ISO for medical devices in healthcare system

QC of medical devices

1. ISO 14001 v. 2004
Environmental Management Systems

2. Quiz
1.According to the ISO 14001 standard, there is a
continual improvement of 5 specific phases based on
the methodology known as Plan-Do-Check-Act. Which
are they?
2.According to the ISO 14001 standard, what is a
preventive action, and how it is different from a
corrective action?

3. EMS
“A system put into place that keeps things
running smoothly”
Denso Manufacturing Michigan, Inc.
•EMS does not have to be certified ISO 14001
•Plant personnel can develop the EMS with/without consulting support
•3rd-Party Auditors are needed for ISO 14001 certification

4. EMS Evolution
•Until 1960s when gained public attention
•Corporations reacted to increased legislation
•Responsible Care Program (Canada) in 1984
•British created the first national EM standard BS 7750 in 1994
•A Canadian standard Z750 was created in 1994
•Legislated in 1993, EU published EMAS in 1994, open in 1995.
•In the U.S. no national standard was developed during the 1990s, however
groups of companies did (e.g. GEMI)
•The first international EMS was ISO 14001 by ISO.
•Based on:
–The success of ISO 9001
–Increasing international concern (UN Conference of Rio 1992)
–Created a Technical Committee 207
•The ISO 14001 was published for the first time in 1996.

5. Why environmental standards?
…to "promote a harmonious and balanced development of
economic activities, sustainable and non-inflationary growth
respecting the environment… the raising of standards of living
and quality of life" (EMAS).
…to support environmental protection and prevention of
pollution in balance with socio-economic needs (ISO 14001)

6. EMS and ISO 14001
•First version finalized and issued in 1996, revised every five years
(2004 current version)
•Market sector created and driven; governments participate but it is
not legislative or regulatory
•Process standard, not performance
•Each participating nation has a committee that develops consensus
and contributes (one vote each, for US it is ANSI)
•14001 is one of the standards in the 14000 series

8. ISO 14001 Standards
•Voluntary
•Set up the by industry: countries can adapted into their legislation
•Is aimed to improve processes not performance itself
•Key aspect is that of continual improvement
•Doesn’t require the publication of an environmental statement
•Provides the company with a guideline on how to manage
environmental aspects
•Requires management commitments and involvement from all
employees

9. ISO, ANSI, Certifiers
•ISO develops International Standards but does not operate any
schemes for assessing conformity with them.
What ISO is not?
•ISO is not an auditor, assessor, registrar, or certifier of management
systems, products, services, materials or personnel, nor does it
endorse or control any such activities performed by other parties.
ANSI coordinates the development of standards in the U.S. and
accredit programs that assess conformance with the standards
•750 certification bodies worldwide

11. Environmental Management System (EMS)
Policy
Management
Review
Implementation
and Operation
Checking and
Corrective Action
Planning

12. The ISO 14001 EMS Model
4.5.1 Monitoring & Measurement
4.5.2 Preventive & Corrective Action
4.5.3 Records
4.5.4 EMS Audit
4.4.1 Resources, Roles,
responsibility and authority
4.4.2 Competence, Training &
Awareness
4.4.3 Communication
4.4.4 Documentation
4.4.5 Document Control
4.4.6 Operational Control
4.4.7 Emergency Preparedness
4.2 Define Policy
4.3.1 Identify Aspects
4.3.2 Legal Requirements
4.3.3 Identify Objectives
Targets and Programs
4.4 Implementation
and Operation
4.5 Checking
4.6 Management Review
3.2 Continual Improvement
3.18 Prevention of Pollution
Products,
Services, and
Activities
P D C A

13. ISO 14001 Environmental Standard v2004
4.1 General Requirements
4.2 Environmental Policy
4.3 Planning
–Environmental aspects
–Legal and other requirements
–Objectives, Targets and Programs
4.4. Implementation and Operation
–Resources, Roles, Responsibilities and Authority
–Competence, Training and Awareness
–Communication
–Documentation
–Controls of documents
–Operational control
–Emergency Preparedness and Response
4.5 Checking
–Monitoring and Measurement
–Evaluation of compliance
–Nonconformity, Corrective action and Preventive action
–Control of records
–Internal audit
4.6. Management Review

14. Environmental Policy
•The environmental policy
describes the organization’s
overall approach and intentions.
•Is the Keystone upon which the
entire EMS is constructed.
•NOT A PUBLIC RELATIONS
DOCUMENT
Policy
Management
Review
Implementation
and Operation
Checking and
Corrective Action
Planning

15. Policy Requirements
To meet ISO 14001 requirements, the policy must:
1.Be appropriate to the nature, scale, and environmental impacts of
the organization activities and goods produced.
2.Include a commitment to continual improvement and prevention of
pollution.
3.Include a commitment to relevant legal requirements.
4.Provide a framework for setting and reviewing environmental
objectives and targets.
5.Be documented, implemented and maintained, and communicated to
all employees (also contractors)
6.Be available to the public.

16. Policy Statement
•Organization must be able to demonstrate
that it is fully aware of all relevant
environmental issues and their potential
impact and importance.
•No list is appropriate to all organizations;
each establishes methods/measures
relevant to its operations.

17. Policy Statement
•Provides a framework for setting
environmental objectives
–Objectives are specific and defined goals that
need to be achieved in order to meet the
requirements of the Environmental Policy.
–Every action, requirement, procedure, etc.
contained within the EMS must have its roots
in the Env. Policy Statement.

18. Policy Statement
•Commitment to continual improvement
–“Process of enhancing the environmental
management system to achieve improvements
in overall environmental performance in line
with the organization's environmental policy.“
–Ties together the Env. Policy Statement and
Management Review elements of ISO 14001.
•Requires the EMS be reviewed and evaluated at a
set frequency for changed aspects and impacts
(yearly is generally acceptable).

19. Policy Statement
•Commitment to P2
–After pollution based objectives have been
set, P2 must be evaluated at one of the
alternative approaches to setting the
Target(s).
–If P2 is not cost-effective, it does not have to
be accepted.

20. Policy Statement
•Commitment to Compliance with Laws, Regs, and
Requirements
–Identify applicable laws & regs
–Determine compliance
–Develop action plan to correct noncompliance
–Establish a system to maintain compliance
•Organization does not need to be in full
compliance in order to conform with 14001
•Continued pattern of noncompliance may need to
nonconformance with ISO 14001.

21. Policy Statement
•Documentation and Communication
–Executive level manager must sign the Policy
Statement and maintained based on
Document Control (4.4.5) proceedures.
–All employees must understand and
recognize the commitments and relate their
job functions with the Policy.
–Policy must be communicated with the public.

22. Planning
–Environmental Aspects.
–Legal and Other
Requirements.
–Objectives and Targets.
–Environmental
Management Program
•Dynamic
•Integrated
Policy
Management
Review
Implementation
and Operation
Checking and
Corrective Action
Planning

23. Planning
Identify
Activities,
Products
and
Services
Identify
Environmental
Aspects and
Impacts
Determine
Priority
Environmental
Aspects
Determine Legal and Other
Requirements
Establish
Objectives
and
Targets
Develop
Environmental
Management
Program

24. Activities, Products and Services
•This is where is described what the facility does
–Consider mission – what ‘facility’ is designed to do
e.g. fast delivery of documents/packages
–Consider activities that support the mission
e.g. vehicle maintenance
–Consider actions that are both regulated and not
regulated
e.g. commuting to work

25. Aspects and Impacts
•Identify environmental aspects of activities products and
services that can be controlled and over which can be
expected to have an influence”
–Aspects: Element of an organization's activities,
products or services that can interact with the
environment.
–Impacts: Any change to the environment, whether
adverse or beneficial, wholly or partially resulting from
an organization's activities, products or services
Video

26. Aspects and Impacts
•Content Requirements of Environmental Aspects
–understand how organization interacts with the environment
–control versus influence
–arrive at a list of significant environmental aspects based upon
impacts
–develop a procedure to support the three step decision making
process
Video

27. Determine Significant Aspects
•The process of arriving at a list of Significant Environmental Aspects
must be a reasonable and understandable procedure be based upon
the following criteria:
1.perceived risk(human health vs. ecosystem);
2.impact analysis (internal, local, regional, global);
3.probability of occurrence
4.direct or indirect control;
5.regulated or non-regulated;
6.resource utilization;
7.community interest;
8.etc.
•Consider normal, unique, and emergency conditions
•Where do opportunities exist for improvement?

28. Legal and Other Requirements
•Identify legal requirements that apply to a facility’s activities – use
audit guides or protocols
•Identify other requirements that apply including corporate policies,
Executive Orders (public organizations), facility initiatives or
voluntary practices
•ISO 14001 does not require documentation for the Legal and Other
Requirements section (4.3.2). However, the only practical way to
demonstrate conformance is to assemble in one place a list and
copies of each applicable environmental law, regulation and
voluntary subscription along with the supporting permits and/or
contracts as evidence.

29. Objectives and Targets
•Consider “legal and other requirements”
•Consider significant aspects
•Reflect corporate policies
•Reflect financial and technical limitations
•Reflect “interested parties”
•Reflect policy commitment and commitment to pollution
prevention
•Consider how you will measure progress

30. Objectives and Targets
•Objectives are the “Goals” that support the “Vision” contained in the
Environmental Policy Statement.

31. ISO 14001 Specifications for
Objectives/Targets
•The ISO 14001 Standard stipulates several criteria that must be considered when establishing
environmental objectives. Specifically:
•Environmental policy commitments to continual improvement, prevention of pollution, and compliance
with legal and other requirements.
•Concentration on controlling significant environmental aspects – the activities, products, and services
with the highest environmental impacts – since reducing their significance (i.e., the risks associated
with them) automatically lowers their impacts.
•Taking consideration of technological options and financial, operational, and business requirements
means that environmental objectives and targets must be practical in terms of being technologically
achievable, within the limits of available budget constraints, and consistent with operational and
business strategies.
–In other words, objectives and targets must be realistic and attainable, not mere dreams or wish
lists.
•The views of interested parties. Any individual, group, agency, or community that may be affected by
or have a stake in the operations of the facility implementing the EMS. This can be a long list,
including:
–National, regional/provincial, local government officials
–Local community representatives
–Public interest groups and other stakeholders (The views of interested parties are also helpful
when an organization makes a decision regarding communication of its environmental aspects).

32. 32
ISO 14001 Environmental
Management Programs:
The organization shall establish and maintain
programs for achieving its objectives and
targets, including:
(a)designation of responsibility for achieving
objectives and targets at each level and
function of the organization
(b)the means and time-frame by which they are to
be achieved

33. 33
Environmental
Management Programs
An EMP is an action plan specifying:
•How objectives and targets will be accomplished
•Who is responsible for achieving them
•Who will manage and supervise the activities
•Who will carry out the work
•What they will do
•What resources are needed (e.g., people, skills,
equipment, time, money)
•When the tasks will be completed (i.e., a schedule)

35. 35
ISO 14001 Planning Sequence
ENVIRONMENTAL
POLICY
Guiding
Light
ENVIRONMENTAL
ASPECTS
Problem
Definition
LEGAL AND
OTHER
REQUIREMENTS

Obligations
OBJECTIVES
AND TARGETS
Goal
Setting
ENVIRONMENTAL
MANAGEMENT
PROGRAMS
Means of
Achieving
Goals

36. Implementation and Operation
•This phase includes 7
elements:
–Resources, Roles,
Responsibilities and Authority
–Competence, Training and
Awareness
–Communication
–Documentation
–Controls of documents
–Operational control
–Emergency Preparedness and
Response
Policy
Management
Review
Implementation
and Operation
Checking and
Corrective Action
Planning

37. Implementation and Operation
Structure and
Responsibility
Training,
Awareness and
Competence
Document Control
EMS Documentation
Emergency
preparedness and
response
Communication
Operational Control
Organization &
Accountability
Capabilities &
Communications
Controls

38. Structure and Responsibility
•Roles and responsibilities are defined, documented,
communicated
•Management will provide resources for implementation
of the system
•Identifies Management Representative (s)
–In charge
–Report to top management

39. Training, Awareness and Competence
•Ensure training and awareness relevant to
–EMS - including policy
–relationship between employees’ activities and environmental
impacts
•Ensure competence training to
–regulatory requirements
–standard operating procedures

40. Communication
•Ensure internal communication
•External communication of significant environmental
impacts is optional, however this decision shall be
documented
•Provide process for responding to external
communication

41. Documentation and Document Control
•Procedures for controlling documents
–can be located - are legible, dated and maintained
–reviewed and revised as necessary and approved
–current versions are available to practitioner
–obsolete documents are removed from use

42. 42
Documentation
•Under ISO 14001, documentation refers to all
written material concerning the EMS
•Documents include policies, procedures,
manuals, plans, diagrams, flowcharts,
correspondence, memoranda related to the
EMS
•Records are documents, but under ISO
14001 are distinguished from documentation:
–Documentation concerns what should happen
–Records contain information on what has
happened

43. 43
Must Document
4.2 ENVIRONMENTAL POLICY
4.3.3 Environmental objectives and targets
4.4.1 Roles, responsibilities, and authority for EMS
4.4.3 Communications from external interested
parties
4.4.4 EMS core elements
4.4.6 Procedures essential for operational control
4.5.1 Monitoring and measurement of key operations
that have potential significant impacts
4.5.1 Compliance with laws and regulations
4.5.3 Records
4.6 MANAGEMENT REVIEW

44. 44
Good Idea to Document
4.3.1 Environmental aspects and impacts
inventory
4.3.2 Significant environmental aspects
4.3.3 Registry of legislation and regulations
4.3.4 Environmental management programs -
action plans to achieve objectives and
targets
4.4.2 Training needs results, and training plans
4.4.7 Emergency response plan
4.5.2 Corrective and preventive actions
4.5.5 EMS audit results

45. 45
What are
Operational Controls?
•Means by which an organization prevents pollution
from operations, e.g.:
–Pollution control equipment such as scrubbers,
filters, precipitators, clarifiers, biological and
chemical treatment, etc.
–Alarms for gas, pH, conductance, tank level, etc.
–Preventive maintenance practices
–Operating procedures

46. 46
Methods of Operational
Control
•Process controls:
–electronic
–mechanical
–monitoring
–observation
•Operating procedures:
–verbal
–documented

47. 47
What is a Procedure?
•An activity carried out according to specified
instructions
•Combination of responsibilities, authority,
resources, instructions needed to
consistently perform an activity
•A procedure may be documented (i.e.,
written), but the document is NOT the
procedure

48. 48
One More Thing from
ISO 14001 4.4.6
The organization shall establish and maintain
procedures related to the identifiable
significant environmental aspects of goods
and services used by the organization and
communicate relevant procedures and
requirements to suppliers and contractors

49. 49
Responsibilities of Contractors
and Suppliers
•The organization is responsible for informing
contractors and suppliers about operating
procedures relating to their goods and services
•Contractors must comply with all EMS
requirements when on site
•Suppliers may be required to meet specified
environmental standards in their own facilities

50. Emergency Preparedness and Response
•Procedures to address accidents and
emergencies
–prevent and mitigate environmental impacts
–review and revise after emergency or
accident
–test where appropriate

52. Checking
•5 elements:
–Monitoring and Measurement.
–Evaluation of compliance
–Non-Conformance and
Corrective and Preventive
Actions.
–Control of Records
–EMS Internal Audit.
Policy
Management
Review
Implementation
and Operation
Checking and
Corrective Action
Planning

53. Checking
RecordsOngoing
Monitoring and
Measuring
Periodic Internal EMS Audits
Non-conformance,
Corrective and
Preventive Action
Periodic Evaluations of compliance

54. Monitoring and Measuring
•Procedures to monitor and measure
activities related to significant aspects
–Root cause analysis
–Audits
–Track performance, operational control and objectives and
targets
–Maintain and calibrate monitoring equipment

55. Evaluation of Compliance
•Periodically evaluate compliance with
applicable legal requirements
•Also evaluate compliance with other
requirements the company subscribes
•Keep records of such evaluations

56. Nonconformity, Corrective and
Preventive Action
–Identify cause of nonconformity
–Develop corrective action and implement it
–Modify procedures if necessary to prevent
recurrence
–Define responsibility and authority to
address non-conformance

57. Control of Records
•Procedures for identification, maintenance and
disposition of environmental records
–Legible and traceable to the activity, product or
service involved

58. Internal EMS Audits
•Periodically audit to determine if the EMS
–is being properly implemented and
maintained, and
–conforms to the standard
•Provide audit information to management

59. Management Review
–Policy
–Audits
–Corrective and Preventive
Action Systems.
–Environmental Objectives
and Targets.
Policy
Management
Review
Implementation
and Operation
Checking and
Corrective Action
Planning

60. Management Review Process

Need to consider:
• audit findings
• progress records on objectives
• changes to facilities
• changes in activities,
products or services
• changes in technology
• concerns of interested parties
• other relevant information
To Assess the
• suitability,
• adequacy, and
• effectiveness of the EMS
In order to determine the need
for change and improvement to:
• the environmental policy
• the objectives and targets
• other elements of the EMS

61. Summary
•An EMS is a formal system for managing the environmental
footprint of organizations
•Most organizations already have several EMS elements in place -
the system relationship is lacking
•An EMS must serve the mission of the organization
•The EMS and related measurement tools are just that- tools.
Alone, they will not guarantee success.
•The organization must use the tools, not just have them.
•Success comes from being committed to continual improvement
for the long term