Quality Procedures and Work Instructions Manual

Quality Procedures and Work Instructions Manual Revision Number: (1) ISSUED TO: MANUAL NO: REVISION NO: ISSUE DATE: President Date 1

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 6.0. Purchasing 5.1 Document Preparation and Issue 5.2 Writing a Quality System Document 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 6.10 Outside Work 2

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 10.1 Incoming Goods Inspection 3

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 15.5 Handling of Contaminated Equipment 4

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 18.0. Training 19.0. Servicing 17.1 Quality Assurance Program 17.2 Quality Assurance Indicators for Patient Care Devices 19.1 Maintenance of Medical Devices 19.2 Service Standards 20.0 Statistical Techniques 5

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. Each section may contain a combination of procedures and work instructions. Procedures will detail the who, how, when, where, and why of a particular function or process undertaken by the organization and have a set structure (purpose, scope, references, definitions, procedure, and documentation). Work instructions are detailed step-by-step instructions that explain how to carry out a particular task. All procedures and work instructions are written in accordance with the Writing a Quality System Document procedure (see Section 5.2 of this document). 6

1.0 Management Review 1 of 4 0 A. Purpose B. Scope This procedure describes the review of the suitability and effectiveness of LEGACY BIOMEDICAL S quality system by management. 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: i) LEGACY BIOMEDICAL staff. 7

Any staff member may indicate problems with, or possible improvements to, the quality system procedures, work practices, work output, product performance, documentation, or records. 1.0 Management Review 2 of 4 0 ii) iii) iv) Customers. A customer, through a suggestion, comment, or complaint, may highlight a component of the quality system that requires review. Performance reports. Reports produced by performance analysis of work done may indicate areas of the quality system that should be reviewed. 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 matters affecting the quality system, the effectiveness of the quality system, the stability 8

of the system in adapting to customer and business needs, and its compliance with the quality standard and quality system objectives. 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 directed to the appropriate Council member who shall be responsible for investigating, responding to, and, if necessary, correcting the matter. 9

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. 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 member or customer). This person shall be consulted to determine whether he or she is satisfied with the outcome of the review, measuring the success of the action from performance reports, or verification of the action through the next internal or external audit. This verification shall be recorded by the source of the review initialing the relevant entry in the Quality Assurance Council meeting minutes. 10

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 2.0 The Quality System 1 of 5 0 A. Purpose B. Scope This procedure describes the establishment and maintenance of the quality system documentation required to meet the quality policy. 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 in accordance with the requirements of ISO 9002. The quality system shall include the following elements: 11

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. Refer to the Management review procedure (see Section 1.0). 12

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 procedures that form an integral part of our quality system. However, a quality plan may be produced for groups of products and services or individual products and services when: 13

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 x) How satisfactory achievement of quality plan will be measured 14

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 Plan File Project file 15

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 processed and recorded as described in this procedure. If a request is received directly by a staff member who is not familiar with the type of work requested, then he or she shall: 16

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 accompanied by an Equipment Service Request (ESR), if the details conveyed on the ESR are unclear or conflict with any problems found, the customer shall be consulted to properly define the work request. 17

3.0 Contract Review 3 of 6 0 ii) iii) iv) 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. 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). 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) vii) Contingencies affecting the cost or delivery schedule shall be identified, and the customer shall be made aware of the effect on cost and delivery. 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 other resources required to carry out the work are available. This process is outlined in the Resource Allocation procedure (see Section 9.11) These resources may include the following: 18

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 undertaken by LEGACY BIOMEDICAL, it shall be confirmed that the supplier can carry out its requirements of the contract. 19

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 staff member undertaking the work shall pass the negotiations on to the appropriate management member. 20

3.0 Contract Review 6 of 6 0 5. Records F. Documentation 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) 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 Figure 3.1 represents a diagram of the contract review processes. 21

4.0 Design Control 1 of 1 0 LEGACY BIOMEDICAL is not engaged in design and development. If, at a future date LEGACY BIOMEDICAL engages in design and development, Policies and Procedures will be written at that time. 22

5.0 Document and Data Control 1 of 8 0 A. Purpose B. Scope This procedure describes the approval, issue, and modification of quality system documentation. 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 1. General 23

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. 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 ii) The document is practicable. 24

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. 5.0 Document and Data Control 3 of 8 0 Table 5.1. Review and Approval Review and Approval Document Type Director, Quality Assurance Quality Control Managers Site Managers Procedures and work instructions Forms Purchase data and specifications Contract specifications Quality plans Training schedules Standards Audit schedules Software Third-party manuals In-house manuals In-house maintenance procedures Reference manuals Drawings 25

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 maintains documents in accordance with procedures. 26

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. 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 comments shall be directed to their immediate supervisor for review with the applicable officers and action if agreed. 27

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. 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. 5. Removal of Obsolete Documents 28

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. 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 hard copy, shall be stored so that they are easily retrieved. All controlled documents shall be recorded in the documentation database as outlined in the Document Preparation and Issue procedure (see Section 5.1) and the Documentation database User Manual. 29

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 Computer Backup Procedure (Section 16.1) Computer Backup File 30

5.1 Document Preparation and Issue 1 of 8 0 A. Purpose B. Scope This procedure describes the method of preparation and update of quality system documentation. 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 LEGACY BIOMEDICAL Quality System Manual 31

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) 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 ii) Device type 32

iii) Manufacturer iv) Model number v) Document type vi) Storage location vii) Status viii) Revision ix) Issue date x) Date received xi) Notes 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 xi) Notes 33

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): 5.1 Document Preparation and Issue 4 of 8 0 b) Files 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 All files compiled from the quality system documents, such as the training, contract review, complaints, incomplete orders, and internal audit files shall be logged into the operational documentation section of the documentation database and marked with a label. This database holds the same information as in 3 a) above. 34

c) Forms and labels 4. Drawings 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. a) All drawings produced in-house shall be referenced appropriately (using a project number, equipment control number, order number, etc.) 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 in house shall: 35

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. 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 update. 36

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. 5.1 Document Preparation and Issue 7 of 8 0 F. Documentation 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. Document Control Procedure (Section 5.0) Documentation Database Computer Backup Work Instruction (Section 16.1) Documentation Database User Manual Document Update File 37

5.1 Document Preparation and Issue 8 of 8 0 Table 2. Document Type Directory General Electronic Design Section Document Type Directory Quality System Manual, procedures, work instructions, forms, etc. Drawings and manuals Mechanical Design Inspection and Preventive Maintenance (IPM) Drawings and manuals IPM procedures Table 3. File Name Directory 38

Document Type File Name Structure File Name Quality System Manual, procedures, work instructions, Document No. File Name forms, etc. 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 5.2 Writing a Quality System Document 1 of 14 0 A. Purpose B. Scope 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. 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 None 39

E. Procedure 1. General a) The procedure detailed in this document shall be used when preparing quality system documents such as the following: 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 accordance with the Documentation Preparation and Issue procedure (see Section 5.1). 40

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. 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. c) Procedures may be written in response to a number of events in the quality system: 41

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. 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 number. 42

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. 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) vii) Documentation. Lists documentation referred to in the procedure. 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 normal duties include the process described by the procedure. 43

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. 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 instruction, Normally, this will be the person with functional control for the activity described in the work instruction. 44

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. 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 help to the reader but is not essential for understanding the instruction. 45

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. 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 BIOMEDICAL. All procedures shall be stored and named as described in item 5 of the Document Preparation and Issue procedure (see Section 5.0). 46

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. 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 procedure shall be reflected in the appropriate page status sheets. 47

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. 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 provided by the author with the assistance of the Site Manager. 48