Changes : source of most anxiety about ISO 9001 -2015 implementation

انتي تسجت انقهك يٍ تطجيقهب 5092نسُخ 1009 يزوألانتغييراد ثب

As per ASQ Quick poll

كًب ورد في إستجيبٌ سريع نهجًعيخ األيريكيخ نهجىدح

SN Change

انتغيير

%

انُسجخ

ئىيخانً

Solutions to mitigate anxiety

( انقهك ) األَزعبج( يف فتخ )حهىل تهطيف

1 Adopting Risk based thinking

تجُي انًُهج انقبئى عهي انًخبطر

50 1.1 Use SWOT analysis

1.2 Use FMEA

https://www.standard.no/Global/PDF/Kvalitet/ISO-TC176-

SC2_N1222_N1222_-_Risk_in_ISO_9001_2014-07.pdf

http://rube.asq.org/audit/2015/01/a-risk-based-thinking-model-for-iso-9001-

2015.pdf

2 Enhancing leadership role in quality

دارح( في َظبو إدارح تحسيٍ دور انقيبدح ) يسؤنيخ األ

انجىدح

27.7 http://www.qualitydigest.com/inside/quality-insider-article/meeting-

requirements-iso-90012015.html

The Quality is everyone’s responsibility : there are no longer a single

representative for quality, no single “quality police.” Companies as a whole

must establish a focus on quality, customers, and companywide

commitment. At the same time, you must look to establishing a quality

“policy”—as opposed to a manual— which will more broadly assess and

help improve organizational quality.

http://advisera.com/9001academy/blog/2015/07/14/how-to-comply-with-

new-leadership-requirements-in-iso-90012015/

3 Dealing with documentation

انتعبيم يع انىثبئك ) انًستُذاد و انسجالد(

11.1 http://www.whittingtonassociates.com/wp-content/uploads/Handout-

Documented-Information.pdf

look below this table

4 Understanding the new clause structure 11.1 Annex SL & HLS : High Level Structure

انجذيذ نجُىد انًىاصفخ هيكمفهى ان http://www.iso.org/iso/news.htm?refid=Ref1621

5 Defining the context of your organization

و تحذيذ سيبق انًُظًخ ) انعًالء و أصحبة انًصبنح

(ثيئخ انعًم

0.1 *Internal Context

*External Context

*As per ISO FDIS 9000:2015 2.2.3 Context of an organization

Understanding the context of the organization is a process. This process determines factors which influence the organization’s purpose, objectives and sustainability. It considers internal factors such as values, culture, knowledge and performance of the organization. It also considers external factors such as legal, technological, competitive, market, cultural, social and economic environments. Examples of the ways in which an organization’s purpose can be expressed include its vision, mission, policies and objectives.