Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
ii. Table of Contents
1 of 4
0
Section
Number
Name
Revision
Date
i. Title Page
ii. Table of Contents
1.0. Management Review
2.0 The Quality System
3.0. Contract Review
5.0. Document and Data Control
5.1 Document Preparation and Issue
5.2 Writing a Quality System Document
6.0. Purchasing
6.1 Approved Supplier Selection
6.2 Purchase Requisition Expenditure Authorization
6.3 Routine Purchase Request
6.4 Urgent Purchase Request
6.5 Standing Order Purchase
6.6 Petty Cash Purchase
6.7 Purchase Requisition Form Completion
6.8 Outstanding Order Progress
6.9 Using a Courier
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
ii. Table of Contents
2 of 4
0
Section
Number
Name
Revision
Date
7.0. Control of Customer-Supplied
Product
8.0. Product Identification and
Traceability
9.0. Process Control
9.1 Special Processes
9.2 Emergency Call
9.3 Inspection
9.4 Risk Assessment of Patient Care Devices
9.5 Selecting Inspection and Preventive Maintenance Items
9.6 Inspection and Preventive Maintenance Scheduling
9.7 Transferring Equipment
9.8 Using the Equipment Management Software
9.9 Training Record Creation
9.10 Training Work Order Creation
9.11 Resource Allocation
9.12 Purchasing Advice
9.13 Equipment Evaluation
9.14 Soldering
10.0. Inspection and Testing
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
ii. Table of Contents
3 of 4
0
11.0. Control of Inspection, Measuring,
and Test Equipment
12.0. Inspection and Test Status
12.1 Equipment Status Tag Completion
12.2 Incoming Work
12.3 Work Dispatch
13.0. Control of Nonconforming Product
13.1 Customer Complaints
14.0. Corrective and Preventive Action
14.1 Performance Reports
15.0. Handling, Storage, Packaging,
Preservation, and Delivery
15.1 Stock Issue
15.2 Stock Control
15.3 Handling and Storage of Static-Sensitive Devices (SSDs)
15.4 Handling of Mercury
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
ii. Table of Contents
4 of 4
0
16.0. Control of Quality Records
16.1 Computer Backup
16.2 Filing of Work Records
16.3 Medical Equipment Service Report Completion
16.4 Medical equipment Service Report and Equipment File Checking
16.5 Equipment File Completion
16.6 Part Record Creation
16.7 Project File Input
16.8 Work Order Completion
16.9 Project Work Order Input
17.0 Internal Quality Audits
17.1 Quality Assurance Program
17.2 Quality Assurance Indicators for Patient Care Devices
18.0. Training
19.0. Servicing
19.1 Maintenance of Medical Devices
19.2 Service Standards
Quality Procedures and Work Instructions Manual
Introduction
This document, Quality Procedures and Work Instructions, hereafter referred to as QPWI, contains or references all procedures and work instructions required to ensure the satisfactory operation of Legacy Biomedical (LEGACY BIOMEDICAL) quality system as described in our Quality System Manual.
QPWI is divided into sections (1.0 to 20.0) corresponding to the ISO 9002 Standard entitled, Quality Systems –Model for Quality Assurance in Design, Development, Production, Installation, and Servicing,
and LEGACY BIOMEDICAL’s Quality System Manual.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
1.0 Management Review
1 of 4
0
A. Purpose
This procedure describes the review of the suitability and effectiveness of LEGACY BIOMEDICAL’S quality system by management.
B. Scope
This procedure shall apply to any management review of any component of LEGACY BIOMEDICAL’S quality system.
C. References
LEGACY BIOMEDICAL Quality System Manual
Joint Commission for the Accreditation of Healthcare Organizations (TJC) Title 21 Code of Federal Regulations
American Society for Healthcare Engineering
D. Definitions
See LEGACY BIOMEDICAL Quality System Manual
E. Procedure
1. The need for a review
a. The need for a review of any component of the quality system may arise from one or
more of the following sources:
Any staff member may indicate problems with, or possible improvements to, the quality system procedures, work practices, work output, product performance, documentation, or records.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
1.0 Management Review
2 of 4
0
ii) Customers.
A customer, through a suggestion, comment, or complaint, may highlight a component of the quality system that requires review.
iii) Performance reports.
Reports produced by performance analysis of work done may indicate areas of the quality system that should be reviewed.
iv) Internal and External Audits.
Regular audits of the quality system may highlight components that need review.
b) Matters requiring review arising from any of the above sources shall be directed for
discussion and action, if necessary, to the Quality Assurance Council.
c) Information on such matters shall be provided to the Council through one of the Council
members. Our staff members shall direct their comments to their Site Manager who sits on the Council. Council members shall then pass this information on to the Director, Quality Assurance, who shall include it on the agenda for the next Quality Assurance Council meeting.
d) The agenda for each meeting shall be made available to each Council member, with a
copy placed on LEGACY BIOMEDICAL’ general bulletin board, no later than three days before each meeting.
2. Quality Assurance Council
a) The function of the Quality Assurance Council is to discuss, investigate, and resolve all
of the system in adapting to customer and business needs, and its compliance with the quality standard and quality system objectives.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
1.0 Management Review
3 of 4
0
b) This can include work practices, procedures, documentation, suppliers, complaints,
corrective and preventive actions, resource allocation, training, performance, and objectives. Its main purpose is to maintain and improve LEGACY BIOMEDICAL’ quality of service.
c) The Council consists of the Director, Quality Assurance, the Purchasing Manager, and
the Site Managers. Other staff members may be asked to attend, if appropriate, or may raise matters through an appropriate Council member.
d) The Director, Quality Assurance shall chair and may designate another member to take
minutes during the Council meetings.
e) The Council shall meet every month but can meet more often if necessary.
f) The December Council meeting each year shall be used to review LEGACY
BIOMEDICAL’ performance over the previous 12 months and to formulate objectives for the next year.
g) The Council shall decide whether a matter placed on the meeting’s agenda requires
further action. 3. Responsibility for Review
a) Matters raised during a Quality Assurance Council meeting that require action shall be
b) Other procedures, such as “Document and data Control” (see Section 5.0), “Control of Nonconforming Product” (see Section 13.0), or “Corrective and Preventive Action” (see Section 14.0) may need to be invoked.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
1.0 Management Review
4 of 4
0
4. Records of Review
a) Minutes of the Quality Assurance Council meetings shall be taken as a record of all
reviews undertaken.
b) The minutes shall be signed by the Director, Quality Assurance to authorize any actions
arising from the meeting.
c) The minutes of each meeting shall be circulated to all staff members, and copies of all
minutes shall be kept for reference in the Quality Assurance Council meetings file in the Director, Quality Assurance’s office.
5. Verification of Action
a) Matters requiring action shall stay on subsequent Council meeting agendas until the
Council is satisfied that the matter has been adequately resolved and that the proper corrective actions have been carried out.
b) Verification of action shall be confirmed by consulting the source of the review (i.e., staff
F. Documentation
Documentation and Data Control Procedure (Section 5.0) Control of Nonconforming Product Procedure (Section 13.0) Corrective and Preventive Action Procedure (Section 14.0)
Quality Assurance Council meetings file
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
2.0 The Quality System
1 of 5
0
A. Purpose
This procedure describes the establishment and maintenance of the quality system documentation required to meet the quality policy.
B. Scope
This procedure shall apply to any component of LEGACY BIOMEDICAL’ Quality system. These components include the Quality System Manual, quality procedures, and specific work instructions.
C. References
LEGACY BIOMEDICAL’ Quality System Manual
D. Definitions
None
E. Procedure
1. General
a) LEGACY BIOMEDICAL’ quality system has been established and shall be maintained
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
2.0 The Quality System
2 of 5
0
i) The Quality System Manual
ii) QPWI
ii) Nationally recognized standards
iv) Third-party documentation
v) Quality forms
vi) Test specifications
vii) Quality records
viii) Management review of the quality system
ix) Audits
b) All quality documentation, including electronic data, shall be controlled as per the
“Document and Data Control” procedure (see Section 5.0), and all new documentation shall be logged and recorded as per the “Document Preparation and Issue” procedure (see Section 5.1). The format of all quality documents shall be as per the “Writing a Quality System Document” procedure (see Section 5.2). A complete list of all controlled quality system documentation, detailing current revision and distribution, is given in the
documentation database.
c) All staff members are required to be aware of quality system requirements and to
implement those parts of the quality system that are applicable to them.
d) The Quality Assurance Council shall ensure that the following steps take place:
i) The procedures developed comply with the objectives of the quality system and
the requirements of ISO 9002.
ii) Those activities that should be subject to procedures have properly documented
procedures and instructions written for them.
iii) The quality system and its documented procedures are effectively implemented.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
2.0 The Quality System
3 of 5
0
e) Regular audits, as described in the “Internal Quality Audits” procedure (see Section
17.0), shall ensure that the quality system procedures and instructions are being implemented in practice.
f) All staff should be aware of changes in technology, instrumentation, and techniques that
may bring an improvement in quality assurance.
g) Whenever possible, a standard of acceptability will be defined for each aspect of
LEGACY BIOMEDICAL’ work that affects quality. This may be to a nationally recognized standard, a manufacturer’s specification, or a standard set by management.
h) All controls, processes, equipment, personnel, training, and other resources required to
achieve the required quality shall be identified and acquired.
i) New processes, inspections, or tests shall be checked for compatibility with current
practice. Refer to the “Process Control” procedure (see Section 9.0)
j) All records that verify that the requirements of the quality system are being met shall be
identified and maintained as per the “Control of Quality Records” procedure (see Section 16.0)
k) When changes are made to the structure of LEGACY BIOMEDICAL, the quality system
may need to be updated by agreement with the Director, Quality Assurance. 2. Production of Quality Plans
a) Quality plans are usually in the form of a reference to the appropriate documented
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
2.0 The Quality System
4 of 5
0
i) New processes, services, or products are developed;
ii) A major improvement in a product or service is required;
iii) Major changes in purchasing or subcontracting are made; and/or
iv) A major new assignment is undertaken or a proposal for a major project is
prepared.
b) With regard to design and development work, a quality plan, known as a design plan,
shall be produced for each project.
c) With major customers or with new types of work not undertaken before, the customer
shall be offered the opportunity to participate in the preparation of the quality plan.
d) The quality plan needs to address the following issues:
i) Assessment of current situation (e.g., existing production, competitors)
ii) Assessment of desired performance (e.g., customer requirements, competitor
performance, market need)
iii) Assessment of tasks and processes necessary to reach desired performance
iv) Resources required and staff responsible for these resources and carrying out
tasks
v) Documents and other records that will be created and how they will be managed
vi) Equipment required, if any
vii) Costs of these resources and date when they will be required
viii) Specification of measurements, tests and inspections for input, processes, and
final product
ix) Specification of process control
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
2.0 The Quality System
5 of 5
0
F. Documentation
LEGACY BIOMEDICAL’ Quality System Manual
Document and Data Control Procedure (Section 5.0) Document Preparation and Issue Procedure (Section 5.1) Writing a Quality System Document Procedure (Section 5.2) Internal Quality Audits Procedure (Section 17.0)
Process Control Procedure (Section 9.0)
Control of Quality Records Procedure (Section 16.0) Quality Plan Cover Sheet
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
3.0 Contract Review
1 of 6
0
A. Purpose
This procedure describes the process that ensures that contract requirements between LEGACY
BIOMEDICAL and its customers are documented and understood and that the resources are available to fulfill the contract. It also details how records of the review are maintained.
B. Scope
This procedure shall apply to any repair, design, development, or service contract supplied by LEGACY BIOMEDICAL to its customers.
C. References
LEGACY BIOMEDICAL Quality System Manual.
D. Definitions
None
E. Procedure
1. Definition and Documentation of Requirements
a) All staff members are responsible for ensuring that requests from customers are correctly
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
3.0 Contract Review
2 of 6
0
i) Redirect the customer to a staff member who can process the request, or, if this is
not possible,
ii) Record the basic details of the request (i.e., location, contact name, contact
number) on a Medical Equipment Service Report (MESR) and pass that MESR on to the appropriate senior technician or Site Manager.
b) All maintenance, repair, installation, training, and commissioning work shall be initiated
by filling out an MESR. This MESR shall be processed as follows:
i) If the work is physically received, such as work being delivered to the depot
receiving area, the “Incoming Work” work instruction (see Section 12.2) shall be followed.
ii) If the work request is received by telephone, mail, or in person, step no. 1 of the
“MESR Completion” work instruction (see Section 16.3) shall be followed.
c) All design and manufacturing work shall be processed and recorded as per the “Design
Control” procedure (see Section 4.0)
d) A customer’s requirements shall be fully understood, any uncertainties clarified, and the
contract or order documented before undertaking the work. This requires the following:
i) The customer shall define exactly what is required. For work received
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
3.0 Contract Review
3 of 6
0
ii) For work requests made by telephone and other relatively simple requests, the
customer’s work details shall be recorded on an MESR and confirmed by summarizing the work done on the Equipment Status Tag attached to the work when returned to the customer. If the work is delivered to the customer
personally, the work done shall be confirmed verbally.
iii) For more complex products and services, such as design and manufacturing, a
written specification from the customer shall be requested or the customer shall be aided by LEGACY BIOMEDICAL staff in the preparation of the specification. The specification shall be reviewed with the customer to ensure that it is accurate. This process is outlined in the “Design Control” procedure (see Section 4.0).
iv) Special delivery and packaging instructions, if requested, shall be recorded on the
“Equipment Status Tag”.
v) Any cost to be incurred by the customer shall be clearly srated and understood by
the customer.
vi) Contingencies affecting the cost or delivery schedule shall be identified, and the
customer shall be made aware of the effect on cost and delivery.
vii) Contracts or orders shall be properly authorized by the customer.
2. Resource Requirements
a) Contracts and specifications shall be reviewed to ensure that the equipment, staff, and
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
3.0 Contract Review
4 of 6
0
i) Personnel availability
ii) Personnel capability
iii) Personnel training requirements
iv) Material availability
v) Facilities and equipment availability
vi) Facilities and equipment capabilities
vii) Subcontractor requirements
viii) Response time or delivery date requirements
b) If deficiencies exist, these shall be discussed with the customer.
c) Customers shall be advised of any likely delays in delivery of goods or services as soon
as possible after LEGACY BIOMEDICAL becomes aware that the delays are possible.
d) For all major assignments and proposals prepared, such as design or manufacturing, a
plan is prepared that describes what will be done, when it will be done, and the resources it will require. This includes, if applicable, an estimate of the number of work-hours and the cost of materials required. Refer to the “Design Control” procedure (see Section 4.0).
e) If staff require training before they carry out an assignment, this shall be identified,
scheduled, and carried out before they work on the contract. 3. Use of Suppliers and Subcontractors
a) The procedures and policy set out in the “purchasing” procedure (see Section 6.0) shall
be used to asses and select suppliers. If a supplier shall be involved in a contract
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
3.0 Contract Review
5 of 6
0
b) If a subcontractor or supplier is making a key input to a customer contract, the supplier
shall be required to apply duplicate conditions to those required of LEGACY BIOMEDICAL by the customer.
c) For each supplier and subcontractor of quality-related inputs, there shall be a designated
contact in LEGACY BIOMEDICAL. This shall usually be the Site Manager that is using the output of the supplier. The Site Managers shall be provided with a copy of any contracts with suppliers relevant to their work.
4. Contract Changes
a) If any change occurs that has an effect on a contract (e.g., a delay), the staff member
undertaking the work shall:
i) Advise and review with the customer how this change will affect the contract;
ii) Obtain agreement from the customer for the change;
iii) Document the change and customer notification and agreement on the applicable
MESR or project file as per the “MESR Completion” work instruction (see Section 16.3) and “Design Control” procedure (see Section 4.0), respectively; and
iv) Notify all appropriate staff of the changes.
b) When an agreement on a change cannot be satisfactorily reached with the customer, the
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
3.0 Contract Review
6 of 6
0
5. Records
All records of contracts and contract reviews, such as ESR’s, MESR’s, and project files, shall be stored and maintained according to the record storage policy set out in the “Control of Quality Records” procedure (see Section 16.0)
F. Documentation
ESR MESR
Equipment Status Tag
Control of Quality Records Procedure (Section 16.0) Purchasing Procedure (Section 6.0)
Design Control Procedure (Section 4.0) Resource Allocation Procedure (Section 9.11) MESR Completion Work Instruction (Section 16.3) Incoming Work Work Instruction (Section 12.2)
G. Appendix
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
4.0 Design Control
1 of 1
0
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
1 of 8
0
A. Purpose
This procedure describes the approval, issue, and modification of quality system documentation.
B. Scope
This procedure shall apply to all quality system documentation used by LEGACY BIOMEDICAL. This documentation shall include the following:
Externally supplied documents (e.g., third-party manuals, standards)
Documentation written in-house (e.g., procedures, work instructions, design plans, contract specifications, drawings, audit schedules)
Computer software (e.g., work records, procedure generating programs, databases) Records (e.g., work records, audit reports, forms, purchasing data)
C. References
LEGACY BIOMEDICAL Quality System Manual
D. Definitions
None
E. Procedure
a) All controlled documents shall be identified and listed in the documentation database. These documents shall be monitored and updated when necessary. Information in controlled documents can be reliably considered accurate and up to date.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
2 of 8
0
b) Uncontrolled documents (i.e., not in the documentation database) may be held in
LEGACY BIOMEDICAL and referred to. However, before using information from an uncontrolled document for repair, design, or purchase, the information must be confirmed to be correct by contacting the supplier or originator of the document. Examples of uncontrolled documents include pamphlets, brochures, and catalogs.
2. Document Approval
a) All documents associated with the quality system shall be reviewed for accuracy and
correctness.
b) The Quality Assurance Council is authorized to delegate the review and approval of
quality system documentation to selected personnel. These personnel and the documents they are authorized to approve are detailed in table 5.1.
c) The Quality Assurance Council shall approve the format of all quality documents,
including forms and software.
d) The reviewing and approving officer reviews the document to ensure that
i) The document expresses the quality policy,
ii) Suppliers and customers receive due consideration, and
e) Where applicable, new documents shall have their status sheets signed by the appropriate approving officer before being released for use. For software, the accompanying
manual’s status sheet shall be signed.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
3 of 8
0
Table 5.1. Review and Approval
Review and Approval Document Type
Director, Quality Assurance Procedures and work instructions
Forms
Purchase data and specifications Contract specifications
Quality plans Training schedules
Quality Control Managers Standards
Audit schedules Software
Site Managers Third-party manuals
In-house manuals
In-house maintenance procedures Reference manuals
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
4 of 8
0
f) Any staff member may make comment on the need for new documentation. These
comments shall be directed to a Site Manager for review.
g) The procedure for the writing of new documentation is described in the “Writing a
Quality System Document” procedure (see Section 5.2).
h) The control of quality records is as defined in the “Control of Quality Records” procedure
(see Section 16.0).
3. Document Issue and Distribution
a) A list of all quality system documents is maintained in the documentation database.
Site Managers are responsible for recording documents in the database.
b) Depending on the type of document, the documentation database shall indicate for each
document such information as the document number, title, revision, issue date, and distribution. The database shall also provide a label for each controlled document that uniquely identifies that document. The process of recording and issuing documentation is detailed in the “Document Preparation and Issue” procedure (see Section 5.1).
c) The Quality Control Managers shall check that the Site Managers prepares, issues, and
d) All revisions to a document shall be distributed to locations or individuals as listed in the documentation database.
e) Site Managers shall ensure that appropriate documentation is available at the required
locations.
f) Controlled documents are issued only to staff who are authorized to receive them and
who have agreed to respect the confidentiality of these documents.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
5 of 8
0
4. Document and Data Changes
a) Documents may be changed and updated in response to requests from customers, audits
or reviews. The original authors of documents and data shall be responsible for the updating of documents.
b) Changes to documentation shall be reviewed for accuracy and correctness and approved
for adequacy by staff authorized by the Quality Assurance Council. This authorization is as detailed in paragraph 2(b) of this procedure.
c) Where applicable, changes to documents shall be reflected in the following ways:
i) On their status sheets, which shall be signed accordingly by the approving officer;
ii) By a vertical line in the right-hand margin opposite the change; and
iii) By a new issue number, which shall be allocated as per the “Document
Preparation and Issue” procedure (see Section 5.1).
d) Any staff member may comment on the need for changes to documentation. These
e) Particular care shall be given to the effect of a change in a document on other related documents.
f) If, in reviewing a change to documentation, the approving officer believes that proposed
changes may have cost ramifications, a major effect on normal procedures, or an effect on other processes not under his/her supervision, then these changes shall be discussed with, and approved by the Quality Assurance Council.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
6 of 8
0
g) The current issue status (revision) of all quality system documentation is recorded and
maintained in the documentation database.
h) The documentation database indicates the location of all copies of documentation that
require reissue and produces this list on a document update sheet. This procedure also produces a record of the document updates (the document update sheet), which is maintained by the Director, Quality Assurance. A new document or an amendment shall be issued to all those locations or individuals named on this sheet.
i) Revised documents shall be given a new issue number, and the entire document shall be
reissued when more than half of the individual pages have been changed.
j) Status sheets shall be updated to reflect the revision status of, and changes to,
documentation.
k) Customers shall be advised of changes to documents normally issued to them and shall be
sent the revised copy if the document is a controlled document. If changes to a document will have a significant impact on the nature or quality of product or service, the customer shall be advised of the impact of these changes.
a) Documents that are obsolete shall be clearly stamped “Obsolete” or “Superseded” on their cover. The document’s obsolete status shall be noted in the documentation database.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
7 of 8
0
b) Site Managers shall ensure that obsolete documents are promptly removed.
c) Quality Control Managers shall regularly conduct inspections to ensure that no
uncontrolled copies of documents are in use.
d) Quality Control Managers shall maintain copies of all obsolete documentation for
reference, legal, and other purposes.
e) The Quality Assurance Council shall monitor the use of documents and follow up any
misuse of documents as advised by the Quality Control Managers or others. It shall also monitor any corrective action arising from misuse of documents. Any outstanding corrective action that is more than two months old shall be referred to the Director, Quality Assurance.
6. Storage of Documents
a) All documents, including completed forms and other records, both computer based and
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.0 Document and Data Control
8 of 8
0
b) Computer records shall be backed up using the “Computer Backup” procedure (see
Section 16.1), and backups shall be recorded in the computer backup file. Where
possible, computer-based backup copies of documents shall be stored at a location remote from the location of the original file. Refer to the “Computer Backup” procedure (see Section 16.1) for the current storage location.
F. Documentation
Document Preparation and Issue Procedure (Section 5.1) Writing a Quality System Document Procedure (Section 5.2) Documentation Database
Document Update Sheet
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
1 of 8
0
A. Purpose
This procedure describes the method of preparation and update of quality system documentation.
B. Scope
This procedure shall apply to all quality system documents used in LEGACY BIOMEDICAL. This documentation shall include the following:
Externally supplied documents (e.g., third-party manuals, reference books, standards)
Documentation written in-house (e.g., procedures, work instructions, contract specifications, drawings, audit schedules)
Computer software (e.g., work record programs, procedure- generating programs, databases) Records (e.g., work records, audit reports, forms, purchasing data)
C. References
D. Definitions
None
E. Procedure
1. General
a) Officers responsible for the review and approval of quality system documentation are as
defined in the “Document and Data Control” procedure (see Section 5.0)
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
2 of 8
0
b) Each quality system document shall have a unique number assigned by the appropriate
responsible officer.
c) All quality system documentation shall be logged into the documentation database,
providing information such as issue, storage location, etc. For instructions on using the documentation database, refer to Documentation Database User Manual.
2. Externally Supplied Documentation
a) Installation, Operation, and Service Manuals.
Inspection, preventive maintenance, and repair will normally be carried out in accordance with the original manufacturer’s/supplier’s manuals and drawings (including, where applicable, authorized modifications). Newly received manuals shall be logged into the technical documentation section of the documentation database and marked with a label. This database holds the following information (information on label as indicated):
i) Unique identification number
iii) Manufacturer
iv) Model number
v) Document type
vi) Storage location
vii) Status
viii) Revision
ix) Issue date
x) Date received
xi) Notes
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
3 of 8
0
b) Technical Reference/Information
Technical data books and other reference material shall be logged onto the operational documentation section of the documentation database and marked with a label. This database holds the following information (information on label as indicated):
i) Unique identification number
ii) Title
iii) Author
iv) Number – optional
v) Document type
vi) Storage location
vii) Status
viii) Revision
ix) Issue date
x) Date received
3. In-House Documentation
a) All quality system documents written in-house, such as the Quality system manual,
Quality Procedures and Work Instructions (QPWI), and customized inspection and
preventive maintenance procedures, shall be logged into the operational documentation section of the documentation database and marked with a label. Each file shall have a status sheet as described in section 6 of this procedure. This database holds the following information (information on label as indicated):
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
4 of 8
0
i) Unique identification number
ii) Title
iii) Author
iv) Number
v) Document type
vi) Storage location
vii) Status
viii) Revision
ix) Issue date
x) Date received
xi) Notes
b) Files
c) Forms and labels
All forms and labels used by the quality system shall be identified in the appendix of this document (QPWI) and shall be identified by a number and a date of issue.
4. Drawings
a) All drawings produced in-house shall be referenced appropriately (using a project
number, equipment control number, order number, etc.)
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
5 of 8
0
b) All drawings produced in-house shall be kept with the relevant project or equipment file,
or service manual.
c) Software masters of drawings produced by CAD packages shall be stored as indicated in
section 5 (below) of this procedure. 5. Software
a) Manufacturer-supplied or in-house software diskettes and their corresponding operation
manuals related to customer or test equipment shall be logged into the technical database section of the documentation database and marked with a label. This database holds the same information as described in section 3 a) above.
b) Operational third-party or in-house software diskettes and their corresponding operation
manuals (Four Rivers, word processing programs, etc.) shall be logged into the
operational database section of the documentation database and marked with a label. This database holds the same type of information as in section 3 a) above.
c) Master copies of in-house software files for procedures, manuals, or drawings produced
i) be saved to a specific directory on LEGACY BIOMEDICAL’ Network Server as shown in Table 2.
ii) be uniquely identified by its file name as shown in Table 3.
iii) in the case of individual project subdirectories, include a text file which shall list
all files located in the subdirectory, together with a brief description of the file contents.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
6 of 8
0
iv) be backed up as per the “Computer Backup” work instruction (see Section 16.1).
6. Status Sheet
The status sheet shall be used whenever possible with in-house documentation to indicate the current issue status (i.e., revision number) of each page in the document. This allows changes to be made without the need for the entire document to be reissued.
7. Document Updating
If a change has to be made to a controlled document, whether on one page or throughout the document, the following procedure shall be followed:
a) Using the document database, choose the appropriate area (technical or
operational) and select “Update Sheets” from the menu.
b) Conduct a search to identify all distributed copies of the document requiring an
c) When satisfied with the search results, print out an update sheet.
d) Produce a new status sheet for the document that reflects the changes made and
the new revision number. Make the appropriate number of copies of this status sheet as indicated by the update sheet.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
7 of 8
0
e) Using the documentation database, update the revision information of each
document copy affected by the change. As this is done for each document copy, check the box marked “COMP.” On the update sheet to record that this change has been made.
f) Locate each document copy, make the required change, and put in the new status
page. As this is done for each document copy, check the box marked “DOC” on the update sheet to record that this change has been made.
g) On completing all changes, sign and date the update sheet and send it to the
Director, Quality Assurance for storage in the document update file.
F. Documentation
Document Control Procedure (Section 5.0) Documentation Database
Computer Backup Work Instruction (Section 16.1) Documentation Database User Manual
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.1 Document Preparation and Issue
8 of 8
0
Table 2. Document Type Directory
Section Document Type Directory
General
Quality System Manual,
procedures, work instructions, forms, etc.
Electronic Design Drawings and manuals
Mechanical Design Drawings and manuals
Inspection and Preventive
Maintenance (IPM) IPM procedures
Document Type File Name Structure File Name
Quality System Manual,
procedures, work instructions, forms, etc.
Document No. File Name
Operator manuals Project No. File Name
Service manuals Project No. File Name
Drawings Project No. + drawing No. File Name
Bill of Materials Project No. + bom extension File Name
IPM procedures Procedure No. File Name
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
1 of 14
0
A. Purpose
This procedure describes the method of writing a quality system document. A documented quality system encourages uniformity in processes, and it establishes a starting point for continuous improvement activity.
B. Scope
This procedure shall apply to all quality system documentation written by the staff of LEGACY BIOMEDICAL.
C. References
LEGACY BIOMEDICAL Quality System Manual
D. Definitions
E. Procedure
1. General
a) The procedure detailed in this document shall be used when preparing quality system
documents such as the following:
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
2 of 14
0
i) Quality procedures
ii) Work instructions
iii) Inspection and preventive maintenance procedures
iv) Manuals
v) Files
vi) Forms
vii) Labels
viii) Software
b) If this format is found to be inappropriate, it shall be brought to the attention of the
Director, Quality Assurance. It is the Director, Quality Assurance’s responsibility to make changes to this procedure.
c) All quality system documents shall be entered into the documentation database in
d) Where quality documents become records, their storage and retention are as defined in the “Control of Quality Records” procedure (see Section 16.0).
2. Quality Procedures
a) Quality procedures explain the how, who, why, when, and where of quality processes
carried out by LEGACY BIOMEDICAL.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
3 of 14
0
b) The Quality Assurance Council shall decide on the need for a new procedure, basing its
decision on the following factors:
i) The importance of the activity in the running of LEGACY BIOMEDICAL,
particularly in its relation to customers and suppliers and the means of producing the goods or services produced and as required by ISO 9002.
ii) The need to clarify the exact process to be followed, particularly for production of
goods and services and documentation of production.
iii) The infeasibility of modifying an existing procedure to incorporate new
information. If possible, existing procedures shall be modified rather than
developing new ones. However, making a procedure too lengthy can mean that it is subject to constant revision merely because its scope is too broad.
i) Management review, audits, and customer complaints. Management review and
audits are likely to indicate the need for new procedures or for substantial alteration of existing procedures. Customer complaints are usually an input to reviews, and these are a source of information about the need for procedures. Other inputs to this review process are identified customer, supplier, market, and legislative requirements.
ii) New products and services developed. Development of procedures is an integral
part of the development of new products and services.
iii) Management and quality system changes. Management changes and other
changes in the business can prompt the need for new procedures.
iv) Quality planning. A procedure is often one of the outcomes of a quality plan.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
4 of 14
0
d) The Quality Assurance Council shall select the person responsible for writing and
implementing the procedure. Normally, this will be the person with functional control for the activity described in the procedure.
e) All quality procedures shall be filed in the QPWI. The master software file of this
document shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.1).
f) Each quality procedure shall be given a title and unique number by the Director, Quality
Assurance.
g) Each page of a quality procedure shall have a header showing its title and section
h) Each page of a quality procedure shall have a header showing its page number, total number of pages, revision number, and revision date.
i) Quality procedures shall have printed at the header a RED logo to differentiate controlled
copies from photocopies.
j) Each quality procedure shall have the following format:
i) Purpose. Describes the essential and fundamental reason for the procedure’s
existence.
ii) Scope. Briefly describes the area and application of the procedure.
iii) References. Refers to information that may be useful to understand the procedure.
This can include glossaries.
iv) Definitions. Define unique terms or language used in the procedure.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
5 of 14
0
v) Procedure. Sets out a concise and objective way exactly what is to be done to
ensure that an activity is carried out to the quality standards required. Where possible, flowcharts shall be used to assist in explaining the procedure.
Procedures are worded so that each action or process is described clearly; the inputs and outputs to each process or action are identified; the person or persons responsible for each action are identified; and an auditor can use the procedure to check whether the procedure is being followed.
vi) Documentation. Lists documentation referred to in the procedure.
vii) Appendix. Includes information that serves only to provide help to the reader but
is not essential for understanding the procedure.
k) Once completed, a procedure’s correctness shall be confirmed by a staff member whose
l) Before release for general use, the procedure shall be approved and reviewed as per the “Document and Data Control” procedure (see Section 5.0)
m) Changes to the QPWI and other documents due to the addition of a new procedure shall
be reflected in the relevant page status sheets.
n) All staff affected by the procedure shall be briefed by the author about the intent and
content of the procedure. Training, if required, is provided by the author with the assistance of the Site Managers.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
6 of 14
0
3. Work Instructions
a) Quality procedures are general documents that may not always provide detailed work
instructions. Where it is necessary to supplement procedures, either to train new workers or to ensure that existing workers carry out the detailed requirements of the job, work instructions are written. Work instructions give a step-by-step account of how to carry out a task.
b) Site Managers shall decide on the need for a new work instruction.
c) Site Managers shall select the person responsible for writing and implementing the work
d) All work instructions shall be filed in the QPWI. The master software file of this
document shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.1)
e) Each work instruction shall be given a title and unique number by the Director, Quality
Assurance.
f) Each page of a work instruction shall have a header showing its title and section number.
g) Included in the header of the work instruction shall be its page number, total number of
pages, revision number, and revision date.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
7 of 14
0
h) Work instructions shall have printed at the header a BLUE logo to differentiate controlled
copies from photocopies.
i) Each work instruction shall have the following format:
i) A brief paragraph outlining the purpose of the work instruction.
ii) A numbered step-by-step instruction forming the body of the work instruction.
iii) A list of documents related or referred to by the work instruction.
iv) An appendix may be included to provide information that serves only to provide
j) Once completed, a work instruction’s correctness shall be confirmed by a staff member whose normal duties include the task described.
k) Before release for general use, the work instruction shall be approved and reviewed as
per the “Document and Data Control” procedure (see Section 5.0).
l) Changes to the QPWI and other documents due to the addition of a new work instruction
shall be reflected in the relevant page status sheets.
m) All staff affected by the work instruction shall be briefed by the author about the intent
and content of the instruction. Training, if required, is provided by the author with the assistance of the Site Managers.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
8 of 14
0
4. Inspection and Preventive Maintenance Procedures
a) IPM procedures are work instructions that specifically describe the tasks and methods
involved in the inspection and/or preventive maintenance of individual types of equipment under the care of LEGACY BIOMEDICAL.
b) IPM procedures consist of those procedures published in the Maintenance Management
for Medical Equipment Manual published by the American Society for Healthcare Engineering and new and customized procedures developed by LEGACY
c) Site Managers shall determine the need for a new or customized IPM procedure.
d) Site Managers shall select the person responsible for writing and implementing the IPM
procedure. Normally, this will be the person with the responsibility for maintaining the equipment involved.
e) Each IPM procedure shall be given a title and date-coded procedure number by the
appropriate Site Manager. This number and title shall be entered into the IPM Procedure Table of the database by the Director, Quality Assurance.
f) IPM procedures shall have a blue logo imprinted in the upper corner to differentiate
controlled copies from photocopies.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
9 of 14
0
g) Each IPM procedure shall have the format provided by the current database.
h) Once completed, an IPM procedure’s correctness shall be confirmed by a staff member
who is experienced with the subject device of the procedure.
i) Before release for general use, the procedure shall be reviewed and approved as per the
“Document and Data Control” procedure (see Section 5.0).
j) Changes to the IPM Procedures Table in the database due to the addition of a new IPM
k) All persons affected by the IPM procedure shall be briefed on the procedure by the author. Training, if required, is provided by the author with the assistance of the Site Manager.
5. Manuals
a) Manuals are written to explain the use, operation, or maintenance of products (hardware
and software) developed by LEGACY BIOMEDICAL.
b) Site Managers shall decide on the need for a new manual.
c) Site Managers shall select the person responsible for writing and implementing the
manual. Normally, this will be the person with the responsibility for using, designing, manufacturing, or maintaining the equipment or software involved.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
10 of 14
0
d) Once completed, a manual’s correctness shall be confirmed by a staff member whose
normal duties include the equipment or software associated with the manual.
e) The master software file of the manual shall be stored and named as described in item 5
of the “Document Preparation and Issue” procedure (see Section 5.1).
f) Before release for general use, the manual shall be reviewed and approved as per the
“Document and Data Control” procedure (see Section 5.0).
g) All staff affected by the manual shall be briefed by the author. Training, if required, is
6. Files
a) Files are used to collate reports, records, and other quality documentation.
b) The LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a
new file.
c) Each file shall be given a title and unique number by the Director, Quality Assurance.
d) Files shall be maintained by the officer named in the appendix of the “Control of Quality
Records” procedure (see Section 16.0).
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
11 of 14
0
7. Forms
a) Forms are used as the basis for most quality records produced by LEGACY
BIOMEDICAL.
b) The LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a
c) The LEGACY BIOMEDICAL Quality Assurance Council shall select the person
responsible for writing and implementing the form. Normally, this will be the person with functional control for the activity related to the form.
d) All quality forms shall be listed in the QPWI appendix. The master software file of these
forms shall be stored and named as described in item 5 of the “Document Preparation and Issue” procedure (see Section 5.1).
e) Each form shall be given a title and unique number by the Director, Quality Assurance.
This number shall be printed on the bottom of the form, along with its revision date, if possible.
f) Once completed, a form’s correctness shall be confirmed by a staff member whose
normal duties include the process affected by the form.
g) Before release for general use, the form shall be reviewed and approved by the LEGACY
BIOMEDICAL Quality Assurance Council.
h) Changes to the QPWI and other documents due to the addition of a new form shall be
reflected in the appropriate page status sheets.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
12 of 14
0
i) All staff affected by the form shall be briefed by the author about the intent, completion,
and use of the form. Training, if required, is provided by the author with the assistance of the Site Manager.
a) Labels are used as the basis for traceability and/or status of goods and work within LEGACY BIOMEDICAL.
b) LEGACY BIOMEDICAL Quality Assurance Council shall decide on the need for a new
label.
c) LEGACY BIOMEDICAL Quality Assurance Council shall select the person responsible
implementing the form. Normally, this will be the person with functional control for the activity related to the label.
d) Each label shall be given a title and unique number by the Director, Quality Assurance.
This number shall be printed on the bottom of the label, along with its revision date, if possible. This shall depend on the label’s size and use.
e) Once completed, a label’s correctness shall be confirmed by a staff member whose
normal duties include the process affected by the label.
f) Before release for general use, the label shall be reviewed and approved by the LEGACY
BIOMEDICAL Quality Assurance Council.
g) Changes to the QPWI and other documents due to the addition of a new label shall be
reflected in the appropriate page status sheets.
i) All staff affected by the label shall be briefed by the author about the intent, completion,
and use of the form. Training, if required, is provided by the author with the assistance of the Site Manager.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
13 of 14
0
9. Software
a) Software may be written by LEGACY BIOMEDICAL for record keeping, data
interrogation, testing, or design.
i) The Quality Assurance Council as a requirement of the quality system,
ii) a customer as a request for work, and/or
iii) a staff member as a work aid.
c) The person assigned responsibility for writing and implementing the software will
depend on the origin and type of request for the software. Normally, this will be the person with functional control for the activity related to the software.
d) All software shall have an associated manual, written in accordance with paragraph 5 of
this procedure.
e) The original file shall be stored and named as described in Section 5.0 of the “ Document
Preparation and Issue” procedure (see Section 5.1). The number and the current revision date shall be printed on any copies, together with any associated documentation.
f) Once completed, the software’s correctness shall be confirmed by a staff member whose
normal duties include the process affected by the software.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
5.2 Writing a Quality System Document
14 of 14
0
g) Changes to the QPWI and other documents due to the addition of a new software shall be
i) All staff affected by the software shall be briefed by the author about the intent,
completion, and use of the software. Training, if required, is provided by the author with the assistance of the Site Manager.
F. Documentation
Document Preparation and Issue procedure (Section 5.1) Control of Quality Records procedure (Section 16.0) Document and Data Control procedure (Section 5.0)
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
6.0 Purchasing
1 of 5
0
This procedure describes the purchasing methods used to ensure that purchased products conform to specified requirements.
B. Scope
This procedure shall apply to any goods or services purchased by LEGACY BIOMEDICAL to enable it to carry out its functions. The goods may be spare parts, test equipment, raw materials, etc. Services may include maintenance contracts or manufacturing work supplied by outside organizations.
C. References
LEGACY BIOMEDICAL Quality System Manual.
D. Definitions
Supplier. Any outside organization providing goods and/or services to LEGACY BIOMEDICAL.
Subcontractor. Any outside organization carrying out work on behalf of LEGACY
BIOMEDICAL.
E. Procedure
1. General
Goods or services purchased by LEGACY BIOMEDICAL shall be initiated and processed by one of the following methods:
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
6.0 Purchasing
2 of 5
0
b) Urgent purchase request (Section 6.4)
c) Standing order purchase (Sections 6.5 and 6.10)
d) Petty cash purchase (Section 6.6)
2. Supplier and Subcontractor Evaluation
a) LEGACY BIOMEDICAL shall select suppliers and subcontractors on the basis of their
ability to meet purchase or subcontract requirements, including quality requirements as per the “Approved Supplier Selection” procedure (See Section 6.1)
b) Selected suppliers and subcontractors shall be listed in the supplier section of the
LEGACY BIOMEDICAL database (known as the “supplier catalog”), where their acceptability and scope of product shall be identified as specified in the “Approved Supplier Selection” procedure (See Section 6.1).
c) Purchasing data shall be monitored by the Director, Purchasing to ensure that only
approved suppliers are used. 3. Purchasing Data
a) All purchasing documents shall contain clear and accurate descriptions of the item or
service required.
Quality Procedures and Work Instructions Manual
Section
Page
Date
Revision
b) Purchase requisitions shall only be raised on suppliers rated as acceptable (A) or conditionally acceptable (C) and whose scope of product is suitable as defined in the supplier catalog. An exception to this shall be if the requisition is to be raised on a new supplier. In this case, the new supplier shall be evaluated as per the “Approved Supplier Selection” procedure (See Section 6.1).
c) The person initiating a requisition is responsible for the accuracy of the data on the
requisition.
d) A purchase requisition form shall be completed and processed as per the “Purchase
Requisition Form Completion” work instruction (See Section 6.7).
e) Purchase requisitions completed by staff members shall be reviewed and approved by
their immediate supervisor.
f) All purchase requisitions must be authorized as described in the “Purchase Requisition
Expenditure Authorization” procedure (See Section 6.2) before any commitment of expenditure.
4. Documentation Control and Progress
a) All officer(s) responsible for controlling purchase documentation shall be provided with a
copy of the work instruction applicable to the purchase method used (See Sections 6.3, 6.4, 6.5, 6.6, or 6.10).
b) The Director, Purchasing shall be responsible for monitoring the progress of requisition
documentation and orders for conformance to promised delivery dates as per the “Outstanding Order Progress” work instruction (See Section 6.8).