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5.1 COMMITMENT REQUIREMENTS

Part 5.1 requirements must be met
1 Demonstrate your ongoing commitment. by your organization’s top managers.

2 Support the development of your QMS.

Part 5.3 discusses the requirements
3 Ensure that a quality policy is established. that your policy must comply with.
Part 5.4.1 discusses the need
4 Ensure that quality objectives are established. to establish quality objectives.

5 Support the implementation of your QMS.

6 Communicate your commitment to quality.

7 Explain why it's important to meet customer requirements.

8 Explain why it's important to meet regulatory requirements.

Part 6 asks you to ensure that
9 Provide suitable implementation resources. QMS resources are provided.

10 Support the maintenance of your QMS.

11 Conduct management reviews.

12 Provide maintenance resources.

5.2 EXTERNAL REQUIREMENTS

Part 5.2 requirements must be met
13 Ensure that external requirements are determined. by your organization’s top managers.

14 Expect customer requirements to be determined.

15 Expect regulatory requirements to be determined.

16 Ensure that external requirements are being met.

17 Expect customer requirements to be met.

18 Expect regulatory requirements to be met.

5.3 POLICY REQUIREMENTS

Part 5.3 requirements must be met
19 Plan your quality policy. by your organization’s top managers.

20 Make sure that it supports your organization's purpose.

21 Make sure that it can be used to set quality objectives.

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22 Make sure that it can be used to review objectives.

23 Draft your quality policy. A quality policy should express top

management's commitment to the quality
management system (QMS) and should
24 Make a commitment to comply with requirements. allow managers to set quality objectives.

25 Make a commitment to maintain QMS effectiveness.

26 Apply your quality policy.

27 Communicate your quality policy.

28 Ensure that it's understood within your organization.

29 Review your quality policy.

30 Make sure that your policy is still suitable.

5.4 PLANNING REQUIREMENTS

5.4.1 ESTABLISH QUALITY OBJECTIVES

Part 5.4 requirements must be met
31 Plan the establishment of quality objectives. by your organization’s top managers.
A quality objective is a quality result that
32 Make sure that your quality objectives are effective. you intend to achieve. Quality objectives
are generally based on or derived from
33 Make sure that your quality objectives are measurable. an organization’s quality policy and must
be consistent with it. They are usually
formulated at all relevant levels within the
34 Make sure that objectives are consistent with quality policy. organization and for all relevant functions.

35 Establish quality objectives for your organization.

36 Set objectives needed to meet product requirements.

37 Establish product oriented objectives in relevant functional areas.

38 Establish product oriented objectives at relevant organizational levels.

39 Set objectives needed to meet regulatory requirements.

40 Establish regulatory objectives in relevant functional areas.

41 Establish regulatory objectives at relevant organizational levels.

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5.4.2 CARRY OUT QUALITY PLANNING

42 Plan how you're going to develop your QMS (per 4.1.1). Part 5.4.2 expects top managers to ensure
that QMS planning is carried out in order
43 Plan how you're going to document your QMS (per 4.1.1). to meet the requirements listed in parts
4.1 and 5.4.1. We have, therefore, listed
these requirements here so that you don't
44 Plan how you're going to structure your QMS (per 4.1.2). have to keep flipping back and forth
between sections (section numbers are
45 Plan how processes will interact with one another (per 4.1.2). shown in parentheses for your convenience).

46 Plan how you're going to manage your QMS (per 4.1.1).

47 Plan how you're going to apply a risk based approach (per 4.1.2). According to ISO 13485 2016, when the
term risk is used it refers to the need to
48 Plan how you're going to comply with process requirements (per 4.1.4). think about what could potentially happen
when a manufacturer fails to meet product
49 Plan how you're going to manage changes to your processes (per 4.1.4). safety or performance requirements or fails
to comply with all applicable regulatory
50 Plan how you're going to validate and revalidate software (per 4.1.6). requirements.
According to the ISO 14971 risk
51 Plan how you're going to monitor your QMS (per 4.1.1). management standard for medical
devices, the concept of risk combines two
52 Plan how you're going to monitor quality objectives (per 5.4.1). variables: the probability of harm and the
severity of harm. For more information,
53 Plan how you're going to monitor outsourced processes (per 4.1.5). see www.praxiom.com/14971.htm

54 Plan how you're going to control your QMS (per 4.1.1).

55 Plan how you're going to control the setting of quality objectives (per 5.4.1).

56 Plan how you're going to develop actions to achieve objectives (per 5.4.1).

57 Plan how you're going to modify actions to achieve objectives (per 5.4.1).

58 Plan how you're going to control changes to your QMS (per 5.4.2).

59 Plan how you're going to protect the integrity of your QMS (per 5.4.2).

60 Plan how you're going to control outsourced processes (per 4.1.5).

61 Plan how you're going to implement your QMS (per 4.1.1).

62 Plan how you're going to maintain your QMS (per 4.1.1).

63 Plan how you're going to support your processes (per 4.1.3).

64 Plan how QMS integrity will be protected when changes are made (per 5.4.2).

ORGANIZATION: YOUR LOCATION:

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5.5 MANAGERIAL REQUIREMENTS

5.5.1 CLARIFY RESPONSIBILITY AND AUTHORITY

Part 5.5 requirements must be met
65 Define QMS responsibilities and authorities. by your organization’s top managers.
According to ISO 13485 2016 section 0.2,
66 Document your organization's QMS responsibilities and authorities.
“When a requirement is required to be
‘documented’, it is also required to be
67 Communicate responsibilities and authorities within your organization. established, implemented and maintained”.

68 Maintain documents that define QMS responsibilities and authorities.

69 Document how QMS personnel are interrelated.

70 Consider people who manage work that affects quality.

71 Consider how these managers relate to other personnel.

72 Ensure that managers have the independence they need to do their work.

73 Ensure that managers have the authority they need to do their work.

74 Consider people who perform work that affects quality.

75 Consider how these workers relate to other personnel.

76 Ensure that these workers have the independence they need to do their work.

77 Ensure that these workers have the authority they need to do their work.

78 Consider people who verify work that affects quality.

79 Consider how these people relate to other personnel.

80 Ensure that these people have the independence they need to do their work.

81 Ensure that these people have the authority they need to do their work.

5.5.2 APPOINT MANAGEMENT REPRESENTATIVE

82 Appoint a member of management to oversee your organization's QMS.

83 Give management representative the necessary authority and responsibility.

84 Assign authority and responsibility for documenting your QMS.

85 Assign authority and responsibility for documenting processes.

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86 Assign authority and responsibility for maintaining process documents.

87 Assign authority and responsibility for reporting to top management.

88 Ask your representative to report on the effectiveness of the QMS.

89 Ask your representative to report on the need for improvement.

A note to this section says that you could also
90 Assign authority and responsibility for promoting corporate awareness.
make your management representative
responsible for liaising with regulatory
91 Ask your representative to make people aware of applicable requirements. authorities and other external parties.

92 Make your personnel aware of all applicable regulatory requirements.

93 Make your personnel aware of all applicable QMS requirements.

5.5.3 ESTABLISH INTERNAL COMMUNICATIONS

94 Establish appropriate internal communication processes.

95 Encourage communication about the effectiveness of your QMS.

5.6 REVIEW REQUIREMENTS

5.6.1 PERFORM REGULAR MANAGEMENT REVIEWS

96 Establish management review procedures. Part 5.6 requirements must be met

by your organization’s top managers.
97 Document your management review procedures. The purpose of a management review is
to evaluate the suitability, adequacy, and
98 Make sure that your QMS is still suitable. effectiveness of an organization's quality
management system, and to look for
99 Make sure that your QMS is still adequate. improvement opportunities. Management
reviews are also used to identify and assess
opportunities to change an organization’s
100 Make sure that your QMS is still effective. quality policy and quality objectives, to
address resource needs, and to look for
101 Schedule your reviews at planned intervals. opportunities to improve its products.

102 Document your management review schedule.

103 Review your QMS at planned intervals.

104 Review the need to change your QMS.

105 Review the need to change your quality policy.

ORGANIZATION: YOUR LOCATION:

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106 Review the need to change your quality objectives.

107 Review the need to improve your QMS.

108 Maintain a record of management reviews. See section 4.2.5 for more on record keeping.

5.6.2 STUDY MANAGEMENT REVIEW INPUTS

109 Study information about your QMS (inputs).

110 Review previous management reviews.

111 Review previous follow up actions.

112 Review the results of previous audits.

113 Review monitoring and measurement activities.

114 Review process monitoring and measurement.

115 Review product monitoring and measurement.

116 Review complaint handling activities.

117 Review previous remedial actions.

118 Review previous corrective actions.

119 Review previous preventive actions.

120 Review new or revised regulatory requirements.

121 Review reports to regulatory authorities.

122 Review recommendations for improvement.

123 Review changes that could affect the QMS.

5.6.3 GENERATE MANAGEMENT REVIEW OUTPUTS

124 Generate management review outputs.

125 Generate decisions and actions to improve your QMS.

126 Improve the suitability of your organization's QMS.

ORGANIZATION: YOUR LOCATION:

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127 Improve the suitability of your QMS processes.

128 Improve the adequacy of your organization's QMS.

129 Improve the adequacy of your QMS processes.

130 Improve the effectiveness of your organization's QMS.

131 Improve the effectiveness of your QMS processes.

132 Generate decisions and actions to deal with regulatory changes.

133 Identify changes needed to respond to new requirements.

134 Identify changes needed to respond to revised requirements.

135 Generate decisions and actions to enhance your products.

136 Enhance products' ability to meet customer requirements.

137 Generate decisions and actions to address resource needs.

138 Establish a record of management reviews. See section 4.2.5 for more on record keeping.

139 Document your management review outputs.

140 Keep a record of management review inputs.

For those who wish to use our publication as a checklist, we have provided a column to the right of each task that you
can use to record your response. You could record a DONE, TO DO, or N/A in this column, or you could simply place a √
to indicate that the task has been or is being performed or you could record an O/S to indicate that an item is outstanding.
In the spaces below, enter the name and location of your organization, who completed this page, who reviewed it, and the dates.

ORGANIZATION: YOUR LOCATION:

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