Project Description

ISO 9001 QMS Certification 質量管理體系認證

– Solution for Customer Trust and Operational Improvement  客戶信賴和運作改善的解決方案

The ISO 9000 family of quality management system (QMS) is a set of standards that helps organizations ensure that they meet the needs of customers and other stakeholders and statutory and regulatory requirements related to a product or service. ISO 9000 deals with the fundamentals of QMS, including the seven quality management principles that underlie the family of standards. Within ISO 9000 family,  ISO 9001 is a well-known standard for certification purpose.

More than million certified companies in the world take advantage of the notable ISO 9001 standard as a tool for managing their organization and for improving their performance continuously. The standard contains internationally applicable requirements for the quality of products and services. ISO 9001:2015 has replaced ISO 9001:2008 with transition period up to Sep 15, 2018.

DQS HK has provided certification service to clients in the Greater China for over 30 years.

世上逾百萬個組織採用 ISO 9001 作為組織管理和持續改善績效的基礎工具, 該標準包含了國際上適用的產品和服務質量管理要求。ISO 9001:2015 已經替代 ISO 9001:2008,其過渡期到 2018年9月15日終止。

DQS香港爲大中華地區的客戶提供了超過30年的認證服務。

ISO 9000 series Quality Management Principles

The ISO 9000 series are based on seven quality management principles (QMP). They are:

  • QMP 1 – Customer focus
  • QMP 2 – Leadership
  • QMP 3 – Engagement of people
  • QMP 4 – Process approach
  • QMP 5 – Improvement
  • QMP 6 – Evidence-based decision making
  • QMP 7 – Relationship management

Principle 1 – Customer focus

Organizations depend on their customers and therefore should understand current and future customer needs, should meet customer requirements and strive to exceed customer expectations.

Principle 2 – Leadership

Leaders establish unity of purpose and direction of the organization. They should create and maintain the internal environment in which people can become fully involved in achieving the organization’s objectives.

Principle 3 – Engagement of people

People at all levels are the essence of an organization and their full involvement enables their abilities to be used for the organization’s benefit.

Principle 4 – Process approach

A desired result is achieved more efficiently when activities and related resources are managed as a process.

Principle 5 – Improvement

Improvement of the organization’s overall performance should be a permanent objective of the organization.

Principle 6 – Evidence-based decision making

Effective decisions are based on the analysis of data and information.

Principle 7 – Relationship management

An organization and its external providers (suppliers, contractors, service providers) are interdependent and a mutually beneficial relationship enhances the ability of both to create value.

Contents of ISO 9001:2015

ISO 9001:2015 Quality management systems — Requirements is a document available from the national standards organization in each country of ISO members.

Contents of ISO 9001:2015 are as follows:

  • Section 1: Scope
  • Section 2: Normative references
  • Section 3: Terms and definitions
  • Section 4: Context of the organization
  • Section 5: Leadership
  • Section 6: Planning
  • Section 7: Support
  • Section 8: Operation
  • Section 9: Performance evaluation
  • Section 10: Continual Improvement

The layout of the ISO 9001:2015 standard follows the Plan-Do-Check-Act (PDCA) cycle in a process-based approach, encouraging risk-based thinking. The established quality objectives can be used to measure the conformity of the requirements (customers and organizations), and to facilitate effective deployment and improve the quality management system.

  • The ISO 9001:2015 standard no longer specifies that the organization shall issue and maintain documented procedures, but it requires the organization to determine the procedures required for its effective operation.
  • The ISO 9001 standard also requires the organization to issue and communicate a documented quality policy, a quality management system scope, and quality objectives.
  • The ISO 9001 standard no longer requires compliant organizations to issue a formal Quality Manual.
  • The ISO 9001 standard does require retention of a number of records, as specified throughout the standard.
  • The organization shall assess risks and opportunities and to determine internal and external issues relevant to its purpose and strategic direction.
  • The organization must demonstrate how the ISO 9001 standard’s requirements are being met.

Key Changes to ISO 9001:2015?

As compared to ISO 9001:2008, some of the key changes to ISO 9001:2015 include:

  • High-Level Structure of 10 clauses is implemented. Now all new standards released by ISO will have this high-level structure.
  • Greater emphasis on building a management system suited to each organization’s particular needs.
  • A requirement that those at the top of an organization be involved and accountable, aligning quality with wider business strategy.
  • Risk-based thinking throughout the standard makes the whole management system a preventive tool and encourages continuous improvement.
  • Less prescriptive requirements for documentation: the organization can now decide what documented information it needs and what format it should be in.
  • Alignment with other key management system standards through the use of a common structure and core text.
  • Inclusion of Knowledge Management principles.
  • Quality Manual and Management representative (MR) are no longer mandatory.

What Organizations can be Certified to ISO 9001?

The requirements set out in ISO 9001:2015 are generic and are intended to be applicable to all organizations, regardless of type, size or nature.

In reality, some may think that ISO 9001 can be applied to manufacturing sector only, but it’s a misunderstanding. No doubt, many companies in manufacturing sector are requested for ISO 9001 certification by their customers. Therefore, quite some companies with manufacturing operation have been the pioneers to go for ISO 9001 certification.

As time goes by, more and more companies in other industries, such as service providers, realizes that the quality management is no less important to them, so they are also going for Quality Management System (QMS) certification against ISO 9001.

Typical Certification Roadmap

  • Training as necessary, such as ISO 9001 standard understanding training or internal auditor training.
  • Establishment of a management system against ISO 9001, with optional support by a consultant.
  • Implementation of management system for a few months, with Plan-Do-Check-Act (PDCA) approach.
  • Process performance monitoring and improvement, as necessary.
  • Internal Audit, with following improvement actions.
  • Management Review.
  • Initial Certification Audit by a Certification Body with accreditation, such as ANAB.
    • Stage 1 Readiness Review is a preliminary document review of the management system, checking the existence and completeness of key documentation such as manual, procedures, policy and objectives, certification scope, risk management plan, process performance, improvement, internal audit and management review results. It’s to judge whether the organization is ready for Stage 2 Audit.
    • Stage 2 Audit is a more detailed and formal audit. The auditors will seek evidence to confirm that the management system has been properly established and implemented in an effective way with PDCA approach.
    • Closure of NCs, in any from the Stage 2 Audit.
  • Issuance of Certificate with a validity of 3 years. After it, the certified organization can use the DQS certification mark for marketing purpose according to the defined rules.
  • Annual Surveillance Audits in the following 2 years to confirm that the organization remains in compliance with the ISO 9001 standard.
  • Recertification Audit well before the expiration of the certificate in the 3rd year, to renew the certificate with another 3-year cycle.

Benefits of Certification | 認證的意義

  • Enhance customer focus and satisfaction 與日俱增的客戶滿意度
  • Build trust from customer and interested parties 客戶與相關團體的持續信賴
  • Foster engagement of employee  良好的員工士氣
  • Clearly define authorities and responsibilities 權責分明
  • Evidence-based decision making 基於事實做出決策
  • Establish efficient and effective corporate processes 建立高效和有效的企業流程
  • Minimize corporate risk 降低營運風險
  • Initiate continuous improvement 持續進步
  • Save time and operating costs 節省時間和營運成本
  • Prevent errors instead of correcting them 防錯而非改錯
  • Brand corporate image 建立品牌力
  • Reduce information gaps 良好的知識管理,減少資訊斷層
  • Be able to react to the fiercely competitive market 對應市場急遽轉變

Why DQS? | 為什麼選擇DQS? 

  • DQS’s primary shareholders (DIN, DGQ, UL) are substantial industrial leaders rooted long history.
    DQS 的主要股東(德國標準化學會、德國質量協會、美國保險商實驗室)是歷史悠久的行業領導者;
  • After issuing Germany’s 1st ISO 9001 certificate in 1986, DQS has globally certified 58,000+ client sites.
    DQS在1986年頒發了德國的第一張 ISO 9001 證書後,至今為全球 58,000 多個場地提供了認證;
  • DQS is one of the founders of and the sole CB of Germany as member of IQNet.
    DQS是國際認證聯盟的創始方之一也是來自德國的唯一認證機構成員;
  • IQNet members have issued appx. 1/4 of management system certificates in the world. DQS clients can benefit from multi-recognition between members.
    IQNet 成員發行了世界上大約 1/4 的管理體系認證證書, DQS 的客戶可以得益於 IQNet 成員之間的互認和合作;
  • DQS is 1st Certification Body in Germany accredited by TGA (now DakkS) for ISO 9001 certification.
    DQS是德國第一家獲得 TGA(現在的DakkS)認可提供ISO 9001 認證的機構;
  • DQS is 1st Certification Body accredited by IATF for ISO/TS 16949 in the world.
    DQS是世界上第一家獲得 IATF 認可提供 ISO/TS 16949 認證的機構;
  • DQS issued the 1st IRIS railway certificate in the world.
    DQS發行了世界上第一張 IRIS 軌道交通管理體系證書;
  • DQS is authorized to provide CE Marking related ISO 13485 certification service.
    DQS被授權提供CE標誌相關的ISO 13485認證服務
  • DQS has a large number of professional auditors across the globe.
    DQS的專業審核員遍佈世界各地;
  • DQS has professional auditors with proficiency in environment and OHS related regulations in HK, Macau, and Mainland China.
    DQS配備熟知香港、澳門、和中國內地環保和職安健法規的專業審核員。

Related Training Courses | 相關培訓課程

The courses include ISO 9001 Internal Auditor, FMEA, SPC, MSA, DOE, QFD, VDA 6.x, CQI Tools, etc.
課程包括ISO 9001內審員、核心工具、試驗設計、質量功能展開、VDA 6.x、CQI工具等。

Training Courses | 培訓課程

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