Use of the Laboratories by sdfwerte

VIEWS: 6 PAGES: 12

									                    CPA et al
        Alan Dean - Pathology Quality Manager

                         &

   Mark Wilkinson – Consultant Histopathologist


7th February 2010                 Directorates of Cellular Pathology &
                                         Laboratory Medicine
                         CPA
                    Company Structure




7th February 2010                 Directorates of Cellular Pathology &
                                         Laboratory Medicine
                       Introduction
• Since its incorporation on the 6th January 1992, CPA (UK) Ltd
  has, with some modifications, used standards based on the
  laboratory sections of the Canadian, Australian and UK
  standards for healthcare. In 1996 the first drafts of a new
  international standard, ISO 15189 Quality management in the
  medical laboratory, were circulated for discussion. In the light of
  changes taking place in relevant International Standards, the
  Board of CPA (UK) Ltd established a Standards Revision Group
  (SRG) to review existing standards. The new standards (see
  section 4.0) were approved at a meeting of the CPA Board on 8
  December 2000 and are reviewed annually.

(PD-LAB-Standards v2.01 Mar 09)



7th February 2010                             Directorates of Cellular Pathology &
                                                     Laboratory Medicine
                             Approach
•  At the outset the SRG established a number of principles for its work.
•  • that a number of significant documents either published or in the
   process of being revised and published be adopted as source material
   (see section 2.0).
• • that some conventions used in writing international standards1 be
   adopted, namely that each clause (or standard in the case of CPA (UK)
   Ltd) shall have a title, that the use of the auxiliary verb „shall‟ denotes a
   requirement and that the use of the auxiliary verb „should‟ a
   recommendation
• • that terms requiring definition would be defined in the terms and
   definitions clause (see section 3.0)
• In drafting these new standards the SRG also drew upon the extensive
   experience gained in the practical implementation of the original CPA
   standards by both the user laboratories and by CPA in conducting
   assessment visits. The SRG sought to write these new standards in
   such a way that compliance with each standard would be unequivocally
   verifiable at an assessment visit.
(PD-LAB-Standards v2.01 Mar 09)


7th February 2010                                     Directorates of Cellular Pathology &
                                                             Laboratory Medicine
                    Structure of Standards
 Each individual standard has a defined structure, namely:
 • a unique alphanumeric followed by a title
 • a short explanatory passage (in italics) which, although not part of the standard, is
    intended to provide a context for the standard
 • the clauses of the standard, each with a unique alphanumeric, give the
    requirements of the standard
 • where appropriate, explanatory notes which may contain recommendations
 • cross references to clauses of the source material

 Where possible references are made to titled clauses of the source
 material. For more detailed cross references, see ISO 15189:2007 Annex
 A that has tables between ISO 15189 and ISO 9001:2000 and ISO 15189
 and ISO/IEC 17025:2005.

 Internationally the word “standard” is used to denote a normative document. Such
 documents are subdivided into clauses which are equivalent to standards in CPA
 (UK) Ltd usage.

 (PD-LAB-Standards v2.01 Mar 09)

7th February 2010                                            Directorates of Cellular Pathology &
                                                                    Laboratory Medicine
                             References
•   The following references are the source material used in the writing of these
    standards.

•  ISO 15189:2007 Medical laboratories – Particular requirements for quality and
   competence (ISO 15189:2007)
• ISO/IEC 17025: 2005 General requirements for the competence of testing and
   calibration laboratories
• ISO 9001:2000 Quality management systems-Requirements
• ISO 9000:2005 Quality management systems-Fundamentals and vocabulary
• ISO 22870:2006 Point-of-care testing (POCT) – Requirements for Quality and
   competence
• European Communities Confederation of Clinical Chemistry: Essential Criteria
   for Quality Systems of Medical Laboratories Eur J Clin Chem Clin Bioch
   1997;35:121-132
• European Communities Confederation of Clinical Chemistry: Additional Essential
   Criteria for Quality Systems of Medical Laboratories Eur J Clin Chem Clin Bioch
   1998;36:249-252
(PD-LAB-Standards v2.01 Mar 09)

7th February 2010                                        Directorates of Cellular Pathology &
                                                                Laboratory Medicine
                                     MHRA
•   The Medicines and Healthcare products Regulatory Agency (MHRA) is
    the government agency which is responsible for ensuring that
    medicines and medical devices work, and are acceptably safe.
•   No product is risk-free. Underpinning all our work lie robust and fact-
    based judgements to ensure that the benefits to patients and the public
    justify the risks.
•   We keep watch over medicines and devices, and we take any
    necessary action to protect the public promptly if there is a problem.
•   We aim to make as much information as possible publicly available.
•   We enable greater access to products, and the timely introduction of
    innovative treatments and technologies that benefit patients and the
    public.
•   We encourage everyone - the public and healthcare professionals as
    well as industry - to tell us about any problems with a medicine or
    medical device, so that we can investigate and take any necessary
    action.
(http://www.mhra.gov.uk/index.htm)

7th February 2010                                  Directorates of Cellular Pathology &
                                                          Laboratory Medicine
              MHRA – How they regulate
•   The MHRA regulates a wide range of materials from medicines and medical
    devices to blood and therapeutic products/services that are derived from tissue
    engineering. This section helps describe how the MHRA manages each of these
    products, including the use of nanotechnology in some of them.
•   The main difference between how medicines and medical devices are regulated
    lies in how a product gets onto the market. All medicines are directly approved
    by the MHRA which issues a 'marketing authorisation', or licence.
    Manufacturers and distributors are also licensed directly by MHRA. Medical
    devices are approved by private sector organisations called 'Notified bodies'.
    Their approval is needed before a CE mark can be put on the device, though the
    manufacture of low risk devices is simply registered with the MHRA. The MHRA
    audits the performance of Notified Bodies. However:
•   when a product is on the market and in use, there are more similarities than
    differences in the ways medicines and devices are regulated
•   there are similar systems for receiving reports of problems with products and
    similar ways of issuing warnings if problems are confirmed after investigation
•   there are also similar systems for inspection of manufacture to ensure that
    companies are complying with regulations, and similar ways of enforcing the law
    if that proves necessary.
http://www.mhra.gov.uk/index.htm



7th February 2010                                       Directorates of Cellular Pathology &
                                                               Laboratory Medicine
                MHRA Decision making
• The MHRA and other related organisations make a lot of
  regulatory decisions. After consulting with a range of
  stakeholders we have set out on five pages the main
  considerations that affect those decisions:
• the role of MHRA and the scope of the document
• the main regulatory decisions that are made about medicines
  and medical devices
• the principles that inform these decisions
• the questions that are considered to ensure that the decisions
  are reasonable
• who makes decisions about medicines and medical devices –
  which includes bodies other than MHRA.

(http://www.mhra.gov.uk/index.htm)

7th February 2010                           Directorates of Cellular Pathology &
                                                   Laboratory Medicine
                    Any Questions?



7th February 2010              Directorates of Cellular Pathology &
                                      Laboratory Medicine
               Human Tissue Authority

                    Dr Mark Wilkinson

               Consultant Histopathologist
                           &
                       HTA Lead

7th February 2010                  Directorates of Cellular Pathology &
                                          Laboratory Medicine
                            HTA

                    http://www.hta.gov.uk/




4th November 2009                     Directorates of Cellular Pathology &
                                             Laboratory Medicine

								
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