Procedure - Context of The Organization

 

 [Full Client Name Reg Caps] Procedure: [Context of the Org Proc. Title] Rev. [Rev Number]

Procedure: [Context of the Org Proc. Title] 1. SUMMARY 1.1.

The purpose purpose of this this proce procedure dure is to define define how how the the compan company’s y’s Strate Strategic gic Direc Direction tion is developed by senior management through the identification of interested parties, issues of concerns, risks and opportunities.

1.2.

The [who?] [who?] is responsi responsible ble for for im imple plement mentatio ation n and and manag managemen ementt of this this proce procedure dure..

2. REVI REVISI SION ON AND AND APPR APPROV OVAL AL Rev.

Date

[Rev Number  ]

[Date of  Issue]

Nature of Changes

Approved By [Procedure  Approver  Name]

Original issue.

3. SCOPE SCOPE OF OF PROD PRODUCT UCTS S AND AND SERVI SERVICE CES S 3.1.

3.2.

[Short [Short Client Client Name Name]] provid provides es the followin following g [Produ [Products cts or Servi Services ces Plur.]: Plur.]: 

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

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[If there there are limita limitation tions, s, use this secti section; on; othe otherwise rwise delete. delete.]] [Short [Short Client Client N Name] ame] limits limits the offering of its products and services as follows: 

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4. INTE INTERE REST STED ED PAR PARTI TIES ES 4.1.

“Interes “Interested ted parti parties” es” are are those those stake stakehold holders ers wh who o receive receive our our [Produ [Products cts or or Services Services Plur.] Plur.],, who may be impacted by them, or those parties who may otherwise have a significant interest in our company. The interested parties applicable to [Short Client Name] are listed in the COTO Log, along with the reason for their inclusion. This includes both internal and external parties.

4.2.

The ident identifica ification tion of of an interes interested ted party party does does not not necessar necessarily ily bring bring tha thatt party party into the the scope 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.

5. ISSU ISSUES ES OF CONC CONCER ERN N 5.1.

For each each inter interest est party party,, the rela related ted issues issues of of concern concern shall shall be identi identified fied in in the COTO Log. 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

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 [Full Client Name Reg Caps] Procedure: [Context of the Org Proc. Title] Rev. [Rev Number]

concerns may impact on the interested party, or may be concerns derived from the party that impact on the company. 5.2.

Issues Issues may may be eithe eitherr inte internal rnal or extern external, al, d depe ependin nding g on wheth whether er the intereste interested d party party is internal or external. In addition, a certain type of party may have both internal and external concerns.

5.3.

When When attempti attempting ng to identify identify iinter nternal nal conc concerns erns,, it may may be usefu usefull to consid consider er techno technolog logical ical concerns, employee concerns, etc.

5.4.

When When attempti attempting ng to identify identify e exter xternal nal conce concerns, rns, itit may b be e useful useful to consider consider conce concerns rns arisin arising g from competition, society and culture, labor relations, statutory and regulatory issues, supply chain, economic issues, etc.

6. RISKS RISKS AND AND OPP OPPOR ORTUN TUNITI ITIES ES 6.1.

Manage Management ment will will then then ident identify ify risks risks and and opportu opportuniti nities es relate related d to the the issues issues of concer concern n within within the COTO Log.

6.2.

Within Within the the COTO COTO Log, Log, ea each ch risk risk and opportu opportunity nity will will be noted, noted, along along with with the the primary primary proce process ss involved, priority, and a bias. The “bias” identifies if the issue is a risk, an opportunity, or some blending of the two.

6.3.

Manage Management ment will will then then determ determine ine a trea treatmen tmentt method method for for each each risk risk or opport opportuni unity. ty. Risks Risks are 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.

6.4.

Where Where a risk risk is determi determined ned to to be treat treated ed via via a Failur Failure e Mode Mode Effects Effects Analysi Analysis s (FME (FMEA) A) style style treatment, these must then be entered into the Risk Register tag within the COTO Log.

6.5.

Opportu Opportuniti nities es are are manag managed ed via via the the Op Opport portuni unity ty Regist Register er tab tab within within the COTO COTO Log Log..

6.6.

For more more on the the manag managemen ementt of risks risks and and opport opportunit unities, ies, see [Risk [Risk Mana Manageme gement nt Proc. Proc. Title Title]. ].

7. STRA STRATE TEGI GIC C DIRE DIRECT CTIO ION N 7.1.

From the informat information ion abov above, e, th the e [Senio [Seniorr Man Manage agemen mentt Team Team Name] Name] devis devises es a “strategi “strategic c direction” which is documented in the records of management review. See the procedure [Management Review Proc. Title].

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