ISO13485:2003

ISO 13485 is derived from ISO 9001

Clause 0: Introduction

• Can be used by an organization for the design and development, production, installation and servicing of medical devices, and the design, development,and provision of related services.
• Question: does your organisation has related services?
• It can also be used by internal and external parties, including certification bodies, to assess the organization’s ability to meet customer and regulatory requirements
• Based on a process approach to quality management. Any activity that receives inputs and converts them to outputs can be considered as a proces

Clause 0: ISO13485 difference with ISO9001:2008 ISO13485 focus on

1. Meeting customer requirements
2. Maintenance of continuing (continuous) effectiveness of the Q system
3. Regulatory, safety & effectiveness

ISO9001 focus on

1. Customer satisfaction
2. Continual improvement
   1. Format chapters ISO13485 follow ISO9001:2008
   2. Effectiveness is focus, not efficient!
   3. Differences with respect to ISO9001 in blue italic

Clause 1 Scope

1.1 General

• Demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory

requirements applicable to medical devices and related services. 1.2 Application

• Possible exclusion of clause 7.3 (design & development)
• Possible non applicable of parts of clause 7
• Both must be justified in quality manual
• Examples: 7.5.1.2.1 (cleanliness), 7.5.1.3 & 7.5.2.2 (sterile); 7.5.3.2.2 (implant)
• Question: what about section 8.2.4.2 (implant)?

“Appropriate” Term

ISO 9000 Quality management systems — Fundamentals and vocabulary

Clause 3 Terms & definitions

• Wherever the term “product” occurs, it can also mean “service”
• Wherever requirements are specified as applying to “medical devices”, the requirements apply equally to “related services as supplied by the

organization”.

• Question: can you give examples of advisory notices?

4.1 General requirements The organization shall establish, document, implement and maintain a quality management system and maintain its effectiveness in accordance with the requirements of this International Standard.

The organization shall a) identify the processes needed for the quality management system and their application throughout theorganization (see 1.2), b) determine the sequence and interaction of these processes, c) determine criteria and methods needed to ensure that both the operation and control of these processes are effective, d) ensure the availability of resources and information necessary to support the operation and monitoring of these processes, e) monitor, measure and analyse these processes, and f) implement actions necessary to achieve planned results and maintain the effectiveness of these processes. These processes shall be managed by the organization in accordance with the requirements of this

International Standard. Where an organization chooses to outsource any process that affects product conformity with requirements, the organization shall ensure control over such processes. Control of such outsourced processes shall be identified within the quality management system (see 8.5.1).

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

4.2.1 General

The quality management system documentation shall include a) 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 control of its processes, e) records required by this International Standard (see 4.2.4), and f) any other documentation specified by national or regional regulations.

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

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

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

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

4.2.2 Quality manual

The organization shall establish and maintain a quality manual that includes a) the scope of the quality management system, including details of and justification for any exclusion and/or non-application (see 1.2), b) the documented procedures established for the quality management system, or reference to them, and c) a description of the interaction between the processes of the quality management system.

The Quality Manual shall outline the structure of the documentation used in the quality management system

4.2.3 Control of documents

Documents required by the quality management system shall be controlled. Records are a special type of document and shall be controlled according to the requirements given in 4.2.4.

A documented procedure shall be established to define the controls needed a) to review and approve documents for adequacy prior to issue, b) to review and update as necessary and re-approve documents, c) to ensure that changes and the current revision status of documents are identified, d) to ensure that relevant versions of applicable documents are available at points of use, e) to ensure that documents remain legible and readily identifiable, f) to ensure that documents of external origin are identified and their distribution controlled, and g) to prevent the unintended use of obsolete documents, and to apply suitable identification to them if they are retained for any purpose.

The organization shall ensure that changes to documents are reviewed and approved either by the original approving function or another designated function which has access to pertinent background information upon which to base its decisions.

The organization shall define the period for which at least one copy of obsolete controlled documents shall be retained. This period shall ensure that documents to which medical devices have been manufactured and tested are available for at least the lifetime of the medical device as defined by the organization, but not less than the retention period of any resulting record (see 4.2.4), or as specified by relevant regulatory requirements.

ISO13485 - 4.2.4 Control of records Tiddler

5.1 Management commitment

Top management shall provide evidence of its commitment to the development and implementation of the quality management system and maintaining its effectiveness by a) communicating to the organization the importance of meeting customer as well as statutory and regulatory requirements, b) establishing the quality policy, c) ensuring that quality objectives are established, d) conducting management reviews, and e) ensuring the availability of resources

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

5.2 Customer focus

Top management shall ensure that customer requirements are determined and are met (see 7.2.1 and 8.2.1).

5.3 Quality policy

Top management shall ensure that the quality policy a) is appropriate to the purpose of the organization, b) includes a commitment to comply with requirements and to maintain the effectiveness of the quality management system, c) provides a framework for establishing and reviewing quality objectives, d) is communicated and understood within the organization, and e) is reviewed for continuing suitability.

5.4.1 Quality objectives

Top management shall ensure that quality objectives, including those needed to meet requirements for product [see 7.1 a)], are established at relevant functions and levels within the organization. The quality objectives shall be measurable and consistent with the Quality Policy

5.4.2 Quality management system planning

Top management shall ensure that a) the planning of the quality management system is carried out in order to meet the requirements given in 4.1, as well as the quality objectives, and b) the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

Responsibility and authority

Top management shall ensure that responsibilities and authorities are defined, documented and communicated within the organization.

Top management shall establish the interrelation of all personnel who manage, perform and verify work affecting quality, and shall ensure the 'independence and authority necessary to perform these tasks.

NOTE National or regional regulations might require the nomination of specific persons as responsible for activities related to monitoring experience from the post-production stage and reporting adverse events (see 8.2.1 and 8.5.1).

5.5.3 Internal communication

Top management shall ensure that appropriate communication processes are established within the organization and that communication takes place regarding the effectiveness of the quality management system.

5.6.1 General

Top management shall review the organization’s quality management system, at planned intervals, to ensure its continuing suitability, adequacy and effectiveness. This review shall include assessing opportunities for improvement and the need for changes to the quality management system, including the quality policy and quality objectives.

Records from management reviews shall be maintained (see 4.2.4 Control of records).

5.6.2 Review input

The input to management review shall include information on a) results of audits, b) customer feedback, c) process performance and product conformity, d) status of preventive and corrective actions, e) follow-up actions from previous management reviews, f) changes that could affect the quality management system, g) recommendations for improvement, and h) new or revised regulatory requirements.

6.1 Provision of resources

The organization shall determine and provide the resources needed a) to implement the quality management system and to maintain its effectiveness, and b) to meet regulatory and customer requirements.

6.2.2 Competence, awareness and training

The organization shall a) determine the necessary competence for personnel performing work affecting product quality, b) provide training or take other actions to satisfy these needs, c) evaluate the effectiveness of the actions taken, d) ensure that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives, and e) 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 procedures for identifying training needs.

6.4 Work environment

The organization shall determine and manage the work environment needed to achieve conformity to product requirements.

The following requirements shall apply. a) The organization shall establish documented requirements for health, cleanliness and clothing of personnel if contact between such personnel and the product or work environment could adversely 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 organization shall establish documented requirements for the work environment conditions and documented procedures or work instructions to monitor and control these work environment conditions (see 7.5.1.2.1). c) The organization shall ensure that all personnel who are required to work temporarily under special 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 of contaminated or potentially contaminated product in order to prevent contamination of other product, the work environment or personnel (see 7.5.3.1).

7.1 Planning of product realization

The organization shall plan and develop the processes needed for product realization. Planning of product realization shall be consistent with the requirements of the other processes of the quality management system (see 4.1 General Requirements).

In planning product realization, the organization shall determine 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 product and the criteria for product acceptance; d) records needed to provide evidence that the realization processes and resulting product meet requirements (see 4.2.4).

The output of this planning shall be in a form suitable for the organization’s method of operations. The organization shall establish documented requirements for risk management throughout product realization. Records arising from risk management shall be maintained (see 4.2.4 Control of records).

NOTE 1 A document specifying the processes of the quality management system (including the product realization processes) and the resources to be applied to a specific product, project or contract, can be referred to as a quality plan. NOTE 2 The organization may also apply the requirements given in 7.3 to the development of product realization processes. NOTE 3 See ISO 14971 for guidance related to risk management.

7.2.1 Determination of requirements related to the product

The 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, where known, c) statutory and regulatory requirements related to the product, and d) any additional requirements determined by the organization.

7.2.3 Customer communication

The organization shall determine and implement effective arrangements for communicating with customers in relation to

a) product information, b) enquiries, contracts or order handling, including amendments, c) customer feedback, including customer complaints (see 8.2.1), and d) advisory notices (see 8.5.1).

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 and development of product.

During the design and development planning, the organization shall determine a) the design and development stages, b) the review, verification, validation and design transfer activities (see Note) that are appropriate at each design and development stage, and c) the responsibilities and authorities for design and development. The organization shall manage the interfaces between different groups involved in design and development to ensure effective communication and clear assignment of responsibility.

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

NOTE Design Transfer activities during the design and development process ensure that design and development outputs are verified as suitable for manufacturing before becoming final production specifications.

7.3.2 Design and development inputs

Inputs relating to product requirements shall be determined and records maintained (see 4.2.4). These inputs shall include a) 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, and e) 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 outputs

The outputs of design and development shall be provided in a form that enables verification against the design and development input and shall be approved prior to release.

Design and development outputs shall 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, and d) 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, manufacturing procedures, 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 in accordance with planned arrangements (see 7.3.1) a) to evaluate the ability of the results of design and development to meet requirements, and b) to identify any problems and propose necessary actions.

Participants in such reviews shall include representatives of functions concerned with the design and development stage(s) being reviewed, as well as other specialist personnel (see 5.5.1 and 6.2.1). Records of the results of the reviews and any necessary actions shall be maintained (see 4.2.4).

7.3.6 Design and development validation

Design and development validation shall be performed in accordance with planned arrangements (see 7.3.1) to ensure that the resulting product is capable of meeting the requirements for the specified application or intended use. Validation shall be completed prior to the delivery or implementation of the product (see Note 1).

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

As part of design and development validation, the organization shall perform clinical evaluations and/or evaluation of performance of the medical device, as required by national or regional regulations (see Note 2).

NOTE 1 If a medical device can only be validated following assembly and installation at point of use, delivery is not considered to be complete until the product has been formally transferred to the customer.

NOTE 2 Provision of the medical device for purposes of clinical evaluations and/or evaluation of performance is not considered to be delivery.

7.4.1 Purchasing process

The organization shall establish documented procedures to ensure that purchased product conforms to specified purchase requirements.

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

The organization shall evaluate and select suppliers based on their ability to supply product in accordance with the organization’s requirements. Criteria for selection, evaluation and re-evaluation shall be established.

Records of the results of evaluations and any necessary actions arising from the evaluation shall be maintained (see 4.2.4).

7.4.2 Purchasing information

Purchasing information shall describe the product to be purchased, including where appropriate a) requirements for approval of product, procedures, processes and equipment, b) requirements for qualification of personnel, and c) quality management system requirements.

The organization shall ensure the adequacy of specified purchase requirements prior to their communication to the supplier.

To the extent required for traceability given in 7.5.3.2, the organization shall maintain relevant purchasing information, i.e. documents (see 4.2.3) and records (see 4.2.4).

Complaint handling and vigilance

• Assistance with Post Market Surveillance activities
• Identification / traceability of products to end users
• Storage conditions at the warehouse and during transport (if applicable)
• Handling conditions
• Packaging and/or labelling activities (if applicable)
• Training of the employee(s) of the distributor(s) on relevant issues of procedures and documentation on above topics

7.4.3 Verification of purchased product

The organization shall establish and implement the inspection or other activities necessary for ensuring that purchased product meets specified purchase requirements.

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 release in the purchasing information.

Records of the verification shall be maintained (see 4.2.4).

Examples of verification

• Incoming inspection
  • 100% full inspection or
  • based on sampling plan (AQL) Acceptance Quality Limit as defined in ISO 2859-1
  • First article inspection or ….
  • Material certificates: evidence of conformity to supplier release tests
• Who has put the inspection flag on? And how is it un-flagged?
• Always again risk based
• What happens if does not conform? Corrective actions?

• Is the verification independent from assembly personnel?

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