Download General requirements of quality management systems in the field of

GENERAL REQUIREMENTS OF QUALITY
MANAGEMENT SYSTEMS IN THE FIELD OF
MEDICAL DEVICES
GENERAL REQUIREMENTS FOR AUDITORS
The international standard which specifies the requirements for a
quality management system that can be used by an organization for the
design, development, production, installation and servicing of medical
devices and the projection, development, and the supply of services related
to them is EN ISO 13485:2003 - MEDICAL DEVICES. QUALITY
MANAGEMENT SYSTEMS.REQUIREMENTS FOR REGULATORY
PURPOSES
This standard specifies requirements for a quality management system
where an organization needs to demonstrate its ability to provide medical
devices and related services that consistently meet customer requirements
and regulatory requirements applicable to medical devices and related
service. It is the most accepted standard internationally for medical devices
producers. ISO 13485 sustains the reduction of unexpected risks for
companies that build, manufacture, or use medical products and services,
both during the manufacturing process and after.
The primary objective of ISO 13485:2003 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 the requirements of ISO 9001 that are not appropriate as
regulatory requirements. Because of these exclusions, organizations whose
quality management systems conform to this International Standard cannot
claim conformity to ISO 9001 unless their quality management systems
conform to all the requirements of ISO 9001.
ISO 13485:2003 specifies requirements for a quality management
system where an organization needs to demonstrate its ability to provide
medical devices and related services that consistently meet customer
requirements and regulatory requirements applicable to medical devices and
related service and supports essential requirements of directives on medical
devices.
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All the requirements for this international standard are specific to
organizations that supply medical devices, regardless of the type or size of
the device.
The general requirements for the quality management system are
discussed in section 4.1 of the standard.
Organizations working in the field of medical devices must establish,
document, implement and maintain a quality management system and
maintain its effectiveness in accordance with this standard
In this context, the organization must:
- identify the processes needed for quality management system so that all
activity is addressed; if regulatory requirements permit exclusions of design
and development controls, this can be used as justification for their
exclusion from the quality management system; if any of the requirements
for the design and development is not applicable for the medical device for
which the system is applied, the organization does not need to include that
requirement in the system; the processes required by this standard that are
applicable to medical devices, but not fulfilled by the organization, are the
responsibility of the organization and are mentioned in the organization's
quality management system; a requirement is considered "adequate" if it is
necessary for:
- a product to comply with specific requirements and/or
- an organization to take corrective measures;
- to determine the sequence and interaction of processes;
- to determine the criteria and methods needed to ensure that both the
operation, and control of these processes are effective;
- to ensure the availability of resources and information necessary to
support the operation and monitoring of these processes;
- to monitor, measure and analyze these processes;
- to implement the necessary actions to achieve planned results and
maintain the effectiveness of processes that comprise the quality
management system.
The organization must manage these processes in accordance with the
requirements of ISO 13485:2003, and if it decides to use processes
outside its capacity, process which could influence the product
conformity with essential requirements, the organization shall ensure
control of these processes, and this control must be identified within
the quality management system.
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Next, we shall discuss all the chapters/sections of the standard.
Documentation requirements: the documentation for the quality
management system must include:
- documented declarations regarding the policies pertaining to quality
and quality objectives
- a quality manual
- documented procedures required by this international standard
- documents required by the organization to ensure the effectiveness of
its planning, operations and the control of its processes
- records required by this international standard. Records shall be
established and maintained to provide evidence of compliance with
the requirements and effective operation of the quality management
system. Records shall remain legible, identifiable and easily
retrievable. Also, a documented procedure must be established to
define the control necessary for identification, storage, protection,
retrieval, period of record retention and disposal.
- any other document specified by national or regional reglementations.
The scope of quality management system documentation can differ from one
organization to another depending on the size of the organization and the
type of its activities, by the complexity of processes and their interaction but
also by staff competence.
The quality manual which must be established and developed by the
organization must include:
- the scope of quality management system
- documented procedures established for the quality management
system
- a description of the interaction between quality management processes
Management Responsibility.
Management at the highest level must provide evidence of commitment to
develop and implement quality management system and maintain its
effectiveness by:
- communicating the importance of customer satisfaction but also
equally the legal and regulatory requirements
- establishing the quality policy
- establishing quality objectives
- leadership management reviews
- ensure the availability of resources
Quality policy
Management at the highest level must ensure that the quality policy:
- is adequate for scope the of the organization
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- maintains the effectiveness of quality management system
- provides a framework for establishing and reviewing quality
objectives
- is communicated and understood within the organization and
- is analyzed for its continuous suitability.
Quality objectives: Management at the highest level must ensure that
quality objectives, including those necessary to meet product
requirements, are established for relevant functions and relevant levels of
the organization. Quality objectives must be measurable and consistent
with quality policy.
Quality management system planning
Management at the highest level must ensure that:
a. quality management system planning is performed in order to fulfill
the general requirements of the process but also the quality objectives,
and
b. quality management system integrity is maintained when changes to
the quality management system are planned and implemented
Responsibility, authority and communication
Responsibilities and authorities must be defined, documented and
communicated throughout the organization. Also, the interrelation of all
personnel who manages, accomplishes and verifies activities which affect
the quality must be established and the required authority to perform these
tasks must be ensured.
Management Representative
Management at the highest level shall appoint a member of the management
team who beside his current responsibilities shall have responsibility and
authority for:
- ensuring that the necessary processes for the quality management
system are established, implemented and maintained
- Reporting to the management at the highest level about the
functioning of the quality management system and about any
necessity of improvement.
- Ensuring awareness of both regulatory and client requirements the
organization.
Also, the management should ensure that appropriate communication
processes are established within the organization and that this
communication refers to effectiveness of the quality management system.
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Management review
The management must periodically review the quality management system
within the organization in order to ensure that it remains appropriate,
adequate and effective. This analysis (review) should include the evaluation
of the opportunities for improvement and the necessity of for change in the
quality management system, including the policy referring to quality and
quality objectives.
The input of the review should include information referring to:
- the results of the audits
- the feedback from the client
- the performance of the processes and the conformity of the product
- follow-up from previous management reviews
- changes that could influence the quality management system
- recommendations for improvement and
- new or revised regulatory requirements
The output of the review should include any decisions and actions referring
to:
- improvements needed to maintain the effectiveness of quality
management system and its processes
- improving the product in relation to customer requirements and
- the need for resources
Human Resources Management –Ensuring resources
The organization should determine and make available the necessary
resources
a. in order to implement the quality management system and to maintain
its effectiveness
b. in order to satisfy regulatory and customer requirements
Human Resources
The personnel performing work that influences the quality of the product
must be competent in terms of education, training, skills and experience
appropriate.
The organization must:
- determine the necessary competence for the personnel that performs
activities that influence the quality of the product
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- evaluate the effectiveness of undertaken actions
- provide training or undertake other actions to satisfy these needs
- ensure that staff is aware of the relevance and importance of its
activities and how they contribute to achieving quality
- maintain adequate records relating to education, training, skills and
experience.
Infrastructure.
The organization must determine, make available and maintain the
infrastructure needed to achieve compliance with the requirements of the
product, by infrastructure understanding:
a. buildings, workspace and associated utilities
b. process equipment (both hardware and software)
c. support services (e.g.: transportation or communication)
Work Environment
The organization must determine and manage the work environment needed
to achieve compliance with product requirements.
The following requirements should apply:
- Documented requirements for health, cleanliness and clothing of
personnel if the contact between such personnel and the product or
environment could negatively affect product quality
- If work environment can have a negative effect on the quality of the
product, documented requirements for the work environment and
documented procedures or work instructions should be established to
monitor and control the conditions of working environment
- The requirement that all staff working temporarily in special
environmental conditions within the working environment is properly
trained or supervised by a trained person
- If necessary, special measures should be established and documented
for controlling the contaminated product or the possibly contaminated
product so as to prevent contamination of other product, work
environment or personnel.
Product realization
The organization must plan and develop the processes necessary for product
realization. Planning of product realization shall be consistent with
requirements for other processes of quality management system.
In planning product realization the organization must determine:
a. the quality objectives and requirements for the product
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b. the necessity to establish processes, documents and to allocate resources
to a specific product
c. required activities for verification, validation, monitoring, inspection and
testing and also product-specific criteria for product acceptance
d. records needed to provide evidence that the realization processes and that
the resulting product meets requirements.
Overall, one can highlight the benefits of quality management system
certification for medical devices:
• customer satisfaction, business partners and legal requirements
• providing the authorities with proofs that the laws and regulations are
respected
• minimize and control the risks
• preventing errors before they correct
• improved quality performance
• transparency and clarity of internal processes
• saving time and costs
Here comes the natural question: To whom is this quality assessment system
addressed. The answer is multiple:
a. to private companies that manufacture on a regular basis medical
devices for medical laboratories
b. to companies that produce medical components,
c. but also equally to
d. consultants who design, manufacture and assemble medical
instruments for medical laboratories
Regarding the requirements for auditors of quality management
systems, they are specified in another international standard EN ISO
19011:2002 - GUIDELINES FOR QUALITY AND / OR
ENVIRONMENTAL MANAGEMENT SYSTEMS Auditing.
This international standard provides guidance for managing audit
programs, conducting internal and external audits of quality management
systems and / or the environment, and on the competence and the evaluation
of the auditors.
Guidance on the necessary competence of an auditor and the auditor's
evaluation process description is embodied in Chapter 7 of the standard.
An auditor must, above all show ethical behavior, fair presentation,
professional responsibility.
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Trust, integrity, confidentiality and discretion are essential for
auditing. The auditor must prove perseverance and the audit reports must be
prepared with honesty, accuracy and responsibility.
The standard provides requirements for the competence of the
auditors is based on proving:
-personal skills
-knowledge and abilities
-educational background, work experience, training as an auditor and
audit experience
The standard develops each category of requirements for both the
auditors and the audit team leaders.
The standard focuses on continuous professional development and on
maintaining audit skills in order to sustain and improve the competence.
EN ISO 19011:2002 also shapes the evaluation of auditors that
encompasses four steps:
-identifying personal skills, knowledge and abilities to meet the needs
of the audit program
- choosing the evaluation criteria (quantitative or qualitative)
-selecting appropriate valuation methods
-conducting the evaluation.
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