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Relevant Interested Parties (RIP)

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In ISO 9001:2015 (plus others), Append A.3 ...

Subclause 4.2 specifies requirements for the organization to determine the interested parties that are relevant to the quality management system and the requirements of those interested parties. However, 4.2 does not imply extension of quality management system requirements beyond the scope of this International Standard. As stated in the scope, this (ISO 9001:2015) International Standard is applicable where an organization needs to demonstrate its ability to consistently provide products and services that meet customer and applicable statutory and regulatory requirements, and aims to enhance customer satisfaction.

There is no requirement in this (ISO 9001:2015) International Standard for the organization to consider interested parties where it has decided that those parties are not relevant to its quality management system. It is for the organization to decide if a particular requirement of a relevant interested party is relevant to its quality management system.

QMSCAPA provides a module for identifying Relevant Interested Parties (RIP) and grouping them by their relationship to the Organization.

In addition, for each RIP, QMSCAPA provides a related database of the Expectations, Objectives and/or Requirements. Inside QMSCAPA the Expectations, Objectives and/or Requirements are referred to as Exp/Obj/Req.

Menu Option - Relevant Interested Parties

Main Menu > Edit Tables > Relevant Interested Parties > 1) Relevant Interested Parties

Browse Table - Relevant Interested Parties (RIP)

1)In the Browse Table image below, section (1) shows

a.Add a new RIP

b.Edit an existing

c.Delete an existing

d.Create Risk Assessment from the highlighted record

2)The top level table with the # (2) shows the RIPs that have been identified

3)The top level table with the # (3) shows needs of the RIP, which are referred to as Expectations, Objectives and, or Requirements.

4)The Risk Assessments for Selected button provides a direct access to the Risk Assessments that have been created for the highlight RIP record in section #2.

5)The RIP (1) button control will print the RIP highlighted RIP record and any related Exp/Obj/Req. The RIP (All) button control will print all RIP records and any related Exp/Obj/Req.

Form - Relevant Interested Parties

1)The RIP Form, Tab 1) contains

a.User-defined Identification field for an alpha/numeric identification of the RIP record. The UDId is copied to the Risk Assessment as the 'Title.'

b.Relationship field with a user-defined Relationship look-up table.

2)Tab 2) Expectations, Objectives or Requirements contains a browse table with the RIP's related Exp/Obj/Req.

3)Section (3) shows the RIP is 'Active' or 'Not Active' and if a Risk Assessment is required or determined.

4)The Comments field should be a summary of the RIP's requirements. This information is copied to the Risk Assessment module as the 'Purpose.'

5)The RIP Form, Tab 2 above) contains:

a.The status of management review;

b.Controls for adding, editing and deleting Expectations, Objectives and Requirements;

c.A table showing the Expectations, Objectives and Requirements determined for RIP.

Form - Relevant Interested Parties > Expectations, Objectives or Requirements

1.The Row Number field is used to control the order the ExpObjReq text appears on the RIP reports. Each RIP may have 999 related records or rows.

2.The EOR Look Up Id field, if not zero (0), opens the RIP ExpObjReq Lookup Table of stored ExpObjReq text examples.

a.The ExpObjReq Description field may be populated by the description information drawn from the ExpObjReq Lookup Table.

b.Also, the ExpObjReq Text field may be populated by the text information drawn from the ExpObjReq Lookup Table.

3.The ExpObjReq Text field is used to record the needs of the RIP. Use the ExpObjReq Text field to record a single Expectation, Objective and/or Requirement.

4.Checkbox Requires Risk Assessment - If the Expectation, Objective and/or Requirement requires a Risk Assessment then check this box and associate the appropriate Risk Assessment and Impact Statement from the QMSCAPA Risk Assessment Module.

5.Risk Assessment Id field lookup button provides direct access to the Risk Assessment Table.