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    Outsorcing Processes Procedure

    Uploaded by

    Diego Matilla

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd

    Outsorcing Processes Procedure

    Uploaded by

    Diego Matilla
    8 views3 pages

    Copyright

    © © All Rights Reserved

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    DOCX, PDF, TXT or read online from Scribd

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    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    8 views3 pages

    Outsorcing Processes Procedure

    Uploaded by

    Diego Matilla

    Copyright:

    © All Rights Reserved
    Download as DOCX, PDF, TXT or read online from Scribd
    Download as docx, pdf, or txt
    of 3

    1.

    0 Scope
    1.1 General
    This Standard Operating Procedure (SOP) is to establish requirements for the control of outsourced
    processes, including the selection of suppliers. It defines controls for suppliers with independent quality
    systems that provide outsourced process activities.

    1.2 Application
    This SOP applies to processes defined in the QMS, or are the regulatory or statutory responsibility of
    Zoppas Industries Romania but are not performed by Zoppas Industries Romania employees.
    Typical outsourced processes may include, but are not limited to design, development, analysis,
    calibration, product warehouse and Facility Management.
    The procedure is to be utilized by Purchasing, Quality, and any organization within Zoppas Industries
    Romania seeking outsourced process work subject to this SOP.
    2.0 References
    A. POLICY-XXX Quality Manual
    B. ISO 13485 Medical Devices – Quality Management Systems – Requirements for Regulatory
    C. Purposes, §1.2 ¶4, §1.4 ¶4,
    D. SOP-XXXX Vendor Qualification
    E. SOP-XXXX Purchasing
    F. Anex A. List of Outsorcing Processes in ZIR.

    3.0 Terms and Definitions


    1. Outsourced Process – A process that the organization needs for its quality management system and
    which the organization chooses to have performed by an external party. It includes processes for
    management activities, provision of resources, product realization and measurement, analysis and
    improvement

    4.0 Responsibility and Authority


    1. Quality Manager – Responsibility includes review, approval, retention, and identification of all
    Supplier Quality Agreements. The Quality Manager als performs supplier audits as necessary.
    2. Purchasing Coordinator – Responsibilities as defined in SOP-XXXX Purchasing and SOPXXXX
    Vendor Qualification, with respect to outsourced process suppliers.
    3. Originating Department Manager – Responsible for selection of the supplier, delivery of requirements,
    and establishment of the Supplier Quality Agreement. The manager shall also assist the Quality Manager
    for any supplier audits.
    4. Human Resources – Responsible for retention of training records.
    5.0 Control Measures

    5.1 Acquisition

    5.1.1 Vendor Qualification

    The process to be performed by the supplier shall first be examined to determine if there are any unique
    certification requirements needed (e.g. a supplier performing calibration should have ISO17025
    certification, a supplier performing design service should be ISO13485 certified) A review of supplier’s
    ISO status shall be performed as part of the Vendor Qualification process. If ISO certified, then a focused
    study of the certification shall be performed by the Quality Manager.

    This may be accomplished by reviewing the scope of the certification or by reviewing relevant portions
    of the Vendor’s Quality manual to verify that no sections that are needed have been excluded or
    otherwise not performed as a normal part of the company’s business. If no ISO certification exists, then
    the Quality Manager shall perform a full study and audit of the relevant company processes to
    determine if the supplier’s processes are sufficient to support the regulatory, statutory, and QMS
    requirements of . Evidence supporting these requirements shall be appended to the Vendor
    Qualification Form. If the evidence supports usage of this vendor in an off-site capacity, the vendor
    Qualification Form shall be positively marked to confirm the status. If the vendor is determined to be
    incapable of performing the desired activities off-site, yet satisfies personnel qualifications necessary for
    the activity, the supplier may be approved in an on-site capacity, provided that personnel are trained as
    appropriate under the Quality System.

    5.1.2 Purchase Orders

    Contracting of service shall be compliant with SOP-XXXX Purchasing procedures and purchase orders
    shall be used.

    5.2 On-Site work

    Any outsourced process work provided on premises shall conform to ’s Quality system. Any personnel
    performing these activities shall be appropriately trained and training records shall be maintained by
    Human Resources.

    5.3 Off-Site Custom Processes

    5.3.1 Outsourced Process Input Requirements

    The Originating Department Manager shall provide, or provide documented approval, of requirements
    for the off-site supplier, as required by ISO13485 to assure the supplier has adequate input for the
    activity to be performed. A record of the transmittal and receipt shall be maintained by the Quality
    Manager.

    5.3.2 Supplier Quality Agreements

    5.3.2.1 Contracts
    A Supplier Quality Agreement shall be established by the Originating Department Manager and
    approved by the Quality manager and the Outsourcing Contractor for each outsourced project. It shall
    be included in, or referenced by a contract or purchase order.

    5.3.2.2 Responsibilities

    The agreement shall clearly indicate the interaction between ’s process and the supplier’s process. It
    shall define:

    Any input that the outsourced organization needs to perform its activity in accordance with ISO13485,
    or IEC 62304 where relevant,

    • Any output that the organization will produce,

    • How the outsourced output will provide input to the next activity of ,

    • Any interactions required of the activity (while it is being performed) that is outsourced, between the
    outsourced organization and

    • Any additional review points needed that would result from outsourcing an activity or portion of an
    activity. These reviews may be joint reviews, or reviews not specifically defined in either quality system
    procedures but necessary to assure compliance to ISO13485.

    5.3.2.3 Audits

    The Supplier Quality Agreement shall contain provisions for to audit the supplier.

    5.3.2.4 Corrective Actions

    The Supplier Quality Agreement shall contain provisions for mutual notifications of any corrective
    and/or preventive actions that need to be addressed to assure conformity to quality system or
    regulatory requirements. It shall also define the monitoring activities necessary to manage any identified
    actions.

    5.3.2.5 Complaints

    The Supplier Quality Agreement shall identify communication methods to both parties where any issues
    are detected with product related to the outsourced process.

    5.3.3 Assessment of Outputs

    The Originating Department manager, or designate, shall review the output of any outsourced process.

    5.4 Off-Site Standardized Processes

    No additional controls beyond vendor qualification and purchase orders are required for standardized
    processes such as calibration.

    5.5 Identification

    The Quality manager shall keep a file with all currently active Supplier Quality Agreements.

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