization
C
U
S
T
O
M
E
R
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
SatisfactIon
Managementresponsibility
Measurement,analysis,
improvement
Input
Output Product
6.1 Provision of resources
6.2 Human resources
6.3 Infrastructure
6.4 Work Environment
CLAUSE 6 : RESOURCE MANAGEMENT
8/13/2019 -03-ISO- Req.
33/89
C - 33
Provision of Resources
- to implement, maintain and improve the QMS
- to enhance customer satisfaction
Human Resources
- Assignment of personnel
eg. Education, training, skills and
experience
CLAUSE 6 : RESOURCE MANAGEMENT
8/13/2019 -03-ISO- Req.
34/89
C - 34
Training, Awareness and Competency
- Determine competence of personnel
- Provide training
- Evaluate the effectiveness of actions taken- Employee awareness
- Records
CLAUSE 6 : RESOURCE MANAGEMENT
CLAUSE 6 RESOURCE MANAGEMENT
8/13/2019 -03-ISO- Req.
35/89
C - 35
Training and competence for employees
Employee Appraisal
CompetenceandTraining needs
Others
Training Program
New Employee
Special Task
Provide Training
Record
New Technology
CLAUSE 6 : RESOURCE MANAGEMENT
CLAUSE 6 RESOURCE MANAGEMENT
8/13/2019 -03-ISO- Req.
36/89
C - 36
Infrastructure- Identify, provide and maintain
- Workspace, buildings, utilities
- Equipment, hardware and software
- Supporting services Work environment
- Identify and manage
- Suitable for conformity to productrequirements
CLAUSE 6 : RESOURCE MANAGEMENT
8/13/2019 -03-ISO- Req.
37/89
C - 37
Questions and Answers ?
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
38/89
C - 38
Productrealization
C
U
S
T
O
M
E
R
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Req
uiremen
ts
Managementresponsibility
Measurement, analysis,
improvement
Input
Resourcemanageme
nt
7.1 Planning of productrealization
7.2 Customer-related
processes
7.3 Design anddevelopment
7.4 Purchasing
7.5 Production and service
provision
7.6 Control of measuringand monitoring
devices
CLAUSE 7 : PRODUCT REALIZATION
Output
CLAUSE 7 PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
39/89
C - 39
Planning of product realization
Planning to determine:
Processes, documents and resources
Objectives for products, projects or
contracts Requirements
Verification monitoring and validationactivities
Criteria for acceptability Records
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
40/89
C - 40
Customer-related Processes
Determination of requirements related toproducts
- Customer requirements
- Product requirements not stated by customers
- Regulatory and statutory requirements
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
41/89
C - 41
Customer-related Processes (contd)
Review of requirement related to products- Prior to commitment to supply
- Requirements are defined
- Requirement differing from those in a tenderor quotation are resolved
- Ability to meet requirements
- No documented requirements : confirmedbefore acceptance
- Changed requirements
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
42/89
C - 42
Customer-related Processes (contd)
Customer communication
- Product
- Enquiries, contracts, orders
- Customer feedback & complaints
- Amendments
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
43/89
C - 43
Design and Development
Design and development planning- Stages
- Review, verification and validation
- Responsibilities and authorities
- Interfaces between different groups /functions
- Update planning output
- Manage effective communication
- Attention to safety, environment andregulatory requirements
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
44/89
C - 44
Design and Development (contd)
Design and development inputs
- Requirements e.g. performance, functions,
statutory etc.
- Resolve incomplete, ambiguous, conflictingrequirements
- Technical specifications for materials,
product and processes
- Review inputs for adequacy
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
45/89
C - 45
Design and Development (contd)
Design and development outputs
- Meet input requirements
- Product acceptance criteria
- Information for purchasing, production andservice operations
- Define product characteristics
- Conform to applicable regulatory requirements
- Approve output documents
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
46/89
C - 46
Design and Development(contd)
Design and development review
- Evaluate the design
- Identify problems
- Follow-up actions
- Records
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
47/89
C - 47
Design and/or Development (contd) Design and development verification
- Output meets inputs requirementse.g. Prototyping, testing, comparative studies etc. and
consider reliability, maintainability, packaging, etc.
- Records Design and development validation
- to ensure that product that meets
specified application or intended use.
e.g. Performed under defined operating conditions- Records
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
48/89
C - 48
Design and/or Development (contd)
Control of design and development changes
- Identified, documented and controlled
e.g. Engineering change request
- Evaluation of the effect of the changes onparts and products
- Review, verify and validation
- Records
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
49/89
C - 49
PurchasingPurchasing process
- Purchased product conforms to requirements
- Type of control depends on vendors control
- Evaluation and selection of suppliers
- Records of evaluation to be compiled
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
50/89
C - 50
PurchasingPurchasing information
- Describe the products to be purchased
- Where appropriate, other requirements
- Company to ensure adequacy prior to
communication to the supplier
- Handling changes to purchase orders
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
51/89
C - 51
Purchasing (contd) Verification of purchased product
- Verification activities at thesuppliers premises
- Company shall plan inspectionactivities to verify purchasedproducts
CLAUSE 7 : PRODUCT REALIZATION
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
52/89
C - 52
Production and service provision Control of production and service provisions
- availability of information on productcharacteristics
- availability of work instructions- suitable equipment
- monitoring and measuring devices
- monitoring and measurement
- release, delivery and post-delivery activities
SERVICE PROVISION
8/13/2019 -03-ISO- Req.
53/89
C - 53
If Specified in contract
After sales services/post-project
Examples : Installation/commissioning
Warranty service/maintenanceservice
Spare-parts sales
Product upgrading
8/13/2019 -03-ISO- Req.
54/89
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
55/89
C - 55
Identification and traceability- Throughout production and service operations
- Status
PRODUCT IDENTIFICATION & TRACEABILITY
8/13/2019 -03-ISO- Req.
56/89
C - 56
Identification:e.g. for Project Number Proposals, account profiles Purchase requests Sales Department Reports Part no./batch (lot) no./ model no. Marking, tagging, physical segregation,
labels, bins cards Traceability (to the extend necessary)
Serial no.Date - code.Batch no.
Raw MaterialsHardware / SoftwareInspection/Test status
ProcessesPersonnelRecords
Accept /Reject, On-
hold, etc
IDENTIFICATION & TRACEABILITY
8/13/2019 -03-ISO- Req.
57/89
C - 57
Examples
Foods and Drinks- Specified mark or bar code
Pharmaceutical- Batch manufacturing records- Raw material batch numbers
Banking and Finance- Unique identification of all accounts, policies
shares certificatesetc.,
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
58/89
C - 58
Customer propertyCustomer property include intellectual property
- Exercise care
- Identify, verify, protect and maintain
- Lost, damage or unsuitable for use shall berecorded and reported to customer
CUSTOMER PROPERTY
8/13/2019 -03-ISO- Req.
59/89
C - 59
EXAMPLES:
Manufacturing
Parts, components, equipment, packingmaterials, tools-on-loan, documents
Retail
Items left for cleaning or repair
Hotel
Wines and wedding cakes during a function
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
60/89
C - 60
Preservation of productsHandling methods + means of handling that prevents damage ordeterioration
Pallets
Containers
Conveyors
Vehicles
CLAUSE 7 : PRODUCT REALIZATION
8/13/2019 -03-ISO- Req.
61/89
C - 61
Preservation of products
Organization shall preserve conformity of products- Packaging, storage and protection
Preservation shall apply to constituents of products
PRESERVATION OF PRODUCTS
8/13/2019 -03-ISO- Req.
62/89
C - 62
Examples:
Handling Method(including safety) Equipment Pallets, containers, conveyors, vehicles, etc.
Storage Receiving & Issuing and storage procedures FIFO Monitor shelf-life items
Segregation of non-conforming goodsAssessment of condition
PRESERVATION OF PRODUCTS
8/13/2019 -03-ISO- Req.
63/89
C - 63
Examples:
Packaging Packaging Specification & Design Methods & Materials Identification Requirements / MarkingAnti-static packaging
Delivery Contractual requirements Time Environment (Temperature)
Protection of the quality of product Documentation
CONTROL OF MONITORING AND MEASURING DEVICES
8/13/2019 -03-ISO- Req.
64/89
C - 64
Control of monitoring and measuring devices Implement control for maintenance & calibration of inspection,
measuring and test equipment
Computer software
CONTROL OF MONITORING AND MEASURING DEVICES
8/13/2019 -03-ISO- Req.
65/89
C - 65
Calibrate or verify at intervals
Traceable to national or international standards
Adjust or re-adjust
Calibration status
Safeguard from adjustments
Protected from damages or deterioration
Handling, maintenance and storage
Assess and record the validity of previous measuringresults when equipment is out of calibration
CONTROL OF MONITORING AND MEASURING DEVICES
8/13/2019 -03-ISO- Req.
66/89
C - 66
Example: Check test hardwares(e.g. jigs, fixtures, templates, patterns)
and/or test software used as suitable forms of inspection
Equipment for measuring design data (for design control) Production equipment which are critical to product / service
characteristics Inspection, Measuring and Test Equipment which demonstrate
product / service conformance to specified requirements
CONTROL OF MONITORING AND MEASURING DEVICES
8/13/2019 -03-ISO- Req.
67/89
C - 67
Examples:
Transportation, Storage, Distribution
Temperature gaugesPressure gauges
Retail
Bar code machineTemperature controlled equipment
Ship RepairRadiographic & non-destructive test equipmentGas detection equipment
Manufacturing
Dimensional instruments
Physical / Chemical Test equipmentHospitalPhysical Test equipment
8/13/2019 -03-ISO- Req.
68/89
C - 68
Questions and Answers ?
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
69/89
C - 69
Productrealization
C
U
S
T
O
M
E
R
CONTINUAL IMPROVEMENT OF THE QUALITY MANAGEMENT SYSTEM
Requirements
Managementresponsibility
Measurement, analysis,
improvement
Input
Resourcemanagement
Output
8.1 General
8.2 Measurement
and monitoring
8.3 Control of
nonconforming
product
8.4 Analysis of data
8.5 Improvement
Product
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
70/89
C - 70
General
- Define, plan and implement measurement andmonitoring activities
- ensure conformity of QMS
- continually improve the QMS- Methodologies including
statistical techniques
8.0 MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
71/89
C - 71
Measurement and monitoring- Perception of customer in meeting
requirements
- Customer satisfaction and/or
dissatisfaction- Methodologies for obtaining and
using information
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
72/89
C - 72
Internal audit- Audit Program
- Conforms to plannedarrangement
- Quality management systemis effectively implementedand maintained
- Documented procedure
PREPARING AND REPORTING AN AUDIT
8/13/2019 -03-ISO- Req.
73/89
C - 73
STEPS: Define audit scope, criteria, frequency and methods
Select auditors - auditors shall not audit their own work Collect information Review documents Establish depth of audit Prepare audit schedule Allocate audit time Identify audit
Prepare Audit Checklists Execute audit Record and report Follow-up activities Close corrective action Management review
AUDIT STRATEGIES AND TECHNIQUES
8/13/2019 -03-ISO- Req.
74/89
C - 74
STRATEGIES TECHNIQUES
Trace Forward
Trace Backward
Task-based
ISO 9000 elements
Clarifying
Interviewing
Observing
Verifying
Collecting Objective
Evidence
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
75/89
C - 75
Monitoring and measurement of processes- Suitable methods for monitoring processes
- Method to demonstrate the ability of processto achieve requirements
- Corrective actions when results not achieved
- KeyProcesses
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
76/89
C - 76
Monitoring and measurement of product
- Measure the characteristics of products- Carried out at appropriate stages of
production
- Evidence of conformity to include the personauthorizing release
- Release shall only be allowed
after completion of
arrangement unless
authorized
INSPECTION & TESTING
8/13/2019 -03-ISO- Req.
77/89
C - 77
Example:
Receiving (Incoming)
NON-QC
(SUPPLIER CERT)
INCOMING MATERIALS, PARTS
SHIP-TO-STOCK
INCOMING QC
ACCEPTED REJECTED
RETURN TOVENDOR
REWORKED
SCRAPPED
STORAGE OR USE
INSPECTION & TESTING
8/13/2019 -03-ISO- Req.
78/89
C - 78
Examples:
In Process: Detailed in QC plan and/or Instructions Sampling, in-process monitoring Identify non-conforming product / service Records
e.g.. Hotel and Catering Industry- Inspection of rooms
- Kitchen hygieneRetail Industry- Inspect display of products
Final Inspect / test final product/ service as planned (QC
plan, instruction) Accept and deliver only conforming product / service
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
79/89
C - 79
Control of nonconforming product
- action to eliminate detected nonconformity
- records for concession
- re-verification of corrected products
- organization to take actions appropriate tothe effects of nonconformity after delivery
CONTROL OF NONCONFORMING PRODUCT
8/13/2019 -03-ISO- Req.
80/89
C - 80
INSPECT / TEST
ACCEPTED
USE
NONCONFORMING
IDENTIFY / SEGREGATE
RECORD
EVALUATE/ DISPOSITION
Objective : Prevent inadvertent use /installation
All stages of process/ service/projectEXAMPLE:
NONCONFORMING REVIEW AND DISPOSITION
8/13/2019 -03-ISO- Req.
81/89
C - 81
DISPOSITION
SCRAP
REGRADE CONCESSION (accepted)REWORK
RecordsResponsibility & Authority
REVIEW
Dispose Team
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
82/89
C - 82
Analysis of data
Data shall include information for customersatisfaction, conformity of productrequirements, characteristics and trend ofprocesses/ products and suppliers:
- Collect from monitoring and measurement- Analyze
- Suitability and effectiveness of the QMS
- Identify improvements
Analysis of Data
8/13/2019 -03-ISO- Req.
83/89
C - 83
Compile &Analyze data
Customerdata
Process
data
Supplier
data
Productdata
complaints
feedback
delivery
quality
rejection,repair
wastage
trends
failures
GENERAL INTENT
8/13/2019 -03-ISO- Req.
84/89
C - 84
Measurement & Monitoring
Analysis of DataImprovement
Opportunity from :
Quality Objectives
Internal Audit
Analysis of Data
Corrective Action
Preventive Action
Management
Review
Customer satisfaction
Internal Audit
Product/ services/ Process Control of Non-conforming
product
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
85/89
C - 85
Continual improvement
- Continually improve effectiveness of qualitymanagement systems
- Corrective action
- Preventive action- Audits, analysis of data
- Management review
Corrective action
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
86/89
C - 86
Corrective action
Action taken to eliminate causes of non-conformities
A documented procedure is needed
Action may involve investigation, analysis, solutionimplementation and recording change
A system of achieving continual (step-by-step) improvement
Records Review
Preventive action
CLAUSE 8 : MEASUREMENT, ANALYSIS AND IMPROVEMENT
8/13/2019 -03-ISO- Req.
87/89
C - 87
Preventive action
Preventive action - action taken to eliminate potential non-conformities
Action may involve investigation, analysis, solutionimplementation and recording change
A documented procedure is needed
Records Review
8/13/2019 -03-ISO- Req.
88/89
C - 88
Questions and Answers ?
8/13/2019 -03-ISO- Req.
89/89
C - 89
Top Related