ISO9001:2015
 
ISO9001:2015

ISO9001:2015 standard

ISO9001:2015 standard explain by ISO.ORG

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ISO9001: 2015 requirements Trainer, Documented Information Writer, Consultant - Solution provider, Internal Auidtor, Cerification Body, Accrediation Body, TC176, ISO

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ISO9001:2015  國際品質管理體系標準 將對應 ISO9001:2008 進行大幅徹底修改,於 2015 年正式頒佈實施 ISO9000:2015 族系列標準,即 ISO9001 - 2015版。在廣泛征求意見的基礎上,做到與國際先進管理慣例接軌,一步到位融入一體化的國際經濟和貿易、業務風險分柝、增強質量管理的穩定性,保證產品質量的一致性、優化質量成本,減少質量損失,提高經濟效益、增強競爭能力,提高市場佔有份額、規範內部管理,增強員工質量意識,提高運行效率和整體業績、以其原理規範企業管理內容。全面提高企業綜合素質和整體水平。

ISO 國際標準化組織經多年努力,ISO/TC 176 總結歸納工業發達國家百年管理之經驗,融匯提升而成的一套科學化、規範化、程式化的系列質量管理標準的統稱,它為使用者 (包括各行各業、各種規模、類型和產品的組織) 提供了與企業綜合管理包括環境管理等體系兼容並蓄的質量管理的依據,規定了質量管理的共同語言和準則的要求。迄今已有八十多個國家等同或等效採用了 ISO 9001,40多個國家開展了第三方評定和註冊,全球已有包括中國逾兩萬家企業在內的 60 多 萬家企業實施該標準並通過認證。一套國際標準,在短期內被國際社會廣泛接受並對國際貿易和經濟發展產生如此廣泛而深遠的影響,創造了國際經濟生活中的一個奇蹟。

ISO9001:2015 是規定範圍和企業管理的重要文件,反映了落實  ISO9001:2015 的理由,並提供了一個 ISO9001:2015 企業團隊落實所需能力的依據,確定了該組織希望遵循的以及能夠審計其業績的各項原則。這是一份經最高管理層簽署的簡明扼要的聲明,對 ISO9001:2015 方案起著推動作用。它是高層對 ISO9001:2015 目標和預期所作的概述。

ISO9001:2015 品質政策由組織的最高管理層主管;從最高的戰略層向下推動。為有效落實,政策必須向全組織及其利益相關人員傳達。為了確保政策與管理層戰略願景和組織的目標一致,應對其不斷進行審查。

具備 ISO9001:2015 品質政策是 ISO9001:2015 取得成功的基礎。它為中層管理人員和工作人員完成必要的活動提供了動力。沒有品質政策文件的結果是整個組織缺乏有關 ISO9001:2015 的意圖和宗旨的資訊和知識。這又造成成員的政治和財政支援不足,中層管理人員關心不夠。

ISO9001:2015 品質政策規定了明確的掌管全組織 ISO9001:2015 品質方案和進程的任務、職責和權限。對一名高級管理層的成員應該賦予其全盤責任,建設該組織整體的 ISO9001:2015 能力。這將確保 ISO9001:2015 品質方案在該組織內部得到應有的重視。

ISO9001:2015 續性管理是一個互動的過程,需要積極掌管。在最初階段, ISO9001:2015  可以用品質方案管理的辦法進行,但是隨著 ISO9001:2015 工作的成熟,應該將其融入該組織的管理作風。落實一項持續改善的方案涉;收集各種資料,確定支援實現組織目標所需要繼續開展的活動;制定可能發生事件的應對計劃和減輕其影響的措施;執行應急計畫。此外,組織必須對這些活動進行協調監督。

 

 

 

Benefits of implementing ISO 9001:2015 Quality Management System :

Provides an opportunity to increase value to the activities of the organization

l   Improve the performance of processes/activities continually

l   Satisfaction of customers

l   Attention to resource management

l   Implementation of statutory and regulatory requirements related to product/services

l   Better management control in business risk

 

Clause on  ISO 9001:2015 Quality Management System :

l   Clause 4: Quality management system

< as same as ISO9001:2008 Clause 4 General requirements >

l   Clause 5 : Leadership

< as same as ISO9001:2008 Clause 5.1 Management responsibility >

l   Clause 6 : Planning

< as same as ISO9001:2008 Clause 5.4.2 Quality management system planning >

New concept : Actions to address risks and opportunities

Risk - combination of the consequences of an event and the associated likelihood of occurrence

prevent, or reduce, undesired effects, and achieve continual improvement.

no requirement for formal risk management

l   Clause 7 : Support

< as same as ISO9001:2008 Clause 6 Resource management  + 4.2 Control of documents & Records +  7.6 Control of monitoring and measuring equipment >

l   Clause 8 : Operation

< as same as ISO9001:2008 Clause 7 Product realization + 8.3 Control of nonconforming product  >

l   Clause 9 : Performance evaluation

< as same as ISO9001:2008 Clause 5.6 Management review + 8.2.2 Internal audit + 8.2.1 Customer satisfaction + 8.4 Analysis of data >

l   Clause 10 : improvement

< as same as ISO9001:2008 Clause 8.5.1 Continual improvement + 8.5.2 Corrective action >

 

Summary of major changes :

 “product” will be replaced by “goods & services”

 “continual improvement” will be replaced by “continual improvement.”

Purchasing” and “outsourcing” will be replaced by “external provision of goods and services”

“documented procedures” will be replaced by “Documented Information”

Risk-based approach to determine the type and extent of controls

Risks which can affect conformity of goods and services as well as customer satisfaction.

The requirement to use the process approach has been more explicit, Any activity or operation which receives inputs and converts them to outputs can be considered as a process. Almost all activities and operations  involved in generating a product or providing a service are processes.

The standard does not include a specific clause for "Preventive Actions".

Control of external provision of goods and services address all forms of external provisions.

The term " Management Responsibility " has been replaced with " Leadership".

The term " Resource Management " has been replaced with " Support".

The term " Product Realization " has been replaced with " Operation".

The term " Measurement, Analysis, and Improvement " has been replaced with " Performance evaluation ".

The term " Corrective Action " has been replaced with " Nonconformity and corrective action ".

 

Impact of the changes:

l   The impact of ISO9001:2015 will be similar to ISO9001:2000 edition, which was a major change for accreditation bodies, certification bodies and consultants.

l   Quality manual may need to be amended by Bright Business Consultants Company Limited.

l   A risk management processes may need to be developed

l   Determine the level and extent of control for supplier and contractor.

l   ISO9001:2015 IQA Internal Auditors will need to become familiar with the revised ISO 9001:2015 standard and so schedule the IQA training with Bright Business Consultants Company Limited.

l   Place detailed plans for revising internal processes or procedures, or plan the arrangements for transition or certification to ISO 9001:2015.

l   The transition period is expected to be around 2-3 years as there are over one million registered ISO 9001 company.

 

 

 

Top management needs to demonstrate an ongoing commitment to the ISO9001:2015 . Through its leadership and actions, management can create an environment in which different actors are fully involved and in which the management system can operate effectively in synergy with the objectives of the organization. They are responsible for:

 

l   ensuring the  ISO9001:2015  is compatible with the strategic direction of the organization;

l   integrating the  ISO9001:2015  requirements into the organization’s business processes;

l   providing the necessary resources for the  ISO9001:2015 ;

l   communicating the importance of effective business continuity management;

l   ensuring that the  ISO9001:2015  achieves its expected outcomes;

l   directing and supporting continual improvement;

l   establish and communicate a business continuity policy;

l   ensuring that  ISO9001:2015  objectives and plans are established;

l   ensuring that the responsibilities and authorities for relevant roles are assigned.

 
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