Comparison ISO 9000_2000 vs ISO 13485_2003

8/11/2019 Comparison ISO 9000_2000 vs ISO 13485_2003

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ISO13485:2003 VS

ISO 9001:2000Ritesh Chintakuntla


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Why not adopt ISO 9001:2000 ?

!

The Medical Device Industry did not agree with allthe changes to ISO 9001:2000

! Harmonizing with the QSR (GMP) requirements

! ISO 9001:2000 places an emphasis on ContinualImprovement and Customer Satisfaction! Harmonizing EN 4600X Standards with ISO 13485

!

Not user friendly

! Lacked Process orientation

!

Could not tailor ISO to scope of registration(service)


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ISO 13485 Series Standards - QMS

! ISO 9000: Quality management system fundamentals and

vocabulary

! Except as noted in section 3 of 13485

! ISO 13485: Quality Management System Requirements

! combines ISO 13485 and 13488

! limitations will be indicated on certificate

! ISO/TS 14969: Quality Management Systems-Medical

Devices-Guidance on the Application of ISO 13485


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What has Changed?

ISO13485 now has a totally new structure,

! 20 elements is too linear,

! Adopted process approach

! Emphasis is now on regulatory requirements for a quality management

system rather than a quality assurance system.

! Increased attention to production of a conforming product and delivery of

a conforming service is included in and is part of the quality management

system.

! There is now only one management system requirement standard, i.e.

ISO

13485, where previously there were two requirement standards: ISO

13485 and ISO 13488.


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2003 Changes Continued

! Went from 20 elements to 8! Elements 4-8 contain all the requirements

! Emphasis on Consistency through Documentation

! Does Allow for permissible exclusions

! Exclusions need justification!

! Organization replaces supplier to refer to the company

implementing the standard

! Supplier replaces subcontractor when referring to

companies that your company purchases goods andservices from


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2003 Changes - Continued

! Top Management must be involved in establishing andcommunicating the purpose and direction of theorganization

! The management system begins and ends with objectives

established by Top management!

Top management responsibility for profit or loss*

! Top Management needs to create an atmosphere inwhich people are not afraid to become involved, anddesire to help the company meet its goals andobjectives


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Why Cant the FDA change Part 820 to

harmonize it with 9000:2000

! The FDA and medical device regulators take issue with following ISO9001:2000 philosophies:

! Customer Satisfaction- goes above and beyond the safety and efficacyof medical devices. Evaluating customer satisfaction beyond safety isnot FDAs purpose

! Continuous Improvement- done simply for the sake of operating moreefficiently is outside the scope of medical device regulatory agencies.

! Documentation- documentation is needed to know what a companyintends to do and what they actually did- ISO 9001:2000 requires lessdocumentation than does 13485:2003

! Process Approach- FDA does not feel its necessary for companies tochange the structure of their documentation.

! FDA is assuming the purpose of the change in ISO is a change indocumentation and that companies do not already use the processapproach.


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FDA/QSR harmonization with the ISO Standards

! The FDA is planning on some level of harmonization with

ISO 13485 in late 2002 early 2003.

! Provided that ISO 13485 will remain more true to the medical

device/regulatory viewpoint

! Many other countries rely on ISO standards in regulatingmedical devices.

! Promotes International Consistency.

! FDA and device regulatory agencies from other countries

can more readily rely on one another's inspections andexchange inspection reports if the quality system

requirements are similar.


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Why Would Medical Device Manufacturers want to maintain ISO

9001:2000 Certification as well as 13485:2003

! Customers (Doctors, Hospitals, OEMs) perceive a level of

security in knowing they are buying from a manufacturer that

has an ISO 9001 certified system.

! Helps companies obtain product certification CE mark,

! Companies do not have to be ISO certified to get CE Mark

! Depending on the product or service companies could opt for

ISO 17025


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Permissible Exclusions - Allowable

! (7.5.3) Identification and traceability - only partially

applicable where there is no specific traceability requirementfor the organizations product

! (7.5.2) Customer property - Nothing is provided from thecustomer to the supplier in the realization of its products or

processes

! (7.6) The organizations needs no measuring and test equipmentto provide evidence of conformity


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Differences


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Guidance standards

ISO 14969:200X will be the guidance document for

implementation to 13485:2003

!Section 3 of ISO 13485 has additional Terms and

Definitions not included in ISO 9000:2000

ISO 9000:2000 and ISO 9004:2000 used as consistent

pair


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Differences: Section 4.1

! 13485: "Maintain the Effectiveness of these

processes"

! Records that you are meeting requirements and statedobjectives

! 9001:2000: Continual Improvement of these

Processes


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Differences: Section 4.2.3

! Organization must define the period for retention of

obsolete documents

! Duration must be for the life of the device

!

or as specified by relevant regulatory requirements(GMP/GLP)

! 9001:2000 Does not specify retention times


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Differences: Section 5

! Section 5.1 of 13485:2003 does not require "Continually

Improving its effectiveness"

! ISO 9001:2000 does.

! Section 5.2 of 13485:2003 focus is on meeting the customers

needs! 9001:2000 is focused on meeting and exceeding the customers needs.

! Section 5.3 of 13485:2003 emphasizes maintaining the system

! 9001:2000 talks about continual improvement


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! Section 6.2.2 of 13485:2003 Requires a procedure

for training where as ISO 9001:2000 does not.

! Section 6.4 Work Environment of 13485:2003 is

more detailed (i.e. health records, cleanliness ofclothing and personnel, environmental

monitoring) than the same section in 9001:2000


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! Section 7.3 Design and Development of 13485:2003references ISO 14971 (Risk Analysis) 9001:2000 does not.

! Section 7.5.1 of 13485:2003 has added sub-clause G, whichtalks about packaging and labeling.

!

Section 7.5.1.1 Cleanliness of Product and contaminationcontrol (Cleaning of product) is added for 13485:2003

! Section 7.5.1.2 Installation (Installing the Device) is added for13485:2003

! Section 7.5.1.3 Servicing (After the Device is installed) is

added for 13485:2003


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Differences: Section 7 - contd

! Section 7.5.2 Validation of processes for production and service

provision- additional requirements for 13485:

! The organization shall establish and maintain documented procedures for

the validation of the application of computer software (and changes to

such software and/or its application) for production and service

operations and measuring and monitoring operations (see 8.2) that affectthe ability of the product to conform to specified requirements. Such

software applications shall be validated prior to initial use. The results of

validation shall be recorded (see 4.2.4).

Particular requirement for sterile medical devices:

!

The organization shall subject the medical device to a validatedsterilization process and record all the process parameters of the

sterilization process (see 4.2.4).


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Differences: Section 7 - contd!

Section 7.5.3 Identification and Traceability- additional requirements for13485:

! Particular requirements for active implantable medical devices and

implantable medical devices:

! a) When defining the extent of traceability, the organization shall include

all components and materials used, and records of the environmentalconditions when these could cause the medical device not to satisfy its

specified requirements.

! b) The organization shall require that its agents or distributors maintain

records of the distribution of medical devices with regard to traceability

and that such records are available for inspection.

! c) The organization shall ensure that the name and address of the

shipping package consignee is recorded (see 4.2.4).


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Section 7.5.5 Preservation of product-

additional requirements for 13485:

! The organization shall establish and maintain documented

procedures for the control of product with a limited shelf-lifeor requiring special storage conditions. Such special storage

conditions shall be controlled and recorded. (FIFO)


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! Section 8.1 Measurement, analysis and

Improvement- additional Requirements for 13485:

! If statistical techniques are used, organization shall establish andmaintain documented proceduresto implement and control their

application.


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!Section 8.2.1 Customer Feedback-

Additional Requirements for 13485:! The organization shall establish and maintain a documented feedback

system to provide early warning of quality problems and for input into the

corrective and preventive action system [see 7.2.3c)].

! If regulations require the organization to gain experience from the post-

production phase, the review of this experience shall form part of the

feedback system (see 8.5.1).


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Section 8.2.4 Monitoring and measurement of Product- additional requirements for

13485:

!Particular requirement for active implantable devices and implantable devices:

!The organization shall record (see 4.2.4) the identity of personnel performing anyinspection or testing.

Section 8.3 Control of nonconforming product- additional requirements for 13485:

!If product needs to be reworked (one or more times), the organization shall document

the rework in a work instruction that has undergone the same authorization andapproval procedure as the original work instruction. Prior to authorization and

approval, a determination of any adverse effect of the rework upon product shall be

made and documented.


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Requirements for Documents 92K

!

ISO 9001:2000 requires a minimum of 6 procedures.

! Quality Manual

! 4.2.3 Control of Documents

! 4.2.4 Control of Records! 8.2.2 Internal Audit

! 8.5.2 Corrective Action

! 8.5.3 Preventive Action


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Requirements for documents 13485

ISO 13485:2003 requires a minimum of 19 procedures!

! Quality Manual

! 4.2.3 Control of Documents

! 4.2.4 Control of Records

! 6.2.2 Competence, awareness and training

!

7.3 Design and Development

! 7.4.1 Purchasing Process

! 7.5.1.2 Installation activities (if applicable)!

7.5.1.3 Servicing activities (when required)

! 7.5.3.1 Identification

! 7.5.3.2 Traceability

! 7.5.5 Preservation of Product

! 7.6 Control of Measuring and Monitoring Devices

! 8.1 Statistical Techniques (if used)

! 8.2.2 Internal Audits

! 8.3 Control of nonconforming product

! 8.4 Analysis of Data

! 8.5 Improvement

!

8.5.2 Corrective Action

! 8.5.3 Preventive Action


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ISO 13485:2003 Certification = Certification to ISO

9001:2000???

! ISO 13485 is a stand alone standard

! It is basedon ISO 9001:2000.

! Primary objective of ISO13485 is to facilitate harmonized medicaldevice regulatory requirements.

!

Includes some particular requirements for medical devices andexcludes some of the ISO 9001:2000 requirements

!

These exclusions prevent users from claiming conformity withISO9001:2000!


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