1) In ISO 9001 : 2015 Standard, there are 132 “shall” wording from Section 4 Context of the organisation to Section 10 Continual Improvement
That’s mean at least 132 actions need to take when implementation of ISO 9001 : 2015.
2) In 9001 : 2015 revision, there are no mandatory requirement for establishing Manual & Procedures.
But documented procedures are communicated and followed easily with organisation.
The most popular system procedure of ISO 9001
-Document & record control
-Control of non-conforming product
-Corrective Action
-Internal Audit
But I recommended our client to establish other documents such as
1. Quality Manual framework
2. Risk & Opportunity
3. Purchasing
4. Management of supplier
5. Management Review
6. Control of measuring equipment
7. Monitoring of Client Satisfaction
3) When your company can fulfil ISO 9001 Clause 4.0 context of the organisation, the pain point is how to identify risk & opportunity
Firstly, the ISO 9001 standard did not require company to define Risk Assessment or Risk Level.
However, the company should identify risk from 6 aspects
Moreover, the company conduct SWOT Analysis through brainstorm meeting. You can identify where the strength, weakness, opportunity and threat are for improvement.
What is more, the company should identify their interested parties and find out their expectations and requirements.
Your company also identify the risk which not to fulfil the expectation & requirement of those interested parties.
From our experience, there are around 25 types of records for trading company operation (<10 staff)
There are around 40 type of records for construction engineering company (~50)
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