Changes and adopting risk-based thinking were identified as the biggest sources of anxiety about implementing ISO 9001:2015 according to an ASQ quick poll, with 50% of respondents citing this. Adopting risk-based thinking approaches like SWOT analysis and FMEA were recommended solutions to mitigate these anxieties. Enhancing leadership's role in quality management was another top concern at 27.7%. Additional solutions included dealing with documentation requirements and understanding the new clause structure and Annex SL high level structure. Defining an organization's context through understanding internal and external factors that influence objectives and sustainability was also emphasized as important for ISO 9001:2015 compliance.

1. Changes : source of most anxiety about ISO 9001 -2015 implementation
‫ثب‬ ‫انتغييراد‬‫أل‬‫يزو‬1009‫نسُخ‬5092‫تطجيقهب‬ ٍ‫ي‬ ‫انقهك‬ ‫تسجت‬ ‫انتي‬
As per ASQ Quick poll
‫نهجىدح‬ ‫األيريكيخ‬ ‫نهجًعيخ‬ ‫سريع‬ ٌ‫إستجيب‬ ‫في‬ ‫ورد‬ ‫كًب‬
SN Change
‫انتغيير‬
%
‫انُسجخ‬
ً‫ان‬‫ئىيخ‬
Solutions to mitigate anxiety
‫تهطيف‬ ‫حهىل‬(‫تخ‬‫ف‬‫يف‬)‫األَزعبج‬ ( ‫انقهك‬ )
1 Adopting Risk based thinking
‫انًخبطر‬ ‫عهي‬ ‫انقبئى‬ ‫انًُهج‬ ‫تجُي‬
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
‫األ‬ ‫يسؤنيخ‬ ( ‫انقيبدح‬ ‫دور‬ ٍ‫تحسي‬‫إدارح‬ ‫َظبو‬ ‫في‬ )‫دارح‬
‫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
)‫انسجالد‬ ‫و‬ ‫انًستُذاد‬ ( ‫انىثبئك‬ ‫يع‬ ‫انتعبيم‬
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

2. ‫ان‬ ‫فهى‬‫هيكم‬‫انًىاصفخ‬ ‫نجُىد‬ ‫انجذيذ‬ http://www.iso.org/iso/news.htm?refid=Ref1621
5 Defining the context of your organization
‫انًصبنح‬ ‫أصحبة‬ ‫و‬ ‫انعًالء‬ ( ‫انًُظًخ‬ ‫سيبق‬ ‫تحذيذ‬‫و‬
‫انعًم‬ ‫ثيئخ‬)
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.