​Excerpt from ISO 9001:2015 below. Also attached is a worksheet that we use for this purpose. Hope this helps.

6.2.1 The organization shall establish quality objectives at relevant functions, levels and processes needed for the quality management system.

​The quality objectives shall:
a) be consistent with the quality policy;
b) be measurable;
c) take into account applicable requirements;
d) be relevant to conformity of products and services and to enhancement of customer satisfaction;
e) be monitored;
f) be communicated;
g) be updated as appropriate.

6.2.2 When planning how to achieve its quality objectives, the organization shall determine:
a) what will be done;
b) what resources will be required;
c) who will be responsible;
d) when it will be completed;
e) how the results will be evaluated.

​Excerpt below is from ISO 9001:215. Attached also is a planning worksheet we use for this purpose, with items (f), (g), and (h) maintained separately. Hope this helps.

The organization shall determine the processes needed for the quality management system and their application throughout the organization, and shall:

a) determine the inputs required and the outputs expected from these processes;
b) determine the sequence and interaction of these processes;
c) determine and apply the criteria and methods (including monitoring, measurements and related performance indicators) needed to ensure the effective operation and control of these processes;
d) determine the resources needed for these processes and ensure their availability;
e) assign the responsibilities and authorities for these processes;
f) address the risks and opportunities as determined in accordance with the requirements of 6.1;
g) evaluate these processes and implement any changes needed to ensure that these processes achieve their intended results;
h) improve the processes and the quality management system.

Congratulations to Coastal Flange Inc. for being recommended for ISO 9001:2015 certification. To learn more about Coastal Flange's products and services, visit http://www.coastalflange.com/.

​The organization will need to determine the interested parties that are relevant to the quality management system and the requirements of those interested parties.

​A few examples are below:

Interested Parties

• Customers
• Employees
• Suppliers
• Partners
• Owners
• Investors
• Insurance companies
• Regulatory bodies
• Creditors
• Trade Unions
• End-users
• ISO Certifying Body
  
• Community

​This is just a sample list. Can you think of any others?

​​​This is the combination of those internal and external factors that affect an organization's approach to the way in which it provides products and services that are delivered to its customer. In the simplest terms, these are the circumstances that affect the way we do business. 

Below are a few examples:

Internal Factors

• Employee relations
• Organizational structure
• Company financial performance
• Organizational culture

External Factors

• Potential legislative or regulatory changes
• Inherent environmental risks (fire, flood, hurricane)
• Economic factors
• Changes in technology
• Competition

​This is just a sample list. Can you think of any others?