Technology

Excerpt from Technical Guide: Implementing A Quality System

Many companies today are turning to formal quality systems to assure continued, consistent product quality
during design, manufacturing, installation, and servicing. The impetus for this trend is many-fold. With the
wide-spread demand for high-quality, well-designed products, consumers are actively looking for the best
product and service. Industry can respond to this demand by implementing a well-defined, structured
quality system. By doing so, most companies are in a good position to achieve maximum success.

Other reasons for implementing a quality system include regulatory and competitive concerns. With the
rapid advance of technology, the successful company today must be on the cutting edge of quality
implementation in product design, and well as in the manufacture, installation, and servicing realms.

Successful implementation of a quality system provides significant opportunities for improved service and
customer satisfaction, improved productivity, efficiency and cost reduction, all of which translate into
improved market share. However, for ultimate realization of these benefits, the well-attuned company must
follow a well-structured plan for planning, organizing and implementing a quality system. One can imagine
that a quality system can be structured from the ground up without utilizing the guidelines found in the FDA
Quality System Regulation and the International Organization for Standardization (ISO). However, with
careful attention to these documents, the basic requirements are already in place.

Background Discussion

ISO Standard 9001:1994 "Quality Systems - Model for Quality Assurance in Design, Development,
Production, Installation and Servicing" and FDA's Quality System Regulation found at 21 CFR §820 is the
model for quality assurance in all aspects of a company's operations. The quality system requirements
specified in the ISO standard are complementary to applicable technical (product) specified requirements,
and thus are more product driven. However, the Quality System Regulation specifies medical device quality
system requirements for use where the company's capability to design and supply conforming product
needs to be demonstrated. The requirements specified are aimed primarily at achieving customer
satisfaction by preventing non-conformity at all stages from design through to servicing. The result is
system driven, rather than product driven.

In its preamble to the Quality System Regulation, FDA identifies that approximately 44 percent of quality
problems that led to voluntary recalls of medical devices were attributed to errors or deficiencies that were
designed into the devices and may have been prevented with adequate design controls. In response to
manufacturer's concerns about needing more time for implementing design controls, FDA designed a two-
stage implementation process. The regulation became effective June 1, 1997. However, with respect to
design controls, under stage one, for a period of one year, FDA granted a special one-year transition
program, during which time, as long as manufacturers were taking steps to come into design control
compliance, no official Agency action would ensue. Stage two, beginning June 1, 1998, began full
compliance provisions for design controls. Accordingly, all parts of the Quality System Regulation must now
be adhered to.

Quality System Regulation Scope

Following public comment and suggestions, FDA generally harmonized ISO 9001:1994, ISO 13485 ("Quality
Systems - Medical Devices - Supplementary Requirements to ISO 9001") and EN 46001 (the European
quality system standard for medical devices). The result is a framework of basic requirements that
manufacturers can use to establish a quality system that is appropriate to the specific devices and
manufacturing processes used in any given environment. FDA notes that "...the quality system regulation is
premised on the theory that the development, implementation and maintenance of procedures designed to
carry out the requirements will assure the safety and effectiveness of devices." Federal Register, Vol 61, No
195, 52612.
Whenever a team is organized to implement or verify compliance with a regulation, the definition section of
the regulation can be very helpful. These definitions become of prime importance during an inspection, or
any other investigational work. Therefore, they should be understood by the management and quality
personnel in the company. Two definitions from the Quality System Regulation that provide direction for this
guide are as follows:

Quality policy means the overall intentions and direction of an organization with respect to quality, as
established by management with executive responsibility.

Quality system means the organizational structure, responsibilities, procedures, processes and resources for
implementing quality management. Federal Register Vol 61, No 195, 52656.

Quality System Requirements

Management Responsibility
(Quality System Reg. 820.20 and ISO 4.1)

Management Responsibility is an area of immense responsibility and pivotal to the success of the
implementation of any quality system. Without complete and unwavering management support, the best
efforts at implementing a successful quality system will fail. It is paramount that the direction for the
system - and complete commitment to it - come from the top management of the organization. Following
are the components of management responsibility.
Quality Policy - Must be stated by executive management and establish the policy, objectives, and
commitment to quality. Top management must ensure that the policy is understood, implemented, and
maintained at all levels of the organization.
Organization - An organizational structure must be established and maintained that will be conducive to
design and production of devices that meet the quality requirements.
Responsibility and Authority - Must be initiated and their inter-relations defined so that personnel
understand the structure. Independence and authority of quality functions must be maintained.
Resources - There must be adequate resources allocated, including trained workforce, management, and
quality assessors.
Management Representative - A member of management must be appointed who has established authority
and responsibility for ensuring the quality system is effective and reporting performance of the quality
system to executive management for review.
Management Review - A documented review at specific intervals must be made by executive management
to determine the suitability and effectiveness of the quality system. The results of the review must be
compared with the quality policy and objectives and must be sufficiently frequent to ensure that the system
is healthy.
Quality Planning - This defines the quality practices, resources, and activities and shows the relationship to
each other.
Quality System Procedures - Management must drive the development of the procedures and instructions
which drive the quality system. An outline to show the structure of the quality system should be created.

Quality Audits (Quality System Reg. 820.22 and ISO 4.17)

Besides being required under the regulation and the standards, internal quality audits are vital to the on-
going health of the system. It is vital that management support the auditing function and work to keep it as
a tool for continuous improvement. Too often, audits are viewed as "police" activity, so the recipients do not
take complete advantage of the information they can provide.

Quality audits must be conducted by individuals who do not have direct responsibility for the areas being
audited. They are used to assure compliance with established quality system requirements. They do not
define requirements; rather they confirm that the requirements are functional. Audits assess whether the
existing quality system is effective. Audit findings which continually repeat will indicate a systemic problem
which management must address. For such occasions, corrective actions are indicated, with reaudits of
deficient areas to assess whether corrective actions were effective.
Personnel (Quality System Reg. 820.25 and ISO 4.2)

Companies must maintain sufficient personnel who possess the education, background, training, and
experience to assure proper performance of their duties. Training procedures must be established which
include assessment of training necessary so that all personnel can adequately perform their responsibilities.
The Quality System Regulation requires that the training plan include methods by which personnel receive
information about the defects that may occur to devices on which they work if they do not perform their job
functions properly. In addition, personnel who perform verification (confirmation by examination and
providing objective evidence that specified requirements have been met) and validation (establishing by
objective evidence that device specifications conform with user needs and intended use) must be made
aware of defects and errors that they may encounter in the performance of their job functions.

Balance of Quality System Elements

The following outline quickly identifies the balance of the elements included in the Quality System
Regulation/ISO quality system scheme.

• Design Controls (Quality System Reg. 820.30 and ISO 4.4)

o Development and Planning
o Input/Output
o Review
o Verification and Validation
o Transfer and Changes
o History File
• Document Controls (Quality System Reg. 820.40 and ISO 4.5)
• Purchasing Controls (Quality System Reg. 820.50 and ISO 4.6)
• Identification and Traceability (Quality System Reg. 820.60 and 820.65 and ISO 4.8)
• Production and Process Controls (Quality System Reg. 820.70 and ISO 4.9)
o Environmental and Contamination Control
o Personnel
o Building/Equipment
o Materials
o Inspection, Measuring and Test Equipment (Quality System Reg. 820.72 and ISO
4.11)
o Process Validation (Quality System Reg. 820.75)
• Acceptance Activities (Quality System Reg. 820.80 and 820.86 and ISO 4.10 and 4.12)
o Receiving, In-Process and Finished Goods Acceptance
o Acceptance Status
• Non-conforming Product (Quality System Reg. 820.90 and ISO 4.13)
o Control of Non-conforming Product
o Review and Disposition
• Corrective and Preventive Action (Quality System Reg. 820.100 and ISO 4.14)
• Labeling and Packaging Controls (Quality System Reg. 820.120 and 820.130 and ISO
4.15)
• Handling, Storage, Distribution and Installation (Quality System Reg. 820.140, 820.150,
820.160, and 820.170 and ISO 4.15 and 4.9)
• Records (Quality System Reg. 820.180 and ISO 4.16)
o Control
o Device Master Record (Quality System Reg. 820.181 and ISO 4.16)
o Device History Record (Quality System Reg. 820.184 and ISO 4.16)
o Quality System Record (Quality System Reg. 820.186 and ISO 4.16)
 o Complaint Files (Quality System Reg. 820.198 and ISO 4.14)
• Servicing (Quality System Reg. 820.200 and ISO 4.19)

• Statistical Techniques (Quality System Reg. 820.250 and ISO 4.20) o ISO Contract Review
(No Quality System Reg. equivalence ISO 4.3)... End of Excerpt