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Table of Contents
1.0 Purpose..........................................................................................................................................................3
2.0 Scope.............................................................................................................................................................3
2.1 Introduction........................................................................................................................................3
2.2 Company Contact Information..........................................................................................................3
3.0 Definitions....................................................................................................................................................3
4.0 References.....................................................................................................................................................3
1.0 Purpose
This document defines [Company Name] Quality System Policies and Procedures for governing the
design, development, manufacture, distribution, installation, and servicing of all [Company Name]
products.
2.0 Scope
[Company Name] acknowledges its responsibility as a manufacturer of [industry/product name] to
adhere to all applicable regulatory and industry standards. This manual specifies the policies and
procedures that comprise the [Company Name] Quality System. The system is compliant with ISO
9001: 2000 standard for Quality Management Systems and The Food and Drug Administrations
Quality System Requirements specified in 21 CFR Part 820.
2.1 Introduction
[Company Name] designs, develops, manufactures, and distributes [products].
3.0 Definitions
Unless otherwise specified, definitions provided in Title 21 of the Code of Federal Regulations, Parts
803 and 820 will be used as the official definition.
Definitions found in ISO 9001, and ISO 8402 will be used for terms defined in these ISO documents
but not referenced in the Code of Federal Regulations.
4.0 References
This manual is organized and written to comply with the provisions of the following documents and
standards:
International Standards Organization Standards ISO 9001:2000;
ISO 13485;
EN 46001;
The Medical Device Directive, MDD 93/42/EEC;
US Department of Health and Human Services, Food and Drug Administration Quality System
Regulation, Title 21 of the Code of Federal Registrations, Part 820.
[Company Name] will comply with the most recent edition of the aforementioned documents and
standards as well as new standards that Quality Assurance deems appropriate. [Company Name] will
make necessary revisions to its Quality System to insure continued compliance will applicable
standards.
All references to specific policies, procedures, or work instructions in this manual are the latest
revision of that document unless otherwise noted.
All references to personnel in this manual are that person or his/her designated representative unless
otherwise stated.
[Company Name is committed to becoming the leader in the [industry] and to deliver high
quality, innovative products that meet or exceed our customer’s requirements. [Company
Name] will deliver defect-free products and services on schedule and on budget while
maintaining compliance with applicable regulatory and industry standards.
The Quality Systems Manager, under the direction of the Chief Executive Officer of [Company
Name], is responsible for the establishing and maintaining of the Quality Policy and the Quality
System. The Quality Systems Manager will insure that all [Company Name] personnel
understand the Quality Policy and the company's commitment to quality. The Quality System
Manager also is responsible for:
The preparation and presentation of the annual Quality System status reports to Senior
Management for their review and possible action in accordance with procedure;
The release and recall of product and services to or from distribution and/or customers;
Documentation control;
Independence of personnel responsible for the inspection, testing, and verification of
products and services including their adequacy and fitness to perform those functions;
Development and use of relevant, statistical-based benchmarks to continuously measure the
Quality System performance and make all personnel aware of their meaning and
significance; and
Regulatory compliance.
All [Company Name] employees are responsible for the quality of products and services
provided.
Complaint and corrective action handling, processing, and closure. Medical device records
maintenance;
Quality Assurance, inspection, and testing technique updates including new instrumentation
and methods development;
Quality Records identification and maintenance.
Measurement identification and compatibility;
Document control;
Participation in product and service design and program status reviews.;
Quality System auditing;
Ascertaining that all outgoing products meet specified requirements; and
Identifying and preventing quality deficiencies in product, process, and the Quality System.
[Insert a description of the Quality System documentation here. Include the following
Quality System (organizational) structure according to ISO 9001:
Tier 1 Quality Manual and Policies
Tier 2 Standard Operating Procedures [SOPs]
Tier 3 Quality Records and Work Instructions [includes data, training records,
files, etc.]
[Insert contract review policy/procedural requirements and responsibilities here. Discuss the
following:
Who assigns personnel to review contracts;
A statement specifying that reviewers are responsible to review contracts to ensure that
customer requirements can be met and that orders are accurate;
Who is responsible for communicating customer requirements to appropriate departments
prior to acceptance;
Specify who will maintain records of all contract reviews;
Specify who is responsible for the input and maintenance of accepted orders into the MRP
system;
A statement specifying the types of contracts secured by the company including: Service
contracts Customer contracts specifying [Company Name] as sole contractor Customer
contracts specifying [Company Name] using subcontractors Customer contracts with
[Company Name] as a subcontractor.]
[Insert document and data control policy/procedural requirements and responsibilities here.
Discuss the following:
Who is responsible for administering document control activities;
How will individual departments control department specific documents, and records;
Who is responsible for approving organization documents.]
Informational literature
Trade publications
Controlled hard copies will be clearly marked as such. Technical Support Services
Department will establish sufficient procedures including tracking lists to assure the
positive location and retrieval of all controlled hard copies that may be issued in
accordance with the Production Document Change Control procedure.
6.6 Purchasing
[Company Name] will establish and maintain procedures to control the purchase of all materials,
supplies, and services used for the manufacture and supply of products and services.
Also discuss which department will generate, approve and review purchase requests
and documentation. Specify how specific technical requirements will be communicated
to subcontractors.]
materials and supplies will be handled in the same manner as those that are purchased in
accordance with Section 6.6 of this manual.
[Insert process control policy/procedural requirements and responsibilities here. Discuss the
following:
[Insert inspection and testing policy/procedural requirements and responsibilities here. Explain
the following:
Employees’ responsibilities and methods used for inspecting their own work;
Who is responsible for various inspection activities including: audit, final test, and product
release; and
Who is responsible for maintaining inspection records.]
Statement regarding who will carry out final inspection and how the results
will be documented;
Statement regarding how final inspection impacts product shipment;
Statement regarding disposition of finished products pending inspection
activities and release authorization prior to distribution.]
Statement regarding who will maintain inspection records, how records will be
maintained, and that the records provide evidence that the product was inspected;
Statement regarding procedures applicable where the product fails
inspection/testing;
Statement regarding identification of inspection authority responsible for the
release of the product;
Specify key items to be included in acceptance record documentation including
Assignment and application of serial number, Acceptance activities performed,
Dates, the acceptance activities were performed, Results, Signature or initials of
the individual(s) conducting the acceptance activities and where appropriate, the
specific equipment used.]
[Insert company policy here. Discuss employee responsibilities regarding the following:
labeling and use of equipment; reporting of damaged/potentially damaged equipment; function
responsible for calibration and maintenance records; calibration of personal tools.]
How equipment and standards will be handled and stored, include how the
activities will be documented;
Inspection of test hardware and software and the availability of test results for
verification purposes;
Use of calibration standards and traceability to test equipment;
Documentation and maintenance of calibration records including:
[Insert inspection and test status policy/procedural responsibilities here. Discuss the following:
Who is responsible for the segregation of nonconforming product and material and the
acquisition of return authorization for materials that are being returned to a supplier;
Who is responsible to acquire disposition for nonconforming product and material, the
procedure used to determine disposition, and the final authority for disposition of product
and material.]
The documentation of the disposition will include the description of the nonconformity
that has been accepted or the reprocessing that was authorized, and the acceptance
criteria that will be used. All reprocessed product will be reinspected in accordance
with the quality plan, documented procedures, and/or acceptance criteria in accordance
with the Material Review Board procedure.
documented procedures resulting from corrective and preventive action in accordance with the
operating procedures listed in section 4.14.4
[Insert corrective and preventive action policy/procedural responsibilities here. Discuss the
following:
6.15.1 Handling
All production and process materials (e.g., components, manufacturing materials,
subassemblies, sterile materials, customer supplied materials, and finished products)
will be handled in such a manner as to prevent confusion, damage, adulteration,
deteriorization, or other adverse effects.
6.15.2 Storage
All materials and products will be stored in designated areas that ensure their integrity
and also afford adequate controls for issuance and receipt. [Company Name] will utilize
sound inventory control methods, including verification of limited life materials and the
first-in-first-out (FIFO) issuance of materials and products.
6.15.3 Labeling
All finished products will be labeled in such a manner as to prevent confusion, and
ensure positive identification by ensuring labels are designed, printed, and are applied
to remain legible and affixed during customary conditions of processing, storage,
handling, distribution, and use.
A Product Identification Label will consist of, but is not limited to:
6.15.4 Packaging
[Company Name] will ensure that packaging and shipping containers are designed and
constructed to ensure that production and process materials, sterile materials, customer
supplied materials, and finished products will be protected against damage,
deterioration or contamination by use of packaging and storage materials which comply
applicable regulations.
6.15.5 Preservation
[Company Name] will apply appropriate methods for preservation and segregation of
product to prevent damage, loss or contamination, excessive storage time, or adverse
environmental conditions.
6.15.6 Distribution
[Company Name] will ensure that only those products approved for release are
distributed. All products will be packaged by [Company Name] in a manner that
ensures the integrity of the product through delivery to the customer. Product shipments
will be identified by model/control numbers, shipping date, customer name and address,
quantity shipped, and shipping personnel. Distribution records will be maintained in the
Device History Record to protect the quality and traceability of items shipped.
[Insert control of quality records policy/procedural responsibilities here. Discus the following:
Device History Records will include but are not limited to the following:
Laboratory Notebooks
Conceptual Drawings and Illustrations
Engineering Drawings
Schematics
Component Specifications
Design Requirements
Program Plans
Design Review Minutes
Engineering Change Orders
Design Verification and Validation Test Plans
Design Verification and Validation Test Results
[Insert Internal quality audit policy/procedural responsibilities here. Discus the following:
A statement regarding how audit reports and documents are maintained and how the
dissemination of audit reports is controlled (e.g., confidential and proprietary);
Define who is responsible for developing and documenting the annual audit schedule and
plan;
A statement regarding audit schedule priorities;
Define who is responsible for conducting internal auditor training and ensuring the
qualifications of internal auditors;
Define who is responsible for assigning auditors to conduct audits, and how the audit
results will be processed;
Define who is responsible for developing corrective action plans and how they are
processed;
Define who is responsible for maintaining and improving the Quality System;
Define who is responsible for reporting the status and effectiveness of the internal audit
plan to senior management.]
6.18 Training
[Company Name] will establish and maintain documented procedures for training and
development to ensure that all personnel are trained to adequately perform their assigned
responsibilities. Personnel performing specific assigned tasks shall be qualified on the basis of
appropriate education, training, and/or experience, as required.
Specific Quality System training requirements including FDA Quality System Regulation,
ISO 9001,Continuous Quality Improvement, Total Quality Management, etc.;
A statement specifying that all personnel will receive Quality System training pertaining to
their specific job requirements and the impact in terms of device defects which may result
from improper performance of their specific job;
Define who will maintain written job descriptions for employment positions;
Define who will conduct job-specific training;
Define how training records will be documented and maintained and who is responsible for
these tasks.]
6.19 Servicing