ECRIN Quality Management System

Standard Operating Procedure

Title: Control of Quality Records

Status: PRIVATE Document no.: SOP-05
Lead Author Approver
Document no.: Effective date: 15/10/2015

Name: Gustavo Sabino SOP/INSTRUCTION/01

Name: Christine Kubiak Review Date: 10/07/2015

Signature: On file Signature: On file Supersedes: Version 1.0

Date: 01/10/2015 Date: 01/10/2015 Version: 1

The signatures above certify that this procedure has been reviewed and accepted, and demonstrates that the
signatories are aware of all the requirements contained herein and are committed to ensuring their provision.

Amendment Record

This procedure is reviewed to ensure its continuing relevance to the systems and process that it
describes. A record of contextual additions or omissions is given below:

Version no. Date Reason for change Main modifications

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 ECRIN Quality Management System

1. PURPOSE

Records are an important organisational asset, they provide the primary route for evidence based
verification and traceability, and demonstrate compliance with users requirements whilst also proving
the efficacy of the ECRIN's quality management system.

2. SCOPE

The scope of this process encompasses all quality records generated by ECRIN's quality management
system. Quality records must be controlled so the information they contain is readily accessible, legible
and suitably maintained.

3. DEFINITIONS AND ABBREVIATIONS

Record: Document stating results or evidence of activities performed.

Retention Period: The length of time that records are to be kept.

4. RESPONSIBILITIES

This procedure applies to all quality management system records and is to be followed by all ECRIN
staff where appropriate. Quality records are generated and maintained by the Quality Manager. For
electronic records, back up procedures are established, employees are responsible for backing up their
data.

5. DESCRIPTION

5.1 Records are maintained to provide evidence of the conformity, implementation, and effective
operation of the quality management system.

5.2 Records retained are required to be legible, readily identifiable, and appropriately retrievable.

5.3 Records
ECRIN quality management records, include but not limited to:

Resource Management documents (CVs, Job description, Confidentiality Agreement, Training

records).
Quality Management Meeting minutes.
Audit and Assessment results
Records such as corrective and preventive actions, complaints & feedback, and document
changes requests.

5.4 The following are controls in place for quality records:

5.4.1 Retrieval: Retrieval for all quality records is identified appropriately as part of the procedure and
quality manager is responsible to ensure the proper retrieval of quality records. Quality Manager will be
contacted in order to retrieve any archived documents, if applicable.

5.4.2 Identification: The title of the record is identified in the list of Quality Records.

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 ECRIN Quality Management System

5.4.3 Storage: The storage of the record is defined by whether it is hard copy or electronic, and where
the document is stored. Electronic back up data are stored by the IT team.

5.4.4 Protection: Hard copy records are stored at the Quality Manager Office where they are protected
by key in a locked cabinet.

5.4.5 Retention time: This requirement, listed in the Retention Period of Quality Records Table,
indicates the minimum time period the record is required to be maintained.

5.4.6 Disposition: The disposition may include archiving the record, if electronic, shredding the record,
deleting the record, or discarding it at the discretion of the Quality Manager. If discard as desired is
listed, it is decided by the Quality Manager whether to hold the record longer, shred, throw away,
delete, or remove by any other means at a designated time.

5.5 Retention Period of Quality Records

Title Storage Location Retention Period

Quality Management meeting
3 years
minutes
Audits and Assessment results 5 years or more, if applicable

Resource Management 5 years *

* Or until the departure of the staff

The retention period of other documents will be define when created.

6. REFERENCES

1. Internal document. ECRIN Glossary.

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