ISO 13485:2016 The Next Revision - DQS Inc. 13485:2016 – The Next Revision ... Relationship to ISO...

ISO 13485:2016 –

The Next Revision

Richard (Rick) Burgess

Medical Program Manager

30 March 2016

© DQS Group 1 March 31, 2016

ISO 13485:2016 – The Next Revision

March 31, 2016 © DQS Group 2

Agenda and Scope

Relationship to ISO 9001

New requirements

Transition Timing

Questions

ISO 13485:2016 - Putting the pieces together


Structure



Structure

Based on ISO 9001:2008



Structure


Does not follow the new high level

structure of ISO 9001:2015



Structure


Does not follow the new high level

structure of ISO 9001:2015

Annex B shows the corresponding sections

of ISO 9001:2015



Considerations for the changes:

Regulatory requirements





Risk Management





Risk Management

Supplier controls





Risk Management

Supplier controls

Feedback





Risk Management

Supplier controls

Feedback

Verification, Validation and Design Transfer





Risk Management

Supplier controls

Feedback

Verification, Validation and Design Transfer

Clarifications

ISO 13485:2003 vs ISO 13485:2016

2003

• Requirements for QMS that can be used by an organization for:

• design and development

• production

• installation and servicing of medical devices

• design, development, and provision of related services.

• Can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements.

2016

• Requirements for QMS that can be used by an organization involved in one or more stages of the life-cycle of a medical device:

• design and development

• production

• storage and distribution

• installation

• servicing

• final decommissioning and disposal of medical devices

• and design and development, or provision of associated activities (e.g. technical support).

• Can also be used by suppliers or other external parties providing product (e.g. raw materials, components, subassemblies, medical devices, sterilization services, calibration services, distribution services, maintenance services) to such organizations. The supplier or external party can voluntarily choose to conform to the requirements of this International Standard or can be required by contract to conform.


0.1 General

ISO 13485:2003 vs ISO 13485:2016

2016

• When a requirement is qualified by the phrase “as appropriate”, it is deemed to be appropriate unless the organization can justify otherwise. A requirement is considered appropriate if it is necessary for:

• product to meet requirements;

• compliance with applicable regulatory requirements;

• the organization to carry out corrective action;

• the organization to manage risks.


0.2 Clarification of concepts

ISO 13485:2003 vs ISO 13485:2016

2016

• When the term “risk” is used, the application of the term within the scope of this International

• Standard pertains to safety or performance requirements of the medical device or meeting applicable regulatory requirements.

• — When a requirement is required to be “documented”, it is also required to be established, implemented and maintained.

• — When the term “product” is used, it can also mean “service”. Product applies to output that is intended for, or required by, a customer, or any intended output resulting from a product realization process.



ISO 13485:2003 vs ISO 13485:2016

2016

• In this International Standard, the following verbal forms are used:

• “shall” indicates a requirement;

• “should” indicates a recommendation;

• “may” indicates a permission;

• “can” indicates a possibility or a capability.

• “Regulatory requirements” encompasses requirements contained laws applicable to the user of this standard. The application of “regulatory requirements” is limited to requirements for the QMS and the safety or performance of the medical device.



ISO 13485:2003 vs ISO 13485:2016

2016

• a) understanding and meeting requirements;

• b) considering processes in terms of added value;

• c) obtaining results of process performance and effectiveness;

• d) improving processes based on objective measurement.


0.3 Process Approach

ISO 13485:2003 vs ISO 13485:2016

2016

• Applicability to organizations that are involved in one or more stages of the life-cycle of a medical device.

• Use by suppliers or external parties that provide product, including quality management system-related services to medical device organizations.

• Identifies responsibilities for monitoring, maintaining, and controlling outsourced processes.

• Allows for clauses 6, 7 and 8 to be not applicable.

• Clarifies that the term “regulatory requirements”


1 Scope

ISO 13485:2003 vs ISO 13485:2016

Several new definitions added and some existing definitions refined

• Customer complaint - complaint

• Distributor

• Importer

• Labeling – redefined

• Life-cycle

• Manufacturer

• Medical Device Family

• Performance Evaluation

• Post-market surveillance

• Product

• Purchased Product

• Risk

• Risk management

• Sterile Barrier System


3 Terms and Definitions

ISO 13485:2003 vs ISO 13485:2016

• Requirements to document the role(s) of the organization based on applicable regulatory requirements

• Determine the processes needed and application of those processes – taking into account the roles of the organization

• Apply risk based approach to control of appropriate processes needed for QMS

• Processes changes to be evaluated for impact on QMS and products produced

• Validation of computer software utilized in the QMS


4.1 General Requirements

ISO 13485:2003 vs ISO 13485:2016

• Defines contents of medical device file

• Description, purpose, labeling, IFU

• Product specifications

• Manufacturing procedures

• Monitoring and measuring procedures

• Requirements/Procedures for installation and servicing as applicable

• Requirements for the protection of confidential health information

• Prevention of deterioration or loss of documents


4.2 Documentation Requirements

ISO 13485:2003 vs ISO 13485:2016

• No significant changes to sections:

• 5.1 Management Commitment

• 5.2 Customer Focus

• applicable regulatory requirements

• 5.3 Quality Policy

• 5.4.1 Quality Objectives


• 5.4.2 Quality Management System Planning

• 5.5.1 Responsibility and authority

• 5.5.2 Management Representative


• 5.5.3 Internal Communication


5 Management Responsibility

ISO 13485:2003 vs ISO 13485:2016

• Documented procedure required

• Inputs expanded • Complaint Handling

• Reporting to regulatory authorities

• Monitoring and measurement of processes

• Monitoring and measurement of product

• Corrective action

• Preventive action

• Applicable new or revised regulatory requirements

• Outputs to be recorded and include the input reviewed and decisions/actions related to:

• Improvement needed for QMS and processes

• Improvement of product related to customr reqs

• Changes needed to response to regulatory requirements

• Resource needs


5.6 Management Review

ISO 13485:2003 vs ISO 13485:2016

• Requirements for documented processes for establishing competence, providing needed training and ensuring awareness of personnel

• Application of risk based approach for determining the methodology used to check effectiveness of training


6.2 Human Resources

ISO 13485:2003 vs ISO 13485:2016

• Documented requirements for infrastructure needs to achieve:

• Product conformity

• Prevent product mix-up

• Ensure orderly handling of product

• Maintenance activities to apply (as appropriate) to equipment used in:

• Production

• Control of work environment

• Monitoring and measurement


6.3 Infrastucture

ISO 13485:2003 vs ISO 13485:2016

• 6.4.1 Work Environment

• Must document requirements for work environments needed to meet product conformity

• 6.4.2 Contamination Control

• Sterile medical devices -

• Documented requirements for control of microorganisms or particulate matter

• Maintain cleanliness during assembly or packaging process


6.4 Work Environment and contamination control

ISO 13485:2003 vs ISO 13485:2016

• Added to requirements to product realization list:

• Inclusion of infrastructure and work environment considerations

• required verification, validation, monitoring, measurement, inspection and test, handling, storage, distribution and traceability activities specific to the product together with the criteria for product acceptance;


7.1 Planning of Product Realization

ISO 13485:2003 vs ISO 13485:2016

• 7.2.1 Determination of requirements related to product

• Determining if any user training is needed to ensure performance and safe use of medical device

• 7.2.2 Review of requirements related to product

• Applicable regulatory requirements are met

• any user training identified is available or planned

• 7.2.3 Communication

• Communication with customers shall be planned and documented

• Shall communicate with regulatory agencies


7.2 Customer Related Processes

ISO 13485:2003 vs ISO 13485:2016

• 7.3.1 General – new/unchanged

• 7.3.2 Design and Development Planning

• D&D planning documents shall be maintained and updated

• Shall document:

• Reviews needed at each D&D stage

• Methods to ensure traceability of outputs to inputs

• Resources needed


7.3 Design and Development

ISO 13485:2003 vs ISO 13485:2016

• 7.3.3 Design and Development Inputs

• Addition of “usability and safety requirements”

• 7.3.4 Design and Development Outputs

• No significant changes

• 7.3.5 Design and Development Review

• No significant changes



ISO 13485:2003 vs ISO 13485:2016

• 7.3.6 Design and Development Verification

• Documented verification plans

• Methods

• acceptance criteria

• As appropriate

• Statistical techniques

• Sample size rationale

• Connection or interface to other medical devices

• Confirm Outputs meet inputs when connected



ISO 13485:2003 vs ISO 13485:2016

• 7.3.7 Design and Development Validation

• Documented validation plans

• Methods

• Acceptance criteria

• As appropriate

• Statistical techniques

• Sample size rationale

• Conducted with representative product

• Rationale for choice documented

• Connection or interface to other medical devices

• Confirm requirements met when connected



ISO 13485:2003 vs ISO 13485:2016

• 7.3.8 Design and Development Transfer

• New section

• Documented procedures for transfer to manufacturing

• Verify:

• Outputs suitable for manufacturing

• Production capability can meet requirements

• Record of results of conclusions of transfer



ISO 13485:2003 vs ISO 13485:2016

• 7.3.9 Control Design and Development Changes

• Determine significance of change to:

• Function

• Performance

• Usability

• Safety

• Applicable regulatory requirements



ISO 13485:2003 vs ISO 13485:2016

• 7.3.10 Design and Development Files

• New section

• File shall be maintained for each device or device family

• Shall include:

• Records of conformity to D&D requirements

• Records for D&D changes



ISO 13485:2003 vs ISO 13485:2016

• 7.4.1 Purchasing Process

• Establishment of criteria for evaluation and selection of suppliers

• Supplier’s ability to provide product that meets reqs

• Performance

• Effect of purchased product on quality of device

• Risk associated with device

• Monitoring and re-evaluation of suppliers

• Non-fulfillment addressed based on:

• Risk associated with purchased product

• Compliance with applicable regulatory requirements


7.4 Purchasing

ISO 13485:2003 vs ISO 13485:2016

• 7.4.2 Purchasing Information

• Shall describe or reference product to be purchased

• Product specifications

• Written agreements (as applicable)

• Notification of changes prior to implementation

• Changes that affect ability to meet specified requirements


7.4 Purchasing

ISO 13485:2003 vs ISO 13485:2016

• 7.4.3 Verification of Purchased Product

• Based on:

• Supplier evaluation results

• Risks associated with purchased product

• Notification of changes:

• Determine if changes affect product realization or device


7.4 Purchasing

ISO 13485:2003 vs ISO 13485:2016

• 7.5.1 Control of Production and Service provision

• Minor changes

• Production and service provision shall be planned, carried out, monitored and controlled to ensure that product conforms to specification.

• Production controls to also include:

• Qualification of infrastructure


7.5 Production and Service Provision

ISO 13485:2003 vs ISO 13485:2016

• 7.5.2 Cleanliness of Product

• Minor changes

• Additional requirement for cleanliness/contamination control:

• c) product cannot be cleaned prior to sterilization or its use, and its cleanliness is of significance in use



ISO 13485:2003 vs ISO 13485:2016

• 7.5.3 Installation Activities

• No changes

• 7.5.4 Servicing Activities

• Service records to be analyzed by organization or supplier:

• a) To determine if the information is to be handled as a complaint

• b) As appropriate, for input to the improvement process

• 7.5.5 Particular Requirements for sterile medical devices

• No change



ISO 13485:2003 vs ISO 13485:2016

• 7.5.6 Validation of processes for production and service

• Documented procedure to include:

• Approval of changes to the processes

• Software validations

• Approach proportionate to risk in use of software

• Effect on product conformity to specifications

• Validation records to include:

• Results

• Conclusions of validation

• Necessary actions



ISO 13485:2003 vs ISO 13485:2016

• 7.5.7 Particular Requirements for validation of processes for sterilization and sterile barrier systems

• Addition of sterile barrier system validations

• Validation records to include:

• Results

• Conclusions of validation

• Necessary actions



ISO 13485:2003 vs ISO 13485:2016

• 7.5.8 Identification

• Requires documented procedure

• Requirement that was in 7.5.3.3 of 2003 version

• Unique Device Identification (UDI)

• As applicable by regulatory requirements

• Shall be a documented system



ISO 13485:2003 vs ISO 13485:2016

• 7.5.9 Traceability

• No changes

• 7.5.10 Customer Property

• No changes

• 7.5.11 Preservation of product

• Additional requirements on protection from expected conditions and hazards:

• Design and construct of packaging and shipping containers

• Documentation of special conditions if packaging is not enough



ISO 13485:2003 vs ISO 13485:2016

• 7.6 Control of monitoring and measuring equipment

• No changes

• 8 Measurement, analysis and improvement

• 8.1 General

• No changes


ISO 13485:2003 vs ISO 13485:2016

• 8.2 Monitoring and Measurement

• 8.2.1 Feedback

• Emphasis on feedback coming from both production and post-production activities

• Utilization of feedback as input to risk management for monitoring and maintaining product requirements


8 Measurement, analysis and improvement

ISO 13485:2003 vs ISO 13485:2016

• 8.2.2 Complaint Handling

• New section

• Requirements for procedure and timely handling of complaints

• Procedure to include:

• Receiving and recording information

• Evaluating information to determine if the feedback constitutes a complaint;

• Investigating complaints;

• Determining the need to report the information to the appropriate regulatory authorities;

• Handling of complaint-related product;

• Determining the need to initiate corrections or corrective actions



ISO 13485:2003 vs ISO 13485:2016

• 8.2.3 Reporting to Regulatory Authorities

• New section

• Procedure required if applicable by regulatory requirements

• Complaints that result in need for:

• Adverse event reporting

• Advisory Notices

• Records of reporting required



ISO 13485:2003 vs ISO 13485:2016

• 8.2.4 Internal Audit

• No changes

• 8.2.5 Monitoring and measurement of processes

• No changes

• 8.2.6 Monitoring and measurement of product

• Minor change

• Records to identify test equipment used



ISO 13485:2003 vs ISO 13485:2016

• 8.3 Control of Nonconforming Product

• 8.3.1 General

• New section

• Clarification of procedure requirements to define controls and related responsibilities and authorities

• Identification

• Documentation

• Segregation

• Evaluation

• Disposition

• Inclusion of determination for investigation and notification of any external party



ISO 13485:2003 vs ISO 13485:2016


• 8.3.2 Actions in Response to nonconforming product detected before delivery

• Acceptance by concession only if:

• Justification provided

• Approval is obtained

• Applicable regulatory requirements met



ISO 13485:2003 vs ISO 13485:2016


• 8.3.3 Actions in Response to nonconforming product detected after delivery

• Minor change

• Expanded section on 2003 requirements

• Addition of records requirement for Advisory Notices

• 8.3.4 Rework

• No changes



ISO 13485:2003 vs ISO 13485:2016

• 8.4 Analysis of Data

• New requirements for:

• Determination of appropriate methods

• To include statistical techniques and use

• Data to now include:

• Audits

• Service reports (as applicable)

• If analysis shows QMS is not sutiable, adequate or effective, analysis is to be used as input for improvements.



ISO 13485:2003 vs ISO 13485:2016

• 8.5 Improvement

• 8.5.1 General

• No changes

• 8.5.2 Corrective Action

• Minor change

• CA’s to be taken without undue delay

• Verify CA has no adverse affect

• 8.5.3 Preventive Action

• Minor change

• Verify PA has no adverse affect



ISO 13485:2016 Transition


When do we have to make the change?




Depends on your organization.




Depends on your organization.

Depends on other standards that your

organization is registered to.



TC Recommendation

ISO TC 210 has recommended a co-

existence period of 3 years



TC Recommendation



Recommending that:

2 years after publication (1 March 2018), all

accredited certificates be to ISO 13485:2016



TC Recommendation



Recommending that:


accredited certificates be to ISO 13485:2016


ISO 13485:2003 certificates will not be valid



What if I have ISO 9001 as well?




All ISO 9001:2008 certificates will expire September 2018




All ISO 9001:2008 certificates will expire September 2018

Upgrade audits for ISO 9001:2015 must occur by 1 July

2018

ISO 13485:2016 – The Next Revision


DQS Inc Contact Information


DQS Inc

1-800-285-4476

[email protected]

www.dqsus.com

Medical Program

Rick Burgess

Medical Program Manager

[email protected]

763-229-9833

mailto:[email protected]

http://www.dqsus.com/

mailto:[email protected]

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