This document and the data contained herein

Transcription

QUALITY MANAGEMENT SYSTEM (QMS) MANUAL
This document and the data contained herein
are the property of ISOLINK, and shall not,
without prior written permission, be reproduced
or used for any unintended purpose.
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Title:
Revision:
QM-0001
ISOLINK QUALITY MANAGEMENT SYSTEM MANUAL
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REVISION HISTORY
Rev
Description of Change
Author
Approval
Submit Date
John Steeves
11/24/2013
0
Initial Release
1
ECN #1293
Joseph Rosario
12/19/2013
2
ECN #1306
Joseph Rosario
1/2/2014
3
ECN #1413
Joseph Rosario
4/24/2014
ISOLINK Proprietary and Confidential Information. Electronic versions of this document are
uncontrolled except when accessed directly from the Isolink Document Control Database.
Printed versions are uncontrolled. Users must verify correct revision before use.
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Company Profile
Company Overview:
Isolink, founded in 1987,is a subsidiary of Skyworks Solutions, Inc. Isolink is the leading supplier of
high performance and high quality optoelectronic radiation tolerant components worldwide. Isolink's
mission is to provide products and services to the high-reliability, military, aerospace, hybrid,
industrial, medical, and telecommunications markets. The company specializes in the manufacture of
high-performance miniature hybrids and hermetically sealed devices. Isolink pioneered the
miniaturization of some of the most advanced optoelectronic components. Our expertise in
optoelectronic components enables us to make products of high quality, achieving high isolation
voltages. A hallmark of Isolink's products is high common mode rejection and radiation tolerance for
high demand environments.
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1.0
Scope, Exclusions and Justification
1.1
Scope of Certification
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Isolink has implemented and maintains a Quality Management System that meets the requirements
of ISO 9001:2008.
Design, Manufacture and Testing of optoelectronic components. Scope of Certification includes the
following locations:
Corporate Office
880 Yosemite Way
Milpitas, CA 95035
1.2
Exclusions
The following specific exclusions apply to ISOLINK QMS.
Section 7.3.6 Design and Development Validation has been intentionally excluded. Isolink does not
validate requirements of the application or intended use for products, this is performed by the end
customer in the application.
Section 7.5.1 Service has been intentionally omitted as we do not provide after sales (post-delivery)
service at this time.
Section 7.5.2 Process Validation has been intentionally omitted as we do not have manufacturing
processes that cannot be verified by subsequent inspection and-or monitoring (testing).
2.0
Referenced Documents
2.1
The following external documents contain provisions, which through reference in this
document constitute provisions of this manual. The latest edition of the documents referred to apply.
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Document Title
ISO 9001
International Organization for Standardization Quality Management
Systems - Requirements
RoHS
DIRECTIVE 2011/65/EU OF THE EUROPEAN PARLIAMENT AND
OF THE COUNCIL of 8 June 2011 on the restriction of the use of
certain hazardous substances in electrical and electronic equipment
Definitions
Acronyms / Terminology
Description / Definition
QMS
Quality Management System, encompassing the Quality Management
System (ISO 9001 based).
Process
A defined methodology to achieve a given objective.
Procedure
A written manifestation of a process. In this Manual, a referenced
procedure is understood to be documented, implemented, and
maintained.
Product Realizations
The system of interrelated processes to bring a product to market and
deliver it to the customer.
Record
Evidence of the implementation and effectiveness of the QMS.
4.0
Quality Management System
4.1
Quality Management System (QMS) General Requirements
Isolink has established, documented, implemented, maintains and continually improves our Quality
Management System that encompasses requirements based on the ISO 9001 internationally
recognized standard.
Isolink has:
•
Determined the processes needed to support the QMS are defined and applied throughout the
organization (as described in this QMS Manual)
•
Determined the sequence and interaction of these processes (as described in Section 4.2 of
this QMS Manual)
•
Determined the criteria and methods required needed to ensure both the operation and control
of these processes are effective (as described in Section 5.4 of this QMS Manual)
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•
Ensured the availability of resources and information necessary to support the operation and
maintenance of these process (as described in Section 5.5 and Section 6 of this QMS Manual)
•
Monitored, Measured (as applicable) and analyzed these processes (as described in Sections
8.2 and 8.4 of this QMS Manual)
•
Implemented actions necessary to achieve planned results and continual improvement of
these processes (as described in Section 8.5 of this QMS Manual).
These processes are aligned with the requirements of ISO 9001.
Where Isolink chooses to outsource any process that affects our ability to meet conformity to product
requirements, Isolink will ensure control over the outsourced processes. This is accomplished by the
processes described in Section 7.4 of this QMS Manual.
4.2
Documentation Requirements
4.2.1 General Requirements
Isolink’s QMS documentation includes:
•
Documented statements of an QMS Policy and Objectives (See Sections 5.3 and 5.4 of this
Quality Manual)
•
A Quality Manual (this document)
•
Documented procedures and records as mandated by ISO 9001 and needed to ensure the
effective operation of the QMS (as referenced in this Quality Manual).
4.2.2 Quality Manual Requirements
Isolink’s has established a Quality Manual that includes:
•
The Scope of the Quality Manual and a listing or exclusions and justification for these
exclusions (as described in Sections 2 of this QMS Manual.
•
A reference to the documents that support the QMS (referenced as appropriate in this
document).
•
A description of the interaction of the processes of the Quality Management System (see
below):
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Customer
Market Research
RFQs, Quotes, Orders
QMS PROCESS MAP
RMP 01
Personnel
Competence
and Skills
Resources
PRP 01
PRP 09
Sales &
Order
Processing
RMP 02
Product
Design
RMP 03
Information,
Doc. Control &
Inf. Tech
Facilities,
Equipment &
Work
Environment
Resource Mngmnt Processes (RMP)
PRP 02
Inspection
Management
PRP 07
Inventory
Policies &
Directions
Management
Responsibility
Processes (MRP)
Receiving
Product Realization Processes
(PRP)
Production
and Quality
Planning
PRP 03
PRP 04
Resource
Needs
PRP 08
Purchasing
MRP 03
Continual
Improvement
MRP 01
Planning &
Objectives
MRP 02
Management
Review
Policies &
Directions
QMS
Performance
PRP 05
Data
Measurement, Analysis
and Improvement Processes (MIP)
Production
Final/Pack
MIP 01
Control of NC
Product
PRP 06
Delivery
Product/
Process
Data
MIP 02
MIP 03
Int. Audit &
C&P Action
Analysis of Data
MIP 04
Customer
Complaints/
Satisfaction
Customer
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Control of Documents
Documents required by the QMS are controlled. A documented procedure has been created that
describes the controls needed to:
•
Approve documents for adequacy prior to issue
•
Review and update as necessary and re-approve documents,
•
Ensure that changes and the current revision status of documents are identified,
•
Ensure that relevant versions of applicable documents are available at points of use,
•
Ensure that documents remain legible and readily identifiable,
•
Ensure that documents of external origin determined by Isolink to be necessary for the
planning and operation of the QMS are identified and their distribution controlled, and to
prevent the unintended use of obsolete documents, and to apply suitable identification to them
if they are retained for any purpose.
4.2.4
Control of Records
Records have been established and are controlled which provides evidence of conformity to
requirements and of the effective operations of our QMS. A documented procedure has been
established that define the controls needed for the identification, storage, protection, retrieval,
retention and disposition of records.
Reference Documents:
SOP-QA-0001 Document and Record Control
5.0
Management Responsibility
5.1
Management Commitment
Isolink’s executive management team ensures commitment to the development and implementation
of the QMS and continually improving its effectiveness by:
•
Communicating to Isolink personnel the importance of meeting customer, as well as the
statutory and regulatory requirements (See Section 5.5.2 of this Manual)
•
Establishing the Quality Policy (See Section 5.3 of this Manual)
•
Ensuring that QMS objectives are established (See Section 5.4 of this Manual)
•
Conducting management reviews (See Section 5.6 of this Manual)
•
Ensuring the availability of resources (See Section 5.5 of this Manual)
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Customer Focus
Isolink’s executive management team ensures that customer requirements are determined and met,
with the aim of enhancing customer satisfaction. This requirement is supported further in sections
7.2.1 and 8.2.1.
5.3
Quality Policy
“At Isolink, we are committed to the never ending quest for perfect quality.”
•
No Field Failures
•
No Customer Returns
•
No Reliability Failures
•
No Yield Loss.
The General Manager has defined the Isolink Quality Policy and ensures that it is communicated and
understood within the organization. The Quality Policy is made available in our Corporate Lobby as
well as on our intranet site. The Quality Policy is reviewed at Management Review meetings for
continuing suitability and is updated as appropriate.
5.4
Planning
5.4.1 Quality Management System Objectives
Top management ensures that QMS Objectives are set at relevant functions and levels of Isolink.
These objectives are measurable, have established targets and supporting plans that align with the
intentions described in our Quality Policy.
5.4.2 Quality Management System Planning
Plans are developed to support the achievement of the QMS Objectives and to meet the overall
scope of our QMS (as described in Section 2 of this QMS Manual). Our change control processes
(See Sections 4.2.3 and Section 7.3.7 of this QMS Manual) ensure that the integrity of the QMS is
maintained as changes and improvements occur.
SOP-AD-0002 Business Scorecard Procedure
5.5
Responsibility, Authority, and Communication
5.5.1 Responsibility and Authority
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Isolink’s executive management team ensures that responsibilities and authorities are defined and
communicated within the organization.
5.5.2 Management Representative
Top management has appointed the Quality Engineering Manager who, irrespective of his other
responsibilities, has responsibility and authority that includes:
•
Ensuring that processes needed for the QMS are established, implemented and maintained
•
Reporting to top management on the performance of the QMS and any need for improvement,
and
•
Ensuring the promotion of awareness of customer and regulatory requirements throughout the
organization that relate to the QMS.
5.5.3 Internal Communications
Top management ensures that appropriate communication processes are established within Isolink
and that communication takes place regarding the effectiveness of the QMS.
SOP-AD-0001 Organizational Responsibility
SOP-AD-0002 Business Scorecard Procedure
5.6
Management Review
5.6.1 General
The Executive Team formally reviews Isolink’s QMS semi-annually to ensure its continuing suitability,
adequacy, and effectiveness. The review includes assessing opportunities for improvement and the
need for changes to the QMS, including a review of the Quality policy and QMS objectives.
Records from the Management Review meetings are maintained by the Management Representative.
5.6.2 Management Review Input
The input to management review includes information on:
•
Results of audits (both internal and external)
•
Customer feedback (including customer complaints)
•
Process performance and product conformity
•
Status of preventive and corrective actions
•
Follow-up actions from previous management reviews
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Changes that could affect the QMS
•
Recommendations for improvement
•
Review of the Quality Policy for ongoing appropriateness
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5.6.3 Management Review Output
The output from the management review includes any decisions and actions related to improvement
of the effectiveness of the QMS and its processes, improvements, product-related issues, customer
requirements, and resource needs.
6.0
Resource Management
6.1
Provision of Resources/Resource Management
Isolink has determined and provides the resources needed to implement and maintain the QMS and
continually improve its effectiveness, and to enhance customer satisfaction by meeting customer
requirements.
6.2
Human Resources
6.2.1 General
Personnel performing work affecting conformity to product requirements are competent on the basis
of appropriate education, training, skills and experience.
6.2.2 Competence, Awareness and Training
To ensure personnel competence is maintained, Isolink:
•
Determines the necessary competence for personnel performing work affecting conformity to
product requirements.
•
Where applicable, provides training or take other actions to achieve the necessary
competence.
•
Ensures the necessary competence has been achieved, ensure that those who work for Isolink
are aware of the relevance and importance of their activities and how they contribute to the
achievement of the QMS objectives.
•
Ensures personnel who work for Isolink are aware of the Quality Policy.
•
Maintains appropriate records of education, training, skills and experience.
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SOP-AD-0001 Organizational Responsibility
SOP-AD-0008 Employee Competency and Training
6.3
Infrastructure
Isolink determines, provides, and maintains the proper infrastructure required to achieve conformity to
product requirements. Infrastructure includes the following, as applicable:
•
Buildings, workspace and associated utilities
•
Process equipment (both hardware and software)
•
Supporting services (such as IT and communication)
SOP-AD-0009 IT/MIS Procedures
SOP-AD-0007 Infrastructure Procedure
6.4
Work Environment
Isolink determines and manages the work environment needed to achieve conformity to product
requirements.
SOP-AD-0007 Infrastructure Procedure
SOP-OP-0003 Lab Environment Control
SOP-QA-0005 ESD Control
7.0
Resource Management
7.1
Planning of Product Realization
Isolink plans and develops required processes for product realization, and ensures that they are
consistent with the requirements of the other processes within the QMS. In Planning Product
Realization, Isolink determines the following:
•
Quality objectives and requirements for the product.
•
Need to establish processes, documents, and provide resources specific to the product.
•
Required verification, validation, monitoring, inspecting, and test activities specific to the
product and the criteria for product acceptance.
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Records needed to provide evidence that the realization processes and resulting product meet
requirements.
SOP-OP-0002 Product Flow Control
7.2
Customer-related Processes
7.2.1 Definition of Requirements Related to the Product
Isolink determines:
•
Requirements specified by the customer, including the requirements for delivery.
•
Requirements not stated by the customer, but necessary for specified or intended use, where
known.
•
Statutory and regulatory requirements related to the product.
•
Any additional requirements determined by Isolink.
7.2.2 Review of Requirements Related to the Product
Isolink reviews requirements related to the product prior to our commitment to supply a product to the
customer and we ensure that:
•
Product requirements are defined and documented
•
Contract or order requirements differing from those previously expressed are resolved, and
Isolink has the ability to meet defined requirements.
•
Records of the results of the review and actions arising from the review are maintained.
•
Where product requirements are changed (amended), Isolink ensures that these requirements
are reviewed, and if accepted, that relevant documents are amended and that relevant
personnel are made aware of the changed requirements.
7.2.3 Customer Communications
Isolink determines and implements effective arrangements for communicating with customers in
relation to:
•
Product information.
•
Enquires, contracts or order handling, including amendments.
•
Customer feedback, including customer complaints.
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SOP-AD-0010 Customer Order Review Process
SOP-AD-0003 Customer Communications
7.3
Design and Development
7.3.1 Design Planning
Isolink has defined a New Product Development protocol that defines a Phased Approach to
development that includes a definition of specific deliverables for design reviews, verifications, and
validation. For specific design projects, a design plan is created that includes deliverables, assigned
responsibilities and timeframes for design and development activities.
Isolink manages the interfaces between different groups (e.g. hardware, software, marketing,
operations, etc.) involved in design and development to ensure effective communication and clear
assignment of responsibility.
Planning output is updated during the course of the design and development.
7.3.2 Design Inputs
Design requirements are defined and documented. Design inputs include functional and performance
requirements of the product; applicable statutory and regulatory requirements; where applicable,
information derived from previous similar designs; and other requirements essential for design and
development. These inputs are reviewed for completeness, adequacy and to address inherent
conflicts. Records of design inputs are maintained.
7.3.3 Design Outputs
Design and development output is provided in a form that allows for verification against the input and
is approved prior to release or the product. Design output also includes appropriate information for
purchasing, production and test activities as well as a reference to product acceptance criteria. The
design output also specifies the characteristics of the product that are essential for the product’s safe
and proper use.
7.3.4 Design Reviews
Systematic reviews of design and development are performed to evaluate the ability of the results of
design and development to meet requirements, and to identify any problems and propose necessary
actions. Participants in design reviews include representatives of functions concerned with the
design and development stage(s) being reviewed. Records of the results of design reviews are be
maintained.
7.3.5 Design Verification
Design verification is performed to ensure that the design and development outputs have met the
design and development input requirements. Records of the results of the verification and any
necessary actions are maintained.
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7.3.6 Design Validation
Design and development validation (Qualification) is performed to ensure that the resulting product is
capable of meeting the requirements for the specified application or intended use (where known.)
Validation is completed prior to release of the product. Records of the results of design validation are
maintained.
7.3.7 Design Changes
Design and development changes are identified and records are maintained. Design changes are
reviewed, verified and validated, as appropriate, and approved prior to implementation. The review of
proposed changes includes evaluation of the effect of the changes on constituent parts and product
already delivered.
SOP-DE-0001 Design and Development
SOP-OP-0002 Product Flow Control Procedure
7.4
Purchasing
7.4.1 Purchasing Process
Isolink ensures that purchased product conforms to specified purchase requirements. The type and
extent of control applied to the supplier and the purchased product is dependent upon the effect of
the purchased product on subsequent product realization and/or the final product.
Isolink evaluates and selects suppliers based on their ability to supply product in accordance with our
organization’s requirements. Criteria for supplier approval and re-evaluation have been established.
Records of the results of evaluations and any necessary actions arising from these evaluations are
maintained.
7.4.2 Purchasing Information
Purchasing information provide to the supplier through our PO System describes the product or
service to be purchased, including where appropriate:
•
Requirements for approval of product, procedures, processes and equipment
•
Requirements for qualification of personnel
•
QMS requirements (such as ISO 9001 Certification)
•
Statutory and Regulatory Requirements that must be met (such as RoHS requirements)
Isolink ensures the adequacy of specified purchase requirements prior to their communication to the
supplier.
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7.4.3 Verification of Purchased Product
Isolink has established and implemented the inspection or verification activities necessary for
ensuring that purchased product meets specified purchase requirements. Isolink provides detailed
instructions to suppliers regarding verification of purchased product in instances where verification of
purchased product is performed at the supplier’s site.
Purchased materials, process equipment or services requiring inspection or qualification prior to
release to production are inspected and qualified by trained and responsible ISOLINK-SKYWORKS
personnel to ensure that they meet specified purchase requirements.
Where purchased material, process equipment or service is verified by Skyworks personnel at the
supplier’s or subcontractor’s premises, verification arrangements are specified in the purchasing
documents.
SOP-PC-0001 Purchasing Procedures
SOP-QA-0009 Incoming Inspection
SOP-QA-0008 Supplier Control
7.5
Production and Service Provision
7.5.1 Control of Production and Service Provision
Isolink and suppliers to Isolink, plan and carry out production and service provision under controlled
conditions. Controlled conditions include, as applicable:
the availability of information that describes characteristics of the product (such as specifications and
drawings)
•
The availability of work instructions, as necessary,
•
The use of suitable equipment,
•
The availability and use of monitoring and measuring devices,
•
The implementation of monitoring and measurement, and
•
The implementation of product release (e.g. final Inspection/QC) and delivery.
7.5.2 Validation of Processes For Production and Service Provision
Isolink does not have manufacturing processes that cannot be verified by subsequent inspection
and/or monitoring (testing) and we have therefore excluded this requirement of ISO 9001.
7.5.3 Identification and Traceability
Where appropriate, Isolink identifies the product by suitable means throughout product realization.
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Where appropriate, Isolink identifies the product status with respect to inspection and test status
throughout product realization.
Where traceability is a requirement, Isolink controls and records the unique identification of the
product and maintains records.
7.5.4 Customer Property
Isolink exercises care with customer property while it is under our control. Isolink identifies, verifies,
protects and safeguards customer property (e.g. customer equipment, materials, Intellectual
Property), provided for use or incorporation into our product. If any customer property is lost,
damaged or otherwise found to be unsuitable for use, Isolink reports this to the customer and
maintain records of this communication.
7.5.5 Preservation of Product
Isolink preserves the product during internal processing and delivery to the intended destination in
order to maintain conformity to requirements. As applicable, preservation of product (e.g. ESD
protection) includes identification, handling, packaging, storage and protection. Preservation also
applies to the constituent parts of a product.
SOP-OP-0001 Manufacturing Overview
SOP-OP-0002 Product Flow Control Procedure
SOP-AD-0006 Customer Owned Property
SOP-QA-0005 ESD Control Procedure
SOP-PC-0002 Material Control
7.6
Control of Monitoring and Measuring Devices
Isolink determines the monitoring and measurement to be undertaken and the monitoring and
measuring devices needed to provide evidence of conformity of product to determined requirements.
When necessary, to ensure valid results, measuring equipment is:
•
Calibrated or verified at specified intervals, or prior to use, against measurement standards to
international or national measurement standards; where no such standards exist, the basis
used for calibration or verification is recorded
•
Adjusted or readjusted as necessary
•
Identified to enable the calibration status to be determined
•
Safeguarded from adjustments that would invalidate the measurement result
•
Protected from damage and deterioration during handling, maintenance and storage
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In addition, Isolink assesses and records the validity of the previous measuring results when the
equipment is found not to conform to requirements. Isolink takes appropriate action on the equipment
and any product affected.
Records of the results of calibration and verification are maintained.
Isolink does not use test instruments where the software is not incorporated (firmware) into the test
device and as such, the requirements for calibration or verification of test software has been
intentionally omitted.
SOP-OP-0004 Calibration Control
8.0
Measurement, Analysis and Improvement
8.1
General
Isolink plans and implements the monitoring, measurement, analysis and improvement processes
needed:
8.2
•
To demonstrate conformity of the product, (See Section 8.2.4 of this QMS Manual)
•
To ensure conformity of the QMS, (See Section 8.2.2 of this QMS Manual) and
•
To continually improve the effectiveness of the Quality Management System (See Section 8.5
of this QMS Manual).
Monitoring and Measurement
8.2.1 Customer Satisfaction
Isolink monitors information relating to customer perception as to whether we have met customer
requirements.
8.2.2 Internal Audit
Isolink conducts internal audits to determine whether the QMS is implemented, effective and
conforms to documented QMS requirements and ISO 9001 requirements. An audit program is in
place, taking into consideration the status and importance of the processes and areas to be audited,
as well as the results of previous audits. The audit criteria, scope, frequency and methods are defined
and documented. Selection of auditors ensures objectivity and impartiality of the audit process.
Auditors do not audit their own work.
Functional Management is responsible for the area being audited and ensuring that actions are taken
without undue delay to eliminate detected nonconformities and their causes. Follow-up actions
include the verification of the actions taken and the reporting of verification results.
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8.2.3 Monitoring and Measurement of Processes
Isolink monitors and measures the performance of the QMS. These methods demonstrate the ability
of our business processes to achieve planned results. When planned results are not achieved,
corrective action are taken, as appropriate, to ensure conformity.
8.2.4 Monitoring and Measurement of Product
Isolink and our suppliers monitor and measure the characteristics of the product to verify that product
requirements have been met. This is carried out at appropriate stages of the product realization
process in accordance with planned arrangements.
Evidence of conformity with product acceptance criteria are maintained by us or our suppliers.
Records indicate the person(s) authorizing release of product to the customer.
The release of product to the customer does not proceed until planned arrangements have been
satisfactorily completed, unless otherwise approved by a relevant authority within Isolink and, where
applicable, by the customer.
SOP-AD-0004 Customer Satisfaction
SOP-QA-0007 Internal Audit
SOP-AD-0002 Business Scorecard
8.3
Control of Nonconforming Product
Isolink ensures that product which does not conform to product requirements are identified and
controlled to prevent its unintended use or delivery.
Where practicable, Isolink and our suppliers deal with nonconforming product by one or more of the
following ways:
•
By taking action to scrap the detected nonconformity.
•
By authorizing its use, release or acceptance under concession by a relevant authority and,
where applicable, by the customer.
•
By taking action to rework the product so that it meets all specifications of the product.
•
By taking action appropriate to the effects, or potential effects, of the nonconformity when
nonconforming product is detected after delivery or use has started.
Records of the nature of nonconformities and any subsequent actions taken, including concessions
obtained, are maintained.
When nonconforming product is reworked, it is subjected to re-verification to demonstrate conformity
to requirements.
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SOP-QA-0003 Nonconforming Material
8.4
Analysis of Data
Isolink determines, collects, and analyzes appropriate data to demonstrate the suitability and
effectiveness of the QMS and to evaluate where continual improvement of the effectiveness of the
QMS can be made. This includes data generated as a result of monitoring and measurement and
from other relevant sources.
The analysis of data provides information about:
•
Customer satisfaction
•
Conformity to product requirements
•
Characteristics and trends of processes and products including opportunities for preventive
action
•
Suppliers
SOP-AD-0004 Customer Satisfaction
SOP-QA-0008 Supplier Control
SOP-AD-0002 Business Scorecard
8.5
Improvement
8.5.1 Continual Improvement
Isolink continually improves the effectiveness of the QMS through the use of the Quality Policy, QMS
objectives, audit results, analysis of data, corrective and preventive actions, and management
reviews.
8.5.2 Corrective Action
Isolink takes action to eliminate the cause of product Quality nonconformities in order to prevent
recurrence. Corrective actions are appropriate to the effects of the nonconformities encountered.
A procedure has been established to define requirements for:
•
Reviewing nonconformities (including customer complaints),
•
Determining the causes of nonconformities,
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Evaluating the need for action to ensure that nonconformities do not recur,
•
Determining and implementing action needed,
•
Maintaining records of the results of action taken
•
Reviewing corrective action taken to ensure effectiveness.
3
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8.5.3 Preventive Action
Isolink determines actions to eliminate the causes of potential nonconformities in order to prevent
their occurrence. Preventive actions are appropriate to the effects of the potential problems.
A procedure has been established to define requirements for:
•
Determining potential nonconformities and their causes,
•
Evaluating the need for action to prevent occurrence of nonconformities,
•
Determining and implementing action needed,
•
Maintaining records of action taken, and
•
Reviewing preventive action taken to ensure effectiveness.
SOP-QA-0002 Corrective-Preventative Action

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