Chapter 1: Setting up a Quality Management System
20
evolves (Figure 1-8).The regulatory professional’s role
in establishing and maintaining a QMS will depend on
how the organization is structured. In some organiza-
tions, QMS compliance is under regulatory, but many
manufacturers leave the responsibility with the quality
function. Responsibilities should be organized to ensure
there are no conflicts of interest. In some organizations,
quality assurance reports to operations or manufac-
turing, with a separate regulatory function reporting
elsewhere. Within ISO 13485, Clause 5.5 relates to
independence, and Clause 8.2.4 discusses planned
arrangements to ensure those releasing product are
authorized to do so, but there is no reference to quality
being a separate function. A close working relationship
between the regulatory professional and the QMS
group is always required to understand and “interpret”
the QMS regulatory requirements.
Certification and Registration
The first step an organization seeking certification should
consider is planning for the external audits, performing
the pre-assessment and undergoing Stage 1 and 2 (initial)
audits (the certification body audit process is described in
further detail below). Formal certification is achieved only
through external (third-party) assessment certified bodies
are accredited to conduct such QMS audits. Several fac-
tors can influence the choice of a certification body, such
as cost, timelines and the scope of the certification body’s
activities. Qualified auditors will be assigned to evaluate
the total QMS. They will provide a plan and a written
report. Benefits and barriers to certification are listed in
Table 1-5.
The Stage 1 audit usually is a one-day, on-site audit
of the partial system: QMS documentation, manage-
ment review and internal audits. It also is intended to
determine readiness for the Stage 2 audit (typically
one to two months later, but ideally no more than
Figure 1-8. Iterative PDCA Cycle
Plan 1
Plan 2
Do
Do
Check
Check
Act
Act
Table 1-5. Benefits and Barriers to Certification
Benefits Barriers
Expanded access to world markets Difficulty identifying and creating new processes for the system
Ability to bid for contracts Developing the necessary documented procedures and instructions
Use as a market differentiator Lack of visible and demonstrated management commitment and support
Display of the certification mark Personnel not following the prescribed procedures per their training
Independent audits by professionals Resistance by some employees to change (e.g., providing process measurements)
Conflicting interpretations within the organization and by the certification body
Table 1-6. Certification Body QMS Assessment Objectives, Scope and Criteria
Objectives Scope Criteria
Conformity of QMS with criteria Physical locations Normative QMS documents (e.g., ISO 13485)
Ability to meet applicable requirements Organizational units
Effectiveness to meet objectives Activities Defined processes and documentation in QMS
Areas for improvement Processes
20
evolves (Figure 1-8).The regulatory professional’s role
in establishing and maintaining a QMS will depend on
how the organization is structured. In some organiza-
tions, QMS compliance is under regulatory, but many
manufacturers leave the responsibility with the quality
function. Responsibilities should be organized to ensure
there are no conflicts of interest. In some organizations,
quality assurance reports to operations or manufac-
turing, with a separate regulatory function reporting
elsewhere. Within ISO 13485, Clause 5.5 relates to
independence, and Clause 8.2.4 discusses planned
arrangements to ensure those releasing product are
authorized to do so, but there is no reference to quality
being a separate function. A close working relationship
between the regulatory professional and the QMS
group is always required to understand and “interpret”
the QMS regulatory requirements.
Certification and Registration
The first step an organization seeking certification should
consider is planning for the external audits, performing
the pre-assessment and undergoing Stage 1 and 2 (initial)
audits (the certification body audit process is described in
further detail below). Formal certification is achieved only
through external (third-party) assessment certified bodies
are accredited to conduct such QMS audits. Several fac-
tors can influence the choice of a certification body, such
as cost, timelines and the scope of the certification body’s
activities. Qualified auditors will be assigned to evaluate
the total QMS. They will provide a plan and a written
report. Benefits and barriers to certification are listed in
Table 1-5.
The Stage 1 audit usually is a one-day, on-site audit
of the partial system: QMS documentation, manage-
ment review and internal audits. It also is intended to
determine readiness for the Stage 2 audit (typically
one to two months later, but ideally no more than
Figure 1-8. Iterative PDCA Cycle
Plan 1
Plan 2
Do
Do
Check
Check
Act
Act
Table 1-5. Benefits and Barriers to Certification
Benefits Barriers
Expanded access to world markets Difficulty identifying and creating new processes for the system
Ability to bid for contracts Developing the necessary documented procedures and instructions
Use as a market differentiator Lack of visible and demonstrated management commitment and support
Display of the certification mark Personnel not following the prescribed procedures per their training
Independent audits by professionals Resistance by some employees to change (e.g., providing process measurements)
Conflicting interpretations within the organization and by the certification body
Table 1-6. Certification Body QMS Assessment Objectives, Scope and Criteria
Objectives Scope Criteria
Conformity of QMS with criteria Physical locations Normative QMS documents (e.g., ISO 13485)
Ability to meet applicable requirements Organizational units
Effectiveness to meet objectives Activities Defined processes and documentation in QMS
Areas for improvement Processes