standard requirements iso 9001-2000 (feb. 05)
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Clause 4 - Quality Management System
4.1General Requirements 4.2Documentation
Requirements4.2.1 General Requirement
QP, QO, QM
Procedure, records4.2.2 Quality Manual
Scope- exclusion
Procedures/ references
Business flow chart
4.2.3 Control of documents
Approval/ reapproval Changes & revision status
Availibility, legibility of docs
External/ obsolete doc4.2.4 Control of records
Identification, storage, protection,
retrieval, retention, disposition
Process & its Linkages
Criteria and methods for control
Resources & information Monitor, measure, analyse
Implementation
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Organization shall establish, document, implement
& maintain QMS & continually improveits
effectiveness in accordance with the requirements
of the StandardISO 9001:2000
4.1 General requirements (1)
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Identify process needed
determine the sequence and interaction of processes
determine criteria and methodsfor effectiveness of
operations and control of processes
ensure the availability of information, resources
monitor, measure and analyse process
implement action necessary to achieve planned results
and continual improvement
4.1 General requirements (2)
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Determineoffering
Designproduct
Acquireorder
Produceproduct
Distributeproduct
Serviceproduct
Marketing Design Production Sales Distribution Servicing
Verb Focus
Noun Focus
Process A Process B Process CNeeds Satisfaction
Verification process
- doc control process- material handling process- data storage process- resource mgt process
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OUTSOURCING (SUBCONTRACTING)
CONTROL
4.1 General requirements (3)
QMS
People, Process
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4.2 Documentation requirements
4.2.1 General
Documented statements of
- Quality Policy- Quality Objectives
- Quality Manual
- Procedures, records
ISO 9001 STANDARD
ORGANIZATION
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Documented Procedure required by ISO9001
(1) Document Control
(2) Record Control
(3) Internal Audit
(4) Nonconformity Control
(5) Corrective Action(6) Preventive Action
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Documented Procedure required by Organization
DerivedDoc
PoliciesPractices
ExternalRef
Standard
Guideline
SOP
Records
Reports
Plans
Test Specs
Procurement
Datas;Customer
Supplier
Industry
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A Quality manual shall be established that includes
scope ( any exclusions ) - Under Clause 7
documented procedure or reference
description of the interaction of the process in the qualitysystem
4.2.2 Quality manual
( Document specifying QMS of an organization )
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QM Framework - Specimen
Introduction(Purpose, Scope, Definition)
Business Overview(Profile, Vision, Mission)
Organization chart
Process Flow
Standard requirement
Procedure/ Approval
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4.2.3 Control of documents
Documented procedure for
approval prior to issue review, update and re-approve documents
changes and status of are identified available at points of use
legible and readily identifiable
external origin are identified and controlled
prevent the unintended use of obsolete
documents, and identification to them
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DOCUMENTS
CONTROLLED UNCONTROLLED
Policies & Practices Specification
Plans/ Schedule/Procedure/W I
Reference Documents
(standards, guides, contracts)
Intentions (proposals, brochures)
Records (results, certificates,reports, meeting minutes)
Memos / Letters
Diaries
Note books
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4.2.4 Control of quality records
Documented Procedure- Legible- Readily Identifiable
- Retrievable
Control : IdentificationStorge
ProtectionRetrievalRetention timeDisposition
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Clause 5
-Management
Responsibility
5.1Mgt Commitment
5.2Customer focus
5.3Quality Policy
5.5Res, Authority, communication
5.4Planning
5.6Management Review
At planned interval
Audit result, customer, product, process, CA,
PA,
follow up, changes, recommendation
Improvement
- QO, QP, Mgt review, resource, communication
- Customer satisfaction
- Align with purpose, framework of objectives,
- commitment, communicate, review
- measurable QO, consistent with QP
- to meet QMS, QO,- to maintain integrity for changes
- Clearly define
- Fully aware
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Top Management
(person/group - direct/control organisation)
show commitment communicate the importance of meeting
customer requirements
statutory and regulatory requirements
establishing a quality policy and quality objectives
conducting management reviews
availability of resources
5.1 Management commitment
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Statutory & Regulatory requirement
Directly / Indirectly related to product
- Environmental, OHSAS, financial laws
-Relationship building- Availability of key personnel
- Information sharing
Customer satisfaction
By - Making employees understand priorities of organization.
Pay attention, understanding, acceptance, correct action of workforce
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Top management must ensure thatcustomer needs and expectations
determined and fulfilled
enhancing customer satisfaction
5.2 Customer focus
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appropriate to the purpose of the organisation
include a commitment to meeting requirements
and continually improve effectiveness of system
provide a framework for establishing andreviewing quality objectives
Communication & Understanding
Review for continuing suitability
5.3 Quality policy(set of guiding principles)
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ORG Purpose : To create customer
Who are customer?
Where they are?
What they buy?
What they need?
What they regard as value?
ORG Goal : To achieve ISO9001-2000
To give customer satisfaction in everything we do
HOW ?
QP states
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Quality Objectives
at relevant functions and levels within organisation
be measurable and consistent with
quality policy
include those needed to meet product requirements
5.4.1 Quality objectives
5.4 Planning
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QUALITY OBJECTIVE
Corporate
Process
Product Departmental/ Functional Personal
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5.4.2 Quality management system planning
Top management shall ensure that
the planning of the system is carried out in orderto meet the requirements(Corporate Plan, Dept Plan, Product Plan)
the integrity of the system is maintained when
changes to system are planned and implemented( Tech, plant, machinery, process, culture, competencylevel of staff )
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5.5.1 Responsibility and authority
5.5 Responsibility, authority and communication
Defineresponsibilities , and authorities
Communicate within organization
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Responsibility and authority for
ensuring the processes are established,implementedand maintained
promoting awareness of customer requirements
through out the organisation
reporting on performance of the system and theneeds for improvement
5.5.2 Management representative
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appropriate communication process are
established within organisation
&
communication takes place regarding the
effectiveness of QMS
5.5.3 Internal communication
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5.6 Management review
5.6.1 General
review QMS at planned intervals for its continuing
- suitability- adequacy- effectiveness
( include assessing opportunities for improvement and the need for changes)
Records maintained
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audit results
customer feedback
process performance and product performance
status of preventive and corrective actions
follow-up actions from earlier reviews
changes that could affect the QMS recommendations for improvement
5.6.2 Review input
Current Performance + improvement opportunities
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The outputs from the review shall include
Improvements of
quality management system and its processes product related to customerrequirements resource needs
5.6.3 Review output
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Clause 6 - Resource Management
6.1 Provision of resources6.2 Human Resources 6.3
Infrastructure
6.4 Work environment
6.2.1 General
6.2.2 Competence, awareness and training
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implement, maintain and improve effectiveness of thesystem
enhance customer satisfaction
The organisation shall determine and provide theresources needed to
6.1 Provision of resources
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applicable education training skills experience
Personnel performing work affecting productquality shall be competent on the basis of
6.2.1 General
6.2 Human resources
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The organisation shall
determine the necessary competence
provide training or other actions
evaluate effectiveness
employees awareness of the relevance andimportance of their activities and how they contributeto the achievement of quality
maintain records
6.2.2 Competence, awarenessand training
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building, workspace and associated facilities process equipment
supporting services
Infrastructure needed to achieve productconformity shall be identified, provided and
maintained, including
6.3 Infrastructure( basic facilities, equipment, service, installation needed for
growth and functioning of org)
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The organisation shall identify and manage thework environment needed to achieve
conformity of product
6.4 Work environment
( set of conditions under which people operate)
Physical, Social, Psychological factors --> Behavior
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Clause 7
-Product
Realization
7.1 Planning of product realization
7.3 Design and Development
7.4 Purchasing
7.2 Customer-related process Know, review Customer Requirement related to
product
Design and Development planning
Design and Development inputs
Design and Development outputs
Design and Development review
Design and Development verification
Design and Development validation
Control of design & development changes
Purchasing process
Purchasing information
Verification of purchased product
QO
Product, Process, Resource requirement
Monitoring & Control
Records for evidence
Customer communication
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Clause 7
-Product
Realization
7.6 Control of monitoring and measuring devices
7.5 Production & service provision
Control of production and service provision
Validation of processes for production and service
provision
Identification and traceability
Preservation of product
Control of monitoring & measuring devices
Customer property
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Sales process Contract process Design process
Procurement process
Production process
Installation process
Supporting process
After sale process
7.1 Planning of product realization
7. Product realization
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Determine quality objectives
Determine products requirements Establish processes,documentation
Provide resources specific to the product
Establish verification, validation, monitoring,
inspection and test, and its criteria
Maintain necessary records
7.1 Planning of product realization
7. Product realization
7 2 C t l t d
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Customer
Necessary for use
Statutory and regulatory requirements(eg. Health & Safety issue, Environmental, Discharge of wastage,
Safe working condition)
Additional requirements(eg. Style, appearance, maintainability, reliability)
7.2.1 Determination of requirementsrelated to product
7.2 Customer-related process
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product requirements resolve differences
ability to meet defined requirements
the results of the review shall be recorded
CHANGES Document - Amend/ Update/ Approval Persons - Notify
Prior committing to supply product, the organisation shall review
7.2.2 Review of requirements related to the product
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Arrangement to be identified and implemented
product information
enquiries, contracts or order handling, amendments
customer feedback, including complaints
7.2.3 Customer communication
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7.3.1 Design and development planning
Organization shall determine
the design and development stages the review, verification and validation that are appropriate
to each design and development stage
responsibilities & authorities for Design & development
manage interfaces between different groups involved in
D&D.
update planning output
7.3 Design and development
Feasibility study (time cost) -
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Feasibility stage
Conceptual stage
Design definition stage
Detail design stage
Development stage
Feasibility study (time, cost) proposed obj Vs practical solution
design detail characteristic method - production/delivery establish
ideas - conceived
theories - tested
design layout risk assessment uncertainty resolved
design development
7 3 2 Design and development inputs
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Inputs shall include
functional and performance requirementsFunctional - speed, power, capacity
Performance - reliability, durability, safety, portability
statutory and regulatory requirementsStatutory - power supply rating, marking, security
Regulatory - health, safety, environmental emission,
certification of compliance required by some country.
information derived from similar previous designs
other requirements
7.3.2 Design and development inputs
7 3 3 Design and development outputs
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7.3.3 Design and development outputs(info, model, specimen)
Provide in a form that enables verification and approve priorrelease
meet the input requirements for design and development
provide appropriate information for purchasing, productionand for service provision
contain or reference product acceptance criteria
specify the characteristics of the product that are essentialfor its safe and proper use
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evaluate the ability to meet requirements
identify problems and propose actions
participants shall include representatives of functions
concerned
records
7.3.4 Design and development reviews
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7.3.5 Design and development verification
ensure that the outputs have satisfied theinput requirements
records maintain
Productrequirement
DesignInput
DesignOutput
DesignVerification
DesignValidation
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To ensure resulting product is capable of fulfilling therequirements for the specified application or
intended use
where practical validation to be completed prior tothe delivery or implementation of the product
Record shall be maintained
7.3.6 Design and development validation
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changes shall be identical and records maintained
verify and validate changes as appropriate
evaluation of changes to include the effect of changes
on constituent parts and delivered products
records and actions maintain
7.3.7 Control of design and developmentchanges
7 4 P h i
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7.4 Purchasing
7.4.1 Purchasing process
ensure purchased product conforms to specifiedpurchase requirements
evaluate and select suppliers based on their ability tosupply product that meet requirements
criteria for selection, evaluation and re - evaluationshall be established
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7.4.2 Purchasing information
Purchasing information shall describe
requirements for approval of product, procedures,
processes and equipment
requirements for qualification of personnel
quality management system requirements
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7.4.3 Verification of purchased product
To ensure purchased product meets requirements
the inspection or other activities
verification at the suppliers premises(Arrangement, Method --- Purchasing Info)
7 5 Production and Service provision
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Plan and carry out production and service provision
under controlled conditions
availability of information that describes the characteristicsof the product
availability of work instruction as necessary
7.5 Production and Service provision
7.5.1 Control of production andservice provision(1)
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7.5.1 Control of production andservice provision(2)
use of suitable equipment
availability and use of monitoring and measuring devices
implementation of monitoring and measurement implementation of release, delivery and post-delivery
activities
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Where the resulting output cannot be verified bysubsequent monitoring or measurement
Validationshall demonstrate the ability of theseprocessed to achieve planned results
7.5.2 Validation of processes forproduction and service provision (1)
7 5 2 Validation of processes for
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7.5.2 Validation of processes forproduction and service provision (2)
defined criteria for review and approval
approval of equipment and qualification of personnel
use of specific methods and procedures
records
revalidation
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7.5.3 Identification and traceability
identify the product by suitable means throughout
product realization
identify the product status with respect to monitoringand measurement requirement
control and record the unique identification of the
product for traceability purpose
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7.5.4 Customer property
identify, verify, protect and safeguard customer property
if any customer property found to be unsuitable for use,
this shall be reported to the customer
include intellectual property
P i f d
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7.5.5 Preservation of product
preserve the conformity of product and constituent of aproduct
include identification, handling, packaging, storage andprotection
7 6 Control of measuring and monitoring devices (1)
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The organisation shall identify
measurements that need to be made and monitoring devices required to assure conformity of product to specified requirements
Monitoring devices to be used and controlled to ensure
that measurement capability is consistent withmeasurement requirements
7.6 Control of measuring and monitoring devices (1)
7 6 C t l f i d it i d i
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Monitoring devices, where applicable shall be
calibrated and adjusted periodically or prior to use
traceable to international or national standards identify the calibrations status
safeguarded from invalid adjustments
7.6 Control of measuring and monitoring devices(2)
7 6 C t l f i d it i d i
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protected from damage and deterioration
take action when the equipment is found not to conform
to requirements
results recorded
7.6 Control of measuring and monitoring devices(3)
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Clause 8
-Measurement,
analysis and
improvement
8.1 General
8.3 Control of non-conforming product
8.2 Monitoring & measurement Customer satisfaction Internal Audit
Monitoring & measurement of processes
Monitoring & measurement of product
8.4 Analysis of data
8.5 Improvement Continual Improvement
Corrective action
Preventive action
8 M t l i d i t
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8. Measurement, analysis and improvement
8.1 General (1)
Plan and implement the monitoring, measurement,
analysis and improvement processes needed include
demonstrate conformity of the product
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8.1 General (2)
ensure conformity of the quality management system
continually improve the effectiveness of system determination of applicable methods, including
statistical techniques
8 2 Monitoring and measurement
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8.2 Monitoring and measurement
8.2.1 Customer satisfaction
monitor information relating to customer perception
methods for obtaining and using this information
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Conduct internal audits at planned intervals to determine that
conforms to the planned arrangements and to the qualitymanagement system requirements
effectively implemented and maintained
8.2.2 Internal audit(1)
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program shall be planned, taking into consideration thestatus and importance of the processes and the results ofprevious audits
the responsibilities and requirements for planning andconducting audits, and for reporting results andmaintaining records shall be defined in a documented
procedure
8.2.2 Internal audit(2)
8 2 3 Monitoring and measurement
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8.2.3 Monitoring and measurementof process
apply suitable methods for monitoring and measurement
of the processes
demonstrate the ability of the processes to achieveplanned results
when results are not achieved, correction and preventiveaction shall be taken
8 2 4 Monitoring and measurement
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8.2.4 Monitoring and measurementof product
monitor and measure the characteristics of the product to
verify that product requirements are fulfilled
evidence shall be maintained
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8.3 Control of nonconforming product
ensure that non conforming product is identified and
controlled to prevent its unintended use or delivery responsibilities and authorities for dealing with
nonconforming product shall be defined in a
documented procedure
8 3 Control of nonconforming prod ct
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Deal with nonconforming product by the following
taking action to eliminate the detected nonconformity
authorizing its use, release or acceptance underconcession
taking action to preclude its original intended use or
application
records of the nature of non conformities and any
subsequent actions taken
8.3 Control of nonconforming product
8 4 Analysis of data
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the suitability and effectiveness of the QMS to identify improvements that can be made to provide information on
- customer satisfaction and/or dissatisfaction- conformance to customer requirements
- characteristics of processes, product and trends- suppliers
Appropriate data shall be collected and analysed to determine:
8.4 Analysis of data
8 5 I t
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Continual improvement to be planned and managed by
use of:
the quality policy objectives
audit results
analysis of data
corrective and preventive action management review
8.5.1 Continual improvement
8.5 Improvement
8 5 2 Corrective action
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8.5.2 Corrective action
take action to eliminate the cause of non conformities in
order to prevent recurrence
documented procedure shall be established
reviewing non conformities determining the causes of non conformities
evaluating the need for action
determining and implementing action needed
records of the results of action taken reviewing corrective action taken
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8.5.3 Preventive action
determine action to eliminate the causes of potential non-
conformities in order to prevent their occurrence
documented procedure shall be established
determining potential non conformities and their causes
evaluating the need for action
determining and implementing action needed
records of the results of action taken reviewing corrective action taken