implementing iso 13485 medical devices with the iqs business system

8/17/2019 Implementing ISO 13485 Medical Devices With the IQS Business System

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ImplementingISO 13485Second edition2003-07-15

Medical devices — Quality managementsystems — Requirements for regulatorypurposes

Implementing ISO 13485 with the IQSBusiness System

This Manual Is For Use with the IQS Quality Performance Management System(tm)

Version 6.X or Higher


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Introduction

Introduction to a full implementation of ISO 13485; 2003 using

the IQS QUALITY PERFORMANCE MANAGEMENT SYSTEM.

This document will outline all the requirements of ISO 13485: 2003 and showshow to implement the requirements within the IQS Quality PerformanceManagement System.

The IQS Quality Performance Management System is a powerful and provensolution that offers a unique model for integrating a quality system to achieveenterprise-wide performance and cost reduction. It allows companies to becomecompetitive and profitable, and to achieve and maintain regulatory compliance.

IQS provides system-wide audit management capabilities, and makes available anumber of application-specific modules to ensure compliance to 21CFR11, ISO13485;2003, EN4600, EN550/EN554, FDA (QSR) Quality System Regulation,and (GCP) Good Lab Practices.

IQS Quality Performance Management System consists of the 16 modules shown below:

IDs for IQS Modules

IQS Modules Abbreviation IQS Module Abbreviation

Customer Management CUSTOMER Statistical Process Control SPC

System Documentation DOCUMENT Nonconformance Management NCM

Product Documentation PRODUCT Corrective Action CORRECT

Process Documentation PROCESS Supplier Management SUPPLIER

Preventive Maintenance EQUIPMENT Quality Costs QCOST

Calibration Management DEVICE PPAP Manager- ProductionPart and Approval Process

PPAP MANAGER


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Employee Involvement EMPLOYEE Internal Audit AUDIT MANAGER

Data Collection (Inspectionand Test)

COLLECT APQP – Advanced ProductQuality Planning

APQP MANAGER

Special Note: Formatting has been altered to differentiate between comments from IQSand the ISO 13485:2003

IQS - Regular print in Arial Font with bullet markings

ISO 13485:2003(E) © ISO 2003 — All rights reserved

ISO 13485 : 2003— Italic print in Times New Roman Font


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ContentsForeword0 Introduction0.1 General0.2 Process approach0.3 Relationship with o ther standards

0.4 Compatibility with other management systems

1 Scope1 1.1 General1 1.2 Application

2 Normative references

3 Terms and definitions

4 Quality management system4.1 General requirements4.2 Documentation requirements

5 Management responsib ilities5.1 Management commitment5.2 Customer focus5.3 Quality pol icy5.4 Planning5.5 Responsibilit y, authority and communication5.6 Management review

6 Resource management6.1 Provision of resources6.2 Human resources6.3 Infrastructure6.4 Work environment

7 Product realization7.1 Planning of product realization7.2 Customer-related processes.7.3 Design and development.7.4 Purchasing7.5 Product ion and service provis ion7.6 Control o f monitoring and measuring devices

8 Measurement, analysis and improvement8.1 General8.2 Monitoring and measurement8.3 Control of nonconforming product

8.4 Analysis of data8.5 Improvement


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0 Introduction

0.1 General

This International Standard specifies requirements for a quality management system that can beused by an organization for the design, development, production, installation and servicing ofmedical devices, and the design, development, and provision of related services.

It can also be used by internal and external parties, including certification bodies, to assess theorganization’s ability to meet customer and regulatory requirements.

Information marked “NOTE” is for guidance in understanding or clarifying the associatedrequirement.

It is emphasized that the quality management system requirements specified in this InternationalStandard are complementary to technical requirements for products.

The adoption of a quality management system should be a strategic decision of an organization.

The design and implementation of an organization's quality management system is influenced byvarying needs, particular objectives, the products provided, the processes employed and the sizeand structure of the organization. It is not the intent of this International Standard to implyuniformity in the structure of quality management systems or uniformity of documentation.

There is a wide variety of medical devices and some of the particular requirements of thisInternational Standard only apply to named groups of medical devices. These groups are definedin Clause 3.

0.2 Process approach

This International Standard is based on a process approach to quality management.

Any activity that receives inputs and converts them to outputs can be considered as a process.

For an organization to function effectively, it has to identify and manage numerous linkedprocesses.

Often the output from one process directly forms the input to the next. The application of a systemof processes within an organization, together with the identification and interactions of theseprocesses, and their management, can be referred to as the “process approach”.

0.3 Relationship with other standards

0.3.1 Relationship w ith ISO 9001 While this is a stand-alone standard, it is based on ISO9001. Those clauses or subclauses that are quoted directly and unchanged from ISO 9001 are in

normal font. The fact that these subclauses are presented unchanged is noted in Annex B. Wherethe text of this International Standard is not identical to the text of ISO 9001, the sentence orindent containing that text as a whole is shown in italics (in blue italics for electronic versions).The nature and reasons for the text changes are noted in Annex B.

0.3.2 Relationship with ISO/TR 14969 ISO/TR 14969 is a Technical Report intended to provideguidance for the application of ISO 13485.

0.4 Compatibility wi th other management systems


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This International Standard follows the format of ISO 9001 for the convenience of users in themedical device community.

This International Standard does not include requirements specific to other managementsystems, such as those particular to environmental management, occupational health and safetymanagement, or financial management.

However, this International Standard enables an organization to align or integrate its own qualitymanagement system with related management system requirements. It is possible for anorganization to adapt its existing management system(s) in order to establish a qualitymanagement system that complies with the requirements of this International Standard.

1 Scope

1.1 GeneralThis International Standard specifies requirements for a quality management system where anorganization needs to demonstrate its ability to provide medical devices and related services thatconsistently meet customer requirements and regulatory requirements applicable to medicaldevices and related services. The primary objective of this International Standard is to facilitate

harmonized medical device regulatory requirements for quality management systems. As a result,it includes some particular requirements for medical devices and excludes some of therequirements of ISO 9001 that are not appropriate as regulatory requirements. Because of theseexclusions, organizations whose quality management systems conform to this InternationalStandard cannot claim conformity to ISO 9001 unless their quality management systems conformto all the requirements of ISO 9001 (see Annex B).

1.2 Application All requirements of this International Standard are specific to organizations providing medicaldevices, regardless of the type or size of the organization. If regulatory requirements permitexclusions of design and development controls (see 7.3), this can be used as a justification fortheir exclusion from the quality management system. These regulations can provide alternativearrangements that are to be addressed in the quality management system. It is theresponsibility of the organization to ensure that claims of conformity with this InternationalStandard reflect exclusion of design and development controls [see 4.2.2 a) and 7.3]. If anyrequirement(s) in Clause 7 of this International Standard is(are) not applicable due to the natureof the medical device(s) for which the quality management system is applied, the organizationdoes not need to include such a requirement(s) in its quality management system [see 4.2.2a)]. The processes required by this International Standard, which are applicable to the medicaldevice(s), but which are not performed by the organization, are the responsibility of theorganization and are accounted for in the organization’s quality management system [see 4.1a)]. In this International Standard the terms “if appropriate” and “where appropriate” are usedseveral times. When a requirement is qualified by either of these phrases, it is deemed to be“appropriate” unless the organization can document a justification otherwise. A requirement is

considered “appropriate” if it is necessary in order for ⎜ the product to meet specifiedrequirements, and/or ⎜ the organization to carry out corrective action.

2 Normative referencesThe following referenced documents are indispensable for the application of this document. Fordated references, only the edition cited applies. For undated references, the latest edition of thereferenced document (including any amendments) applies.

ISO 9000:2000, Quality management systems — Fundamentals and vocabulary

3 Terms and definitions


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For the purposes of this document, the terms and definitions given in ISO 9000 apply, togetherwith the following. The following terms, used in this edition of ISO 13485 to describe the supplychain, have been changed to reflect the vocabulary currently used:

supplier -------------> organization ----------> customer

The term “organization” replaces the term “supplier” used in ISO 13485:1996, and refers to theunit to which this International Standard applies. Also, the term “supplier” now replaces the term“subcontractor”.

Throughout the text of this International Standard, wherever the term “product” occurs, it can alsomean “service”. Wherever requirements are specified as applying to “medical devices”, therequirements apply equally to related services as supplied by the organization. The followingdefinitions should be regarded as generic, as definitions provided in national regulations can differslightly and take precedence.

PROCESS is a documentation technique that is based on supplier (input) – process – andcustomer (output) definitions. PROCESS also allows documentation of front office-serviceorganizations and their related “products.”

3.1 active implantable medical device active medical device which is intended to be totally orpartially introduced, surgically or medically, into the human body or by medical intervention into anatural orifice, and which is intended to remain after the procedure

3.2 active medical device medical device relying for its functioning on a source of electricalenergy or any source of power other than that directly generated by the human body or gravity

3.3 advisory notice notice issued by the organization, subsequent to delivery of the medical

device, to provide supplementary information and/or to advise what action should be taken in the

use of a medical device, the modification of a medical device, the return of the medical device tothe organization that supplied it, or the destruction of a medical device

NOTE Issue of an advisory notice might be required to comply with national or regional regulations.

3.4 customer complaint written, electronic or oral communication that alleges deficienciesrelated to the identity, quality, durability, reliability, safety or performance of a medical device thathas been placed on the market

3.5 implantable medical device medical device intended to be totally or partially introduced intothe human body or a natural orifice, or to replace an epithelial surface or the surface of theeye, by surgical intervention, and which is intended to remain after the procedure for at least 30days, and which can only be removed by medical or surgical intervention

NOTE This definition applies to implantable medical devices other than active implantable medical devices.

3.6 labeling written, printed or graphic matter ⎜ affixed to a medical device or any of its containers

or wrappers, or ⎜ accompanying a medical device, related to identification, technical description,and use of the medical device, but excluding shipping documents NOTE Some regional and nationalregulations refer to “labeling” as “information supplied by the manufacturer.”

3.7 medical device any instrument, apparatus, implement, machine, appliance, implant, in vitroreagent or calibrator, software, material or other similar or related article, intended by themanufacturer to be used, alone or in combination, for human beings for one or more of thespecific purpose(s) of diagnosis, prevention, monitoring, treatment or alleviation of

disease, ⎜ diagnosis, monitoring, treatment, alleviation of or compensation for aninjury, ⎜ investigation, replacement, modification, or support of the anatomy or of a physiological


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process, ⎜ supporting or sustaining life, ⎜ control of conception, ⎜ disinfection of medicaldevices, ⎜ providing information for medical purposes by means of in vitro examination ofspecimens derived from the human body, and which does not achieve its primary intended actionin or on the human body by pharmacological, immunological or metabolic means, but which maybe assisted in its function by such means.

NOTE This definition has been developed by the Global Harmonization Task Force (GHTF). Seebibliographic reference [15].

3.8 sterile medical device category of medical device intended to meet the requirements forsterility

NOTE The requirements for sterility of a medical device might be subject to national or regional regulationsor standards.

4 Quality management system

4.1 General requirementsThe organization shall establish, document, implement and maintain a quality management

system and maintain its effectiveness in accordance with the requirements of this InternationalStandard.

The organization shalla) identify the processes needed for the quality management system and their applicationthroughout the organization (see 1.2),

The IQS Quality Performance Management System defines the processes of the qualitymanagement system throughout the organization.

b) determine the sequence and interaction of these processes,

The IQS software provides data-entry structure, defined business rules, and software wizards thatautomate interaction. This reduces cost saving by eliminating labor and error-proofing businessprocesses.

c) determine criteria and methods needed to ensure that both the operation and control of theseprocesses are effective,


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IQS provides the ability to define, measure, and report on a critical business processes. Thisincludes;

• Program Management

• Management review meetings

• Providing real-time metrics with drill down capability (NCMR, RMA, COMPLAINTS,

SUPPLIER ISSUES, and DOCUMENT CONTROL• Track all assignments and assignment closure.

d) ensure the availability of resources and information necessary to support the operation andmonitoring of these processes,

IQS provides the following modules to ensure the availability of resources and informationnecessary to support the operation and monitoring of these processes.

• EMPLOYEE provides the ability to define current resources and associated skills.

• EQUIPMENT provides the ability to manage manufacturing equipment, office equipment,buildings, and other assets.

• DEVICE provides the ability to manage all the measuring and test equipment.

• DOCUMENT, PROCESS, and PRODUCT provide the information necessary to support

the operations.

e) monitor, measure and analyze these processes, and

AUDIT MANAGER provides an extensive framework for the definition of effectiveness and forscheduling and recording the process audits, including posting nonconformance reports andcorrective actions.

f) implement actions necessary to achieve planned results and maintain the effectiveness ofthese processes.

IQS manages implementation of actions by maintaining all the task assignments across the entireenterprise quality and compliance management processes. All assignments are brought to asingle screen (My To Do List) when a user logs into the software, to help track and display theeffectiveness of planned actions.


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NOTE Processes needed for the quality management system referred to above should include processesfor management activities, provision of resources, product realization and measurement.

New Product Development activities can be managed across the supply chain


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4.2 Documentation requirements

4.2.1 GeneralThe quality management system documentation shall includea) documented statements of a quality policy and quality objectives,

b) a quality manual,c) documented procedures required by this International Standard,d) documents needed by the organization to ensure the effective planning, operation and controlof its processes,e) records required by this International Standard (see 4.2.4), andf) any other documentation specified by national or regional regulations.

Where this International Standard specifies that a requirement, procedure, activity or specialarrangement be “documented”, it shall, in addition, be implemented and maintained.

The standard requires more than just a document inventory accessible via a website. IQSprovides complete document lifecycle management, including: document inventory, documentchange requests, document audits, and direct links between document changes and training

records.


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For each type or model of medical device, the organization shall establish and maintain a fileeither containing or identifying documents defining product specifications and qualitymanagement system requirements (see 4.2.3). These documents shall define the completemanufacturing process and, if applicable, installation and servicing.

PRODUCT stores the product specifications.

PRODUCT defines the complete manufacturing process as applicable, installation and servicingprocedures. This includes

- the team of customers, internal , and suppliers that designed and approved the product- the product characteristics or requirements- the bill of material- the suppliers you buy it from (if purchased)- the customers you sell it to- all related documentation

Product – Characteristics

What are the productand processrequirements that mustbe controlled to meetdesign intent?


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- the equipment used to manufacture it- the gages used to inspect it- the Design FMEA, the Process Flow, the Process FMEA, and the control plan- a complete change history (ECR – engineering change requests)- links out to CAD drawing, operation sketches, pictures, etc.

NOTE 1 The extent of the quality management system documentation can differ from one organization toanother due to a) the size of the organization and type of activities, b) the complexity of processes and theirinteractions, and c) the competence of personnel.

The definition of a quality management system is the same, regardless of company size - just like anaccounting system. The amount and approach to documentation can be accommodated to match theorganization’s size within the IQS software.

NOTE 2 The documentation can be in any form or type of medium.

IQS software will manage and control both hard-copy and electronic documents.

4.2.2 Quality ManualThe organization shall establish and maintain a quality manual that includes:a) the scope of the quality management system, including details of and justification for anyexclusion and/or non-application (see 1.2),b) the documented procedures established for the quality management system, or reference tothem, andc) a description of the interaction between the processes of the quality management system. Thequality manual shall outline the structure of the documentation used in the quality managementsystem.


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The IQS Business Model provides the framework. IQS also provides Level I, II, III templates toassist your organization in creation of a robust quality manual. All the of quality manual contentsare controlled with the software.

4.2.3 Control of documentsDocuments required by the quality management system shall be controlled. Records are aspecial type of document and shall be controlled according to the requirements given in 4.2.4. Adocumented procedure shall be established to define the controls neededa) to review and approve documents for adequacy prior to issue,

IQS provides document management across the draft, revision, currency, and obsolescenceprocess.

b) to review and update as necessary and re-approve documents,

All new documents, and all change request require approval. Starting with a change request,


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If approved, a document approval workflow is defined.

NOTE: See related document on IQS compliance with 21CFR11 – Electronic Signature

Document Change Request

Manage documentchange requests.

What is the suggestedchange?

Who is responsible andwhen is it due to beclosed?

Who needs to approveand have they yet?

Are there any tasks thatneed to be completed?

Document Change Request – Approved By

The Document – Team –

Approved By list, includingHierarchy and Stop If Not

Approved information, isautomatically posted to theChange Request when theDocument ID is entered.

Email notification isavailable from the IQS MyTo Do List™ to tellindividuals that changerequests are pending theirapprovals.

Approved By records haveLogin / Password securityif your organizationrequires an ElectronicSignature process!


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c) to ensure that changes and the current revision status of documents are identified,

IQS maintains a complete archive and change history record.

d) to ensure that relevant versions of applicable documents are available at points of use,

Document – Change History

Track revision levels,revision dates, andunlimited text for allchanges made to adocument.

Depending on yourimplementation of thesystem this informationcan be entered manuallyor can automatically postfrom a DocumentChange Request.


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IQS also identifies that the people who need training on the new or changed document, andrecords of the training are maintained.

Document Change Request – Revision Update

Upon closing an ApprovedChange Request the

system will..

- Prompt the user to enterthe new Revision Level,Revision Date, andChange History text thatwill automatically post tothe ID.

- Archive (or make a copyof) the previous revision ofthe ID.

Document Change Request – Training Wizard

Upon closing an ApprovedJob Change Request thesystem will..

- Activate a TrainingWizard providing a list ofall personnel who need tobe re-trained because ofthe job revision.

- The Training Wizard willthen allow the creation of anew Training Course, or

Schedule a new date foran existing TrainingCourse and automaticallysign-up this personnel list.


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e) to ensure that documents remain legible and readily identifiable,

IQS controls, the ability to access the most current version. Printed copies are identified as“Uncontrolled Copies” and the system is the master record.

f) to ensure that documents of external origin are identified and their distribution controlled, and

IQS is designed to manage external documents, and can identify them as such. IQS linkcapability will directly reference and view external documents on external websites.

g) to prevent the unintended use of obsolete documents, and to apply suitable identification tothem if they are retained for any purpose.

Obsolete documents have a status of obsolete in IQS.

Documents – Reference Tab

What department “owns”the document?

What is the subject of thedocument?

If an external,document where isit located?

User Defined table fieldsand Reference text fieldsare provided tocustomize your trackingprocess!

Prompts on all IQS UserDefined fields andReference fields are re-

definable.


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- PROCESS: all process documentation (part number independent) material

- AUDIT MANAGER: audits, findings, and observations

- PPAP: entire PPAP process – new device submittal

- APQP: entire APQP process – new device development

- EQUIPMENT: all equipment information

- DEVICE: all measuring device information

- COLLECT: all inspection and test data- SPC: data analysis - charts - Cp - % conformance

- NCM: nonconformance and trends

- CORRECT: Corrective and Preventive Action (CAPA)

- QCOST: appraisal, failure versus prevention costs

5 Management responsib ility

5.1 Management commitmentTop management shall provide evidence of its commitment to the development andimplementation of the quality management system and maintaining its effectiveness bya) communicating to the organization the importance of meeting customer as well as statutory

and regulatory requirements,b) establishing the quality policy,

All of the quality management system policy and procedures are controlled within IQS. Alltraining on these documents is tracked in IQS.

c) ensuring that quality objectives are established,d) management reviews conducted,

All Management review meetings can be documented in IQS.


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e) ensuring the availability of resources.

The IQS Analytics Engine tracks and provides evidence of management commitment to theimplementation of the quality management system by reporting from the key modules listedbelow.

• EMPLOYEE provides the ability to define current resources and their skills.• EQUIPMENT provides the ability to manage manufacturing equipment, office equipment,

buildings, and other assets.

• DEVICE provides the ability to manage all the measuring and test equipment.

• The documentation suite (DOCUMENT, PROCESS, and PRODUCT) provide theinformation necessary to support the operations.

NOTE: For the purposes of this International Standard, statutory requirements are limited to the safetyand performance of the medical device only.

5.2 Customer focusTop management shall ensure that customer requirements are determined and are met (see7.2.1 and 8.2.1).

CUSTOMER goes beyond traditional CRM (Customer Relationship Management). CUSTOMERprovides one click access to a variety of customer transactions, including: a complete contact list,cross reference to the products sold to them, their ratings of performance, customer ownedgaging and tooling/equipment, all communication records (including complaints),nonconformances, change requests, corrective actions, etc.

Executive Reporting – Red, Yellow, Green


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5.3 Quality policyTop management shall ensure that the quality policya) is appropriate to the purpose of the organization,

b) includes a commitment to comply with requirements and to maintain the effectiveness of thequality management system,c) provides a framework for establishing and reviewing quality objectives,d) is communicated and understood within the organization, ande) is reviewed for continuing suitability.

IQS can document and track employee training of the Quality policy and Quality objectives asevidence of communication within the organization and Management commitment to carry outquality planning,

5.4 Planning

5.4.1 Quality objectivesTop management shall ensure that quality objectives, including those needed to meetrequirements for product [see 7.1 a)], are established at relevant functions and levels within theorganization. The quality objectives shall be measurable and consistent with the quality policy.

5.4.2 Quality management system planningTop management shall ensure thata) the planning of the quality management system is carried out in order to meet the requirementsgiven in 4.1, as well as the quality objectives, andb) the integrity of the quality management system is maintained when changes to the qualitymanagement system are planned and implemented.


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5.5 Responsibil ity, authority and communication

5.5.1 Respons ibility and authorityTop management shall ensure that responsibilities and authorities are defined, documentedand communicated within the organization. Top management shall establish the interrelation of all

personnel who manage, perform and verify work affecting quality, and shall ensure theindependence and authority necessary to perform these tasks.

NOTE: National or regional regulations might require the nomination of specific persons as responsible foractivities related to monitoring experience from the post-production stage and reporting adverse events (see8.2.1 and 8.5.1).

5.5.2 Management representativeTop management shall appoint a member of management who, irrespective of otherresponsibilities, shall have responsibility and authority that includesa) ensuring that processes needed for the quality management system are established,implemented and maintained,b) reporting to top management on the performance of the quality management system and anyneed for improvement (see 8.5), and

c) ensuring the promotion of awareness of regulatory and customer requirements throughoutthe organization.

NOTE: The responsibility of a management representative can include liaison with external parties onmatters relating to the quality management system.

EMPLOYEE provides the ability to define the Management Representative Job Description, and track theskills, along with the training required to execute the position.


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5.5.3 Internal communicationTop management shall ensure that appropriate communication processes are established withinthe organization and that communication takes place regarding the effectiveness of the qualitymanagement system.

EMPLOYEE provides complete tracking of internal communication.


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c) process performance and product conformity,


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d) status of preventive and corrective actions,


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e) follow-up actions from previous management reviews,


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f) changes that could affect the quality management system,


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g) recommendations for improvement, and

Show reports or graphs of:customer suggestionsemployee suggestionssupplier suggestionschange requests – document, process, product

h) new or revised regulatory requirements.

5.6.3 Review ou tputThe output from the management review shall include any decisions and actions related to

a) improvements needed to maintain the effectiveness of the quality management system and itsprocesses,b) improvement of product related to customer requirements, andc) resource needs.

EMPLOYEE can track the management review meetings and all action items or tasks.

In EMPLOYEE, Project Maintenance tasks coming from Management Review can: track all theassignments, bring action items to the employee or employees responsible for completing thetasks to their My To Do List, and control in a single system all the outputs from the meeting.


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6 Resource management

6.1 Provision of resourcesThe organization shall determine and provide the resources needed a) to implement the qualitymanagement system and to maintain its effectiveness, and b) to meet regulatory and customerrequirements.

6.2 Human resources

6.2.1 GeneralPersonnel performing work affecting product quality shall be competent on the basis ofappropriate education, training, skills and experience.

6.2.2 Competence, awareness and trainingThe organization shalla) determine the necessary competence for personnel performing work affecting product quality,

EMPLOYEE starts by defining skill files.

Skills – Skil l Tab

What are the skillsrequired to run yourorganization?

These skills can thenbe assigned to JobDescriptions andTraining Courses.

When Training Course Attendance records areentered, TrainingCourse Skills will postto the Employee Skillstable.


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EMPLOYEE then cross reference employee files for training gap analysis

Job Description

What are the jobsrequired to run your

organization?

Define the skills,documentation andeducation needed toattain a job title.

Complete revisioncontrol available if jobrequirements change.


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b) provide training or take other actions to satisfy these needs,

EMPLOYEE manages all the course inventory, course registration, and course attendancerecords.

Training Courses

A training course is anyform of education. Fromfive minute on the jobinstructions to acollegiate masterscourse.

Manage all trainingoffered internally by your

organization as well asexternally by schools,institutions, etc.

There are no right orwrong Training Courses,e.g., a Training Coursecould be created basedon a single procedureand another coursecould be created for allprocedures.


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c) evaluate the effectiveness of the actions taken,

Training Courses – Audience

For which departments / jobs is the training course

intended?

An Audience is a Function(Department), a Job, or acombination of the two.

Audience records areintegrated with theemployee table as eachemployee in the system isassigned a Function andJob code.

Based on the Audiencecode(s), the system will

query the employee tableand automatically sign-upall employees to a trainingcourse schedule.

Training Courses – Update Wizard

If a Training Course isrevised who needs tobe re-trained?

When a TrainingCourse is revised forany reason, e.g., Skillsare added, removed orrevised, Documentsare added, removed orrevised, the TrainingCourse Update Wizardautomates the processof re-training theappropriate personnel.


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d) ensure that its personnel are aware of the relevance and importance of their activities and howthey contribute to the achievement of the quality objectives, ande) maintain appropriate records of education, training, skills and experience (see 4.2.4).

NOTE National or regional regulations might require the organization to establish documented proceduresfor identifying training needs.

6.3 InfrastructureThe organization shall determine, provide and maintain the infrastructure needed to achieveconformity to product requirements. Infrastructure includes, as applicablea) buildings, workspace and associated utilities,b) process equipment (both hardware and software), andc) supporting services (such as transport or communication).

EQUIPMENT provides the ability to manage manufacturing equipment, office equipment,buildings, and other assets.

The organization shall establish documented requirements for maintenance activities, includingtheir frequency, when such activities or lack thereof can affect product quality. Records of suchmaintenance shall be maintained (see 4.2.4).

6.4 Work envi ronmentThe organization shall determine and manage the work environment needed to achieveconformity to product requirements. The following requirements shall apply.a) The organization shall establish documented requirements for health, cleanliness and clothingof personnel if contact between such personnel and the product or work environment couldadversely affect the quality of the product (see 7.5.1.2.1).b) If work environment conditions can have an adverse effect on product quality, the organizationshall establish documented requirements for the work environment conditions and documentedprocedures or work instructions to monitor and control these work environment conditions (see7.5.1.2.1).c) The organization shall ensure that all personnel who are required to work temporarily underspecial environmental conditions within the work environment are appropriately trained or

supervised by a trained person [see 6.2.2 b)].d) If appropriate, special arrangements shall be established and documented for the control ofcontaminated or potentially contaminated product in order to prevent contamination of otherproduct, the work environment or personnel (see 7.5.3.1).

7 Product realization

7.1 Planning of product realizationThe organization shall plan and develop the processes needed for product realization. Planningof product realization shall be consistent with the requirements of the other processes of thequality management system (see 4.1). In planning product realization, the organization shalldetermine the following, as appropriate:a) quality objectives and requirements for the product;

b) the need to establish processes, documents, and provide resources specific to the product;c) required verification, validation, monitoring, inspection and test activities specific to the productand the criteria for product acceptance;d) records needed to provide evidence that the realization processes and resulting productmeet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization’s method ofoperations. The organization shall establish documented requirements for risk management


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throughout product realization. Records arising from risk management shall be maintained (see4.2.4).

NOTE 1 A document specifying the processes of the quality management system (including the productrealization processes) and the resources to be applied to a specific product, project or contract, can bereferred to as a quality plan.

NOTE 2 The organization may also apply the requirements given in 7.3 to the development of productrealization processes.

NOTE 3 See ISO 14971 for guidance related to risk management.

IQS provides extensive product realization capability, starting with an overall project launch process in the APQP Manager.

This template drive approach provides flexibility to determine the product realization process for all, or typesof new products.


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The definition of requirements, include all of the following:

Product – Team

Teams are three listsmade up of employees,customers and suppliers.

Developed By – Whocreated the productdocument?

Distributed To – Whogets new revisions of theproduct document whena change is made?

Approved By – Whoneeds to approvechanges to the productdocument and is therean approval order fornotification?


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What are the productand processrequirements that mustbe controlled to meetdesign intent?

Product – Documents

Do we have a way tocross-reference thedocumentation requiredto produce a product?


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Product – Equipment

Do we have a way to

cross-reference themachines required tomanufacture a product?

Product – Devices

Do we have a way tocross-reference themeasuring devices usedto accept / rejectproduct?


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IQS provides process failure mode and effect analysis for risk mitigation.

Product – Process Flow

The Process Flow iswhere Operations are

defined and thecharacteristics to becontrolled in each areselected.

These operations andtheir characteristics areshared by the ProcessFMEA and ControlPlan.

Process FMEA

The Process / FunctionRequirements column isautomatically populated bythe Operation /Characteristic combinationdefined in the ProcessFlow.

Double-click to expand afield during data entry andediting.

- Unlimited Processes

- A Process can haveunlimited Failures andEffects- A Failure can haveunlimited Causes- A Cause can haveunlimited Actions


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Based on the risk analysis and the process flows, IQS then provides the ability to createcontrol plans to minimize risk.

All of the product realization process is done under a robust product change requestprocess and documents change history.

Product – Control Plan

The Part / ProcessNumber, Process Name/ Operation Description,Char No, Product,Process, Special CharClass fields areautomatically populatedwith each Operation /Char combinationdefined in the ProcessFlow.

Double-click to expand

a field during data entryand editing.

A Characteristic canhave unlimitedInspections.


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7.2 Customer-related processes

7.2.1 Determination of requirements related to the productThe organization shall determine

a) requirements specified by the customer, including the requirements for delivery and post-delivery activities,b) requirements not stated by the customer but necessary for specified or intended use, whereknown,c) statutory and regulatory requirements related to the product, and d) any additionalrequirements determined by the organization.

All product requirements are managed in a single view in IQS.

Product – Change History

Track revision levels,revision dates, and

unlimited text for allchanges made to aproduct.

Depending on yourimplementation of thesystem this informationcan be enteredmanually or canautomatically post froma Product ChangeRequest.


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All requirements can be further categorized for analysis and reporting.


What are the productand process

requirements that mustbe controlled to meetdesign intent?


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7.2.2 Review of requirements related to the productThe organization shall review the requirements related to the product. This review shall beconducted prior to the organization's commitment to supply a product to the customer (e.g.submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts ororders) and shall ensure thata) product requirements are defined and documented,b) contract or order requirements differing from those previously expressed are resolved, and

c) the organization has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review shall be maintained (see4.2.4).

Where the customer provides no documented statement of requirement, the customerrequirements shall be confirmed by the organization before acceptance.

Where product requirements are changed, the organization shall ensure that relevant documentsare amended and that relevant personnel are made aware of the changed requirements.

NOTE In some situations, such as internet sales, a formal review is impractical for each order. Instead thereview can cover relevant product information such as catalogues or advertising material.

7.2.3 Customer communicationThe organization shall determine and implement effective arrangements for communicating withcustomers in relation toa) product information,b) inquiries, contracts or order handling, including amendments,c) customer feedback, including customer complaints (see 8.2.1), andd) advisory notices (see 8.5.1)

IQS provides the framework for managing all customer communication, starting with acommunication record.


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If the communication results in a nonconformance, a Post NCM wizard automatically creates therelated NCM, and cross references the records for traceability.

Communication Records

Do we have a system totrack customer

complaints?

A log to manage allinterface, to and from,customers and potentialcustomers.

Not only can you satisfyISO requirements bytracking customercomplaints, but go to thenext level by enteringinformation requests,quotes, suggestions,emails, phone calls, etc.

Communication – Nonconformances

When the situationrequires it aCommunication recordcan be escalated byposting aNonconformance record.

The Communication andNonconformance recordsare then automaticallycross-referenced.


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7.3 Design and development

7.3.1 Design and development planning The organization shall establish documented

procedures for design and development. The organization shall plan and control the design anddevelopment of product. During the design and development planning, the organization shalldeterminea) the design and development stages,

APQP provides the framework for definition of the design and development stages.

All of the steps are defined.

APQP Project

What is the ProgramName?

Who is tracking theproject?

Who is responsible forthe project?

When is it due?


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Project – Steps

What are the projectsteps that need to be

completed for thisprogram?

Steps can be enteredmanually orautomatically postedfrom a Template.

Templates - Dependingon your businessprocess, differenttemplates can becreated and storedbased on customerrequirements, product

lines, etc.

Project – Steps – Assignment/Status

How do we assignresponsibility to a step?

When is it due?

Is the step open orclosed?

Do we track planned /actual dates to compareplanning andexecution?

Every APQP ProjectStep has an

Assignment / Statuswindow.


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b) the review, verification, validation and design transfer activities (see Note) that are appropriateat each design and development stage, and

c) the responsibilities and authorities for design and development.

All assignments and responsibilities are tracked.

All of these steps can be further supported with detailed process checklists and records.

Project Steps – Assignment/Status & Attachments

What is our proof astep is completed?

Attachments can beIQS system recordsor AdditionalDocuments.

Additional Documentsare external files:images,spreadsheets, wordprocessing, etc


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The organization shall manage the interfaces between different groups involved in design anddevelopment to ensure effective communication and clear assignment of responsibility.

This is one of the most powerful parts of the IQS software – a single enterprise database andbusiness process is used to assure interfaces with all groups. Everyone that logs into thesystem, regardless of their department – see their assignments in the My To Do List screen.

Planning output shall be documented, and updated as appropriate, as the design anddevelopment progresses (see 4.2.3).

NOTE: Design transfer activities during the design and development process ensure that design anddevelopment outputs are verified as suitable for manufacturing before becoming final productionspecifications.

7.3.2 Design and development inputsInputs relating to product requirements shall be determined and records maintained (see 4.2.4).These inputs shall includea) functional, performance and safety requirements, according to the intended use,b) applicable statutory and regulatory requirements,c) where applicable, information derived from previous similar designs,

d) other requirements essential for design and development, ande) output(s) of risk management (see 7.1).

These inputs shall be reviewed for adequacy and approved. Requirements shall be complete,unambiguous and not in conflict with each other.

7.3.3 Design and development outputsThe outputs of design and development shall be provided in a form that enables verificationagainst the design and development input and shall be approved prior to release. Design anddevelopment outputs shall

Project Steps – Assignment/Status & Checklists

Can we define achecklist(s) to assure

the proper completionof detailed steps?

Can a checklist havequestion(s) that needto be answered?

Can each checklistquestion be assignedto an employee with adue date?


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a) meet the input requirements for design and development,b) provide appropriate information for purchasing, production and for service provision,c) contain or reference product acceptance criteria, andd) specify the characteristics of the product that are essential for its safe and proper use.

Records of the design and development outputs shall be maintained (see 4.2.4).

NOTE: Records of design and development outputs can include specifications, manufacturingprocedures, engineering drawings, and engineering or research logbooks.

7.3.4 Design and development review At suitable stages, systematic reviews of design and development shall be performed inaccordance with planned arrangements (see 7.3.1)a) to evaluate the ability of the results of design and development to meet requirements, andb) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the designand development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and6.2.1).

Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

7.3.5 Design and development verificationVerification shall be performed in accordance with planned arrangements (see 7.3.1) to ensurethat the design and development outputs have met the design and development inputrequirements. Records of the results of the verification and any necessary actions shall bemaintained (see 4.2.4).

This part of the APQP process is directly entered into IQS.


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IQS records, processes, and maintains records of all change requests.

7.4 Purchasing

7.4.1 Purchasing processThe organization shall establish documented procedures to ensure that purchased productconforms to specified purchase requirements.

IQS provides extensive capability to management of suppliers.

The Purchasing process can be documented in DOCUMENT or PROCESS.

Example PURCHASING Model

Control# Description1.0.0 Supplier Management

1.1.0 Request for New Supplier

1.2.0 Preliminary Supplier Data1.3.0 Selection1.4.0 Supplier Surveys

1.4.1 Self1.4.2 On Site1.4.3 From Third Party

1.5.0 Trial Orders1.6.0 Approval1.7.0 Certification1.8.0 De-certification1.9.0 Nonconformance Reports1.10.0 Corrective Action Requests1.11.0 Purchase Order Quality Clauses1.12.0 Supplier Information Request1.13.0 Single Sourcing1.14.0 Use of Smell and Disadvantaged Business1.15.0 Supplier Education and Training

2.0.0 Negotiating2.1.0 Payment Terms2.2.0 Contracts2.3.0 Leases2.4.0 Blanket Purchase Orders2.5.0 Consignments2.6.0 Delivery Terms2.7.0 Termination of Agreements2.8.0 Long Term Partnerships2.9.0 Performance Based Contracts

3.0.0 Evaluating3.1.0 Value Analysis

3.1.1 Value Definition3.1.2 Cost, Demand, Quality Parameters3.1.3 Technological Forecasting

3.2.0 Pricing Analysis3.2.1 Administered Prices3.2.2 Cost Buy Analysis3.2.3 Marginal Cost Pricing


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3.2.4 Discounts3.2.5 Forward Buying3.2.6 Competitive Bidding3.2.7 Learning Curve Analysis3.2.8 Terms3.2.9 Escalator Clauses

3.3.0 Supplier Performance3.4.0 Potential Suppliers

4.0.0 Ordering4.1.0 Direct Material4.2.0 Indirect Material4.3.0 Services4.4.0 Purchase Requisitions4.5.0 Blanket Purchase Orders4.6.0 Sealed Bids

5.0.0 Quantity and Inventory Control5.1.0 Responsibility for Determination5.2.0 Declining Inventory by Value/Use5.3.0 ABC Analysis5.4.0 Control Systems

5.5.0 Order Point - Safety Stock5.6.0 Just-In-Time Purchasing

6.0.0 Business Law Issues5.1.0 Uniform Commercial Code5.2.0 Contract Law5.3.0 Contract Performance5.4.0 Warranty and Contract Compliance

7.0.0 Expediting7.1.0 Order Follow Up7.2.0 Specification Changes

8.0.0 Budgeting9.0.0 Information System

9.1.0 Purchase Order Status

9.2.0 Supplier Product Catalogs9.3.0 New Product Communication9.4.0 Potential New Suppliers9.5.0 Delivery Status9.6.0 Supplier Status

10.0.0 Disposal System10.1.0 Product Scrap10.2.0 Hazardous Waste10.3.0 Surplus Equipment10.4.0 Surplus Materials

11.0.0 Purchasing Performance Indicators11.1.0 Performance Objectives11.2.0 Department Analysis

11.3.0 Buyer Analysis

The type and extent of control applied to the supplier and the purchased product shall bedependent upon the effect of the purchased product on subsequent product realization or the finalproduct.

IQS provides the ability to audit suppliers based on supplier types and associated risks.


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All audit findings can be documented for follow-up.

Audit – Audit Tab

Do we have a masterlist of all our supplier

audits and auditquestions?

Can we track revisionchanges on supplieraudits when questionsare removed or added?

Use audits to helpsuppliers define areasof their organization thatneed improvement.

Audit Schedule – Schedule Tab

Do we have a system thatallows us to schedulesupplier audits?

Can we implement anaudit or audits to aspecific customer everysix months?

Do we have a validauditors list or can anyemployee audit asupplier?

An Audit Result record

becomes the Last Date,the system thenautomatically calculatesthe Next Date based onthe Interval.


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Audit Result – Result Tab

Enter audit results to:

1) Document resultvalues, and..

2) Automaticallycalculate an audit’s lastand next dates if it isscheduled.

When question resultvalues are entered thesystem will post ascore.

The Total Score can beposted as an SupplierRating record.

Audit Result – Nonconformances

When the situationrequires it an Audit

Result record can beescalated by posting aNonconformancerecord.

The Audit Result andNonconformancerecords are thenautomatically cross-referenced.


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7.4.3 Verification of purchased productThe organization shall establish and implement the inspection or other activities necessary forensuring that purchased product meets specified purchase requirements.

IQS provides powerful receiving inspection and dock-to-stock business rules when integrated withERP software.

Supply Chain Tracking


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Receiving Inspection Plans

Receiving Inspection Results


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If a problem is found in receiving, or anywhere a Supplier NCM is created.

Skip Lot Management

Receipts are downloaded from ERP System

Supplier Nonconformances


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Repeated, or high-risk, issues can automatically create Supplier CAPA records.

IQS further enables Supplier involvement with Web Access.

Corrective Action Requests


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Where the organization or its customer intends to perform verification at the supplier’s premises,the organization shall state the intended verification arrangements and method of product releasein the purchasing information.

Records of the verification shall be maintained (see 4.2.4)

All of the supplier management activities define the basis for Supplier Approval Status.

Supplier Web Access


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Placing all of the information into IQS provides the ability to create automatically 100% defensiblesupplier scorecards.

IQS provides Purchasing with single screen access to pertinent supplier information

Supplier Approval Status

Status

• Pending• Approved• Not Approved• Suspended

By Part Number

By Entity

Supplier Scorecards


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7.5 Production and service provis ion

7.5.1 Control of production and service provision

7.5.1.1 General requirements The organization shall plan and carry out production and service provision under controlledconditions. Controlled conditions shall include, as applicablea) the availability of information that describes the characteristics of the product,

All product characteristics and revision history is maintained in IQS.

A Single Screen to Access Supplier Information


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b) the availability of documented procedures, documented requirements, work instructions, andreference materials and reference measurement procedures as necessary,

All related product information is available from a single screen in IQS.


What are the productand process

requirements that mustbe controlled to meetdesign intent?


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c) the use of suitable equipment,d) the availability and use of monitoring and measuring devices,e) the implementation of monitoring and measurement,f) the implementation of release, delivery and post-delivery activities, andg) the implementation of defined operations for labeling and packaging.

The organization shall establish and maintain a record (see 4.2.4) for each batch of medicaldevices that provides traceability to the extent specified in 7.5.3 and identifies the amountmanufactured and amount approved for distribution. The batch record shall be verified andapproved.

NOTE: A batch can be a single medical device.

7.5.1.2 Control of production and service provision — Specific requirements

7.5.1.2.1 Cleanliness of product and contamination control

The organization shall establish documented requirements for cleanliness of product ifa) product is cleaned by the organization prior to sterilization and/or its use, orb) product is supplied non-sterile to be subjected to a cleaning process prior to sterilization and/orits use, orc) product is supplied to be used non-sterile and its cleanliness is of significance in use, ord) process agents are to be removed from product during manufacture.

If product is cleaned in accordance with a) or b) above, the requirements contained in 6.4 a) and6.4 b) do not apply prior to the cleaning process.


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NOTE Servicing can include, for example, repair and maintenance.

7.5.1.3 Particular requirements for sterile medical devicesThe organization shall maintain records of the process parameters for the sterilization processwhich was used for each sterilization batch (see 4.2.4). Sterilization records shall be traceable toeach production batch of medical devices (see 7.5.1.1).

7.5.2 Validation of processes for product ion and service provis ion

7.5.2.1 General requirements

The organization shall validate any processes for production and service provision where theresulting output cannot be verified by subsequent monitoring or measurement. This includes anyprocesses where deficiencies become apparent only after the product is in use or the service hasbeen delivered.

Validation shall demonstrate the ability of these processes to achieve planned results.

The organization shall establish arrangements for these processes including, as applicablea) defined criteria for review and approval of the processes,

Equipment – PM Activit ies – PM Activity Tab

Define an unlimitednumber of scheduled

preventive maintenanceactivities for each pieceof equipment.

Who performs themaintenance?

Is it scheduled bycalendar days, usage orwhatever comes first?

What is themaintenance interval indays?

When is the last time itwas done and when is itdue next?


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IQS provides the ability to document the process and audit the process then document the auditfindings.

b) approval of equipment and qualification of personnel,c) use of specific methods and procedures,d) requirements for records (see 4.2.4), ande) revalidation.

The organization shall establish documented procedures for the validation of the application ofcomputer software (and changes to such software and/or its application) for production andservice provision that affect the ability of the product to conform to specified requirements. Suchsoftware applications shall be validated prior to initial use.

Records of validation shall be maintained (see 4.2.4)

7.5.2.2 Particular requirements for sterile medical devices The organization shall establishdocumented procedures for the validation of sterilization processes. Sterilization processes shallbe validated prior to initial use. Records of validation of each sterilization process shall bemaintained (see 4.2.4).

7.5.3.1 IdentificationThe organization shall identify the product by suitable means throughout product realization, andshall establish documented procedures for such product identification.

The organization shall establish documented procedures to ensure that medical devices returnedto the organization are identified and distinguished from conforming product [see 6.4 d)].

7.5.3.2 Traceability

7.5.3.2.1 GeneralThe organization shall establish documented procedures for traceability. Such procedures shalldefine the extent of product traceability and the records required (see 4.2.4, 8.3 and 8.5).

Where traceability is a requirement, the organization shall control and record the uniqueidentification of the product (see 4.2.4).

NOTE Configuration management is a means by which identification and traceability can be maintained.

IQS provides the ability to document all final medical device configurations, including serialized

subcomponents and versions of all related documentation shipped with the product with the Assembly AsBuilt Traceability functionality. The Assembly Maintenance screen will define the AssemblyProduct ID and Serial Number and then provide a table for listing all the components andcomponent serial numbers. The final assembly approval off process and shipping approvals arealso logged.

Assembly Maintenance Screen


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The components list automatically generates Product’s BOM listing.

Assembly – Components Maintenance Wizard

The + sign indicates that there is indented BOM information under the row that belongs to theProduct. The > symbol indicates that this is a BOM product for the row with the + above it.

Multiple documents like assembly manuals, installation instructions, etc. with the version of theenclosures, as well as any Microsoft recognizable document, can be attached to the assemblyshipment record.

The reporting capability is significant, for both pre- and post-shipment analysis. With a singlereport, there is verification that all corrective actions and nonconformances for all serial numbersfor all component and final assembly are closed, prior to shipment. When a warranty claim orReturned Material Authorization is issued, again, with a single report, detailed information isprovided about who, what, when, and how the product was manufactured.

7.5.3.2.2 Particular requirements for active implantable medical devices and implantablemedical devices

In defining the records required for traceability, the organization shall include records of allcomponents, materials and work environment conditions, if these could cause the medical devicenot to satisfy its specified requirements.


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The organization shall require that its agents or distributors maintain records of the distribution ofmedical devices to allow traceability and that such records are available for inspection.

Records of the name and address of the shipping package consignee shall be maintained (see4.2.4).

7.5.3.3 Status identificationThe organization shall identify the product status with respect to monitoring and measurementrequirements. The identification of product status shall be maintained throughout production,storage, installation and servicing of the product to ensure that only product that has passed therequired inspections and tests (or released under an authorized concession) is dispatched, usedor installed.

7.5.4 Customer propertyThe organization shall exercise care with customer property while it is under the organization’scontrol or being used by the organization. The organization shall identify, verify, protect andsafeguard customer property provided for use or incorporation into the product. If any customerproperty is lost, damaged or otherwise found to be unsuitable for use, this shall be reported to thecustomer and records maintained (see 4.2.4).

NOTE Customer property can include intellectual property or confidential health information.

Physical customer assets are managed in EQUIPMENT.

Any form of customer specific information can be controlled in CUSTOMER.


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7.5.5 Preservation of product

The organization shall establish documented procedures or documented work instructions forpreserving the conformity of product during internal processing and delivery to the intendeddestination. This preservation shall include identification, handling, packaging, storage andprotection. Preservation shall also apply to the constituent parts of a product. The organizationshall establish documented procedures or documented work instructions for the control of productwith a limited shelf-life or requiring special storage conditions. Such special storage conditionsshall be controlled and recorded (see 4.2.4).

7.6 Control of monitoring and measuring devicesThe organization shall determine the monitoring and measurement to be undertaken and themonitoring and measuring devices needed to provide evidence of conformity of product todetermined requirements (see 7.2.1).

DEVICE provides complete control for monitoring and measuring devices.

What are IQS Links?

The ability to link an

IQS database record toexternal files, e.g.,images, spreadsheets,word processing, isavailable with everysolution in the IQSQuality PerformanceManagement System™.

Tell the system theapplication that createdthe file, the path tolocate the file, and itcan be launched fromIQS!

And if your organizationprefers, files can alsobe embedded in thedatabase.


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b) be adjusted or re-adjusted as necessary;

Device – Calibration Info Tab

Who calibrates thisdevice?

Is calibration scheduledby calendar days, usageor both?

What is the interval indays this device comesdue for calibration?

Do we want the systemto warn us when deviceis coming due?

When is the last time thedevice was calibratedand when is it duenext?

Calibration – Characteristics

An actual result andafter adjustment resultwhen necessary can berecorded for eachDevice Characteristic.

Results are Yes / No for Attribute Characteristicsand numeric for VariableCharacteristics.

Device Characteristicsautomatically load when

the Device ID is entered.


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c) be identified to enable the calibration status to be determined;

d) be safeguarded from adjustments that would invalidate the measurement result;

e) be protected from damage and deterioration during handling, maintenance and storage.

In addition, the organization shall assess and record the validity of the previous measuringresults when the equipment is found not to conform to requirements. The organization shall takeappropriate action on the equipment and any product affected. Records of the results ofcalibration and verification shall be maintained (see 4.2.4). When used in the monitoring andmeasurement of specified requirements, the ability of computer software to satisfy the intendedapplication shall be confirmed. This shall be undertaken prior to initial use and reconfirmed asnecessary.


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NOTE See ISO 10012 for guidance related to measurement management systems.

8 Measurement, analysis and improvement

8.1 GeneralThe organization shall plan and implement the monitoring, measurement, analysis andimprovement processes neededa) to demonstrate conformity of the product,b) to ensure conformity of the quality management system, andc) to maintain the effectiveness of the quality management system.

This shall include determination of applicable methods, including statistical techniques, and theextent of their use.

NOTE National or regional regulations might require documented procedures for implementation and controlof the application of statistical techniques

8.2.1 Feedback

As one of the measurements of the performance of the quality management system, theorganization shall monitor information relating to whether the organization has met customerrequirements. The methods for obtaining and using this information shall be determined. Theorganization shall establish a documented procedure for a feedback system [see 7.2.3 c)] toprovide early warning of quality problems and for input into the corrective and preventive actionprocesses (see 8.5.2 and 8.5.3). If national or regional regulations require the organization to gainexperience from the post-production phase, the review of this experience shall form part of thefeedback system (see 8.5.1).

Calibration – Nonconformances

Can we escalate theissue and post the

Calibration record to aNonconformance?

The Calibration andNonconformancerecords are thenautomatically cross-referenced.


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8.2.2 Internal audi tThe organization shall conduct internal audits at planned intervals to determine whether thequality management systema) conforms to the planned arrangements (see 7.1), to the requirements of this InternationalStandard and to the quality management system requirements established by the organization,andb) is effectively implemented and maintained.

An audit program shall be planned, taking into consideration the status and importance of theprocesses and areas to be audited, as well as the results of previous audits. The audit criteria,scope, frequency and methods shall be defined. Selection of auditors and conduct of audits shallensure objectivity and impartiality of the audit process. Auditors shall not audit their ownwork. The responsibilities and requirements for planning and conducting audits, and for reportingresults and maintaining records (see 4.2.4) shall be defined in a documented procedure. Themanagement responsible for the area being audited shall ensure that actions are taken withoutundue delay to eliminate detected nonconformities and their causes. Follow-up activities shallinclude the verification of the actions taken and the reporting of verification results (see 8.5.2).

NOTE See ISO 19011 for guidance related to quality auditing.

8.2.3 Monitoring and measurement o f processesThe organization shall apply suitable methods for monitoring and, where applicable,measurement of the quality management system processes. These methods shall demonstratethe ability of the processes to achieve planned results. When planned results are not achieved,correction and corrective action shall be taken, as appropriate, to ensure conformity of theproduct.

8.2.4 Monitoring and measurement of product

8.2.4.1 General requirementsThe organization shall monitor and measure the characteristics of the product to verify thatproduct requirements have been met. This shall be carried out at appropriate stages of theproduct realization process in accordance with the planned arrangements (see 7.1) and

documented procedures (see 7.5.1.1).

Evidence of conformity with the acceptance criteria shall be maintained. Records shall indicatethe person(s) authorizing release of product (see 4.2.4). Product release and service deliveryshall not proceed until the planned arrangements (see 7.1) have been satisfactorily completed.

8.2.4.2 Particular requirement for active implantable medical devices and implantablemedical devicesThe organization shall record (see 4.2.4) the identity of personnel performing any inspection ortesting.

8.3 Control of nonconforming productThe organization shall ensure that product which does not conform to product requirements is

identified and controlled to prevent its unintended use or delivery. The controls and relatedresponsibilities and authorities for dealing with nonconforming product shall be defined in adocumented procedure. The organization shall deal with nonconforming product by one or moreof the following ways:a) by taking action to eliminate the detected nonconformity;b) by authorizing its use, release or acceptance under concession;c) by taking action to preclude its original intended use or application. The organization shallensure that nonconforming product is accepted by concession only if regulatory requirements aremet.


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Records of the identity of the person(s) authorizing the concession shall be maintained (see4.2.4). Records of the nature of nonconformities and any subsequent actions taken, includingconcessions obtained, shall be maintained (see 4.2.4). When nonconforming product is correctedit shall be subject to re-verification to demonstrate conformity to the requirements. Whennonconforming product is detected after delivery or use has started, the organization shall takeaction appropriate to the effects, or potential effects, of the nonconformity.

If product needs to be reworked (one or more times), the organization shall document the reworkprocess in a work instruction that has undergone the same authorization and approval procedureas the original work instruction. Prior to authorization and approval of the work instruction, adetermination of any adverse effect of the rework upon product shall be made and documented(see 4.2.3 and 7.5.1).

8.4 Analys is of dataThe organization shall establish documented procedures to determine, collect and analyzeappropriate data to demonstrate the suitability and effectiveness of the quality managementsystem and to evaluate if improvement of the effectiveness of the quality management systemcan be made.

This shall include data generated as a result of monitoring and measurement and from other

relevant sources. The analysis of data shall provide information relating toa) feedback (see 8.2.1),b) conformity to product requirements (see 7.2.1),c) characteristics and trends of processes and products including opportunities for preventiveaction, andd) suppliers. Records of the results of the analysis of data shall be maintained (see 4.2.4).

8.5 Improvement

8.5.1 GeneralThe organization shall identify and implement any changes necessary to ensure and maintain thecontinued suitability and effectiveness of the quality management system through the use of thequality policy, quality objectives, audit results, analysis of data, corrective and preventive actions

and management review. The organization shall establish documented procedures for the issueand implementation of advisory notices. These procedures shall be capable of beingimplemented at any time. Records of all customer complaint investigations shall be maintained(see 4.2.4). If investigation determines that the activities outside the organization contributed tothe customer complaint, relevant information shall be exchanged between the organizationsinvolved (see 4.1). If any customer complaint is not followed by corrective and/or preventiveaction, the reason shall be authorized (see 5.5.1) and recorded (see 4.2.4). If national or regionalregulations require notification of adverse events that meet specified reporting criteria, theorganization shall establish documented procedures to such notification to regulatory authorities.

8.5.2 Correct ive actionThe organization shall take action to eliminate the cause of nonconformities in order to preventrecurrence. Corrective actions shall be appropriate to the effects of the nonconformities

encountered. A documented procedure shall be established to define requirements fora) reviewing nonconformities (including customer complaints),b) determining the causes of nonconformities,c) evaluating the need for action to ensure that nonconformities do not recur,d) determining and implementing action needed, including, if appropriate, updatingdocumentation (see 4.2),e) recording of the results of any investigation and of action taken (see 4.2.4), andf) reviewing the corrective action taken and its effectiveness.


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8.5.3 Preventive action The organization shall determine action to eliminate the causes ofpotential nonconformities in order to prevent their occurrence. Preventive actions shall beappropriate to the effects of the potential problems. A documented procedure shall be establishedto define requirements fora) determining potential nonconformities and their causes,b) evaluating the need for action to prevent occurrence of nonconformities,c) determining and implementing action needed,d) recording of the results of any investigations and of action taken (see 4.2.4), ande) reviewing preventive action taken and its effectiveness