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  • M E S Y U A R AT

    J AWATA N K U A S A K U A L I T I U P M KALI KE- 32

    PADA 12 APRIL 2017 (RABU) JAM 9.00 PAGI

    DI DEWAN SENAT, TINGKAT 1,

    BANGUNAN CANSELORI PUTRA

  • “ P U S A T P E N G U R U S A N

    J A M I N A N K U A L I T I

    & P E M B U D A Y A A N

    K U A L I T I ”

    AGENDA 7

    JK KUALITI UPM KALI KE-32

    SISTEM PENGURUSAN KUALITI (SPK):

    PERALIHAN DARIPADA ISO 9001:2008

    KEPADA ISO 9001:2015 &

    PELAKSANAAN TINDAKAN

  • TELAH DIPERSIJILKAN DENGAN SATU

    PENSIJILAN (ISO 9001:2008) MULAI TAHUN 2011 HINGGA

    KINI

  • Tahun

    2010

    Tahun

    2011

    Sijil setiap

    PTJ

    Cadangan 1 Sijil Gabungan 28

    sijil dan penambahan 4 PTJ yang belum

    mendapat pensijilan

    Gabungan 1 Sijil

    Mendapat Pensijilan pada

    27/12/2011

    Pensijilan Semula kerana menggunakan nombor sijil AR2020

    (milik Fakulti Perubatan Veterinar)

    Tahun

    2012

    Tahun

    2013

    Tahun

    2014 Tahun

    2015

    Tahun

    2016

    Tahun

    2017

    Melepasi Audit Pensijilan

    Semula

    Melepasi Audit Pemantauan 1

    Penambahan Entiti 1. Pusat Pengimejan

    Diagnostik Nuklear 2. Pusat Sumber dan

    Pendidikan Kanser 3. Pejabat Penasihat

    Undang-Undang 4. Putra Science Park

    Melepasi Audit

    Pemantauan 2 Audit Pensijilan Semula Melepasi Audit

    Pemantauan 1

    Peralihan

    Standard baharu:

    MS ISO 9001:2015

    Audit Pemantauan 2

    11 – 15, 18 – 20 & 25 – 26 SEPT. 2017

    Peralihan

    Standard:

    MS ISO 9001:2008

    Peralihan

    Standard:

    MS ISO 9001:2000

    PENGURUSAN & PENAMBAHBAIKAN KUALITI:

    Pengekalan Pensijilan Sistem Pengurusan Kualiti (QMS) ISO 9001

  • 2017: U P M K O M I T E D U N T U K

    D A N A K A N D I A U D I T M E N G G U N A K A N S TA N D A R D

    B A H A R U

    ISO 9001: 2015

    P E N G E K A L A N

    P E N S I J I L A N

  • No. Pensijilan:

    AR2020 Tempoh Sah:

    16 OKT. 2015 – 6 JULAI 2018

    P E N G E K A L A N

    P E N S I J I L A N

    2017:

    menggunakan standard

  • ABOUT

    Sist em

    Pengurusan Kualit i ad alah

    e n j i n d alam

    pelaksanaan t indakan

    un t uk m encap ai

    m at lam at pelan

    st rat egik UPM

    Q U A L I T Y MANAGEMENT

    S Y S T E M

  • PERUBAHAN KONSEPTUAL DALAM ISO 9001:2015

    Clause 4 – CONTEXT OF THE ORGANIZATION

    Clause 4.2: Understanding the needs and expectations of interested parties ……the organization shall determine: (a) the interested parties (b) the requirements of these interested parties

    Clause 5 - LEADERSHIP Clause 5.1: Leadership and commitment

    5.1.2: Customer Focus Top Management shall demonstrate leadership and commitment with respect to customer focus by ensuring: (a) Customer and applicable statutory and regulatory

    requirements are determined, understood and consistently met;

    (b) The risks and opportunities that can affect conformity of products and services and the ability to enhance customer satisfaction are determined and addressed;

    (c) The focus on enhancing customer satisfaction is maintained.

    Memberi penekanan kepada:

    1 . Pelanggan (C u s t o m e r F o c u s )

  • PERUBAHAN KONSEPTUAL DALAM ISO 9001:2015

    2. Komitmen Pihak Pengurusan

    Clause 5 - LEADERSHIP Clause 5.1: Leadership and commitment

    5.1.1: General

    Top Management shall demonstrate leadership and commitment with respect to the quality management system by: (a) taking accountability for the effectiveness of the QMS; (b) ensuring that the quality policy and quality objectives are established for the QMS

    and are compatible with the context and strategic direction of the organization; (c) ensuring the integration of QMS requirements into the organization’s business

    processes; (d) promoting the use of the process approach and the risk-based thinking; (e) ensuring that the resources needed for the QMS are available; (f) communicating the importance of effective QMS and confirming to the QMS

    requirements; (g) ensuring that the QMS achieves its intended results; (h) engaging, directing and supporting persons to contribute to the effectiveness of

    the QMS; (i) promoting improvement; (j) supporting other relevant management roles to demonstrate their leadership as it

    applies to their areas of responsibility.

  • PERUBAHAN KONSEPTUAL DALAM ISO 9001:2015

    3. Pemik i ran Berasaskan Ris iko (Risk -based Th ink ing )

    0.3.3

    5.1.1 (d)

    5.1.2 (b)

    6.1.2 (a)

    Annex A – A.4 Risk-based Thinking)

    4.4.1 (f)

     Clause 9 – analysis and evaluation the effectiveness of actions taken to address risks and opportunities

    9.1.3 (e)

     Clause 9 –Discuss the effectiveness of actions taken to address risks and opportunities

    9.3.2 (e)

     Clause 10 – when NCR arises, update risk and opportunities determined during planning

    10.2.1 (e)

    process approach, which incorporates:  The PDCA cycle, and  Risk-based thinking

  • PERUBAHAN KONSEPTUAL DALAM ISO 9001:2015

    4 . M e n j a j a r k a n ( A l i g n i n g ) D a s a r d a n O b j e k t i f S P K b e r s a m a H a l a Tu j u S t ra te g i k O r ga n i s a s i

    Clause 5 - LEADERSHIP Clause 5.1: Leadership and commitment

    5.1.1: General

    Top Management shall demonstrate leadership and commitment with respect to the QMS by:

    (c) Ensuring the integration of QMS into the organization’s business process

    Clause 5 - LEADERSHIP Clause 5.2: Policy

    5.2.1: Establishing the quality policy Top Management shall establish, implement and maintain the quality policy that: (a) is appropriate to the purpose and context

    of the organization and supports its strategic direction;

  • PERUBAHAN KONSEPTUAL DALAM ISO 9001:2015

    5. Dokumentas i yang F leks ibal documented information is used for all document requirements either to maintain or retain

    Clause 7 – SUPPORT Clause 7.5: Documented information

    7.5.1 The organization’s quality management system shall include: (a) Documented information required by this International

    Standard; (b) Documented information determined by the organization as

    being necessary for the effectiveness of the QMS Note: 3 kategori dokumen:  Maintain documented information

    - pengekalan dokumen  Retain documented information

    - pengekalan rekod  Information

    - Maklumat yang boleh ditentukan oleh organisasi berhubung pengekalan maklumat

  • PERUBAHAN KONSEPTUAL DALAM ISO 9001:2015

    6 . M e ny e d i a k a n P r o d u k & Pe r k h i d m a ta n ya n g B a i k s e c a ra Ko n s i s te n

    Clause 8.0: OPERATION Clause 8.1 Operational planning and control

    The organization shall plan, implement and control the processes needed to meet the requirements for the provision of

    products and services, and to implement the actions determined in the planning…..

    8.2 Requirements for products and services 8.3 Design and development of products and services 8.4 Control of external provided processes, products and services 8.5 Production and service provision 8.6 Release of products and services 8.7 Control of nonconforming outputs

  • PERUBAHAN STRUKTUR SPK DALAM BENTUK KITARAN PDCA

    Introduction 0.3: Process approach

    0.3.1: The p r o c e s s a p p r o a c h involves the systematic definition and management of processes, and their interactions, so as to achieve the intended results in accordance with the

    quality policy and strategic direction of the organization.

    0.3.2: P l a n - D o - C h e c k - A c t c y c l e The PDCA cycle can be applied to all process and the quality management system as a whole

    0.3.3: R i s k - b a s e d t h i n k i n g An organization needs to plan and implement actions to address risk and opportunities…… for increasing the effectiveness of QMS

  • INTRODUCTION: 0.2 –PROCESS APPROACH IN THE PDCA CYCLE

  • Kepimpinan (5)

    Perancangan (6)

    Penilaian Prestasi

    (9)

    Penambah- baikan

    (10)

    Sokongan (7) Operasi (8)

    PLAN DO

    CHECKACT

    Sistem Pengurusan Kualiti (4)

    Organisasi & Konteksnya

    (4)

    Keperluan & Ekspektasi

    Pihak Berkepentingan

    yang Releven (4)

    KEPERLUAN PELANGGAN

    KEPUTUSAN SPK

    Kepuasan Pelanggan

    Produk & Perkhidmatan

    Nota: Nombor dalam kurungan merujuk kepada klausa dalam standard

    4.1

    4.2

    4.4

    4.1

    4.4

    INTRODUCTION: 0.3.2 – THE STRUCTURE OF THE INTERNATIONAL STANDARD IN THE PDCA CYCLE

    MALAYSIAN STANDARD

  • PLAN PLAN

    DO

    CHECK ACT

    DO

    ACTCHECK and

  • SIRI 1 - 6

    SIRI TINDAKAN KE ARAH PERALIHAN KEPADA MS ISO 9001:2015:

  • JAN FEB MAC APRIL

    TARIKH PERKARA TARIKH PERKARA TARIKH PERKARA TARIKH PERKARA

    QMS 17

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