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Mgt Guide

Managing Compliance Effectively

 is fundamental to

Meeting Market and Customer Needs

    

The information below provides a brief outline of the essential elements and activities which should be considered by any organisation when addressing product compliance.

Why not consider using Stanimore's Compliance Management Services.  We can provide:

expert Compliance Management Advise; or

Compliance Management Resources (outsource all or part of your organisationís Product Compliance function).

It is probably more cost effective than you may think.

 

   

Product Compliance Function Outline

Overall Goals

The overall goals of any product compliance function within an organisation should be to:

  1. Understand market and customer needs/requirements concerning product compliance with technical standards, specifications and regulation

  2. Minimise the companyís legal exposure by ensuring all regulatory compliance and product approval requirements for target markets are met

    Essentially, this means:-
    Minimise, or reduce to an agreed acceptable risk level, the organisationís liability/exposure associated with the supply of product in a particular market or region
    (i.e. all issues impacting supply of product such as product compliance legislation/regulations or product approval requirements etc); and

  3. Minimise the impact of market driven (government/customer) product requirements by providing a resource/ability to confirm or deny compliance with those requirements

    Essentially, this means:-
    Facilitate the organisationís ability to, when required, intelligently and knowledgeably respond to Government tenders and customer procurement specifications stipulating product requirements (i.e. such documents typically require a product complies with international or national standards/specifications, internal company purchase specifications or industry codes etc)

 

 Specific Product Regulatory Compliance and Approval Activities 

  1. Ensure the organisation and the organisationís product presently comply and continue to comply with all product regulations, product approval and associated requirements in all geographic markets where the organisation or the organisationís distributors are supplying product (target markets);

  2. Proactively work with organisationís product engineering and design teams to ensure an understanding of market technical requirements as well as advising of any changes or pending changes to those requirements etc;

  3. In relation to any product to be supplied, determine applicable compliance requirements and product approvals required in the "target markets" and fulfil those requirements:
    1. New products

                                                               i.      Obtain and review all necessary product compliance documentation to ensure product compliance;

                                                              ii.      Resolve any compliance anomalies;

                                                            iii.      Where necessary, obtain required product approval(s);

                                                            iv.      Where necessary, establish product Technical Construction Files (TCFs) or product Compliance Folders (CFs)

                                                             v.      Prepare Declarations of Conformity for signature as necessary;

    1. Product Variants/Modifications

                                                               i.      Obtain and review all necessary compliance documentation concerning the variation/modification to ensure continued product compliance;

                                                              ii.      Resolve any compliance anomalies;

                                                            iii.      Where necessary, obtain new product approvals or apply to update existing product approval(s);

                                                            iv.      Incorporate new information in existing product Technical Construction Files (TCFs) or product Compliance Folders (CFs) as required relating to compliance of product variations/modifications (including review findings, record of compliance decisions and actions taken as a result of such product variation/modification documentation review)

                                                             v.      Prepare new Declarations of Conformity for signature as required

  1. Maintain an up-to-date master record of the compliance status of each product and an up-to-date master record of all product Technical Construction Files (TCFs) or product Compliance Folders (CFs) and their status

  2. Provide resource for internal compliance enquiries (i.e. from product design teams, Sales or Marketing function etc)

  3. Advise on compliance issues/arrangements relating to the supply of 3rd party products

 

External Compliance Enquiries

Provide resource capable of responding intelligently and knowledgeably to external enquiries from customers, distributors/suppliers, regulatory or approval bodies concerning a productís conformance with any requirements.  Such requirements may be regulatory requirements, formal standards, defacto standards/specifications or customer/government tender or procurement specifications.

     

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Last modified: 19 July, 2005