Types of Internal Possible needs and

How to capture key issues:

interested parties: expectations:

Employees and Shared culture, attitudes Employee meetings, consultation and

contractors and job security feedback

Competitive pricing, Client/customer reviews and relationship

Clients and customers
reliability and value management/customer feedback

Beneficial supplier-client Supplier reviews and relationship

Suppliers
relationships management

Unions and worker Representation and Consultation and feedback on employment

representatives cooperation and safety issues

Table 3 Needs and Expectation of Interested Parties

Example for Determination of Risk and Opportunities

(Combining the requirements 4.1,4.2 and 6.1)

Organizational
Risks/opportunities Priority Action
context issue
External context issues
Flood of the channel close Flood in the basement (raw high Move storage to the ground floor of the
to the plant , (twice per materials storage) new building
year)
Advancements in medium Plan to update machinery as funding
Technology
production technology allows
Environmental Not aware of legal high Seek assistance from Association of
regulations requirements Metallurgic Organizations
Competitors having a medium - Benchmark competitors
Market competition "greener" reputation within - Improve communications with the
the community community
Parking and loading of vans high When designing the new building, allow
Social I reputation/ public in the street creates nuisance space for parking inside SB's premises
image to traffic and school

Internal context issues

John handing over company
No act ion . John's retirement will be
Organization to Bill low
gradual
and Hillary
Loss of knowledge due to
Organizational Find replacement and ensure an overlap
the retirement high
knowledge of 6 months minimum
of 2 of the 3 supervisors
SB's capabilities exceeded
Carefully plan the infrastructure and
Strategic direction with new medium
personnel needed for the expansion
expansion
Activities, products and Several environmental
high Establish operational controls
services impacts

6
 Records Requirements

Clause Documented information (Records)

7.1.5.1 Monitoring and measuring resources
7.1.5.2 Monitoring and measuring equipment calibration records
7.2 Records of competency in staff
8.2.3.2 Product/service requirements review records
8.3.3 Design and development inputs record
8.3.4) Records of design and development controls
8.3.5 Records of design and development outputs
8.3.6 Record of design and development changes
8.4.1 Criteria for evaluation and selection of suppliers
8.5.1 Characteristics of product or service to be provided
8.5.2 Identification and Traceability records
8.5.3 Records about customer property including any changes
8.5.6 Production/service provision change control records
8.6 Release of products and services
8.7.2) Control of nonconforming outputs
9.1.1 Monitoring and measurement results
9.2.2 Internal Audit results
9.3.3 Results of the management review
10.2.2 Results of corrective actions including opportunities for improvement

Table2- Records required by the ISO 9001:2015 Standards

Structure and format of Procedure

A document that contain necessary information to accomplish a task in effective manner

A procedure can be define by the organization with

- Text
- Flow charts
- tables
- A combination of above

Typical contents and format for a Documented Procedure

Contents
1. Title
2. Purpose
3. Scope
4. Responsibility and Authority
5. Description of activities
6. References
7. Review, approval and revision
Title
The title should clearly identify the documented procedure

Example1 The Procedure for Control of documents

Example-2 The Procedure for vendor Evaluation