Context of the Organization
1. SCOPE OF PRODUCTS AND SERVICES
1.1. Lyra (Pvt) Ltd provides the following P.P.E Clothing & Footwear(s)
Manufacturer of Personal Protective Clothing, Body Armor and
Military & Blast Protective Shoes.
2. INTERESTED PARTIES
2.1. “Interested parties” are those stakeholders who receive our P.P.E Clothing & Footwear who may be impacted by them, or those parties who may otherwise have a significant interest in our company. The interested parties applicable to Lyra (Pvt) Ltd are listed in the Issues Log, along with the reason for their inclusion. This includes both internal and external parties.
2.2. The identification of an interested party does not necessarily bring that party into the scope of the QMS; for example, labor union leadership may be identified as an interested party, but that does not mean QMS documents and policies must be developed related to them.
3. ISSUES OF CONCERN
3.1. For each interest party, the related issues of concern shall be identified in the Issues Log. These issues may reflect direct concerns of the party (for example, customers are concerned about quality of products or services they purchase) or they may be indirect concerns. Such concerns may impact on the interested party, or may be concerns derived from the party that impact on the company.
3.2. Issues may be either internal or external, depending on whether the interested party is internal or external. In addition, a certain type of party may have both internal and external concerns.
3.3. When attempting to identify internal concerns, it may be useful to consider technological concerns, employee concerns, etc.
3.4. When attempting to identify external concerns, it may be useful to consider concerns arising from competition, society and culture, labor relations, statutory and regulatory issues, supply chain, economic issues, etc.
4. RISKS AND OPPORTUNITIES
4.1. Management will then identify risks and opportunities related to the issues of concern identified in the Issues Log.
4.2. In the Issues Log, each risk and opportunity will be noted, along with the primary process involved, priority, and a bias. The “bias” identifies if the issue is a risk, an opportunity, or some blending of the two.
4.3. Management will then determine a treatment method for each risk or opportunity. Risks are managed to reduce their likelihood and consequence, while opportunities are managed to increase their likelihood and consequence. Blended issues may require more complex treatment.
4.4. Where a risk is determined to be treated via a Failure Mode Effects Analysis (FMEA) style treatment, these must then be entered into the Risk Register.
4.5. . To help determine which opportunities should be pursued, the Opportunity Register may be used to conduct an “opportunity pursuit assessment.” This register is similar to the Risk Register, but ranks potential positive opportunities by their likelihood and benefit.
4.6. For more on the management of risks and opportunities, including completing the Risk Register, see Risk Management Procedure.
5. STRATEGIC DIRECTION
5.1. From the information above, the Director, Managing Director, General Manager, Production Manager, Management Representative, Finance Manager devises a “strategic direction” which is documented in the records of management review. See the procedure Management Review Procedure
Note:
Optionally following records are maintained online at http://www.companycertification.com/lyra
- Issues Log
- Risk Register (FMEA/SWOT)
- Opportunity Register